11 - HEALTH CARE TECHNOLOGY
ICS 11 Details
HEALTH CARE TECHNOLOGY
MEDIZINTECHNIK
TECHNOLOGIES DE LA SANTE
ZDRAVSTVENO VARSTVO
General Information
Frequently Asked Questions
ICS 11 is a classification code in the International Classification for Standards (ICS) system. It covers "HEALTH CARE TECHNOLOGY". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 11545 standards classified under ICS 11 (HEALTH CARE TECHNOLOGY). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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- Standard2 pagesEnglish languagesale 15% off
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard92 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping - regardless if they are covered by the Medical Device Regulation [7] or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods.
FprEN 16615 is applicable for four methods of application of products for wiping and/or mopping:
a) soaking any non-specified wipe or mop with product;
b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop;
c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation;
d) pre-impregnation of specified wipes or mop by the manufacturer as ready-to-use wipes or mops.
In all types of application, the water control is done with the standard wipe (5.3.2.17.1), because it is a process or method control.
This document does not apply to products that are sprayed on or flooding surfaces, without wiping in the contact time. In this case, the methods of phase 2/ stage 2 without mechanical action apply.
The test-surface (5.3.2.16) was selected as standard surface to cover all non-porous surfaces. This document does not apply to the testing of the influence of different surfaces.
This document is applicable to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions;
- in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
NOTE This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
- Standard56 pagesEnglish languagee-Library read for1 day
NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
- Standard60 pagesEnglish languagee-Library read for1 day
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- Amendment10 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the optical and geometrical properties of semi-finished blanks.
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IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4. Medical Electrical Equipment or Medical Electrical Systems which incorporate lasers as sources of energy being transferred to the Patient or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. Laser Products for these applications classified as a Class 1, Class 1M, Class 2, Class 2M or Class 3R Laser Product, are covered by IEC 60825-1:2014 and by the general standard. If a clause or subclause is specifically intended to be applicable to ME Equipment only, or to ME Systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies to ME Equipment and to ME Systems, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. If the laser equipment is Class 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition;
b) it addresses technical and safety issues which have arisen since publication of the third edition;
c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4;
d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.
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IEC 60601-2-22: 2026 Amendment 1
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This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.
This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
This document is not applicable to pulse oximeter equipment intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function.
This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use.
This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
- Draft150 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for male condoms made from natural rubber latex.
This document does not specify requirements related to any medicinal substances applied to or delivered by the condom.
NOTE The safety and effectiveness of any medicinal substance are assessed according to national and regional regulations.
- Draft88 pagesEnglish languagee-Library read for1 day
This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 3 ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply.
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 5 ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME.
NOTE 6 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 7 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789.
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber
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This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
intended for use with patients who can breathe spontaneously; and
intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming.
Respiratory high-flow therapy equipment can be:
fully integrated ME equipment; or
a combination of separate items forming a ME system.
This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.
NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode.
NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.
EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.
NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in the general standard, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in the general standard, 4.2.
This document does not specify the requirements for:
ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
ventilators or accessories intended for anaesthet
- Draft117 pagesEnglish languagee-Library read for1 day
This document specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies the general requirements intended to
protect the rights, safety and well-being of human subjects, users or other persons,
ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
define the responsibilities of the sponsor and principal investigator, and
assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).
NOTE For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.
- Draft99 pagesEnglish languagee-Library read for1 day
This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in Annexes A, B, C, D, E, F, G, H, I, J and K. EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Clause C.5[228]. NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device.
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- Amendment7 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
dental implants incorporating animal or human components or bioactive characteristics;
custom-made devices that have no pre-fabricated connection;
implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 [5].
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This document specifies requirements for the optical and geometrical properties of semi-finished blanks.
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard92 pagesEnglish languagee-Library read for1 day
This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required. This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biological effects.
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IEC 80601-2-52:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included in the scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable functions.
This document is applicable to either a BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM or both. The combination of BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM with a compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
This document does not apply to:
- MEDICAL BEDS for CHILDREN and ADULTS with atypical anatomies (ADULTS ranging outside the definition for ADULTS in 202.3.222) covered by IEC 80601-2-89;
- SPECIALITY MATTRESS covered by ISO 20342 series;
- devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table);
- all requirements for MEDICAL BEDS with special functionality.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
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ISO 80601-2-61:2026 This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.
This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
This document is not applicable to pulse oximeter equipment intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function.
This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use.
This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
- Standard150 pagesEnglish languagesale 15% off
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This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.
This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.
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ISO 80601-2-90:2026 This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
- intended for use with patients who can breathe spontaneously; and
- intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming.
Respiratory high-flow therapy equipment can be:
- fully integrated ME equipment; or
- a combination of separate items forming a ME system.
This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.
NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode.
NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.
EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.
NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in the general standard, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in the general standard, 4.2.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
- ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79;
- ventilatory support equipm
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This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[4], an oxygen concentrator[12] or liquid oxygen equipment[7]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
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ISO 80601-2-74:2026 This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 3 ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply.
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 5 ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME.
NOTE 6 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 7 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789.
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber air (i.e., are not directly connected to the patient).
This document is not applicable to nebulizers used for the delivery of a drug to patients.
NOTE 8 ISO 27427 specifies the safety and performance requirements for nebulizers.
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This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.
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ISO 80601-2-67:2026 This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator[4], an oxygen concentrator[12] or liquid oxygen equipment[7].
