SIST EN ISO 14971:2020
(Main)Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2019)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2019)
Le présent document spécifie la terminologie, les principes et un processus de gestion des risques relatifs aux dispositifs médicaux, y compris les logiciels utilisés en tant que dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro. Le processus décrit dans le présent document vise à aider les fabricants de dispositifs médicaux à identifier les dangers associés au dispositif médical, à estimer et évaluer les risques correspondants, à maîtriser ces risques et à surveiller l'efficacité des moyens de maîtrise.
Les exigences du présent document s'appliquent à tous les stades du cycle de vie d'un dispositif médical. Le processus décrit dans le présent document s'applique aux risques associés à un dispositif médical, tels que les risques concernant la biocompatibilité, la sécurité des données et des systèmes, l'électricité, les parties en mouvement, le rayonnement et l'aptitude à l'utilisation.
Le processus décrit dans le présent document peut aussi s'appliquer aux produits qui ne sont pas nécessairement des dispositifs médicaux dans certaines juridictions et peut être utilisé par d'autres personnes impliquées dans le cycle de vie de dispositifs médicaux.
Le présent document ne s'applique pas à ce qui suit:
— les décisions relatives à l'utilisation d'un dispositif médical au cours d'une procédure clinique particulière; ou
— la gestion des risques commerciaux.
Le présent document impose aux fabricants d'établir des critères objectifs d'acceptabilité des risques, mais ne spécifie pas de niveaux de risque acceptables.
La gestion des risques peut faire partie intégrante d'un système de management de la qualité. Cependant, le présent document n'exige pas du fabricant qu'il mette en place un système de management de la qualité.
NOTE Des recommandations relatives à l'application du présent document sont données dans l'ISO/TR 24971[9].
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2019)
Ta dokument določa terminologijo, načela in proces za obvladovanje tveganja medicinskih
pripomočkov, vključno s programsko opremo kot medicinskim pripomočkom ter in vitro diagnostičnimi medicinskimi pripomočki. Postopek, opisan v tem dokumentu, je namenjen podpori proizvajalcem medicinskih pripomočkov pri identificiranju nevarnosti, povezanih z medicinskim pripomočkom, pri ocenjevanju in vrednotenju s tem povezanih tveganj, pri nadzorovanju teh tveganj in spremljanju uspešnosti ukrepov nadzora.
Zahteve tega dokumenta veljajo za vse faze življenjskega cikla medicinskega pripomočka. Postopek, opisan v tem dokumentu, se uporablja za tveganja, povezana z medicinskimi pripomočki, kot so tveganja v zvezi z biološko združljivostjo, varnostjo podatkov in sistemov, elektriko, premikajočimi se deli, sevanjem in uporabljivostjo.
Postopek, opisan v tem dokumentu, je mogoče uporabiti tudi za izdelke, ki niso nujno medicinski
pripomočki v nekaterih zakonodajah in ki jih mogoče uporabljajo tudi drugi, vključeni v življenjski cikel medicinskega pripomočka.
Ta dokument se ne uporablja za:
‒ odločitve glede uporabe medicinskega pripomočka v okviru določenega kliničnega postopka ali
‒ poslovno obvladovanje tveganja.
Ta dokument od proizvajalcev zahteva, da vzpostavijo objektivne kriterije za sprejemljivost tveganja, vendar ne določa sprejemljivih stopenj tveganja.
Obvladovanje tveganja je lahko sestavni del sistema vodenja kakovosti. Vendar ta dokument od proizvajalca ne zahteva, da ima uveden sistem vodenja kakovosti.
OPOMBA: Navodila za uporabo tega dokumenta je mogoče najti v ISO/TR 2497.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2020
Nadomešča:
SIST EN ISO 14971:2012
Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2019)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO
14971:2019)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
(ISO 14971:2019)
Ta slovenski standard je istoveten z: EN ISO 14971:2019
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 14971
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2019
ICS 11.040.01
Supersedes EN ISO 14971:2012
English version
Medical devices - Application of risk management to
medical devices (ISO 14971:2019)
Dispositifs médicaux - Application de la gestion des Medizinprodukte - Anwendung des
risques aux dispositifs médicaux (ISO 14971:2019) Risikomanagements auf Medizinprodukte (ISO
14971:2019)
This European Standard was approved by CEN on 5 August 2019.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2019 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 14971:2019 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14971:2019) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2020, and conflicting national standards shall be
withdrawn at the latest by June 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14971:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14971:2019 has been approved by CEN as EN ISO 14971:2019 without any modification.
INTERNATIONAL ISO
STANDARD 14971
Third edition
2019-12
Medical devices — Application of risk
management to medical devices
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
Reference number
ISO 14971:2019(E)
©
ISO 2019
ISO 14971:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 14971:2019(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for risk management system . 7
4.1 Risk management process . 7
4.2 Management responsibilities . 8
4.3 Competence of personnel . 9
4.4 Risk management plan . 9
4.5 Risk management file .10
5 Risk analysis .10
5.1 Risk analysis process .10
5.2 Intended use and reasonably foreseeable misuse .10
5.3 Identification of characteristics related to safety .11
5.4 Identification of hazards and hazardous situations .11
5.5 Risk estimation .11
6 Risk evaluation .12
7 Risk control .12
7.1 Risk control option analysis .12
7.2 Implementation of risk control measures .13
7.3 Residual risk evaluation .13
7.4 Benefit-risk analysis .14
7.5 Risks arising from risk control measures .14
7.6 Completeness of risk control .14
8 Evaluation of overall residual risk .14
9 Risk management review .15
10 Production and post-production activities.15
10.1 General .15
10.2 Information collection .15
10.3 Information review .16
10.4 Actions .16
Annex A (informative) Rationale for requirements .17
Annex B (informative) Risk management process for medical devices .26
Annex C (informative) Fundamental risk concepts .30
Bibliography .36
ISO 14971:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical
equipment used in medical practice.
This third edition cancels and replaces the second edition (ISO 14971:2007), which has been technically
revised. The main changes compared to the previous edition are as follows:
— A clause on normative references has been included, in order to respect the requirements for fixed
in Clause 15 of ISO/IEC Directives, Part 2:2018.
— The defined terms are updated and many are derived from ISO/IEC Guide 63:2019. Defined terms
are printed in italic to assist the reader in identifying them in the body of the document.
— Definitions of benefit, reasonably foreseeable misuse and state of the art have been introduced.
— More attention is given to the benefits that are expected from the use of the medical device. The term
benefit-risk analysis has been aligned with terminology used in some regulations.
— It is explained that the process described in ISO 14971 can be used for managing risks associated
with medical devices, including those related to data and systems security.
— The method for the evaluation of the overall residual risk and the criteria for its acceptability are
required to be defined in the risk management plan. The method can include gathering and reviewing
data and literature for the medical device and for similar medical devices and similar other products
on the market. The criteria for the acceptability of the overall residual risk can be different from the
criteria for acceptability of individual risks.
— The requirements to disclose residual risks have been moved and merged into one requirement,
after the overall residual risk has been evaluated and judged acceptable.
— The review before commercial distribution of the medical device concerns the execution of the risk
management plan. The results of the review are documented as the risk management report.
iv © ISO 2019 – All rights reserved
ISO 14971:2019(E)
— The requirements for production and post-production activities have been clarified and restructured.
More detail is given on the information to be collected and the actions to be taken when the collected
information has been reviewed and determined to be relevant to safety.
— Several informative annexes are moved to the guidance in ISO/TR 24971, which has been revised
in parallel. More information and a rationale for the requirements in this third edition of ISO 14971
have been provided in Annex A. The correspondence between the clauses of the second edition and
those of this third edition is given in Annex B.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
ISO 14971:2019(E)
Introduction
The requirements contained in this document provide manufacturers with a framework within which
experience, insight and judgment are applied systematically to manage the risks associated with the
use of medical devices.
This document was developed specifically for manufacturers of medical devices on the basis of
established principles of risk management that have evolved over many years. This document could be
used as guidance in developing and maintaining a risk management process for other products that are
not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the
medical device life cycle.
This document deals with processes for managing risks associated with medical devices. Risks can be
related to injury, not only to the patient, but also to the user and other persons. Risks can also be related
to damage to property (for example objects, data, other equipment) or the environment.
Risk management is a complex subject because each stakeholder can place a different value on the
acceptability of risks in relation to the anticipated benefits. The concepts of risk management are
particularly important in relation to medical devices because of the variety of stakeholders including
medical practitioners, the organizations providing health care, governments, industry, patients and
members of the public.
It is generally accepted that the concept of risk has two key components:
— the probability of occurrence of harm; and
— the consequences of that harm, that is, how severe it might be.
