prEN ISO 11135

SLOVENSKI STANDARD
oSIST prEN ISO 11135:2023
01-junij-2023
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 11135:2023)
Sterilization of health care products - Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO/DIS 11135:2023)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11135:2023)
Stérilisation des produits de santé - Oxyde d’éthylène - Exigences de mise au point, de
validation et de contrôle de routine d’un processus de stérilisation pour des dispositifs
médicaux (ISO/DIS 11135:2023)
Ta slovenski standard je istoveten z: prEN ISO 11135
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11135:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 11135:2023
oSIST prEN ISO 11135:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11135
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-03-30 2023-06-22
Sterilization of health care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11135:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11135
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:

Sterilization of health care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11135:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
1.1 Inclusions. 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Quality management system .14
5 Sterilizing agent characterization .15
5.1 General . 15
5.2 Sterilizing agent . 15
5.3 Microbicidal effectiveness . .15
5.4 Material effects . 15
5.5 Safety and the environment . 15
6 Process and equipment characterization .16
6.1 General . 16
6.2 Process characterization . 16
6.3 Equipment characterization . 17
7 Product definition .18
7.1 General . 18
7.2 Product safety, quality and performance . 18
7.3 Microbiological quality . 18
7.4 Documentation . 19
8 Process definition .19
9 Validation . .20
9.1 General . 20
9.2 Installation qualification (IQ) . 20
9.2.1 Equipment . 20
9.2.2 Installation qualification specifications. 20
9.3 Operational qualification (OQ) . 21
9.4 Performance qualification (PQ) . 21
9.4.1 General . 21
9.4.2 Performance qualification — Microbiological .22
9.4.3 Performance qualification — Physical .22
9.5 Review and approval of validation . 23
10 Routine monitoring and control.25
11 Product release from sterilization .26
12 Maintaining process effectiveness .27
12.1 General . 27
12.2 Maintenance of equipment . 27
12.3 Requalification . 27
12.4 Assessment of change . .28
12.5 Assessment of equivalence .28
12.5.1 Process equivalence .28
12.5.2 Product equivalence .28
Annex A (informative) Guidance on the application of the normative requirements .29
Annex B (informative) Guidance on selection of PCD and demonstration of appropriateness
for MPQ .55
iii
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
Annex C (informative) Guidance on the number and placement of PCDs, test units,
temperature and humidity sensors and product residual samples .61
Annex D (informative) Guidance on process equipment operational qualification/
requalification . .67
Annex E (informative) Guidance on the establishment of minimum temperature of product
and conditions of acclimation for the sterilization load prior to entering the
sterilization process .77
Annex F (normative) Microbiological Performance Qualification (MPQ) .83
Annex G (informative) Guidance on establishing process D value for use in cycle calculation
methods (Overkill and BI/Bioburden) .86
Annex H (informative) Guidance on establishing specifications for parametric release .94
Annex I (normative) Single batch release .98
Annex J (informative) Guidance on establishing routine cycle specification and evaluation
of process deviations . 100
Annex K (informative) Guidance on evaluating process and product equivalence . 104
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 112
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered .116
Bibliography .119
iv
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(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 198, Sterilization of health care products.
This third edition cancels and replaces the second edition (ISO 11135:2014 and Amd1:2018), which has
been technically revised.
The main changes are as follows:
— addition of informational guidance Annexes B, D, E, G, H, J and K;
— more defined requirements for microbiological performance qualification in Annex F;
— incorporation of relevant elements of ISO/TS 21387:2020 into Annexes A and H.
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.
v
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. Medical devices produced under
standard manufacturing conditions in accordance with the requirements for quality management
systems (see for example ISO 13485) may, prior to sterilization, have microorganisms on them, albeit
in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the
microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents
used to sterilize medical devices can generally best be described by an exponential relationship
between the numbers of microorganisms surviving and the extent of treatment with the ethylene
oxide (EO); inevitably this means that there is always a finite probability that a microorganism may
survive regardless of the extent of treatment applied. For a given treatment, the probability of survival
is determined by the number and resistance of microorganisms and by the environment in which the
organisms exist during treatment. It follows that the sterility of any one medical device in a population
subjected to sterilization processing cannot be guaranteed and the sterility of a processed population
is defined in terms of the probability of there being a viable microorganism present on a medical device.
This document describes requirements that, if met, will provide an ethylene oxide sterilization process
intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore,
conformance with the requirements ensures that validations conducted following this document
provide products that meet the defined requirements for sterile products with a high degree of
confidence. The specification for this probability is a matter for regulatory authorities and can vary
from country to country (see for example EN 556-1 and ANSI/AAMI ST67).
