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EN ISO 11607-1:2020/A1:2023

(Amendment)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

2021-11-09-JO-Following roundtable discussion on 2021-11-09 between EC desk officer, CCMC and CEN/TC 102, it was agreed that the assessment at ENQ will be performed by the Medical Device EC desk officer for a finale assessment at Enquiry. If positive, CEN/TC 102 may decide to skip the Formal Vote and proceed to publication.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme - Änderung 1 (ISO 11607-1:2019/Amd 1:2023)

No scope available

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement 1: Application de la gestion des risques (ISO 11607-1:2019/Amd 1:2023)

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A1: Uporaba obvladovanja tveganj (ISO 11607-1:2019/Amd 1:2023)

General Information

Status
Published
Publication Date
24-Oct-2023
ICS
11.080.30 - Sterilized packaging
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 4 - Packaging materials
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
25-Oct-2023
Completion Date
25-Oct-2023
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
Mandate
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN ISO 11607-1:2020/A1:2024 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

Relations

Amends
EN ISO 11607-1:2020 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Effective Date
10-Jun-2020

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EN ISO 11607-1:2020/A1:2024 - BARVEEN ISO 11607-1:2020/A1:2024 - BARVE
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11607-1:2020/A1:2024
01-marec-2024
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A1: Uporaba
obvladovanja tveganj (ISO 11607-1:2019/Amd 1:2023)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems - Amendment 1: Application of risk
management (ISO 11607-1:2019/Amd 1:2023)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme -
Änderung 1 (ISO 11607-1:2019/Amd 1:2023)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage -
Amendement 1: Application de la gestion des risques (ISO 11607-1:2019/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020/A1:2023
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020/A1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11607-1:2020/A1:2024

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SIST EN ISO 11607-1:2020/A1:2024


EN ISO 11607-1:2020/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2023
EUROPÄISCHE NORM
ICS 11.080.30
English Version

Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems - Amendment 1: Application of risk
management (ISO 11607-1:2019/Amd 1:2023)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage - Amendement 1: Application de la gestion und Verpackungssysteme - Änderung 1 (ISO 11607-
des risques (ISO 11607-1:2019/Amd 1:2023) 1:2019/Amd 1:2023)
This amendment A1 modifies the European Standard EN ISO 11607-1:2020; it was approved by CEN on 12 September 2023.

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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2020/A1:2023 E
worldwide for CEN national Members.

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SIST EN ISO 11607-1:2020/A1:2024
EN ISO 11607-1:2020/A1:2023 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 9

2

---------------------- Page: 4 ----------------------
SIST EN ISO 11607-1:2020/A1:2024
EN ISO 11607-1:2020/A1:2023 (E)
European foreword
This document (EN ISO 11607-1:2020/A1:2023) has been prepared by Technical Committee ISO/TC
198 "Sterilizat
...

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