All stakeholders need to understand that the use of a medical device involves an inherent degree of risk,
even after the risks have been reduced to an acceptable level. It is well known that in the context of a
clinical procedure some residual risks remain. The acceptability of a risk to a stakeholder is influenced
by the key components listed above and by the stakeholder’s perception of the risk and the benefit. Each
stakeholder’s perception can vary depending upon their cultural background, the socio-economic and
educational background of the society concerned and the actual and perceived state of health of the
patient. The way a risk is perceived also takes into account other factors, for example, whether exposure
to the hazard or hazardous situation seems to be involuntary, avoidable, from a man-made source, due
to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society.
As one of the stakeholders, the manufacturer reduces risks and makes judgments relating to the safety
of a medical device, including the acceptability of residual risks. The manufacturer takes into account
the generally acknowledged state of the art, in order to determine the suitability of a medical device
to be placed on the market for its intended use. This document specifies a process through which the
manufacturer of a medical device can identify hazards associated with the medical device, estimate and
evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of
the controls throughout the life cycle of the medical device.
The decision to use a medical device in the context of a particular clinical procedure requires the residual
risks to be balanced against the anticipated benefits of the procedure. Such decisions are beyond the
scope of this document and take into account the intended use, the circumstances of use, the performance
and risks associated with the medical device, as well as the risks and benefits associated with the clinical
procedure. Some of these decisions can be made only by a qualified medical practitioner with knowledge
of the state of health of an individual patient or the patient’s own opinion.
For any particular medical device, other standards or regulations could require the application of
specific methods for managing risk. In those cases, it is necessary to also follow the requirements
outlined in those documents.
vi © ISO 2019 – All rights reserved
ISO 14971:2019(E)
The verbal forms used in this document conform to the usage described in Clause 7 of the ISO/
IEC Directives, Part 2:2018. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe permission (e.g. a permissible way to achieve compliance with a
requirement or test);
— “can” is used to express possibility and capability; and
— “must” is used to express an external constraint that is not a requirement of the document.
INTERNATIONAL STANDARD ISO 14971:2019(E)
Medical devices — Application of risk management to
medical devices
1 Scope
This document specifies terminology, principles and a process for risk management of medical devices,
including software as a medical device and in vitro diagnostic medical devices. The process described in
this document intends to assist manufacturers of medical devices to identify the hazards associated with
the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor
the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The
process described in this document applies to risks associated with a medical device, such as risks related
to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical
devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not
specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does
not require the manufacturer to have a quality management system in place.
[9]
NOTE Guidance on the application of this document can be found in ISO/TR 24971 .
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
accompanying documentation
materials accompanying a medical device (3.10) and containing information for the user or those
accountable for the installation, use, maintenance, decommissioning and disposal of the medical device
(3.10), particularly regarding safe use
Note 1 to entry: The accompanying documentation can consist of the instructions for use, technical description,
installation manual, quick reference guide, etc.
ISO 14971:2019(E)
Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types.
3.2
benefit
positive impact or desirable outcome of the use of a medical device (3.10) on the health of an individual,
or a positive impact on patient management or public health
Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes
related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on
public health.
3.3
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 63:2019, 3.1]
3.4
hazard
potential source of harm (3.3)
[SOURCE: ISO/IEC Guide 63:2019, 3.2]
3.5
hazardous situation
circumstance in which people, property or the environment is/are exposed to one or more hazards (3.4)
Note 1 to entry: See Annex C for an explanation of the relationship between hazard and hazardous situation.
[SOURCE: ISO/IEC Guide 63:2019, 3.3, modified — Note 1 to entry added.]
3.6
intended use
intended purpose
use for which a product, process (3.14) or service is intended according to the specifications, instructions
and information provided by the manufacturer (3.9)
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, use environment, and operating principle are typical elements of the intended use.
[SOURCE: ISO/IEC Guide 63:2019, 3.4]
3.7
in vitro diagnostic medical device
IVD medical device
device, whether used alone or in combination, intended by the manufacturer (3.9) for the in vitro
examination of specimens derived from the human body solely or principally to provide information for
diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials,
specimen receptacles, software, and related instruments or apparatus or other articles
[SOURCE: ISO 18113-1:2009, 3.27, modified — NOTE deleted.]
3.8
life cycle
series of all phases in the life of a medical device (3.10), from the initial conception to final
decommissioning and disposal
[SOURCE: ISO/IEC Guide 63:2019, 3.5]
2 © ISO 2019 – All rights reserved
ISO 14971:2019(E)
3.9
manufacturer
natural or legal person with responsibility for the design and/or manufacture of a medical device (3.10)
with the intention of making the medical device (3.10) available for use, under his name, whether or not
such a medical device (3.10) is designed and/or manufactured by that person himself or on his behalf by
another person(s)
Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all
applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to
be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory
Authority (RA) within that jurisdiction.
Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These
responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse
event reporting and notification of corrective actions.
Note 3 to entry: “Design and/or manufacture” may include specification development, production,
fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or
remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for
a medical purpose.
Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another
person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided
the assembly or adaptation does not change the intended use of the medical device.
Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on
behalf of the original manufacturer and who makes it available for use under his own name, should be considered
the manufacturer of the modified medical device.
Note 6 to entry: An authorised representative, distributor or importer who only adds its own address and
contact details to the medical device or the packaging, without covering or changing the existing labelling, is not
considered a manufacturer.
Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the
person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[SOURCE: ISO/IEC Guide 63:2019, 3.6]
3.10
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer (3.9) to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices (3.10),
— providing information by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its function by such means
Note 1 to entry: Products which can be considered to be medical devices in some jurisdictions but not in others
include:
ISO 14971:2019(E)
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO/IEC Guide 63:2019, 3.7]
3.11
objective evidence
data supporting the existence or verity of something
Note 1 to entry: Objective evidence can be obtained through observation, measurement, test or by other means.
[SOURCE: ISO 9000:2015, 3.8.3, modified — Note 2 to entry deleted.]
3.12
post-production
part of the life cycle (3.8) of the medical device (3.10) after the design has been completed and the medical
device (3.10) has been manufactured
EXAMPLE Transportation, storage, installation, product use, maintenance, repair, product changes,
decommissioning and disposal.
3.13
procedure
specified way to carry out an activity or a process (3.14)
Note 1 to entry: Procedures can be documented or not.
[SOURCE: ISO 9000:2015, 3.4.5]
3.14
process
set of interrelated or interacting activities that use inputs to deliver an intended result
Note 1 to entry: Whether the “intended result” of a process is called output, product or service depends on the
context of the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are
generally the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.
[SOURCE: ISO 9000:2015, 3.4.1, modified — Notes to entry 4, 5 and 6 are deleted.]
3.15
reasonably foreseeable misuse
use of a product or system in a way not intended by the manufacturer (3.9), but which can result from
readily predictable human behaviour
Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and
professional users.
Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional.
[SOURCE: ISO/IEC Guide 63:2019, 3.8]
4 © ISO 2019 – All rights reserved
ISO 14971:2019(E)
3.16
record
document stating results achieved or providing evidence of activities performed
Note 1 to entry: Records can be used, for example, to formalize traceability and to provide evidence of verification,
preventive action and corrective action.
Note 2 to entry: Generally records need not be under revision control.
[SOURCE: ISO 9000:2015, 3.8.10]
3.17
residual risk
risk remaining after risk control (3.21) measures have been implemented
[SOURCE: ISO/IEC Guide 63:2019, 3.9]
3.18
risk
combination of the probability of occurrence of harm (3.3) and the severity (3.27) of that harm (3.3)
[SOURCE: ISO/IEC Guide 63:2019, 3.10, modified — Note 1 to entry deleted.]
