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)

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 assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

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)

- No scope available -

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)

General Information

Status
Published
Public Enquiry End Date
19-Oct-2017
Publication Date
12-Jan-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Dec-2019
Due Date
15-Feb-2020
Completion Date
13-Jan-2020

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SLOVENSKI STANDARD
SIST EN ISO 11135:2014/A1:2020
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
SIST EN ISO 11135:2014/A1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11135:2014/A1:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 11135:2014/A1:2020
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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

---------------------- Page: 4 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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.
---------------------- Page: 6 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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.
---------------------- Page: 7 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)

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.
---------------------- Page: 8 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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.
---------------------- Page: 9 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)

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.
---------------------- Page: 10 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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.
---------------------- Page: 11 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)

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.
---------------------- Page: 12 ----------------------
SIST EN ISO 11135:2014/A1:2020
EN ISO 11135:2014/A1:2019 (E)
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
...

SLOVENSKI STANDARD
SIST EN ISO 11135:2014/oprA1:2017
01-oktober-2017
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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/DAmd
1:2017)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid -Anforderungen an

die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens

für Medizinprodukte (ISO 11135:2014/DAM 1:2017)

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: Titre manque (ISO 11135:2014/DAmd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 11135:2014/prA1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11135:2014/oprA1:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11135:2014/oprA1:2017
---------------------- Page: 2 ----------------------
SIST EN ISO 11135:2014/oprA1:2017
DRAFT AMENDMENT
ISO 11135:2014/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-08-08 2017-10-30
Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
AMENDMENT 1

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
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 11135:2014/DAM 1:2017(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 2017
---------------------- Page: 3 ----------------------
SIST EN ISO 11135:2014/oprA1:2017
ISO 11135:2014/DAM 1:2017(E) ISO/DIS 11135:2014 Amd.1
Contents Page

Foreword ............................................................................................................................................................ iv

Amendment 1: Revision of Annex E, Single batch release ............................................................................ 1

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
© ISO 2017 – All rights reserved iii
---------------------- Page: 4 ----------------------
SIST EN ISO 11135:2014/oprA1:2017
ISO/DIS 11135:2014 Amd.1
Contents Page

Foreword ............................................................................................................................................................ iv

Amendment 1: Revision of Annex E, Single batch release ............................................................................ 1

© ISO 2017 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST EN ISO 11135:2014/oprA1:2017
ISO/DIS 11135:2014 Amd.1
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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 11135:2014 Amd.1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care

products.
This amendment modifies ISO 11135:2014, Annex E.
iv © ISO 2017 – All rights reserved
---------------------- Page: 6 ----------------------
SIST EN ISO 11135:2014/oprA1:2017
ISO/DIS 11135:2014 Amd.1
DRAFT INTERNATIONAL STANDARD ISO/DIS 11135:2014 Amd.1
Sterilization of health-care products — Ethylene oxide —
Foreword
Requirements for the development, validation and routine

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

control of a sterilization process for medical devices

(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 AMENDMENT 1: Revision of Annex E, Single batch release

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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

Page 74 and page 75 - Replace Annex E with:

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

Annex E

ISO 11135:2014 Amd.1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care

products. (normative)
Single Batch Release
This amendment modifies ISO 11135:2014, Annex E.
E.1 General

This annex specifies the requirements for the release of product from a single batch for a sterilization process

where there is only sufficient product to comprise a single sterilization load, for example, during research and

development of new product or for clinical trial product. This approach is not intended for routine sterilization.

Single batch release data can be used in validation of the sterilization process under an approved protocol.

NOTE Attention is drawn to the possible existence of national or regional regulations for clinical product. Where such

regulations are in force, the requirements of these regulations apply.
E.2 Procedure

E.2.1 Assess the packaged product to determine if it can be assigned to an existing product family for

sterilization purposes. This assessment considers product composition, design, packaging, bioburden and

load density. The outcome of this assessment, including the rationale for decisions reached, is documented.

E.2.2 If the packaged product can be assigned to an existing product family refer to 12.5.2 and D.12.5.11.1.

E.2.3 Where there is no existing product family(ies), or where packaged product cannot be assigned to an

existing product family, the rationale for selection and quantity of the samples shall be documented.

E.2.3.1 A representative number of samples taken fr
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