SIST EN ISO 11137-2:2015/A1:2023
(Amendment)Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
2022-06-21 - lack of compliance - publication on hold
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis - Änderung 1 (ISO 11137-2:2013/Amd 1:2022)
No scope available
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante - Amendement 1 (ISO 11137-2:2013/Amd 1:2022)
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/Amd 1:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11137-2:2015/A1:2023
01-september-2023
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka
sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/Amd 1:2022)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis - Änderung 1 (ISO 11137-2:2013/Amd 1:2022)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante - Amendement 1 (ISO 11137-2:2013/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2015/A1:2023
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2015/A1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11137-2:2015/A1:2023
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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2023
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose - Amendment 1 (ISO
11137-2:2013/Amd 1:2022)
Stérilisation des produits de santé - Irradiation - Partie Sterilisation von Produkten für die
2: Établissement de la dose stérilisante - Amendement Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der
1 (ISO 11137-2:2013/Amd 1:2022) Sterilisationsdosis - Änderung 1 (ISO 11137-
2:2013/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 11137-2:2015; it was approved by CEN on 29 May 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2015/A1:2023 E
worldwide for CEN national Members.
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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 7
2
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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
European foreword
This document (EN ISO 11137-2:2015/A1:2023) has been prepared by Technical Committee ISO/TC
198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 11137-2:2015 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2023,
and conflicting national standards shall be withdrawn at the latest by October 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request M/575 of 14.4.2021 given to CEN by
the European Commission and supports general safety and performance requirements of
EU Regulations(s).
For the relationship with EU Directive(s) see informative Annex ZA and Annex ZB, which are an integral
part of this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
The following referenced documents are indispensable for the application of this document. For
undated references, the edition of the referenced document (including any amendments) listed below
applies. For dated references, only the edition cited applies. However, for any use of this standard
within the meaning of Annex ZA or ZB, the user should always check that any referenced document has
not been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11137-2:2013/Amd 1:2022 has been approved by CEN as EN ISO 11137-
2:2015/A1:2023 without any modification.
3
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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
4
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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
Table ZA.1 – Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
Clause(s) / sub-
General Safety and
clause(s)
Performance Requirements Remarks / Notes
of Regulation (EU) 2017/745
of this EN
11.4 first sentence only 4,5,6,7,8,9,10 This standard provides requirements
for the establishment of the
sterilization dose in the development,
validation and routine control of a
sterilization process using ionising
radiation for medical devices. This
General Safety and Performance
Requirement is addressed only with
regard to devices for which
sterilization by ionising radiation is
appropriate and only in conjunction
with EN ISO 11137-1.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging for
maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of sterility by ionising
radiation are not covered. Evidence
that the integrity of the packaging is
maintained to the point of use is not
covered.
11.5 4,5,6,7,8,9,10 This standard provides requirements
for the establishment of the
sterilization dose in the development,
validation and routine control of a
sterilization process ionising
radiation for medical devices. This
General Safety and Performance
Requirement is addressed only with
regard to devices for which
sterilization by ionising radiation is
appropriate and only in conjunction
with EN ISO 11137-1.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for maintenance
of sterility is not covered. Aspects of
manufacture other than those related
to attainment of sterility by ionising
radiation are not covered.
5
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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Reference in International Title Corresponding
Clause 2 Standard Edition European Standard
Edition
ISO 11137- ISO 11137- Sterilization of health care EN ISO 11137-
1:2006/Amd1:2013 1:2006/Amd1:2013 products — Radiation — Part 1: 1:2006+A1:2013
Requirements for development,
validation and routine control of
a sterilization process for
medical devices
ISO 11137- ISO 11137- Sterilization of health care EN ISO
1:2006/Amd2:2018 1:2006/Amd2:2018 products — Radiation — Part 1: 11137-1:2015+A2:2019
Requirements for development,
validation and r
...