3.19
risk analysis
systematic use of available information to identify hazards (3.4) and to estimate the risk (3.18)
[SOURCE: ISO/IEC Guide 63:2019, 3.11]
3.20
risk assessment
overall process (3.14) comprising a risk analysis (3.19) and a risk evaluation (3.20)
[SOURCE: ISO/IEC Guide 51:2014, 3.11]
3.21
risk control
process (3.14) in which decisions are made and measures implemented by which risks (3.18) are reduced
to, or maintained within, specified levels
[SOURCE: ISO/IEC Guide 63:2019, 3.12]
3.22
risk estimation
process (3.14) used to assign values to the probability of occurrence of harm (3.3) and the severity (3.27)
of that harm
[SOURCE: ISO/IEC Guide 63:2019, 3.13]
3.23
risk evaluation
process (3.14) of comparing the estimated risk (3.18) against given risk (3.18) criteria to determine the
acceptability of the risk (3.18)
[SOURCE: ISO/IEC Guide 63:2019, 3.14]
3.24
risk management
systematic application of management policies, procedures (3.13) and practices to the tasks of analysing,
evaluating, controlling and monitoring risk (3.18)
[SOURCE: ISO/IEC Guide 63:2019, 3.15]
ISO 14971:2019(E)
3.25
risk management file
set of records (3.16) and other documents that are produced by risk management (3.24)
3.26
safety
freedom from unacceptable risk (3.18)
[SOURCE: ISO/IEC Guide 63:2019, 3.10]
3.27
severity
measure of the possible consequences of a hazard (3.4)
[SOURCE: ISO/IEC Guide 63:2019, 3.17]
3.28
state of the art
developed stage of technical capability at a given time as regards products, processes (3.14) and services,
based on the relevant consolidated findings of science, technology and experience
Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology
and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state
of the art described here is sometimes referred to as the “generally acknowledged state of the art”.
[SOURCE: ISO/IEC Guide 63:2019, 3.18]
3.29
top management
person or group of people who directs and controls a manufacturer (3.9) at the highest level
[SOURCE: ISO 9000:2015, 3.1.1, modified — “An organization” replaced by “a manufacturer”, Notes to
entry deleted.]
3.30
use error
user action or lack of user action while using the medical device (3.10) that leads to a different result
than that intended by the manufacturer (3.9) or expected by the user
Note 1 to entry: Use error includes the inability of the user to complete a task.
Note 2 to entry: Use errors can result from a mismatch between the characteristics of the user, user interface,
task, or use environment.
Note 3 to entry: Users might be aware or unaware that a use error has occurred.
Note 4 to entry: An unexpected physiological response of the patient is not by itself considered use error.
Note 5 to entry: A malfunction of a medical device that causes an unexpected result is not considered a use error.
[SOURCE: IEC 62366-1:2015, 3.21, modified — Note 6 to entry deleted.]
3.31
verification
confirmation, through the provision of objective evidence (3.11), that specified requirements have been
fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.
Note 3 to entry: The word “verified” is used to designate the corresponding status.
6 © ISO 2019 – All rights reserved
ISO 14971:2019(E)
[SOURCE: ISO/IEC Guide 63:2019, 3.19]
4 General requirements for risk management system
4.1 Risk management process
The manufacturer shall establish, implement, document and maintain an ongoing process for:
a) identifying hazards and hazardous situations associated with a medical device;
b) estimating and evaluating the associated risks;
c) controlling these risks, and
d) monitoring the effectiveness of the risk control measures.
This process shall apply throughout the life cycle of the medical device.
This process shall include the following elements:
— risk analysis;
— risk evaluation;
— risk control; and
— production and post-production activities.
Where a documented product realization process exists, it shall incorporate the appropriate parts of
the risk management process.
[5]
NOTE 1 Product realization processes are described in, for example, Clause 7 of ISO 13485:2016 .
NOTE 2 A documented process within a quality management system can be used to address safety in a
systematic manner, in particular to enable the early identification of hazards and hazardous situations in complex
medical devices.
NOTE 3 A schematic representation of the risk management process is shown in Figure 1. Depending on the
specific life cycle phase, individual elements of risk management can have varying emphasis. Also, risk management
activities can be performed iteratively or in multiple steps as appropriate to the medical device. Annex B contains
a more detailed overview of the steps in the risk management process.
Compliance is checked by inspection of the appropriate documents.
ISO 14971:2019(E)
Figure 1 — A schematic representation of the risk management process
4.2 Management responsibilities
Top management shall provide evidence of its commitment to the risk management process by ensuring:
— the provision of adequate resources; and
— the assignment of competent personnel (see 4.3) for risk management.
Top management shall define and document a policy for establishing criteria for risk acceptability.
The policy shall provide a framework that ensures that criteria are based upon applicable national or
regional regulations and relevant International Standards, and take into account available information
such as the generally acknowledged state of the art and known stakeholder concerns.
NOTE 1 The manufacturer’s policy for establishing criteria for risk acceptability can define the approaches
to risk control: reducing risk as low as reasonably practicable, reducing risk as low as reasonably achievable, or
[9]
reducing risk as far as possible without adversely affecting the benefit-risk ratio. See ISO/TR 24971 for guidance
on defining such policy.
Top management shall review the suitability of the risk management process at planned intervals to
ensure continuing effectiveness of the risk management process and shall document any decisions and
actions taken. If the manufacturer has a quality management system in place, this review may be part of
the quality management system review.
NOTE 2 The results of reviewing production and post-production information can be an input to the review of
the suitability of the risk management process.
8 © ISO 2019 – All rights reserved
ISO 14971:2019(E)
NOTE 3 The documents described in this subclause can be incorporated within the documents produced by the
manufacturer’s quality management system and these documents can be referenced in the risk management file.
Compliance is checked by inspection of the appropriate documents.
4.3 Competence of personnel
Persons performing risk management tasks shall be competent on the basis of education, training, skills
and experience appropriate to the tasks assigned to them. Where appropriate, these persons shall have
knowledge of and experience with the particular medical device (or similar medical devices) and its use,
the technologies involved or the risk management techniques employed. Appropriate records shall be
maintained.
NOTE Risk management tasks can be performed by representatives of several functions, each contributing
their specialist knowledge.
Compliance is checked by inspection of the appropriate records.
4.4 Risk management plan
Risk management activities shall be planned. For the particular medical device being considered,
the manufacturer shall establish and document a risk management plan in accordance with the risk
management process. The risk management plan shall be part of the risk management file.
This plan shall include at least the following:
a) the scope of the planned risk management activities, identifying and describing the medical device
and the life cycle phases for which each element of the plan is applicable;
b) assignment of responsibilities and authorities;
c) requirements for review of risk management activities;
d) criteria for risk acceptability, based on the manufacturer’s policy for determining acceptable
risk, including criteria for accepting risks when the probability of occurrence of harm cannot be
estimated;
NOTE 1 The criteria for risk acceptability are essential for the ultimate effectiveness of the risk
management process. For each risk management plan the manufacturer needs to establish risk acceptability
criteria that are appropriate for the particular medical device.
e) a method to evaluate the overall residual risk, and criteria for acceptability of the overall residual
risk based on the manufacturer’s policy for determining acceptable risk;
NOTE 2 The method to evaluate the overall residual risk can include gathering and reviewing data and
literature for the medical device being considered and similar medical devices on the market and can involve
judgment by a cross-functional team of experts with application knowledge and clinical expertise.
f) activities for verification of the implementation and effectiveness of risk control measures; and
g) activities related to collection and review of relevant production and post-production information.
[9]
NOTE 3 See ISO/TR 24971 for guidance on developing a risk management plan and on establishing
criteria for risk acceptability.
NOTE 4 Not all parts of the plan need to be created at the same time. The plan or parts of it can be
developed over time.
If the plan changes d
...
SLOVENSKI SIST EN ISO 14971
STANDARD
maj 2020
Medicinski pripomočki – Uporaba obvladovanja tveganja pri medicinskih
pripomočkih (ISO 14971:2019)
Medical devices – Application of risk management to medical devices
(ISO 14971:2019)
Medizinprodukte – Anwendung des Risikomanagements auf Medizinprodukte
(ISO 14971:2019)
Dispositifs médicaux – Application de la gestion des risques aux dispositifs
médicaux (ISO 14971:2019)
Referenčna oznaka
ICS 11.040.01 SIST EN ISO 14971:2020 (sl)
Nadaljevanje na straneh II in od 1 do 43
2021-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 14971 : 2020
NACIONALNI UVOD
Standard SIST EN ISO 14971 (sl), Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2019), 2020, ima status slovenskega standarda in je istoveten
evropskemu standardu EN ISO 14971 (en, de, fr), Medical devices – Application of risk management to
medical devices (ISO 14971:2019), 2019.
Ta standard nadomešča SIST EN ISO 14971:2012.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 14971:2019 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/CLC/TC 3 Vodenje kakovosti in ustrezni splošni vidiki medicinskih pripomočkov
(Quality management and corresponding general aspects for medical devices). Slovenski standard
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem od treh
uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ Varovanje
zdravja.
Odločitev za privzem tega standarda je dne 24. aprila 2020 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZA Z NACIONALNIMI STANDARDI
Ta dokument se ne sklicuje na druge standarde.
