EN ISO 11607-1:2020/A1:2023

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

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.

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

European foreword
This document (EN ISO 11607-1:2020/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 11607-1:2020 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 11607-1:2019/Amd 1:2023 has been approved by CEN as EN ISO 11607-
1:2020/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)
Remarks / Notes
Requirements of
of this EN
Regulation (EU) 2017/745
1 6.1.1 (including Partially covered: Covered for the packaging of
Annex F), 6.1.2, 6.1.3, sterile devices making sure that the sterile

6.1.4, 6.1.5, 6.1.6, packaging is safe for its intended purpose by
6.1.8, 6.2.1, 6.2.2, applying risk management considering the
6.2.3, 6.2.4 (if generally acknowledged state of the art.
applicable), 6.2.5
Does not cover the weighing against the benefits
to the patient as this needs to consider the
specific intended purpose of the packaged device
and cannot be covered by sterile packaging alone.
3 4.2, Annex F Partially covered: Covered for sterile packaging
as the focus of EN ISO 11607-1:2020/A1:2023 is

to provide a framework for applying risk
management to SBSs.
Does not cover the benefits-risk ratio to the
patient as this needs to consider the specific
intended purpose of the packaged 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 11607-1:
2020/A1:2023, GSPR 3 (f) only covered for
production phase and if post-production
information is available, to determine if risks are
controlled appropriately.
4 5.1.10, 6, 7.5, 8, 10, Partially covered: Applying this principle for
maintenance of sterility through rigorous
Annex F.7
performance and stability testing and by
qualification of materials, design with systematic
risk reduction, process development to minimize
risk.
Addresses also instructions for use and label as
relevant for integrity inspections, aseptic
presentation and for reusable materials and/or
reusable preformed sterile barrier systems.
5 6.1.2, 6.2.3, 7 Partially covered: GSPR 5 (a) is only addressed
partially, ergonomic features not directly

addressed
GSPR 5 (b) is addressed as design factors include
user requirements and environment for
packaging, packaging usability evaluation is a test
General Safety and
Clause(s) / sub-
Performance
clause(s)
Remarks / Notes
Requirements of
of this EN
Regulation (EU) 2017/745
that will address ergonomic features for aseptic
presentation (Clause 7).
6 6.1.6, 8 Partially covered for sterile packaging and
maintenance of sterility, shelf-life aging studies,

all from a packaging point of view.
7 6.1.6, 8 Partially covered for sterile packaging and
maintenance of sterility.
10 Not covered.
11.1 4.2, Annex F, 6.1.1, Partially covered: GSPR 11.1 (b) and (d) are
6.1.2, 6.1.3 6.1.6, covered only in respect of the function of the

6.1.8, 7 sterile barrier system(s) to protect the sterility of
the medical device from the point of sterilisation
to the point of use, and to allow for aseptic
presentation. The standard includes a way to
evaluate the packaging design in terms of
usability to provide supportive evidence for GSPR
11.1 (b) covering the aspect of aseptic
presentation.
The standard includes a packaging performance
and stability testing approach for sterile barrier
system integrity as supportive evidence for GSPR
11.1 (d).
GSPR 11.1 (a), and 11.1 (c) are not covered.
The standard does not address infection risks
rd
related to 3 parties or other persons.
11.2 Applicable only for reusable sterilization
containers and reusable materials.

No presumption of conformity.
11.4 4.2, 4.4, 5.2, 6.1.3, Partially covered: GSPR 11.4 is covered only in
6.1.4, 6.1.6, 6.1.9, 8.1, respect of the function of sterile barrier system(s)

8.2.1, 8.2.2, 8.3.1, to protect the sterility of the device from the
8.3.2, 8.3.3, 8.3.4, point of sterilisation to the point of use and to
8.3.5, 8.3.6 allow for aseptic presentation. 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 does not include
criteria.
11.5 4.2, 4.4, 5.3.1, 5.3.2, Partially covered: GSPR 11.5 is covered only in
5.3.3, 6.1.2, 6.1.3, respect of the compatibility between the

General Safety and
Clause(s) / sub-
Performance
clause(s)
Remarks / Notes
Requirements of
of this EN
Regulation
...