Generic requirements of the quality management systems for design and development, production,
installation and servicing are given in ISO 9001 and particular requirements for quality management
systems for medical device production are given in ISO 13485. The standards for quality management
systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness
of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization
is an example of such a process. For this reason, sterilization processes are validated for use, the
performance of the sterilization process monitored routinely and the equipment is maintained and
calibrated.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor
associated with the provision of reliable assurance that the product is sterile and, in this regard,
suitable for its intended use. Attention is therefore given to a number of considerations including:
— the microbiological status of incoming raw materials and/or components;
— the validation and routine control of any cleaning and disinfection procedures used on the product;
— the control of the environment in which the product is manufactured or reprocessed, assembled
and packaged;
— the control of equipment and processes;
— the control of personnel and their hygiene;
— the manner and materials in which the product is packaged;
— the conditions under which product is stored.
The type of contamination on a product to be sterilized varies and this impacts upon the effectiveness
of a sterilization process. Products that have been used in a health care setting and are being presented
for resterilization in accordance with the manufacturer's instructions (see ISO 17664-1) are a special
case. There is the potential for such products to possess a wide range of contaminating microorganisms
and residual inorganic and/or organic contamination in spite of the application of a cleaning process.
Hence, it is important to pay particular attention to the validation and control of the cleaning and
vi
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
disinfection processes used during reprocessing. Mixed product loads are common in health care
facilities with throughput volumes dictated by historical and predicted demand for sterile product.
The requirements are the normative parts of this document with which conformance is claimed. The
guidance given in the informative annexes is not normative and is not provided as a checklist for
auditors. Annexes A to K provide explanations and methods that are regarded as being suitable means
for complying with the requirements for industry and health care facilities.
The guidance, in annexes, is intended for people who have a basic knowledge of the principles of
EO sterilization. Methods other than those given in the guidance can be used if they are effective in
achieving conformance with the requirements of this document.
The development, validation and routine control of a sterilization process comprises a number of
discrete but interrelated activities; e.g. calibration, maintenance, product definition, process definition,
installation qualification, operational qualification and performance qualification. While the activities
required by this document have been grouped together and are presented in a particular order, this
document does not require that the activities be performed in the order in which they are presented.
The activities required are not necessarily sequential, as the programme of development and validation
can be iterative. It is possible that performing these different activities will involve a number of
separate individuals and/or organizations, each of whom undertakes one or more of these activities.
This document does not specify the particular individuals or organizations to carry out the activities.
It is important that patient safety be addressed by minimizing exposure to EO and its by-products
during product use. ISO 10993-7 specifies limits for EO and ethylene chlorohydrin (ECH); however,
no exposure limits are set for ethylene glycol (EG) because risk assessment indicates that when EO
residues are controlled, it is unlikely that biologically significant residues of EG would be present.
vii
oSIST prEN ISO 11135:2023
oSIST prEN ISO 11135:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 11135:2023(E)
Sterilization of health care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
This document specifies requirements for the development, validation and routine control of an
ethylene oxide sterilization process for medical devices in both the industrial and health care facility
settings, and it acknowledges the similarities and differences between the two applications.
NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety
measures. The major differences relate to the unique physical and organizational conditions in health care
facilities, and to the initial condition of reusable medical devices being presented for sterilization.
NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing
areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience.
The primary function of the health care facility is to provide patient care; medical device reprocessing is just one
of a myriad of activities that are performed to support that function.
NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize
large numbers of similar single-use medical devices. Health care facilities, on the other hand, handle and process
both new medical devices and reusable medical devices of different types and with varying levels of bioburden.
They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a
medical device prior to sterilization. In this document, alternative approaches and guidance specific to health
care facilities are identified as such.
NOTE 4 EO gas and its mixtures are effective sterilants for medical devices that are sensitive other modalities
such as moist heat and ionizing radiation
NOTE 5 Although the scope of this document is limited to medical devices, it specifies requirements and
provides guidance that can be applicable to other health care products.
NOTE 6 See Annex A for guidance on Clauses 1 to 12.
1.2 Exclusions
1.2.1 This document does not specify requirements for the development, validation and routine
control of a process for inactivating the causative agents of spongiform encephalopathies such as
scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations
have been produced in particular countries for the processing of materials potentially contaminated
with these agents.
NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This document does not detail a specified requirement for designating a medical device as
sterile.
NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”.
See for example EN 556–1 or ANSI/AAMI ST67.
1.2.3 This document does not specify a quality management system for the control of all stages of
production of medical devices.