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 14971:2019
PREDHODNA IZDAJA
– standard SIST EN ISO 14971:2012
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO 14971:2020
to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO 14971:2019 in je objavljen z dovoljenjem
Upravni center
CEN-CENELEC
Rue de la Science 23
B-1040 Bruselj
This national document is identical with EN ISO 14971:2019 and is published with the permission of
CEN-CENELEC
Management Centre
Rue de la Science 23
B-1040 Brussels
II
EVROPSKI STANDARD EN ISO 14971
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2019
EUROPÄISCHE NORM
ICS 11.940.01 Nadomešča EN ISO 14971:2012
Slovenska izdaja
Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih (ISO 14971:2019)
Medical devices – Application of Dispositifs médicaux – Application Medizinprodukte – Anwendung
risk management to medical de la gestion des risques aux des Risikomanagements auf
devices (ISO 14971:2019) dispositifs médicaux Medizinprodukte (ISO 14971:2019)
(ISO 14971:2019)
Ta evropski standard je CEN odobril 5. avgusta 2019.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi
je predpisano, da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni
standard. Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so
na voljo pri Upravnem centru CEN-CENELEC ali članih CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori
Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije,
Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Republike Severna Makedonija, Romunije,
Slovaške, Slovenije, Srbije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.
CEN-CENELEC
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Upravni center CEN-CENELEC
Rue de la Science 23, B-1040 Bruselj
© 2019 CEN/CENELEC Lastnice avtorskih pravic so vse države članice CEN in Ref. št. EN ISO 14971:2019 E
CENELEC.
SIST EN ISO 14971 : 2020
VSEBINA Stran
Evropski predgovor . 3
Predgovor . 4
Uvod . 6
1 Področje uporabe . 8
2 Zveze s standardi . 8
3 Izrazi in definicije . 8
4 Splošne zahteve za sistem obvladovanja tveganja . 14
4.1 Proces obvladovanja tveganja . 14
4.2 Odgovornost vodstva . 15
4.3 Kompetentnost osebja . 16
4.4 Načrt obvladovanja tveganja . 16
4.5 Dokumentacija o obvladovanju tveganja . 17
5 Analiza tveganja . 17
5.1 Proces analize tveganja . 17
5.2 Predvidena uporaba in razumno predvidljiva napačna uporaba . 18
5.3 Identifikacija karakteristik v zvezi z varnostjo . 18
5.4 Identifikacija nevarnosti in nevarnih stanj . 18
5.5 Ocena tveganja . 19
6 Vrednotenje tveganja . 19
7 Nadzor tveganja . 19
7.1 Analiza možnosti nadzora tveganja . 19
7.2 Izvajanje ukrepov nadzora tveganja . 20
7.3 Vrednotenje preostalega tveganja . 21
7.4 Analiza razmerja med koristmi in tveganji . 21
7.5 Tveganja, ki izhajajo iz ukrepov nadzora tveganja . 21
7.6 Popolnost nadzora tveganja . 21
8 Vrednotenje celotnega preostalega tveganja . 21
9 Pregled obvladovanja tveganja . 22
10 Aktivnosti med proizvodnjo in po proizvodnji . 22
10.1 Splošno . 22
10.2 Zbiranje informacij . 22
10.3 Pregled informacij . 23
10.4 Ukrepi . 23
Dodatek A (informativni): Utemeljitev zahtev . 24
Dodatek B (informativni): Proces obvladovanja tveganja za medicinske pripomočke . 33
Dodatek C (informativni): Temeljni pojmi tveganja . 37
Literatura . 43
SIST EN ISO 14971 : 2020
Evropski predgovor
Ta dokument (EN ISO 14971:2019) je pripravil tehnični odbor ISO/TC 210 "Vodenje kakovosti in ustrezni
splošni vidiki za medicinske pripomočke" v sodelovanju s tehničnim odborom CEN/CLC/TC 3 "Vodenje
kakovosti in ustrezni splošni vidiki za medicinske pripomočke", katerega sekretariat vodi NEN.
Ta evropski standard mora dobiti status nacionalnega standarda bodisi z objavo istovetnega besedila
ali z razglasitvijo najpozneje do junija 2020, nacionalne standarde, ki so v nasprotju s tem standardom,
pa je treba razveljaviti najpozneje do junija 2020.
Opozoriti je treba na možnost, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic.
CEN ne prevzema odgovornosti za identifikacijo posameznih ali vseh takih patentnih pravic.
Ta dokument nadomešča EN ISO 14971:2012.
V skladu z notranjimi predpisi CEN-CENELEC morajo ta evropski standard obvezno uvesti nacionalne
organizacije za standardizacijo naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Republike Severna
Makedonija, Romunije, Srbije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
Razglasitvena objava
Besedilo standarda ISO 14971:2019 je CEN odobril kot EN ISO 14971:2019 brez kakršnihkoli
sprememb.
SIST EN ISO 14971 : 2020
Predgovor
ISO (Mednarodna organizacija za standardizacijo) je svetovna zveza nacionalnih organov za standarde
(članov ISO). Mednarodne standarde navadno pripravljajo tehnični odbori ISO. Vsak član, ki želi delovati
na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti zastopan v tem
odboru. Pri delu sodelujejo tudi mednarodne vladne in nevladne organizacije, povezane z ISO. V vseh
zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO tesno sodeluje z
Mednarodno elektrotehniško komisijo (IEC).
Postopki, uporabljeni pri pripravi tega dokumenta, in predvideni postopki za njegovo vzdrževanje so
opisani v Direktivah ISO/IEC, 1. del. Posebna pozornost naj se nameni različnim kriterijem odobritve,
potrebnim za različne vrste dokumentov ISO. Ta dokument je bil pripravljen v skladu z uredniškimi pravili
Direktiv ISO/IEC, 2. del (glej www.iso.org/directives).
Opozoriti je treba, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic. ISO ne
prevzema odgovornosti za identifikacijo posameznih ali vseh takih patentnih pravic. Podrobnosti o
morebitnih patentnih pravicah, opredeljenih med pripravo tega dokumenta, bodo navedene v uvodu
in/ali na seznamu ISO s prejetimi patentnimi izjavami (glej www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem dokumentu, so informacije za uporabnike in ne pomenijo
podpore blagovni znamki.
Za razlago prostovoljne narave standardov, pomena specifičnih pojmov in izrazov ISO, povezanih z
ugotavljanjem skladnosti, ter informacij o tem, kako ISO spoštuje načela Svetovne trgovinske
organizacije (WTO) v tehničnih ovirah pri trgovanju (TBT), glej spletno mesto
www.iso.org/iso/foreword.html.
Ta dokument sta pripravila tehnični odbor ISO/TC 210, Vodenje kakovosti in ustrezni splošni vidiki za
medicinske pripomočke, in IEC/SC 62A, Skupni vidiki električne opreme, ki se uporablja v medicinski
praksi.
Ta tretja izdaja razveljavlja in nadomešča drugo izdajo (ISO 14971:2007), ki je strokovno revidirana.
Glavne spremembe glede na predhodno različico so naslednje:
‒ vključena je točka glede zvez s standardi za upoštevanje zahtev, določenih v 15. točki 2. dela
Direktiv ISO/IEC:2018;
‒ definirani izrazi so posodobljeni in številni izhajajo iz ISO/IEC Vodila 63:2019. Definirani izrazi so
natisnjeni v ležeči pisavi za pomoč bralcem pri prepoznavanju izrazov v glavnem delu besedila;
‒ vključene so definicije za korist, razumno predvidljivo napačno uporabo in stanje tehnike;
‒ več pozornosti je namenjeno koristim, ki se pričakujejo od uporabe medicinskega pripomočka. Izraz
analize razmerja med koristmi in tveganji je usklajen s terminologijo, ki se uporablja v nekaterih
predpisih;
‒ pojasnjeno je, da se lahko proces, opisan v standardu ISO 14971, uporablja za obvladovanje
tveganja, povezanega z medicinskimi pripomočki, vključno s tistimi, ki so povezani z varnostjo
podatkov in sistemov;
‒ metodo za vrednotenje celotnega preostalega tveganja in kriterije za njegovo sprejemljivost je treba
določiti v načrtu obvladovanja tveganja. Ta metoda lahko vključuje zbiranje in pregledovanje
podatkov oziroma literature za medicinske pripomočke in podobne medicinske pripomočke ter
podobne druge izdelke na trgu. Kriteriji za sprejemljivost celotnega preostalega tveganja se lahko
razlikujejo od kriterijev za sprejemljivost posameznih tveganj;
‒ zahteve za razkrivanje preostalih tveganj so premaknjene in združene v eno zahtevo, po tem ko je
bilo celotno preostalo tveganje ovrednoteno in ocenjeno kot sprejemljivo;
‒ pregled pred dajanjem medicinskega pripomočka v promet je povezan z izvedbo načrta
obvladovanja tveganja. Rezultati tega pregleda so navedeni v poročilu o obvladovanju tveganja;
SIST EN ISO 14971 : 2020
‒ zahteve za aktivnosti med proizvodnjo in po proizvodnji so bile pojasnjene in prestrukturirane. Več
podrobnosti je podanih za informacije, ki jih je treba zbrati, in za ukrepe, ki jih je treba izvesti, ko so
zbrane informacije pregledane in opredeljene kot pomembne za varnost;
‒ več informativnih dodatkov je premaknjenih v napotke tehničnega poročila ISO/TR 24971, ki je bilo
vzporedno pregledano. Več informacij in utemeljitev zahtev v tej tretji izdaji standarda ISO 14971
je navedenih v dodatku A. Primerjava med točkami druge izdaje in te tretje izdaje je podana v
dodatku B.
