SIST EN ISO 11607-1:2020/A1:2024
(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
Relations
Standards Content (Sample)
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 (EU) 2017/745
6.1.5, 6.1.6, 6.1.9, packaging and the selected sterilisation processes
and packaging system validation consisting of
8.1, 8.2.1, 8.2.2, 8.3.1,
usability evaluation, performance testing and
8.3.2, 8.3.3, 8.3.4,
sterile barrier system stability testing as well as
8.3.5, 8.3.6, 9.1
validation of forming, sealing and assembling
processes following
EN ISO 11607-2:2020/A1:2023.
11.6 Not covered.
11.7 Not covered.
11.8 Not covered.
13 Not covered.
22.1 7 Partially covered: No specific requirements for
lay persons.
User and environment of use are factors to
include into the design and the standard includes
a way to evaluate the packaging design in terms
of usability to provide supportive evidence for
covering the aspect of aseptic presentation.
22.2 7 Partially covered: No specific requirements for
lay persons, user and environment of use are
factors to include into the design and the
standard includes a way to evaluate the
packaging design in terms of usability to provide
supportive evidence for covering the aspect of
aseptic presentation.
No requirements for risk from unintended cuts
and pricks such as needle stick injuries.
23.3 Not covered.
(a), but refers to EN ISO 15223-1 for symbols.
23.4 Not covered.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 5636-5 ISO 5636-5:2013 Paper and board — Determination None
of air permeance and air resistance
For applicable standard
(medium range) — Part 5: Gurley
edition see Column 2
method
ISO 11607-2 ISO 11607-2:2019 Packaging for terminally sterilized EN ISO 11607-2:2020
medical devices — Part 2:
ISO 11607- EN ISO 11607-
Validation requirements for
2:2019/Amd1:202 2:2020/A11:2022
forming, sealing and assembly
EN ISO 11607-
processes
2:2020/A1:2023
The documents listed in the Column 1 of table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
Annex ZB
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 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) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance 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 ZB.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 standard differs from a definition of the same term set out in Regulation (EU)
2017/746, the differences shall be indicated in the Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/746, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
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 In vitro Diagnostic
Regulation (EU) 2017/746).
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) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘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’, ‘prevented’ 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, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZB.1, it means that it is
not addressed by this European Standard.
Table ZB.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/746 [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
2017/746
1 6.1.1 (including Partially covered: Covered for the packaging of
Annex F), 6.1.2, sterile devices making sure that the sterile
6.1.3, 6.1.4, 6.1.5, packaging is safe for its intended purpose by
6.1.6, 6.1.8, 6.2.1, applying risk management considering the
6.2.2, 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.
Post market surveillance under GSPR 3 (e) is
not covered, not part of the scope of EN ISO
11607-1: 2020/A1:2023, GSPR 3 (f) only
covered for production phase information.
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 that will address ergonomic features for
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of
Remarks / Notes
Regulation (EU)
of this EN
2017/746
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 (a) and (c) 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 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 (a) 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 (c).
GSPR 11.1 (b) is not covered.
The standard does not address infection risks
rd
related to 3 parties or other persons.
11.2 4.2, 4.4, 5.2, 6.1.3, Partially covered: GSPR 11.2 is covered only in
6.1.4, 6.1.6, 6.1.9, respect of the function of sterile barrier
8.1, 8.2.1, 8.2.2, system(s) to protect the sterility of the device
8.3.1, 8.3.2, 8.3.3, from the point of sterilisation to the point of
8.3.4, 8.3.5, 8.3.6 use and to 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.
11.3 4.2, 4.4, 5.3.1, 5.3.2, Partially covered: GSPR 11.3 is covered only in
5.3.3, 6.1.2, 6.1.3, respect of the compatibility between the
6.1.5, 6.1.6, 6.1.9, packaging and the selected sterilisation
8.1, 8.2.1, 8.2.2, processes and packaging system validation
8.3.1, 8.3.2, 8.3.3, consisting of usability evaluation, performance
8.3.4, 8.3.5, 8.3.6, testing and sterile barrier system stability
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/746
9.1 testing as well as validation of forming, sealing
and assembling processes following EN ISO
11607-2:2020/A1:2023.
11.4. Not covered.
11.5. Not covered.
11.6. Not covered.
12. Not covered.
19.1 7 Partially covered: No specific requirements for
lay persons, user and environment of use are
factors to include into the design and the
standard includes a way to evaluate the
packaging design in terms of usability to
provide supportive evidence for covering the
aspect of aseptic presentation.
19.2 7 Partially covered: No specific requirements for
lay persons, user and environment of use are
factors to include into the design and the
standard includes a way to evaluate the
packaging design in terms of usability to
provide supportive evidence for covering the
aspect of aseptic presentation.
