EN ISO 11137-1:2015/A2:2019
(Amendment)Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte - Änderung 2: Überarbeitung von 4.3.4 und 11.2 (ISO 11137 1:2006/Amd.2:2018)
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 - Amendement 2: Révision de 4.3.4 et de 11.2 (ISO 11137-1:2006/Amd 2:2018)
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke - Dopolnilo A2: Revizija točke 4.3.4 in 11.2 (ISO 11137-1:2006/Amd 2:2018)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2020
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke - Dopolnilo A2: Revizija točke 4.3.4 in 11.2 (ISO 11137-1:2006/Amd
2:2018)
Sterilization of health care products - Radiation - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices - Amendment
2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte - Änderung 2 (ISO 11137-1:2006/Amd
2:2018)
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 - Amendement 2: Révision de 4.3.4 et de 11.2 (ISO 11137-
1:2006/Amd 2:2018)
Ta slovenski standard je istoveten z: EN ISO 11137-1:2015/A2:2019
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 11137-1:2015/A2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Sterilization of health care products - Radiation - Part 1:
Requirements for development, validation and routine
control of a sterilization process for medical devices -
Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-
1:2006/Amd 2:2018)
Stérilisation des produits de santé - Irradiation - Partie Sterilisation von Produkten für die
1: Exigences relatives à la mise au point, à la validation Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen
et au contrôle de routine d'un procédé de stérilisation an die Entwicklung, Validierung und Lenkung der
pour les dispositifs médicaux - Amendement 2: Anwendung eines Sterilisationsverfahrens für
Révision de 4.3.4 et de 11.2 (ISO 11137-1:2006/Amd Medizinprodukte - Änderung 2 (ISO 11137-
2:2018) 1:2006/Amd 2:2018)
This amendment A2 modifies the European Standard EN ISO 11137-1:2015; it was approved by CEN on 4 November 2019.
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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-1:2015/A2:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices
[OJ L 189] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be
covered. 7
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L
331] aimed to be covered . 9
Annex ZD (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 11
Annex ZE (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 14
European foreword
This document (EN ISO 11137-1:2015/A2:2019) 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 11137-1:2015 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2020, and
conflicting national standards shall be withdrawn at the latest by May 2020.
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 modifies EN ISO 11137-1:2006/Amd 1:2013 with a revised European Foreword and
European Annexes ZA, ZB and ZC, and additional European Annexes ZD and ZE.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s) and Regulation(s), see informative Annex ZA, ZB, ZC, ZD and ZE,
which are an integral part of this document.
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, ZB, ZC, ZD or ZE, 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.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10012-1 EN ISO 10012:2003 ISO 10012:2003
ISO 11137-2 EN ISO 11137-2:2015 ISO 11137-2:2013
ISO 11737-1 EN ISO 11737-1:2006 ISO 11737-1:2006
ISO 11737-2:2009 EN ISO 11737-2:2009 ISO 11737-2:2009
ISO 13485:2003 EN ISO 13485:2016 ISO 13485:2016
NOTE Some standards normatively referred to by EN ISO 11137-1/Amd 2:2019 are undated. These referred
standards also include normative references to other dated and undated standards. For undated normative
references, it should always be assumed that the latest edition applies.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11137-1:2006/Amd 2:2018 has been approved by CEN as EN ISO 11137-
1:2015/A2:2019 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical
devices [OJ L 189] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request
M/BC/CEN/89/9 to provide one voluntary means of conforming to essential requirements of Council
Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating
to active implantable medical devices [OJ L 189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 10of 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 Annex I of Directive
90/385/EEC [OJ L 189]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 90/385/EEC
7 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the development,
validation and routine control of a
sterilization process using radiation
for medical devices, including
requirements that the sterilized
medical device is safe and performs
as intended after sterilization. This
Essential Requirement is addressed
only with regard to devices for
which sterilization by irradiation is
appropriate.
This relevant Essential 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 sterilization by radiation
are not covered.
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.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169]
aimed to be covered
This European Standard has been prepared under a Commission's standardization request
M/BC/CEN/89/9 to provide one voluntary means of conforming to essential requirements of Council
Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 ZB 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 ZB.1, it means that it is not addressed by this
European Standard.
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