Uporabnik naj vse povratne informacije ali vprašanja o tem dokumentu posreduje nacionalnemu organu
za standarde v svoji državi. Celoten seznam teh organov je na voljo na spletnem mestu
www.iso.org/members.html.
SIST EN ISO 14971 : 2020
Uvod
Zahteve, ki jih vsebuje ta dokument, proizvajalcem zagotavljajo okvir, znotraj katerega so sistematično
uporabljene izkušnje, vpogled in presoja za obvladovanje tveganj, povezanih z uporabo medicinskih
pripomočkov.
Ta dokument je bil pripravljen posebej za proizvajalce medicinskih pripomočkov na podlagi uveljavljenih
načel obvladovanja tveganja, ki so se razvijala več let. Ta dokument se lahko uporablja kot napotek pri
razvijanju in vzdrževanju procesa obvladovanja tveganja za druge izdelke, ki v nekaterih zakonodajah
niso nujno medicinski pripomočki, ter za dobavitelje in druge stranke, ki so vključeni v življenjski cikel
medicinskega pripomočka.
Ta dokument obravnava procese za obvladovanje tveganj, povezanih z medicinskimi pripomočki.
Tveganja so lahko povezana s poškodbo, ne le pacienta, ampak tudi uporabnika in drugih oseb.
Tveganja so lahko povezana s poškodovanjem lastnine (na primer predmetov, podatkov, druge opreme)
ali okolja.
Obvladovanje tveganja je kompleksna zadeva, saj lahko vsak udeleženec pripisuje drugačno vrednost
sprejemljivosti tveganj glede na predvidene koristi. Pojmi obvladovanja tveganja so še posebno
pomembni v zvezi z medicinskimi pripomočki zaradi različnih udeležencev, vključno z zdravniki,
zdravstvenimi organizacijami, vladami, industrijo, pacienti in posamezniki.
Splošno sprejeto je, da ima pojem tveganje dva ključna sestavna dela:
‒ verjetnost nastanka škode in
‒ posledice te škode, tj. kako resna bi lahko bila.
Vsi udeleženci morajo razumeti, da uporaba medicinskega pripomočka vključuje določeno stopnjo
tveganja, tudi če so bila tveganja zmanjšana na sprejemljivo raven. Dobro znano je, da v okviru
kliničnega postopka ostanejo nekatera preostala tveganja. Na sprejemljivost tveganja s strani
udeleženca vplivata zgoraj navedena ključna sestavna dela ter udeleženčevo dojemanje tveganja in
koristi. Dojemanje posameznega udeleženca se lahko zelo razlikuje, odvisno od njegovega kulturnega
ozadja, družbeno-ekonomskih razmer in izobrazbe zadevne družbe ter dejanskega in zaznanega
zdravstvenega stanja pacienta. V načinu dojemanja tveganja se upoštevajo tudi drugi dejavniki, na
primer, ali je videti, kot da je izpostavljenost nevarnosti ali nevarnemu stanju neprostovoljna, ali se ji je
mogoče izogniti, ali jo povzroča človek, ali jo povzroča malomarnost, ki izvira iz slabo razumljivega
vzroka, ali je usmerjena v ranljivo skupino znotraj družbe.
Proizvajalec, kot eden od udeležencev, zmanjša tveganja in sprejema odločitve v zvezi z varnostjo
medicinskega pripomočka, vključno s sprejemljivostjo preostalih tveganj. Proizvajalec upošteva splošno
sprejeto stanje tehnike, da ugotovi primernost medicinskega pripomočka za dajanje na trg za predvideno
uporabo. Ta dokument določa postopek, s katerim lahko proizvajalec medicinskega pripomočka
identificira nevarnosti, povezane z medicinskim pripomočkom, oceni in ovrednoti tveganja, povezana s
temi nevarnostmi, nadzoruje ta tveganja in spremlja uspešnost tega nadzorovanja v življenjskem ciklu
medicinskega pripomočka.
Za odločitev, da se nek medicinski pripomoček uporabi v določenem kliničnem postopku, morajo biti
preostala tveganja uravnotežena s pričakovanimi koristmi tega postopka. Takšne odločitve niso
obravnavane v tem dokumentu in upoštevajo predvideno uporabo, okoliščine uporabe, izvedbo in
tveganja, ki so povezana z medicinskim pripomočkom, kot tudi tveganja in koristi, povezana s kliničnim
postopkom. Nekatere od teh odločitev lahko sprejme samo usposobljen zdravnik, ki je seznanjen z
zdravstvenim stanjem posameznega pacienta oziroma z mnenjem samega pacienta.
Za kateri koli poseben medicinski pripomoček lahko drugi standardi ali predpisi zahtevajo uporabo
specifičnih metod obvladovanja tveganja. V takih primerih je treba upoštevati zahteve, navedene v teh
dokumentih.
SIST EN ISO 14971 : 2020
Glagolske oblike, uporabljene v tem dokumentu, so skladne z uporabo, opisano v 7. točki Direktiv
ISO/IEC, 2. del: 2018. V tem dokumentu pomožni glagol:
‒ "je treba" pomeni, da je upoštevanje zahteve ali preskusa obvezno v skladu s tem dokumentom;
‒ "naj" pomeni, da je upoštevanje zahteve ali preskusa priporočeno, vendar ni obvezno v skladu s
tem dokumentom;
‒ "lahko" se uporablja za opis dovoljenja (npr. dovoljeni način za doseganje skladnosti z zahtevo ali
preskusom);
‒ "je mogoče" se uporablja za izražanje možnosti in sposobnosti ter
‒ "morati" se uporablja za izražanje zunanje omejitve, ki ni zahteva tega dokumenta.
SIST EN ISO 14971 : 2020
Medicinski pripomočki – Uporaba obvladovanja tveganja pri
medicinskih pripomočkih
1 Področje uporabe
Ta dokument določa terminologijo, načela in proces za obvladovanje tveganja medicinskih
pripomočkov, vključno s programsko opremo kot medicinskim pripomočkom ter in vitro diagnostičnimi
medicinskimi pripomočki. Postopek, opisan v tem dokumentu, je namenjen podpori proizvajalcem
medicinskih pripomočkov pri identificiranju nevarnosti, povezanih z medicinskim pripomočkom, pri
ocenjevanju in vrednotenju s tem povezanih tveganj, pri nadzorovanju teh tveganj in spremljanju
uspešnosti ukrepov nadzora.
Zahteve tega dokumenta veljajo za vse faze življenjskega cikla medicinskega pripomočka. Postopek,
opisan v tem dokumentu, se uporablja za tveganja, povezana z medicinskimi pripomočki, kot so
tveganja v zvezi z biološko združljivostjo, varnostjo podatkov in sistemov, elektriko, premikajočimi se
deli, sevanjem in uporabljivostjo.
Postopek, opisan v tem dokumentu, je mogoče uporabiti tudi za izdelke, ki niso nujno medicinski
pripomočki v nekaterih zakonodajah in ki jih mogoče uporabljajo tudi drugi, vključeni v življenjski cikel
medicinskega pripomočka.
Ta dokument se ne uporablja za:
‒ odločitve glede uporabe medicinskega pripomočka v okviru določenega kliničnega postopka ali
‒ poslovno obvladovanje tveganja.
Ta dokument od proizvajalcev zahteva, da vzpostavijo objektivne kriterije za sprejemljivost tveganja,
vendar ne določa sprejemljivih stopenj tveganja.
Obvladovanje tveganja je lahko sestavni del sistema vodenja kakovosti. Vendar ta dokument od
proizvajalca ne zahteva, da ima uveden sistem vodenja kakovosti.
[9].
OPOMBA: Navodila za uporabo tega dokumenta je mogoče najti v ISO/TR 24971
2 Zveze s standardi
Ta dokument se ne sklicuje na druge standarde.
