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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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.
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.
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 routine control of
a sterilization process for
medical devices
ISO 11737-1 ISO 11737-1:2018 Sterilization of health care EN ISO 11737-
products — Microbiological 1:2018+A1:2021
methods — Part 1:
Determination of a population of
microorganisms on products
ISO 11737-2 ISO 11737-2:2019 Sterilization of health care EN ISO 11737-2:2020
products — Microbiological
methods — Part 2: Tests of
sterility performed in the
definition, validation and
maintenance of a sterilization
process
ISO 13004 ISO 13004:2022 Sterilization of health care Previous edition
products — Radiation — published is CEN ISO/TS
Substantiation of selected 13004:2014
sterilization dose: Method
VDmaxSD
The documents listed in the Column 1 of table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of table ZA.2.
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 product(s) falling within the scope of
this standard.
Annex ZB
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 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) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, p
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