20.3 Not covered: EN ISO 11607-1:2020/A1:2023
covers GSPR 20.3 (a) but refers to ISO 15223-1
for symbols.
20.4 Not covered.
The documents listed in the Column 1 of table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 11607-1
Second edition
2019-02
AMENDMENT 1
2023-09
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging
systems
AMENDMENT 1: Application of risk
management
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
Reference number
ISO 11607-1:2019/Amd.1:2023(E)
ISO 11607-1:2019/Amd.1:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 11607-1:2019/Amd.1:2023(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 carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 102, Sterilizers for medical purposes, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 11607 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iii
ISO 11607-1:2019/Amd.1:2023(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
AMENDMENT 1: Application of risk management
Clause 1, Scope
Delete the following text:
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in
sterile barrier systems and sterilized.
3.7
Replace term and definition entry with the following:
3.7
labelling
label, instructions for use and any other information that is related to identification, technical
description, intended purpose and proper use of the medical device, but excluding shipping documents
[SOURCE: ISO 13485:2016, 3.8]
Clause 3
Add the following term entries:
3.32
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 63: 2019, 3.2]
3.33
intended use
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, use environment, and operating principle are typical elements of the intended use.
Note 2 to entry: "intended use" is used in the United States and "intended purpose" is used in the European
Union. These terms have essentially the same meaning. Throughout this document, the term "intended use" is
used.
[SOURCE: ISO/IEC Guide 63:2019, 3.4, modified — "intended purpose" was added to term, Note 2 to
entry was added.]
ISO 11607-1:2019/Amd.1:2023(E)
3.34
process
set of interrelated or interacting activities that use inputs to deliver an intended result
Note 1 to entry: Whether the "intended result" of a process is called output, product or service depends on the
context of the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are
generally the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.
[SOURCE: ISO 9000:2015, 3.4.1, modified — Notes to entry 4, 5 and 6 have been deleted]
3.35
reasonably foreseeable misuse
use of a product or system in a way not intended by the manufacturer, but which can result from readily
predictable human behaviour
Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and
professional users.
Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional.
[SOURCE: ISO/IEC Guide 63:2019, 3.8]
3.36
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO/IEC Guide 63:2019, 3.10, modified — Note 1 to entry has been deleted]
4.2
Replace the text with the following:
4.2 Risk management
A risk management process conforming with the requirements of Annex F shall be implemented.
NOTE Annex F details requirements for the packaging risk management process, which is
a subset of risk management for medical devices. Annex G provides background information on
risk management for medical device packaging. Additional requirements for risk management
of medical devices including sterile packaging can be specified by some regulatory jurisdictions.
ISO 14971 covers application of risk management to medical devices and guidance on the application
of ISO 14971 can be found in ISO/TR 24971.
4.4.3, NOTE
Replace with the following:
NOTE Annex B contains a list of test methods. Publication of a method by a standards body
does not make it validated by the user of the test method.
6.1.1
Replace the text with the following:
6.1.1 The packaging system shall be designed to minimize the risks, as specified in Annex F, to the
user and patient during intended use and/or reasonably foreseeable misuse.
ISO 11607-1:2019/Amd.1:2023(E)
NOTE See also 4.2 as well as Annex G for guidance on packaging risk management.
Bibliography
Add the following entries to the Bibliography:
[170] ISO/TR 24971, Medical devices — Guidance on the application of ISO 14971
[171] ISO/IEC Guide 63:2019, Guide to the development and inclusion of aspects of safety in International
Standards for medical devices
[172] ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
Annex F, Annex G
Add the following new Annexes F and G after Annex E.
ISO 11607-1:2019/Amd.1:2023(E)
Annex F
(normative)
Risk management
F.1 Risk management process
An ongoing risk management process applicable to packaging systems shall be established,
implemented, documented and maintained. This process shall include:
a) identification of hazards and hazardous situations associated with the packaging system (see F.4,);
b) estimation (see F.5) and evaluation (see F.6) of the associated risks;
c) risk control (see F.7);
d) monitoring of the effectiveness of the risk control measures (see F.8).
F.2 Application of the risk management process
This process shall apply throughout the phases of design and development, validation, production and
post-production of the packaging system. The following shall be included:
a) Design and development phase
— Packaging system design (see Clause 6).
NOTE G.2.7.4 provides guidance on general requirements for design and G.2.8.2 provides guidance on
usability for aseptic presentation. Sealing and assembly process development is addressed in G.2.7.5
and ISO 11607-2.
b) Validation phase
— Performance and stability testing (see Clause 8 and G.2.8.3);
— Usability evaluation (see Clause 7 and G.2.8.2).
NOTE Process validation is addressed in G.2.8.4 and ISO 11607-2.
c) Production phase
— Packaging system changes (see Clause 9 and G.2.10).