3 Izrazi in definicije
V tem dokumentu se uporabljajo naslednji izrazi in definicije.
ISO in IEC hranita terminološke zbirke podatkov za uporabo pri standardizaciji na naslednjih naslovih:
‒ brskanje po spletni strani ISO: na voljo na spletnem mestu https://www.iso.org/obp
‒ IEC Electropedia: na voljo na spletnem mestu http://www.electropedia.org/
3.1
spremna dokumentacija
materiali, ki spremljajo medicinski pripomoček (3.10) in vsebujejo informacije za uporabnika ali tiste, ki
so odgovorni za namestitev, uporabo, vzdrževanje, izločitev iz uporabe in odstranitev medicinskega
pripomočka (3.10), zlasti glede varne uporabe
Opomba 1: Spremno dokumentacijo lahko sestavljajo navodila za uporabo, tehnični opis, navodila za namestitev, hitri
referenčni vodnik itd.
SIST EN ISO 14971 : 2020
Opomba 2: Spremna dokumentacija ni nujno pisni ali natisnjeni dokument, ampak lahko vključuje zvočne, vizualne ali taktilne
materiale in materiale večpredstavnostnih vrst.
3.2
korist
pozitiven vpliv ali želeni rezultat uporabe medicinskega pripomočka (3.10) za zdravje posameznika ali
pozitiven vpliv na obravnavo pacienta ali javno zdravje
Opomba 1: Koristi lahko vključujejo pozitivne vplive na klinične rezultate, pacientovo kakovost življenja, rezultate, povezane
z diagnozo, pozitiven vpliv diagnostičnih naprav na klinične rezultate ali pozitiven vpliv na javno zdravje.
3.3
škoda
poškodba ali ogrozitev zdravja ljudi ali poškodovanje lastnine ali okolja
[VIR: ISO/IEC Vodilo 63:2019, 3.1]
3.4
nevarnost
možen izvor škode (3.3)
[VIR: ISO/IEC Vodilo 63:2019, 3.2]
3.5
nevarno stanje
okoliščine, v katerih so ljudje, lastnina ali okolje izpostavljeni eni ali več nevarnostim (3.4)
Opomba 1: Za razlago povezave med nevarnostjo in nevarnim stanjem glej dodatek C.
[VIR: ISO/IEC Vodilo 63:2019, 3.3, spremenjeno – Dodana je opomba 1.]
3.6
predvidena uporaba
predviden namen
uporaba, za katero so izdelek, proces (3.14) ali storitev predvideni, v skladu s specifikacijami, navodili
in informacijami, ki jih zagotovi proizvajalec (3.9)
Opomba 1: Tipični elementi predvidene uporabe so predvidena medicinska indikacija, populacija pacientov, del telesa ali
vrsta tkiva, na katerega vplivajo, profil uporabnika, okolje uporabe in načelo delovanja.
[VIR: ISO/IEC Vodilo 63:2019, 3.4]
3.7
in vitro diagnostični medicinski pripomoček
medicinski pripomoček IVD
pripomoček, ki ga je proizvajalec (3.9) predvidel za uporabo samostojno ali v kombinaciji za preiskave
vzorcev in vitro iz človeškega telesa izključno ali zlasti za pridobivanje podatkov za namene diagnostike,
spremljanja ali združljivosti, vključno z reagenti, kalibratorji, kontrolnimi materiali, vsebniki za vzorce,
programsko opremo in s tem povezanimi instrumenti ali aparaturami ali drugimi predmeti
[VIR: ISO 18113-1:2009, 3.27, spremenjen – OPOMBA je izbrisana.]
3.8
življenjski cikel
vse faze v življenjski dobi medicinskega pripomočka (3.10), od začetne zasnove do končne izločitve iz
uporabe in odstranitve
[VIR: ISO/IEC Vodilo 63:2019, 3.5]
SIST EN ISO 14971 : 2020
3.9
proizvajalec
fizična ali pravna oseba, ki je odgovorna za zasnovo in/ali proizvodnjo medicinskega pripomočka (3.10)
z namenom, da je medicinski pripomoček (3.10) na voljo za uporabo pod njenim imenom, ne glede na
to, ali je takšen medicinski pripomoček (3.10) zasnovala in/ali proizvedla ta oseba sama ali druge osebe
v njenem imenu
Opomba 1: Fizična ali pravna oseba je pravno odgovorna za zagotavljanje skladnosti z vsemi veljavnimi zakonodajnimi
zahtevami za medicinski pripomoček v državah ali zakonodajah, kjer je pripomoček na voljo ali se prodaja, razen
če to odgovornost zakonodajni organ v zakonodaji prenese na drugo osebo.
Opomba 2: Odgovornosti proizvajalca so opisane v drugih navodilih GHTF. Te odgovornosti vključujejo izpolnjevanje zahtev
pred in po dajanju na trg, kot sta poročanje o stranskih učinkih in obvestilo o korektivnih ukrepih.
Opomba 3: "Zasnova in/ali proizvodnja" lahko vključuje razvoj specifikacij, proizvodnjo, izdelavo, sestavo, obdelavo,
pakiranje, prepakiranje, označevanje, ponovno označevanje, sterilizacijo, namestitev ali ponovno izdelavo
medicinskega pripomočka ali združevanje več pripomočkov in po možnosti drugih izdelkov za medicinske
namene.
Opomba 4: Vsaka oseba, ki v skladu z navodili za uporabo sestavi ali prilagodi medicinski pripomoček, ki ga je dobavila druga
oseba za posameznega pacienta, ni proizvajalec, če sestava ali prilagoditev ne spremeni predvidene uporabe
medicinskega pripomočka.
Opomba 5: Vsaka oseba, ki spremeni njegovo predvideno uporabo ali spremeni medicinski pripomoček in ne deluje v imenu
prvotnega proizvajalca ter da ta pripomoček na voljo za uporabo pod lastnim imenom, naj se šteje za proizvajalca
spremenjenega medicinskega pripomočka.
Opomba 6: Pooblaščeni predstavnik, distributer ali uvoznik, ki zgolj doda svoj naslov in kontaktne podatke na medicinski
pripomoček ali embalažo, pri tem pa ne prekrije ali spremeni obstoječih označb, se ne šteje za proizvajalca.
Opomba 7: V obsegu, v katerem za dodatno opremo veljajo zakonodajne zahteve za medicinski pripomoček, se oseba,
odgovorna za zasnovo in/ali proizvodnjo te dodatne opreme, šteje za proizvajalca.
[VIR: ISO/IEC Vodilo 63:2019, 3.6]
3.10
medicinski pripomoček
instrument, aparatura, orodje, stroj, naprava, vsadek, reagent za uporabo in vitro, programska oprema,
material ali drug oziroma podoben predmet, ki ga je proizvajalec (3.9) predvidel za uporabo, samostojno
ali v kombinaciji, pri ljudeh za enega ali več določenih zdravstvenih namenov:
‒ diagnosticiranje, preprečevanje, spremljanje, zdravljenje ali lajšanje bolezni;
‒ diagnosticiranje, spremljanje, zdravljenje ali lajšanje poškodb;
‒ preiskovanje, nadomeščanje, spreminjanje ali podpora anatomskih funkcij ali fizioloških procesov;
‒ podpora ali ohranjanje življenja;
‒ nadzor spočetja;
‒ razkuževanje medicinskih pripomočkov (3.10);
‒ zagotavljanje informacij s preiskavo vzorcev in vitro iz človeškega telesa
in ki svojega glavnega predvidenega učinka na človeško telo ne dosega na farmakološki, imunološki
ali metabolični način, vendar pa so mu lahko ti procesi pri njegovem delovanju v pomoč.
Opomba 1: Izdelki, ki se lahko v nekaterih zakonodajah štejejo za medicinske pripomočke, v drugih pa ne, vključujejo:
‒ snovi za dezinfekcijo,
‒ pripomočke za invalidne osebe,
‒ pripomočke s tkivi živalskega in/ali človeškega izvora,
‒ pripomočke za oploditev in vitro ali tehnologije za oploditev z biomedicinsko pomočjo.
[VIR: ISO/IEC Vodilo 63:2019, 3.7]
SIST EN ISO 14971 : 2020
3.11
stvaren dokaz
podatki, ki potrjujejo obstoj ali resničnost nečesa
Opomba 1: Stvaren dokaz je mogoče pridobiti z opazovanjem, meritvami, preskusi ali z drugimi sredstvi.
[VIR: ISO 9000:2015, 3.8.3, spremenjen – Opomba 2 je izbrisana.]
