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SIST EN ISO 11135:2014/A1:2020

(Amendment)

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)

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
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Dec-2019
Due Date
15-Feb-2020
Completion Date
13-Jan-2020
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
90/385/EEC - 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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
EN ISO 11135:2014/A1:2019 - 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)

Relations

Amends
SIST EN ISO 11135:2014 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Effective Date
01-Oct-2017
Revised
oSIST prEN ISO 11135:2023 - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)
Effective Date
29-Jul-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.
...

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