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
NOTE The effective implementation of defined and documented procedures is necessary for the development,
validation and routine control of a sterilization process for medical devices. Such procedures are commonly
considered to be elements of a quality management system. It is not a requirement of this document to have a
full quality management system during manufacture or reprocessing. The necessary elements are referenced
at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality
management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
National and/or regional regulations for the provision of medical devices can require the implementation of a full
quality management system and the assessment of that system by a third party.
1.2.4 This document does not specify requirements for occupational safety associated with the
design and operation of EO sterilization facilities.
NOTE EO is toxic, flammable and explosive. National or regional regulations exist in some countries
concerning safety requirements for the handling of EO and for premises in which EO is used. Refer to the
Bibliography for further information on safety.
1.2.5 This document does not cover sterilization by injecting EO or mixtures containing EO directly
into packages or a flexible chamber.
NOTE See ISO 14937 for validation of these types of EO processes.
1.2.6 This document does not cover analytical methods for determining levels of residual EO and/or
its reaction products.
NOTE 1 For further information see ISO 10993-7.
NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for
the level of EO residues present on or in medical devices.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-2, Sterilization of health care products — Biological indicators — Part 2: Biological indicators
for ethylene oxide sterilization processes
ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 11737-2, Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
3.1
aeration
part of the sterilization process during which ethylene oxide and/or its reaction products desorb from
the medical device until predetermined levels are reached
Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room.
[SOURCE: ISO 11139:2018, 3.7]
3.2
aeration area
either a chamber or a room in which aeration occurs
3.3
assurance of sterility
qualitative concept comprising all activities that provide confidence that product is sterile
[SOURCE: ISO 11139:2018, 3.17]
3.4
batch
defined quantity of a product intended or purported to be uniform in character and quality produced
during a specified cycle of manufacture
[SOURCE: ISO 11139:2018, 3.21]
3.5
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.6
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified
sterilization process
[SOURCE: ISO 11139:2018, 3.29]
3.7
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
[SOURCE: ISO 11139:2018, 3.31]
3.8
chamber
part of equipment in which a load is processed
[SOURCE: ISO 11139:2018, 3.36]
3.9
chamber pre-heating
process that raises the temperature of internal chamber surfaces prior to the commencement of an
operating cycle
[SOURCE: ISO 11139:2018, 3.37]
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
3.10
chamber reference temperature
temperature at a specified point within the chamber
[SOURCE: ISO 11139:2018, 3.38]
3.11
chamber volume
enclosed space of a chamber, including the volume of nozzles to the first connection or weld, and
excluding the volume of permanent internal parts
[SOURCE: ISO 11139:2018, 3.318.1]
3.12
change control
assessment and determination of the appropriateness of a proposed alteration to product, process, or
equipment
[SOURCE: ISO 11139:2018, 3.39]
3.13
chemical indicator
test system that reveals a change in one or more pre-specified process variables based on a chemical or
physical change resulting from exposure to a process
[SOURCE: ISO 11139:2018, 3.43]
3.14
conditioning
treatment of product prior to the exposure phase to attain a specified temperature, relative humidity,
or other process variable throughout the load
Note 1 to entry: This part of the sterilization cycle can be carried out either at atmospheric pressure or under
vacuum.
Note 2 to entry: See preconditioning (3.45).
[SOURCE: ISO 11139:2018, 3.58]
3.15
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.16
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in advance of, in conjunction with, or after a corrective action.
[SOURCE: ISO 11139:2018, 3.64]
3.17
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.
[SOURCE: ISO 11139:2018, 3.65]
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
3.18
cycle parameter
value of a cycle variable including its tolerance used for control, monitoring, indication, and recording
of an operating cycle
[SOURCE: ISO 11139:2018, 3.72]
3.19
cycle variable
property used to control, monitor, indicate, or record an operating cycle
[SOURCE: ISO 11139:2018, 3.74]
3.20
D value
D value
time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test
microorganisms
[SOURCE: ISO 11139:2018, 3.75]
3.21
development
act of elaborating a specification
[SOURCE: ISO 11139:2018, 3.79]
3.22
dew point
temperature at which the saturation water vapour pressure is equal to the partial pressure of the water
vapour in the atmosphere
Note 1 to entry: Any cooling of the atmosphere below the dew point would produce water condensation.
[SOURCE: ISO 11139:2018, 3.80]
3.23
equilibration time
period between the attainment of defined sterilization process parameters at the reference
measurement point and the attainment of the specified sterilization process parameters at all points
within the load
[SOURCE: ISO 11139:2018, 3.105]
3.24
establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO 11139:2018, 3.107]
3.25
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
[SOURCE: ISO 11139:2018, 3.116]
3.26
flushing
procedure by which the ethylene oxide is removed from the load and chamber by either multiple
alternate admissions of filtered air, inert gas or steam and evacuations of the chamber or continuous
passage of filtered air, inert gas or steam through the load and chamber
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
3.27
fractional cycle
operating cycle in which the exposure phase is reduced compared with that specified for the
sterilization cycle
Note 1 to entry: For EO processes, the dwell time within the exposure phase is reduced.
