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: Überarbeitung von Anhang E, Freigabe einer einzelnen Charge (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
Publication Date
19-Nov-2019
Withdrawal Date
30-May-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
20-Nov-2019
Completion Date
20-Nov-2019

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Standards Content (Sample)

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.
...

SLOVENSKI STANDARD
SIST EN ISO 11135:2014/oprA1:2017
01-oktober-2017
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR(WLOHQRNVLG=DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH'RSROQLOR$5HYL]LMD'RGDWND( ,62'$PG
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.

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SIST EN ISO 11135:2014/oprA1:2017

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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

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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.
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ii © ISO 2017 – All rights reserved
© ISO 2017 – All rights reserved iii

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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

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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 t
...

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