3.12
po proizvodnji
del življenjskega cikla (3.8) medicinskega pripomočka (3.10), potem ko je bila zasnova dokončana in je
bil medicinski pripomoček (3.10) proizveden
PRIMER: Transport, skladiščenje, namestitev, uporaba izdelka, vzdrževanje, popravilo, spremembe izdelka, izločitev iz
uporabe in odstranitev.
3.13
postopek
specificiran način za izvedbo aktivnosti ali procesa (3.14)
Opomba 1: Postopki so lahko dokumentirani ali ne.
[VIR: ISO 9000:2015, 3.4.5]
3.14
proces
skupek medsebojno povezanih ali med seboj vplivajočih aktivnosti, ki s pomočjo vhodnih podatkov
dosežejo predvideni rezultat
Opomba 1: Ali se bo "predvideni rezultat" procesa imenoval rezultat, izdelek ali storitev, je odvisno od referenčnega konteksta.
Opomba 2: Vhodni podatki za proces so na splošno rezultati drugih procesov in rezultati procesa so na splošno vhodni podatki
za druge procese.
Opomba 3: Dva ali več medsebojno povezanih in med seboj vplivajočih zaporednih procesov je ravno tako mogoče imenovati
proces.
[VIR: ISO 9000:2015, 3.4.1, spremenjen – Opombe 4, 5 in 6 so izbrisane.]
3.15
razumno predvidljiva napačna uporaba
uporaba izdelka ali sistema na način, ki ga proizvajalec (3.9) ni predvidel, ki pa mogoče izvira iz zlahka
predvidljivega človeškega ravnanja
Opomba 1: Zlahka predvidljivo človeško ravnanje vključuje ravnanje vseh vrst uporabnikov, npr. laičnih in profesionalnih
uporabnikov.
Opomba 2: Razumno predvidljiva napačna uporaba je lahko namerna ali nenamerna.
[VIR: ISO/IEC Vodilo 63:2019, 3.8]
3.16
zapis
dokument, ki navaja dosežene rezultate ali podaja dokaz o izvedenih aktivnostih
Opomba 1: Zapisi se lahko uporabljajo na primer za formaliziranje sledljivosti in za dokazovanje overitve, preventivnega
ukrepa in korektivnega ukrepa.
Opomba 2: Zapisov na splošno ni treba nadzirati z revizijo.
[VIR: ISO 9000:2015, 3.8.10]
SIST EN ISO 14971 : 2020
3.17
preostalo tveganje
tveganje, ki ostane po izvedbi ukrepov za nadzor tveganja (3.21)
[VIR: ISO/IEC Vodilo 63:2019, 3.9]
3.18
tveganje
kombinacija verjetnosti nastanka škode (3.3) in resnosti (3.27) te škode (3.3)
[VIR: ISO/IEC Vodilo 63:2019, 3.10, spremenjeno – Opomba 1 je izbrisana.]
3.19
analiza tveganja
sistematična uporaba razpoložljivih informacij za identifikacijo nevarnosti (3.4) in oceno tveganja (3.18)
[VIR: ISO/IEC Vodilo 63:2019, 3.11]
3.20
ocenjevanje tveganja
celovit proces (3.14), ki vsebuje analizo tveganja (3.19) in vrednotenje tveganja (3.20)
[VIR: ISO/IEC Vodilo 51:2014, 3.11]
3.21
nadzor tveganja
proces (3.14), v katerem se sprejemajo odločitve in izvajajo ukrepi, s katerimi se tveganje (3.18) zmanjša
na določene stopnje oziroma se ohranja znotraj njih
[VIR: ISO/IEC Vodilo 63:2019, 3.12]
3.22
ocena tveganja
proces (3.14), ki se uporablja za določitev vrednosti verjetnosti nastanka škode (3.3) in resnosti (3.27)
te škode
[VIR: ISO/IEC Vodilo 63:2019, 3.13]
3.23
vrednotenje tveganja
proces (3.14) primerjanja ocenjenega tveganja (3.18) z danimi kriteriji tveganja (3.18) za določanje
sprejemljivosti tveganja (3.18)
[VIR: ISO/IEC Vodilo 63:2019, 3.14]
3.24
obvladovanje tveganja
sistematična uporaba upravljavske politike, postopkov (3.13) in praks pri nalogah analiziranja,
vrednotenja, nadzorovanja in spremljanja tveganja (3.18)
[VIR: ISO/IEC Vodilo 63:2019, 3.15]
3.25
dokumentacija o obvladovanju tveganja
skupek zapisov (3.16) in drugih dokumentov, ki so nastali med obvladovanjem tveganja (3.24)
SIST EN ISO 14971 : 2020
3.26
varnost
odsotnost nesprejemljivega tveganja (3.18)
[VIR: ISO/IEC Vodilo 63:2019, 3.10]
3.27
resnost
merilo možnih posledic nevarnosti (3.4)
[VIR: ISO/IEC Vodilo 63:2019, 3.17]
3.28
stanje tehnike
(angl. state of the art)
razvojna stopnja tehnične usposobljenosti v danem času, ki se nanaša na izdelke, procese (3.14) in
storitve ter temelji na relevantnih konsolidiranih spoznanjih znanosti, tehnologije in izkušenj
Opomba 1: Stanje tehnike vključuje, kar je trenutno in na splošno sprejeto kot dobra praksa v tehnologiji in medicini. Stanje
tehnike ne pomeni nujno tehnično najnaprednejše rešitve. Stanje tehnike, opisano tukaj, se včasih imenuje
"splošno priznano stanje tehnike".
[VIR: ISO/IEC Vodilo 63:2019, 3.18]
3.29
najvišje vodstvo
oseba ali skupina oseb, ki na najvišji ravni usmerja in nadzoruje proizvajalca (3.9)
[VIR: ISO 9000:2015, 3.1.1, spremenjen – "Organizacijo" je nadomestil izraz "proizvajalec". Opombe so
izbrisane.]
3.30
napaka pri uporabi
ukrep uporabnika ali odsotnost ukrepa uporabnika med uporabo medicinskega pripomočka (3.10), ki
privede do drugačnega rezultata, kot ga je predvidel proizvajalec (3.9) ali ga je pričakoval uporabnik
Opomba 1: Napaka pri uporabi vključuje nezmožnost uporabnika, da dokonča nalogo.
Opomba 2: Napake pri uporabi so lahko posledica neujemanja med lastnostmi uporabnika, uporabniškega vmesnika, naloge
ali okolja uporabe.
Opomba 3: Uporabniki se morda zavedajo ali ne zavedajo, da je prišlo do napake pri uporabi.
Opomba 4: Nepričakovan fiziološki odziv pacienta se sam po sebi ne šteje za napako pri uporabi.
Opomba 5: Okvara medicinskega pripomočka, ki povzroči nepričakovan rezultat, se ne šteje za napako pri uporabi.
[VIR: IEC 62366-1:2015, 3.21, spremenjen – Opomba 6 je izbrisana.]
3.31
overjanje
potrditev na podlagi stvarnega dokaza (3.11), da so bile specificirane zahteve izpolnjene
Opomba 1: Stvaren dokaz, potreben za overjanje, je lahko rezultat pregleda ali drugih oblik določanja, kot sta na primer
izvajanje alternativnih izračunov ali pregledovanje dokumentov.
Opomba 2: Aktivnosti, ki se izvedejo za overjanje, se včasih imenujejo postopek preverjanja.
Opomba 3: Izraz "overjeno" se uporablja za oznako ustreznega stanja.
[VIR: ISO/IEC Vodilo 63:2019, 3.19]
SIST EN ISO 14971 : 2020
4 Splošne zahteve za sistem obvladovanja tveganja
4.1 Proces obvladovanja tveganja
Proizvajalec mora vzpostaviti, izvajati, dokumentirati in vzdrževati stalen proces za:
a) identificiranje nevarnosti in nevarnih stanj, povezanih z medicinskim pripomočkom;
b) ocenjevanje in vrednotenje povezanih tveganj;
c) nadzorovanje teh tveganj in
d) spremljanje uspešnosti ukrepov nadzora tveganja.
Ta proces je treba upoštevati v celotnem življenjskem ciklu medicinskega pripomočka.
Ta proces mora vključevati naslednje elemente:
‒ analiza tveganja,
‒ vrednotenje tveganja,
‒ nadzor tveganja in
‒ aktivnosti med proizvodnjo in po proizvodnji.
Če obstaja dokumentiran proces realizacije izdelka, mora vključevati ustrezne dele procesa
obvladovanja tveganja.
[5]
OPOMBA 1: Procesi realizacije izdelka so opisani na primer v 7. točki standarda ISO 13485:2016 .