[SOURCE: ISO 11139:2018, 3.123]
3.28
gas concentration
weight of a specific gas in a given volume
Note 1 to entry: Concentration can be expressed as mg/L or g/m .
[SOURCE: ISO 11139:2018, 3.125]
3.29
half cycle
test cycle in which the extent of treatment is reduced by 50 % as compared with an operating cycle
Note 1 to entry: A cycle in which the exposure time to EO gas is reduced by 50 % compared to that specified in
the sterilization process.
[SOURCE: ISO 11139:2018, 3.129]
3.30
health care facility
HCF
governmental and private organizations and institutions devoted to the promotion and maintenance of
health, and the prevention and treatment of diseases and injuries
EXAMPLE A health care facility can be a hospital, nursing home, extended care facility, free-standing
surgical centre, clinic, medical office, or dental office.
3.31
health care product
medical device, including in vitro diagnostic medical device, or medicinal product, including
biopharmaceutical
[SOURCE: ISO 11139:2018, 3.132]
3.32
holding time
period during which process parameters are maintained, within their specified tolerances
Note 1 to entry: For the purposes of EO processes, holding time is commonly referred to as dwell time.
[SOURCE: ISO 11139:2018, 3.133]
3.33
humidity
measure of water vapour present in a gas
Note 1 to entry: Humidity is usually expressed as absolute humidity (i.e. vapour pressure density), relative
humidity, or dew point.
[SOURCE: ISO 11139:2018, 3.136]
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
3.33.1
absolute humidity
measure of water vapour in the air, regardless of temperature
Note 1 to entry: It is expressed as grams of moisture per cubic meter of air (g/m ).
[SOURCE: ISO 11139:2018, 3.136.1]
3.33.2
relative humidity
measure of water vapour in the air expressed as a percentage of the maximum for a given temperature
Note 1 to entry: It is expressed as a percent.
[SOURCE: ISO 11139:2018, 3.136.2]
3.34
inoculated carrier
supporting material on or in which a specified number of viable test microorganisms has been deposited
[SOURCE: ISO 11139:2018, 3.144]
3.35
load
product, equipment, or materials to be processed together within an operating cycle
[SOURCE: ISO 11139:2018, 3.155]
3.36
load configuration
distribution and orientation of a load
[SOURCE: ISO 11139:2018, 3.156]
3.37
load volume
space occupied by product and any packaging and carrier(s)
[SOURCE: ISO 11139:2018, 3.318.3]
3.38
master product
health care product or procedure set used to represent the most difficult to sterilize item in a product
family or processing category
[SOURCE: ISO 11139:2018, 3.160]
3.39
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software
material, or other similar or related article, intended by the manufacturer 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;
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological, or metabolic
means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions, but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for
sterilization;
— 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 11139:2018, 3.166]
3.40
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
[SOURCE: ISO 11139:2018, 3.176]
3.41
monitoring
continual checking, supervising, critically observing, or determining the status, in order to identify
change from the performance level required or expected
[SOURCE: ISO 11139:2018, 3.180]
3.42
operating cycle
complete set of stages of a process that is carried out, in a specified sequence
Note 1 to entry: Loading and unloading are not part of the operating cycle.
[SOURCE: ISO 11139:2018, 3.188]
3.43
overkill approach
method of defining a sterilization process that achieves a maximal sterility assurance level (SAL) for
−6
product substantially less than 10
[SOURCE: ISO 11139:2018, 3.190]
3.44
parametric release
declaration that product is sterile based on records demonstrating that the sterilization process
variables were delivered within specified tolerances
Note 1 to entry: This method of process release does not include the use of biological indicators.
[SOURCE: ISO 11139:2018, 3.193]
oSIST prEN ISO 11135:2023
ISO/DIS 11135:2023(E)
3.45
preconditioning
treatment of product, prior to the operating cycle, to attain specified values for temperature, relative
humidity, and/or other process variables
[SOURCE: ISO 11139:2018, 3.200]
3.46
process challenge device
PCD
item providing a defined resistance to a cleaning, disinfection, or sterilization process and used to
assess performance of the process
Note 1 to entry: For the purpose of this document, an item can be product, surrogate product or other device that
is inoculated directly or indirectly. See 7.1.6 and D.7.1.6.
Note 2 to entry: In this document, a distinction is made between an internal PCD and an external PCD. An
internal PCD is used to demonstrate that the selected product SAL is achieved. A PCD located within the confines
of t
...