SIST EN ISO 11135:2014/A1:2020

SLOVENSKI STANDARD
01-februar-2020
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke - Dopolnilo A1: Revizija dodatka E (ISO 11135:2014/Amd 1:2018)
Sterilization of health-care products - Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization process for medical devices
- Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd
1:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid -Anforderungen an
die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens
für Medizinprodukte - Änderung 1 (ISO 11135:2014/Amd 1:2018)
Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de
validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs
médicaux - Amendement 1: Révision de l'Annexe E, Libération d'un lot unique (ISO
11135:2014/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 11135:2014/A1:2019
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 11135:2014/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Sterilization of health-care products - Ethylene oxide -
Requirements for the development, validation and routine
control of a sterilization process for medical devices -
Amendment 1: Revision of Annex E, Single batch release
(ISO 11135:2014/Amd 1:2018)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die
Exigences de développement, de validation et de Gesundheitsfürsorge - Ethylenoxid -Anforderungen an
contrôle de routine d'un processus de stérilisation die Entwicklung, Validierung und Lenkung der
pour des dispositifs médicaux - Amendement 1: Anwendung eines Sterilisationsverfahrens für
Révision de l'Annexe E, Libération d'un lot unique (ISO Medizinprodukte - Änderung 1 (ISO 11135:2014/Amd
11135:2014/Amd 1:2018) 1:2018)
This amendment A1 modifies the European Standard EN ISO 11135:2014; it was approved by CEN on 6 November 2019.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 11 December 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 NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

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 11135:2014/A1:2019 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 11135:2014/A1:2019) 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 11135:2014 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 11135:2014 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 EN ISO
ISO standard
ISO 10012 EN ISO 10012:2003 ISO 10012:2003
ISO 10993-7 EN ISO 10993-7:2008 ISO 10993-7:2008
ISO 11138-1:2006 EN ISO 11138-1:2006 ISO 11138-1:2006
ISO 11138-2:2009, EN ISO 11138-2:2009 ISO 11138-2:2009
ISO 11140-1 EN ISO 11140-1:2014 ISO 11140-1:2014
ISO 11737-1 EN ISO 11737-1:2018 ISO 11737-1:2018
ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009
ISO 13485:2003/Cor 1:2009 EN ISO 13485:2016 ISO 13485:2016

NOTE Some standards normatively referred to by EN ISO 11135:2014/A1:2019 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 11135:2014/Amd 1:2018 has been approved by CEN as EN ISO 11135:2014/A1:2019
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 for medical
devices using ethylene oxide,
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 ethylene oxide 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 ethylene
oxide 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.
Table ZB.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 93/42/EEC
8.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the development,
validation and routine control of a
sterilization process for medical
devices using ethylene oxide,
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 ethylene oxide 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 ethylene
oxide are not covered.
8.4 4,5,6,7,8,9,10,11,12 This relevant Essential Requirement
is only partly addressed in this
European Standard. This Essential
Requirement is addressed only with
regard to devices for which
sterilization by ethylene oxide is
appropriate. Aspects of manufacture
other than those related to
sterilization by ethylene oxide 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 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
This European standard has been prepared under a Commission’s standardisation request, M/252,
concerning the development of European standards relating to in vitro diagnostic medical devices, to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [OJ L
331].
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 ZC.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 98/79/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 Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7of the Directive.
NOTE 3 This Annex ZC 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 ZC.1, it means that it is not addressed by this
European Standard.
Table ZC.1 — Correspondence between this European Standard and Annex I of Directive
98/79/EC [OJ L 331]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 98/79/EC
B.2.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the development,
validation and routine control of a
sterilization process for medical
devices using ethylene oxide,
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 ethylene oxide 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 ethylene
oxide are not covered.
B.2.4 4,5,6,7,8,9,10,11,12 This relevant Essential
requirement is addressed only
with regard to:
sterilization, not covering other
special microbiological state
devices for which sterilization
by ethylene oxide is
appropriate
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 ZD
(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 a Commission’s standardisation request 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].
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 ZD.1 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.
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 a
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