SIST EN ISO 11607-2:2020/A1:2024

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/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 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens - Änderung 1 (ISO 11607-2:2019/Amd 1:2023)

No scope available

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage - Amendement 1: Application de la gestion des risques (ISO 11607-2:2019/Amd 1:2023)

Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A1: Uporaba obvladovanja tveganja (ISO 11607-2:2019/Amd 1:2023)

General Information

• Status: Published
• Public Enquiry End Date: 19-Oct-2022
• Publication Date: 11-Jan-2024
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-Dec-2023
• Due Date: 11-Feb-2024
• Completion Date: 12-Jan-2024
• 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
• Directive: 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
• Mandate: 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: EN ISO 11607-2:2020/A1:2023 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)

Relations

• Amends: SIST EN ISO 11607-2:2020 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
• Effective Date: 01-Feb-2024

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11607-2:2020/A1:2024
01-februar-2024
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A1:
Uporaba obvladovanja tveganja (ISO 11607-2:2019/Amd 1:2023)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes - Amendment 1: Application of risk
management (ISO 11607-2:2019/Amd 1:2023)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens - Änderung 1 (ISO 11607-2:2019/Amd 1:2023)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage - Amendement 1:
Application de la gestion des risques (ISO 11607-2:2019/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020/A1:2023
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2020/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 11607-2:2020/A1:2024

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SIST EN ISO 11607-2:2020/A1:2024


EN ISO 11607-2:2020/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2023
EUROPÄISCHE NORM
ICS 11.080.30
English Version

Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes - Amendment 1: Application of risk
management (ISO 11607-2:2019/Amd 1:2023)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 2: Exigences de validation pour les sterilisierende Medizinprodukte - Teil 2:
procédés de formage, scellage et assemblage - Validierungsanforderungen an Prozesse der
Amendement 1: Application de la gestion des risques Formgebung, Siegelung und des Zusammenstellens -
(ISO 11607-2:2019/Amd 1:2023) Änderung 1 (ISO 11607-2:2019/Amd 1:2023)
This amendment A1 modifies the European Standard EN ISO 11607-2:2020; 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 11607-2:2020/A1:2023 E
worldwide for CEN national Members.

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SIST EN ISO 11607-2:2020/A1:2024
EN ISO 11607-2:2020/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. 10
2

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SIST EN ISO 11607-2:2020/A1:2024
EN ISO 11607-2:2020/A1:2023 (E)
European foreword
This document (EN ISO 11607-2:2020/A1:2023) has been prepared by Technical Committee ISO/TC
198 "Sterilization of health ca
...

SLOVENSKI STANDARD
SIST EN ISO 11607-2:2020/oprA1:2022
01-oktober-2022
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A1 (ISO
11607-2:2019/DAM 1:2022)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM
1:2022)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens - Änderung 1 (ISO 11607-2:2019/DAM 1:2022)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage - Amendement 1 (ISO
11607-2:2019/DAM 1:2022)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020/prA1
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2020/oprA1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11607-2:2020/oprA1:2022

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SIST EN ISO 11607-2:2020/oprA1:2022
DRAFT AMENDMENT
ISO 11607-2:2019/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-08-02 2022-10-25
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
AMENDMENT 1
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage
AMENDEMENT 1
ICS: 11.080.30
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 11607-2:2019/DAM 1:2022(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 2022

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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)
DRAFT AMENDMENT
ISO 11607-2:2019/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:

Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
AMENDMENT 1
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage
AMENDEMENT 1
ICS: 11.080.30
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO 11607-2:2019/DAM 1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)
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 ca
...