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SIST EN ISO 11607-2:2020/kprA1:2023

(Amendment)

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/FDAM 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/FDAM 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/FDAM 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/FDAM 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/FDAM 1:2023)

General Information

Status
Not Published
Public Enquiry End Date
19-Oct-2022
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
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
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
10-Jun-2020

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

---------------------- Page: 2 ----------------------
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

---------------------- Page: 3 ----------------------
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: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
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

---------------------- Page: 4 ----------------------
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
...

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