This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
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This document contains definitions of terms related to intraocular lenses as well as definitions related to the methods used to evaluate these IOLs.
NOTE The terms are listed in the alphabetical order of the English terms.
- Standard20 pagesEnglish languagee-Library read for1 day
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories: intended for use with patients who can breathe spontaneously; and intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming. Respiratory high-flow therapy equipment can be: fully integrated ME equipment; or a combination of separate items forming a ME system. This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode. NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode. NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in the general standard, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84; ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79; ventilatory support equipment or accessories intende
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This document defines terms and definitions used in the process chain for computer-aided design and computer-aided manufacturing (CAD/CAM) systems in dentistry.
NOTE: See Annex A for a flow chart of the process chain.
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This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system. This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1. NOTE 3 ISO 5367 specifies other safety and performance requirements for breathing tubes. This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients. NOTE 4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier. EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies. EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies. EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies. EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply. EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies. This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture. NOTE 5 ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME. NOTE 6 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 7 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789. This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber air (i.e., are not directly connected to the patient). This document is not applicable to nebulizers used for the delivery of a drug to patients. NOTE 8 ISO 27427 specifies the safety and performance requirements for nebulizers.
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ISO 80601-2-69:2026 This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.
EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function.
EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.
EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2].
EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.
This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.
NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.
This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
NOTE 3 See also 4.2 of the general standard.
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This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products). The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability. This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. This document is not applicable to pulse oximeter equipment intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.
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This document is applicable to type D and type SD hose assemblies with hoses made of elastomers and bonded plastics for the transport of gaseous, vaporous, liquid or powdery substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −30 °C to +100 °C, depending on the medium, and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Table 2 and Table 3). For hoses with a lining made of PTFE and derivatives, temperatures from −30 °C to +140 °C are permissible.
Hose assemblies in accordance with this document are classified into four types, A – D, A – SD. B – D, B – SD.
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This document specifies quality requirements for the chart, test procedure and acceptance level for near, far, and colour vision acuity of NDT personnel. Information for grey scale perception and low contrast can be found in the annexes. This document also specifies the qualification requirements for personnel permitted to carry out the test.
This document is only applicable to vision acuity under defined conditions similar to those encountered during routine NDT inspection. This document does not address an individual’s overall visual acuity and users are advised to consider the need for a general eye examination by specialist medical personnel to ensure general vision acuity.
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NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
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This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping - regardless if they are covered by the Medical Device Regulation [7] or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods.
FprEN 16615 is applicable for four methods of application of products for wiping and/or mopping:
a) soaking any non-specified wipe or mop with product;
b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop;
c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation;
d) pre-impregnation of specified wipes or mop by the manufacturer as ready-to-use wipes or mops.
In all types of application, the water control is done with the standard wipe (5.3.2.17.1), because it is a process or method control.
This document does not apply to products that are sprayed on or flooding surfaces, without wiping in the contact time. In this case, the methods of phase 2/ stage 2 without mechanical action apply.
The test-surface (5.3.2.16) was selected as standard surface to cover all non-porous surfaces. This document does not apply to the testing of the influence of different surfaces.
This document is applicable to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions;
- in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
NOTE This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
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IEC 61267:2025 applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined X-ray radiation conditions. This document deals with methods for generating X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment.
IEC 61267:2025 cancels and replaces the second edition published 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) removing former Annex C “Measurement of the practical peak voltage”;
b) inserting informative “Tabulated values for the squared signal-to-noise ratio per air kerma (SNR2in)” and normative “Additional X-ray radiation conditions as used in mammography and determination of the corresponding nominal aluminium half-value layers”;
c) revision of X-ray radiation conditions;
d) new method for verification of X-ray radiation conditions;
e) change of term definitions.
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This document is applicable for evaluating absorbent incontinence products for urine, faeces, or both for adults and children. It provides a context for the procedures described in other International Standards and for published testing procedures. General factors relating to incontinence products and their usage are also addressed.
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This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.
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This document specifies requirements for transportable liquid oxygen systems that are common to both base units and portable units and requirements that are particular to base units.
Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded from this document.
NOTE 1 Throughout this document the term “units” is used where the requirement applies to both base units and portable units.
NOTE 2 ISO 18777 - 2 specifies those requirements particular to portable units.
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This document specifies the general principles for the establishment of herbal reference substances, covering production, quality control, report, instruction and labelling, packaging, storage and transportation. This document applies to herbal reference substances that are sold and used as reference standards for the quality control of herbal medicines in international trade, including raw materials and finished products.
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This document outlines requirements for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows: mitigation of threats encountered in providing diagnostic services during a pandemic; consideration for quality assurance of diagnostic service provision in a pandemic context; possible response measures to the surge in diagnostic demand. This document does not cover the specific procedures involved in providing pandemic-response medical tests, such as the specimen collection protocols in the specimen collection units or screening stations (e.g. walk-through or drive-through), experimental procedures and the quality management systems of medical laboratories. Furthermore, this document does not address the pandemic responses related to the medical treatment of infected patients in care units (e.g. emergency unit and in-patient unit) and the transferring of confirmed patients within the healthcare organization during a pandemic.
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This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
dental implants incorporating animal or human components or bioactive characteristics;
custom-made devices that have no pre-fabricated connection;
implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 [5].
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