SLOVENSKI STANDARD
SIST EN ISO 11137-2:2015/oprA1:2021
01-marec-2021
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka
sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/DAmd 1:2021)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis - ÄNDERUNG 1 (ISO 11137 2:2013/DAM 1:2021)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante - Amendement 1 (ISO 11137-2:2013/DAmd 1:2021)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2015/prA1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2015/oprA1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11137-2:2015/oprA1:2021
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SIST EN ISO 11137-2:2015/oprA1:2021
DRAFT AMENDMENT
ISO 11137-2:2013/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-02-01 2021-04-26
Sterilization of health care products — Radiation —
Part 2:
Establishing the sterilization dose
AMENDMENT 1
Stérilisation des produits de santé — Irradiation —
Partie 2: Établissement de la dose stérilisante
AMENDEMENT 1
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 11137-2:2013/DAM 1:2021(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 2021
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(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.
Amendment 1 to ISO 11137-2:2013 was prepared by Technical Committee ISO/TC 198, Sterilization of
health care products.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved iii
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SIST EN ISO 11137-2:2015/oprA1:2021
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
Sterilization of health care products — Radiation —
Part 2:
Establishing the sterilization dose
AMENDMENT 1
Add a new 6.4:
6.4 If a sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy is established in accordance with
ISO/TS 13004, it shall be substantiated by one of the following methods:
SD
a) Method VD of ISO/TS 13004;
max
b) Method 1 (see Clause 7), subject to the derived sterilization dose taking a value less than or equal
−6
to the selected sterilization dose and achieving maximally an SAL of 10 ;
c) Method 2 (see Clause 8), subject to the derived sterilization dose taking a value less than or equal
−6
to the selected sterilization dose and achieving an SAL of 10 ; or
d) a method providing equivalent assurance to that of a), b) or c) above in achieving maximally an SAL
−6
of 10 .
Add related content under Clause 9 so that it reads:
9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose
Rationale and methods for substantiation of sterilization doses of 15 and 25 kGy using Method VD
max
are provided below. Rationale and methods for substantiation of sterilization doses of 17,5, 20, 22,5,
27,5, 30, 32,5 or 35 kGy using Method VD are provided in ISO/TS 13004.
max
© ISO 2021 – All rights reserved 1
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable
medical devices
This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard,
a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Essential Requirements (ERs)
Clauses of this EN Qualifying remarks/Notes
of Directive 90/385/EEC
7 4,5,6,7,8,9,10,11,12 This standard provides require-
ments for the development,
validation and routine control of a
sterilization process using ionising
radiation. This Essential Require-
ment is addressed only with regard
to devices for which sterilization
by ionising radiation is appropri-
ate and only in conjunction with
EN ISO 11137-1.
This relevant Essential Require-
ment is only partly addressed in
this European Standard. Design
and packaging for maintenance of
sterility during transportation and
storage are not covered. Aspects
of manufacture other than those
related to sterilization by ionising
radiation are not covered.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users
of this standard should consult frequently the latest list published in the Official Journal of the
European Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope
of this standard.
© ISO 2021 – All rights reserved 3
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SIST EN ISO 11137-2:2015/oprA1:2021
ISO 11137-2:2013/DAM 1:2021(E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN/CENELC by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard,
a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZB.1 — Correspondence between this European Standard and EU Directive 93/42/EEC
Essential Requirements (ERs)
Clauses of this EN Qualifying remarks/Notes
of Directive 93/42/EEC
8.3 4,5,6,7,8,9,10 This standard provides require-
ments for the development, val-
idation and routine control of a ster-
ilization process ionising radiation
for medical devices . This Essential
Requirement is addressed only
with regard to devices for which
sterilization by ionising radiation is
appropriate and only in conjunction
with EN ISO 11137-1.
This relevant Essential Require-
ment is only partly addressed in
this European Standard. Design
and packaging for maintenance of
sterility during transportation and
storage are not covered. Aspects
of manufacture other than those
related to sterilization by ioni
...
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