NOTE Process control and monitoring, assembly, use of reusable sterile barrier systems, process
changes and revalidation are addressed in ISO 11607-2 and G.2.9.
d) Post-production phase
— If post-production information is available on the performance of the packaging system, it
shall be analysed to determine if risks are controlled appropriately or if unidentified hazards
or hazardous situations are present. Consequent corrective and preventive actions shall be
implemented as needed.
NOTE 1 The corrective and preventive actions can include redesign, additional controls or
revalidation.
ISO 11607-1:2019/Amd.1:2023(E)
NOTE 2 This document does not include requirements for collecting post-production
information or for reporting adverse events and field safety corrective actions to authorities or other
related activities. This is typically established based on the requirements of the quality management
system.
F.3 Risk management plan
F.3.1 General
A risk management plan shall be documented in accordance with the risk management process for each
packaging system including at least the following:
— the scope of the planned risk management activities;
— criteria for risk acceptability;
— activities for verification of the implementation and effectiveness of risk control measures.
Risk management plans and related records and documentation for packaging systems may be
combined with those for the medical device.
F.3.2 Criteria for risk acceptability
Criteria for risk acceptability shall be developed based on the following principles (see also G.2.6):
— align with the device to be packaged and its intended use;
— align with the intended use environment and related aseptic presentation;
— differentiate between essential design requirements for functionality (e.g. integrity) and lesser
impact requirements (e.g. dimensional variance);
— consider the hazards defined in Table F.1, taking into account generally acknowledged state-of-the-
art acceptance criteria as applicable (e.g. biocompatibility).
NOTE Local regulatory requirements can provide mandatory criteria for risk acceptability, or these criteria
can be based on the generally accepted state-of- the-art.
F.3.3 Similar packaging systems
Risk management plans for similar packaging systems may be combined, in which case the rationale for
these similarities shall be documented.
F.4 Specific hazards and hazardous situations to be addressed
For each of the hazards below, considering both normal and fault conditions, sequences of events shall
be identified, and the resulting hazardous situations shall be evaluated:
— Microbial contamination;
— Chemical contamination;
— Adverse environmental, processing and use conditions;
— Misleading information.
Table F.1 provides examples of hazards and potential relevant factors.
ISO 11607-1:2019/Amd.1:2023(E)
Table F.1 — Hazards and potential relevant factors
Hazard Potential relevant factors
Microbial contamination Airborne, surface or material microbial contamination
Bio-incompatible or toxic materials or components, process residuals (e.g. EO resid-
Chemical contamination uals), incompatibility between device and packaging materials, sterilization process,
labelling system
Exposure to incompatible temperature / pressure / humidity or moisture / UV lighting
/ shock / vibration
(all storage and transport conditions)
Inadequate or uncontrolled manufacturing process including the work environment
Adverse environmental,
Inappropriate sterilization method, inappropriate sterilization process cycle or steri-
processing and use con-
lization process failure
ditions
Use-related activities affecting patient safety including foreseeable misuse, such as
human error
Use-related activities affecting user safety, e.g. involved in transport and storage and
dispensing (e.g. sharp edges, weight)
Disposal factors: contamination, sharp edges, gas from incineration
Label design error
Selection of label material and printing technology leading to incorrect ink transfer
Misleading information
and poor legibility
Mix-ups (e.g. incorrect label, wrong file or information, data)
NOTE For further guidance see G.2.2 on hazards to be addressed, G.2.3 on identification of sequences of
events and G.2.4 on related hazardous situations. Table G.1 provides examples of relationship between hazards,
foreseeable sequences of events and resulting hazardous situations.
F.5 Risk estimation
For each identified hazardous situation, the associated risk(s) shall be estimated using available
information or data.
Hazardous situations shall be assessed based on their probability of occurrence and the potential
severity of related harm. For hazardous situations for which the probability of the occurrence of harm
cannot be estimated, the possible consequences shall be listed for use in risk evaluation and risk control.
The risk estimate may include detectability if the ability to detect the hazardous situation can be
directly assessed.
NOTE See G.2.5 for guidance on risk estimation applied to medical packaging.
F.6 Risk evaluation
Under risk evaluation, estimated risks shall be compared against criteria for risk acceptability defined
in the risk management plan to determine if the risk is acceptable or not and to identify risks to be
controlled.
NOTE See G.2.6 for guidance on risk evaluation applied to medical packaging.
F.7 Risk control
Risks shall be controlled by implementing appropriate measures such that they are reduced to, or
maintained within, levels as defined by the criteria for risk acceptability.
NOTE For further guidance on risk control see G.2.7.
ISO 11607-1:2019/Amd.1:2023(E)
Risk control in packaging system design for terminally sterilized medical devices shall be based on the
following principles in the priority order listed:
a) Eliminate or reduce risks to an
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