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INTERNATIONAL ISO
STANDARD 11607-2

Second edition
2019-02

AMENDMENT 1
2023-09

Packaging for terminally sterilized

medical devices —
Part 2:
Validation requirements for forming,
sealing and assembly processes
AMENDMENT 1: Application of risk
management
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

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Reference number
ISO 11607-2:2019/Amd.1:2023(E)

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ISO 11607-2:2019/Amd.1:2023(E)

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© 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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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.

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ISO 11607-2:2019/Amd.1:2023(E)

Packaging for terminally sterilized medical devices —

Part 2:
Validation requirements for forming, sealing and assembly
processes
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 packaged
and sterilized.

Clause 2, Normative references

Correct ISO 11607-1:2018 to ISO 11607-1:2019 and ISO 11607-1:2019/Amd 1:2023.

Clause 3
Add the following:
3.29
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 63:2019, 3.2]
3.30
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 were deleted.]
3.31
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 was deleted.]

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ISO 11607-2:2019/Amd.1:2023(E)

4.2
Replace the text with the following:
4.2   Risk management
A risk management process conforming with the requirements of Annex B shall be implemented.
NOTE Annex B details requirements for the risk management process for forming, sealing and
assembly of sterile barrier systems, which is a subset of risk management for medical devices. 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 the NOTE with the following text:
NOTE ISO 11607-1:2019, 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.

Clause 7
Correct ISO 11607-1:2018 to ISO 11607-1:2019

Bibliography
Add the following new entry:
[17] ISO/TR 24971:2020, Medical devices — Guidance on the application of ISO 14971

Annex B
Add the following new Annex B after Annex A.

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ISO 11607-2:2019/Amd.1:2023(E)

Annex B
(normative)

Risk management

B.1 General
An ongoing risk management process shall be established, implemented, documented and maintained
to minimize the risk for the user and the patient. This process shall include:
a) identification of hazards and hazardous situations associated with the forming, sealing and
assembly processes for packaging (see B.4);
b) estimation (see B.5) and evaluation (see B.6) of the associated risks;
c) risk control (see B.7);
d) monitoring the effectiveness of the risk control measures (see B.8).
NOTE ISO/TR 24971:2020, Annex B provides examples of techniques that support risk analysis. FMEA is an
example of a risk analysis tool.

B.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 process for forming, sealing and assembly of sterile barrier systems. The
following shall be included:
a) Design and development phase
— Forming, sealing and assembly process development (see 5.1).
NOTE 1 Process development includes defining required process elements (e.g. sealers, conveyers,
forming equipment, assembly tools). See Annex A for information on process development.

NOTE 2 Packaging system design is addressed in ISO 11607-1.

b) Validation phase
— Process validation (see 5.2, 5.3, 5.4 and 5.5).
NOTE Performance testing, stability testing and usability evaluation are addressed in ISO 11607-1.

c) Production phase
— Process control and monitoring (see 5.6);
— Assembly (see Clause 6);
— Use of reusable sterile barrier systems (see Clause 7) if applicable;
— Process changes and revalidation (see 5.7).
NOTE Packaging system changes are addressed in ISO 11607-1.

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ISO 11607-2:2019/Amd.1:2023(E)

d) Post-production phase
— If post-production information is available, which can be related to the performance of the
process for forming, sealing and assembly of sterile barrier systems, 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.

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.

NOTE 3 For guidance on risk management for medical device packaging see ISO 11607-1:2019/Amd1:​2023,
Annex G.

B.3 Risk management plan

B.3.1 General
A risk management plan shall be documented in accordance with the risk management process for each
process for forming, sealing and assembly of sterile barrier systems 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 forming, sealing and assembly of
sterile barrier systems may be combined with those for the medical device.

B.3.2 Criteria for risk acceptability

Criteria for risk acceptability shall be developed based on the following principles:
— align with the device SBS specification or preformed SBS specification as applicable;
— differentiate between critical and essential requirements (e.g. integrity) and lesser impact
requirements (e.g. dimensional variance);
— consider the hazards defined in Table B.1, taking into account generally acknowledged state-of-the-
art acceptance criteria as applicable.
NOTE 1 Local regulatory requirements can provide mandatory criteria for risk acceptability or these criteria
can be based on the generally accepted state of the art.

NOTE 2 The manufacturing of a preformed SBS will only need a preformed SBS specification.

Risk management plans for similar processes for forming, sealing and assembly of sterile barrier
systems may be combined, in which case the rationale for these similarities shall be documented.

B.4 Specific hazards and hazardous situations to be addressed

For each of the following hazards, considering both normal and fault conditions, sequences of events
shall be identified and the resulting hazardous situations from the process evaluated.
— microbial contamination;
— chemical contamination;

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ISO 11607-2:2019/Amd.1:2023(E)

— adverse environmental and processing conditions;

— misleading information.
See Table B.1 for examples of hazards and contributing factors.

Table B.1 — Hazards and contributing factors

Hazard Possible contributing factors
Microbial contamination Airborne, surface or material microbial contamination
Chemical contamination Process residuals (e.g. lubricants), cleaning agents
Exposure of packaging materials to incompatible temperature / pressure / humidity
Adverse environmental or moisture / UV lighting / shock / vibration
and processing conditions Inadequate or uncontrolled manufacturing process including the work environment
and human factors
Labelling / printing application inadequate
Misleading information
Misallocation (e.g. incorrect label, information, data)

B.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 the 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.

B.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.

B.7 Risk control

Risk 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.
Risk control in packaging system forming, assembly and sealing for terminally sterilized medical
devices shall be based on the following principles in the priority order listed:
a) eliminate and reduce risk through process development as well as consideration of potential design
modifications of packaging or contents, to make the process inherently safe;
b) take adequate measures to control the process (e.g. process monitors, in-process controls, alarms,
alignment aids/fixtures);
c) provide information on potential failure modes to operators and inspect the output.

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ISO 11607-2:2019/Amd.1:2023(E)

B.8 Monitoring effectiveness of risk control measures

The implementation of risk control measures shall be verified.
If both design and manufacturing process outputs meet the acceptance criteria established in process
validation activities, the effectiveness of risk controls is then verified.
Any deviations from desired process performance shall be investigated and the risk analysis reviewed
and adapted as required.

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