OPOMBA 2: Dokumentiran proces znotraj sistema vodenja kakovosti se lahko uporabi za obravnavanje varnosti na
sistematičen način, predvsem za zagotavljanje zgodnjega identificiranja nevarnosti in nevarnih stanj pri
kompleksnih medicinskih pripomočkih.
OPOMBA 3: Shematska predstavitev procesa obvladovanja tveganja je prikazana na sliki 1. Posamezni elementi obvladovanja
tveganja imajo lahko različen poudarek, odvisno od določene faze življenjskega cikla. Prav tako se lahko aktivnosti
obvladovanja tveganja ponavljajo ali izvajajo v več korakih, kot je ustrezno za določen medicinski pripomoček.
Dodatek B vsebuje podrobnejši pregled korakov procesa obvladovanja tveganja.
Skladnost se preverja s pregledom ustreznih dokumentov.
SIST EN ISO 14971 : 2020
Slika 1: Shematski prikaz procesa obvladovanja tveganja
4.2 Odgovornost vodstva
Najvišje vodstvo mora priskrbeti dokaze o svoji zavezanosti procesu obvladovanja tveganja z:
‒ zagotavljanjem ustreznih virov in
‒ dodelitvijo usposobljenega osebja (glej točko 4.3) za obvladovanje tveganja.
Najvišje vodstvo mora določiti in dokumentirati politiko za opredeljevanje kriterijev za sprejemljivost
tveganja. Politika mora podajati okvir, ki zagotavlja, da kriteriji temeljijo na veljavnih nacionalnih ali
regionalnih predpisih in na ustreznih mednarodnih standardih ter da upoštevajo razpoložljive
informacije, kot so npr. informacije o splošno sprejetem stanju tehnike in znanih pomislekih
udeležencev.
OPOMBA 1: Proizvajalčeva politika za opredeljevanje kriterijev za sprejemljivost tveganja lahko določa pristope za nadzor
tveganja: zmanjšanje tveganja, kolikor je razumno izvedljivo, zmanjšanje tveganja, kolikor je razumno dosegljivo,
ali zmanjšanje tveganja, kolikor je mogoče brez negativnega vpliva na razmerje koristi in tveganja. Glej
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ISO/TR 24971 za navodila glede določanja takšne politike.
Najvišje vodstvo mora pregledati primernost procesa obvladovanja tveganja v načrtovanih presledkih,
da zagotovi stalno uspešnost procesa obvladovanja tveganja, ter dokumentirati vse sprejete odločitve
SIST EN ISO 14971 : 2020
in ukrepe. Če ima proizvajalec uveden sistem vodenja kakovosti, se lahko ta pregled izvede v okviru
pregleda sistema vodenja kakovosti.
OPOMBA 2: Rezultati pregledovanja proizvodnih in poproizvodnih informacij so lahko vhodni podatki za pregled primernosti
procesa obvladovanja tveganja.
OPOMBA 3: Dokumenti, opisani v tej podtočki, so lahko vključeni v dokumente, pripravljene v okviru sistema vodenja kakovosti
pri proizvajalcu, in na te dokumente se lahko sklicuje dokumentacija o obvladovanju tveganja.
Skladnost se preverja s pregledom ustreznih dokumentov.
4.3 Kompetentnost osebja
Osebe, ki opravljajo naloge obvladovanja tveganja, morajo imeti ustrezno znanje, usposobljenost,
veščine in izkušnje za naloge, ki so jim dodeljene. Če je ustrezno, morajo te osebe imeti znanje in
izkušnje z določenim medicinskim pripomočkom (ali podobnimi medicinskimi pripomočki) ter njegovo
uporabo, z zadevno tehnologijo ali tehnikami obvladovanja tveganja. Ustrezne zapise je treba hraniti.
OPOMBA: Naloge obvladovanja tveganja lahko izvajajo predstavniki z različnimi funkcijami, pri čemer vsak od njih prispeva
svoje strokovno znanje.
Skladnost se preverja s pregledom ustreznih zapisov.
4.4 Načrt obvladovanja tveganja
Aktivnosti obvladovanja tveganja morajo biti načrtovane. Za vsak posamezen medicinski pripomoček,
ki se obravnava, mora proizvajalec vzpostaviti in dokumentirati načrt obvladovanja tveganja v skladu s
procesom obvladovanja tveganja. Načrt obvladovanja tveganja mora biti del dokumentacije o
obvladovanju tveganja.
Ta načrt mora vključevati vsaj:
a) obseg načrtovanih aktivnosti obvladovanja tveganja, v katerem so identificirani in opisani
medicinski pripomoček ter faze življenjskega cikla, na katere se nanaša vsak posamezni element
načrta;
b) dodelitev odgovornosti in pooblastil;
c) zahteve za pregled aktivnosti obvladovanja tveganja;
d) kriterije za sprejemljivost tveganja na podlagi politike proizvajalca za opredeljevanje sprejemljivega
tveganja, vključno s kriteriji za sprejemanje tveganj, kadar ni mogoče oceniti verjetnosti nastanka
škode;
OPOMBA 1: Kriteriji za sprejemljivost tveganja so bistvenega pomena za končno uspešnost procesa obvladovanja
tveganja. Za vsak načrt obvladovanja tveganja mora proizvajalec vzpostaviti kriterije za sprejemljivost
tveganja, ki so primerni za določen medicinski pripomoček.
e) metodo za vrednotenje celotnega preostalega tveganja in kriterije za sprejemljivost celotnega
preostalega tveganja na podlagi politike proizvajalca za določanje sprejemljivega tveganja;
OPOMBA 2: Metoda za vrednotenje celotnega preostalega tveganja lahko vključuje zbiranje in pregledovanje podatkov
oziroma literature za medicinski pripomoček, ki se obravnava, in podobne medicinske pripomočke na trgu
ter lahko vključuje odločitve interdisciplinarne skupine strokovnjakov z uporabnim znanjem in kliničnimi
izkušnjami.
f) aktivnosti za overjanje izvajanja in uspešnosti ukrepov za nadzor tveganja in
g) aktivnosti v zvezi z zbiranjem in pregledovanjem ustreznih proizvodnih ter poproizvodnih informacij.
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OPOMBA 3: Glej ISO/TR 24971 za navodila glede priprave načrta obvladovanja tveganja in vzpostavljanja kriterijev
za sprejemljivost tveganja.
OPOMBA 4: Ni nujno, da so vsi deli načrta izdelani istočasno. Načrt oziroma njegovi deli lahko nastajajo postopoma.
SIST EN ISO 14971 : 2020
Če se načrt med življenjskim ciklom medicinskega pripomočka spremeni, je treba zapis o spremembah
hraniti v dokumentaciji o obvladovanju tveganja.
Skladnost se preverja s pregledom dokumentacije o obvladovanju tveganja.
4.5 Dokumentacija o obvladovanju tveganja
Za določen medicinski pripomoček, ki se obravnava, mora proizvajalec vzpostaviti in vzdrževati
dokumentacijo o obvladovanju tveganja. Dokumentacija o obvladovanju tveganja mora poleg zahtev
drugih točk tega dokumenta za vsako identificirano nevarnost zagotavljati sledljivost do:
‒ analize tveganja;
‒ vrednotenja tveganja;
‒ izvedbe in overitve ukrepov nadzora tveganja in
‒ rezultatov vrednotenja preostalih tveganj.
OPOMBA 1: Zapisi in drugi dokumenti, ki sestavljajo dokumentacijo o obvladovanju tveganja, so lahko del drugih dokumentov
in dokumentacije, ki jih na primer zahteva sistem vodenja kakovosti proizvajalca. Ni nujno, da dokumentacija o
obvladovanju tveganja fizično vsebuje vse zapise in druge dokumente. Vendar pa mora vsebovati vsaj sklice ali
kazalnike na vso potrebno dokumentacijo, tako da lahko proizvajalec pravočasno zbere informacije, navedene v
dokumentaciji o obvladovanju tveganja.
OPOMBA 2: Dokumentacija o obvladovanju tveganja je lahko v poljubni obliki ali vrsti predstavnosti.
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OPOMBA 3: Glej ISO/TR 24971 za navodila glede vzpostavljanja dokumentacije o obvladovanju tveganja za sestavne dele
in pripomočke, ki so bili zasnovani brez uporabe standarda ISO 14971.
5 Analiza tveganja
5.1 Proces analize tveganja
Proizvajalec mora izvesti analizo tveganja za določen medicinski pripomoček, kot je opisano v točkah
od 5.2 do 5.5. Izvedba načrtovanih aktivnosti analize tveganja in rezulta
...
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