ISO/FDIS 11137-1
(Main)Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Stérilisation des produits de santé — Irradiation — Partie 1: Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
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FINAL DRAFT
International
Standard
ISO/TC 198
Sterilization of health care
Secretariat: ANSI
products — Radiation —
Voting begins on:
2024-12-17
Part 1:
Requirements for the development,
Voting terminates on:
2025-02-11
validation and routine control of
a sterilization process for medical
devices
Stérilisation des produits de santé — Irradiation —
Partie 1: Exigences relatives à la mise au point, à la validation
et au contrôle de routine d'un procédé de stérilisation pour les
dispositifs médicaux
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 198
Sterilization of health care
Secretariat: ANSI
products — Radiation —
Voting begins on:
Part 1:
Requirements for the
Voting terminates on:
development, validation and
routine control of a sterilization
process for medical devices
Stérilisation des produits de santé — Irradiation —
Partie 1: Exigences relatives à la mise au point, à la validation
et au contrôle de routine d'un procédé de stérilisation pour les
dispositifs médicaux
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 SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General . 9
5 Sterilizing agent characterization . 9
5.1 Sterilizing agent .9
5.2 Microbicidal effectiveness . .9
5.3 Material effects .10
5.4 Environmental considerations .10
6 Process and equipment characterization . 10
6.1 Process .10
6.2 Equipment .10
7 Product definition .11
8 Process definition .12
8.1 Establishing the maximum acceptable dose, D . 12
max,acc
8.2 Establishing the sterilization dose, D . 12
ster
8.3 Specifying the maximum acceptable dose and the sterilization dose . 12
8.4 Transference of maximum acceptable, verification or sterilization dose between
radiation sources . 13
8.4.1 Transference of maximum acceptable dose . 13
8.4.2 Transference of verification dose or sterilization dose . 13
9 Validation . .13
9.1 Installation qualification (IQ) . 13
9.2 Operational qualification (OQ) . 13
9.3 Performance qualification (PQ) .14
9.4 Review and approval of validation . 15
10 Routine monitoring and control.16
11 Product release from sterilization . 17
12 Maintaining process effectiveness . 17
12.1 Demonstration of continued effectiveness .17
12.1.1 General .17
12.1.2 Frequency of determinations of bioburden .17
12.1.3 Frequency of sterilization dose audits .18
12.2 Recalibration .19
12.3 Maintenance of equipment .19
12.4 Requalification of equipment .19
12.5 Assessment of change . 20
Annex A (informative) Guidance on this document .21
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .37
Annex ZB (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .40
Bibliography .42
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 204,
Sterilization of medical devices, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 11137-1:2006), which has been technically
revised.
The main changes are as follows:
— addition of ISO 13004 as a normative reference;
— addition of ISO/ASTM 52628 as a normative reference for dosimetry in radiation processing and
alignment of terminology across the document to ASTM standards terminology;
— update of Clause 4 to align with ISO/TC 198 documents;
— increase of the allowable limits above which the potential induced radioactivity shall be assessed to
11 MeV for electrons and 7.5 MeV for X-rays (see 5.1.2);
— addition of a requirement to ensure that failure of a control function does not lead to a failure in recording
process parameters such that an ineffective process appears effective (see 6.1);
— simplification of content on transfer
...
ISO/TC 198/WG 2
Secretariat: AAMI (for ANSI)
Date: 2024-12-06
Sterilization of health care products – — Radiation – —
Part 1:
Requirements for the development, validation and routine control of
a sterilization process for medical devices
Stérilisation des produits de santé — Irradiation —
Partie 1: Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de
stérilisation pour les dispositifs médicaux
FDIS stage
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General . 10
5 Sterilizing agent characterization . 10
5.1 Sterilizing agent . 10
5.2 Microbicidal effectiveness . 11
5.3 Material effects . 11
5.4 Environmental considerations . 11
6 Process and equipment characterization . 11
6.1 Process . 11
6.2 Equipment . 11
7 Product definition . 12
8 Process definition . 13
8.1 Establishing the maximum acceptable dose, D . 13
max,acc
8.2 Establishing the sterilization dose, D . 13
ster
8.3 Specifying the maximum acceptable dose and the sterilization dose . 14
8.4 Transference of maximum acceptable, verification or sterilization dose between
radiation sources . 14
9 Validation . 14
9.1 Installation qualification (IQ) . 14
9.2 Operational qualification (OQ) . 15
9.3 Performance qualification (PQ) . 16
9.4 Review and approval of validation . 17
10 Routine monitoring and control . 17
11 Product release from sterilization . 18
12 Maintaining process effectiveness . 18
12.1 Demonstration of continued effectiveness . 18
12.2 Recalibration . 21
12.3 Maintenance of equipment . 21
12.4 Requalification of equipment . 21
12.5 Assessment of change . 21
Annex A (informative) Guidance on this document . 22
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 39
Annex ZB (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 43
Bibliography . 46
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 204,
Sterilization of medical devices, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 11137-1:2006), which has been technically
revised.
The main changes are as follows:
— — addition of ISO 13004 as a normative reference;
— — addition of ISO/ASTM 52628 standard practice as a normative reference for dosimetry in radiation
processing as a normative reference and alignment of terminology across the document to ASTM
standards terminology;
— — replacementupdate of Clause 4Clause 4 to align with the updated common Clause 4 for ISO/TC 198
documents;
— — increase of the allowable limits above which the potential induced radioactivity shall be assessed to
11 MeV for electrons and 7.5 7.5 MeV for X-rays (see 5.1.25.1.2););
— — addition of a requirement to ensure that failure of a control function does not lead to a failure in
recording process parameters such that an ineffective process appears effective (see 6.16.1););
iv
— — simplification of content on transference of verification dose or sterilization dose based on published
data that demonstrates that differences in operating conditions of the two radiation sources have no effect
on microbicidal effectiveness for product that does not promote microbial growth (see 8.4.28.4.2););
— — clarification on the use of dose measurements and the recording of process variables for process
control has been clarified (see 10.610.6 and 10.710.7););
— — clarification has been provided on the allowable interval of time for quarterly dose audits, allowing for
an interval of four months provided there are four dose audits per year (see 12.1.212.1.2););
SD
— — addition of references for all VD dose levels contained in both ISO 11137-2 and ISO 13004 (see
max
8.2.28.2.2 and 12.1.212.1.2););
— — additional information has been included on bioburden determination for productproducts with very
low bioburden (see 12.1.2.212.1.2.2););
— — addition of guidance related to new or modified normative content;
— — addition of references to the Bibliography.
A list of all parts in the ISO 11137 series can be found on the ISO website.
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
Introduction
A sterile medical device is one that is free of viable microorganisms. International Standards, which specify
requirements for validation and routine control of sterilization processes, require, when it is necessary to
supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to
sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in
accordance with the requirements for quality management systems (see, for example, ISO 13485) can, prior
to sterilization, have microorganisms on them. prior to sterilization. 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 either physical or chemical agents, or both,
used to sterilize medical devices can generally best be described byas an exponential relationship between
the numbersnumber of microorganisms surviving and the extent of treatment with the sterilizing agent;
inevitably. Inevitably, this means that there is always a finite probability that a microorganism can 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 microorganisms 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 a radiation sterilization process, intended to
sterilize medical devices. Furthermore, conformance with the requirements ensures that this activity is both
reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level
of probability of there being a viable microorganism present on product after sterilization. Specification of 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 system for design and development, production, installation
and servicing are given in ISO 9001 and particular, while specific requirements for qu
...
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