EN ISO 11607-2:2020/A1:2023

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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
European foreword
This document (EN ISO 11607-2:2020/A1:2023) has been prepared by Technical Committee ISO/TC
198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This Amendment to the European Standard EN ISO 11607-2:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2024, and
conflicting national standards shall be withdrawn at the latest by April 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), see informative Annex ZA and Annex ZB, which
are integral parts of this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
Endorsement notice
The text of ISO 11607-2:2019/Amd 1:2023 has been approved by CEN as EN ISO 11607-
2:2020/A1:2023 without any modification.

Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall indicated in the Annex Z. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in
this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
1 4.2, Annex B Partially covered: Covers this GSPR for the packaging
of sterile medical devices through process
5.1, 5.2, 5.3, 5.4,
development, validation of the sealing and assembly
5.5, 5.6, 5.7,
process, production control by applying risk
6.1, 6.2, 6.3,
management to all these phases.
if applicable 7, 8
Does not cover the weighing against the benefits to
the patient as this needs to consider the specific
intended purpose of the medical device and cannot
be covered by sterile packaging alone.
3 4.2, Annex B Partially covered: Covered for sterile packaging by
providing a framework for applying risk

management to sterile packaging over the phases of
design, process development, validation and
production.
Does not cover the benefits-risk ratio to the patient
as this needs to consider the specific intended
purpose of the medical device and cannot be covered
by sterile packaging alone.
Evaluation of production and post market
surveillance information under GSPR 3 (e) against
overall risk and benefit risk-ratio is not covered, not
part of the scope of EN ISO 11607-2:2020/A1:2023.
GSPR 3 (f) only covered (see B.2) for production
phase and if post-production information is
available, to determine if risks are controlled
appropriately.
4 4.2, Annex B Partially covered: Applying this principle for
maintenance of sterility through rigorous

performance and stability testing and by
qualification of materials, design with systematic
risk reduction, process development to minimize
risk.
5  Not covered: Applicable only to EN ISO 11607-
1:2020/A1:2023.
6 Not covered: Applicable only to EN ISO 11607-
1:2020/A1:2023.
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
7 4.2, Annex B, Partially covered for sterile packaging by validating
the forming, assembly and sealing process.
5.1, 5.2, 5.3, 5.4,
5.5, 5.6, 5.7,
6.1, 6.2, 6.3,
if applicable: 7, 8
10 Not covered.
11.1 4.2, Annex B Partially covered: GSPR 11.1 (b) and (d) are covered
only in respect of the function of the sterile barrier
5.1, 5.2, 5.3, 5.4,
system(s) to protect the sterility of the device from
5.5, 5.6, 5.7,
the point of sterilisation to the point of use and to
6.1, 6.2, 6.3,
allow for aseptic presentation and only if the
if applicable: 7, 8
requirements of EN ISO 11607-1:2020/A1:2023 are

met as well.
GSPR 11.1 (a), and 11.1 (c) are not covered.
Clause 5 addresses the requirements of packaging
processes and the way to validate.
Subclause 5.7 addresses management of changes and
revalidations to maintain the process in the state of
control.
SBS assembly requirements are listed in Clause 6.
Specifics for reusable SBS are covered in Clause 7.
Specifics for sterile fluid-path SBS are covered in
Clause 8.
11.2 Not covered: Applicable only to reusable sterilization
containers and reusable materials (EN ISO 11607-

1:2020/A1:2023).
No presumption of conformity.
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
11.4 4.2, Annex B, 4.3, Partially covered: GSPR 11.4 is covered only in
respect of the function of sterile barrier system(s) to
5.1, 5.2, 5.3, 5.4,
protect the sterility of the device from the point of
5.5, 5.6, 5.7
sterilisation to the point of use and to allow for
6.1, 6.2, 6.3,
aseptic presentation but only if the requirements of
if applicable: 8
EN ISO 11607-1:2020/A1:2023 are met as well

(requirements for materials, sterile barrier systems
and packaging systems). In this respect damage to
the “packaging which is intended to maintain their
sterile condition” is taken to mean damage to or loss
of integrity of the sterile barrier system only.
Regarding the aspects of “clearly evident integrity of
the packaging”, this document includes
considerations for seals and closure quality
properties as supportive requirements for
compliance.
Clause 5 addresses the requirements of packaging
processes and the way to validate.
Subclause 5.7 addresses management of changes and
revalidations to maintain the process in the state of
control.
SBS assembly requirements are listed in clauses 6.
Specifics for
...