EN ISO 11607-2:2020/prA1

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)

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/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)

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)

General Information

• Status: Not Published
• Publication Date: 01-Sep-2024
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 26-Jun-2023
• Completion Date: 31-Mar-2023
• 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
• Directive: 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
• Mandate: 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: SIST EN ISO 11607-2:2020/oprA1:2022 - 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)

Relations

• Amends: 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

Standards Content (Sample)

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
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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
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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: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
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
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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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 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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

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.

This amendment revises Clause 3 and 4.2 and adds a normative Annex B on risk management.

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 2022 – All rights reserved
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SIST EN ISO 11607-2:2020/oprA1:2022
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
AMENDMENT 1
Introduction
Add the following as the last paragraph:

Amendment 1 expands on the application of risk management throughout the phases of design and

development, validation and production of the packaging system.
Clause 1

Delete the following text from the scope: It is applicable to industry, to health care facilities, and to

wherever medical devices are placed in sterile barrier systems and sterilized.
Clause 2
Correct the normative reference ISO 11607-1:2018 to ISO 11607-1:2019.
Clause 3
Add the following:
3.xx
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 63: 2019, 3.2]
3.xx
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.
[SOURCE: ISO/IEC Guide 63:2019, 3.4]
3.xx
process
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)

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 are deleted]
3.xx
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 deleted]
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

[1]

medical devices and guidance on the application of ISO 14971 can be found in ISO/TR 24971 .

4.4.3
Replace the NOTE to 4.4.3 with the following text:

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.
Annex B
Add the following Annex B after Annex A.
© ISO 2022 – All rights reserved
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(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 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 FMEA is an example of risk analysis tool that is used widely in the industry.

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
— Sealing and assembly process development (see 5.1).
NOTE 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.

b) 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.
c) 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

© ISO 2022 – All rights reserved
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)

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 This can include redesign, additional controls or revalidation.

NOTE 2 ISO 11607-2 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.

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 a minimum

— 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 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:

— aligned with the device to be packaged and its intended use;
— aligned with the intended use environment and related aseptic presentation;

— differentiate between critical and essential design 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.
B.3.3 Similar processes for forming, sealing and assembly

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 evaluated.
— Microbial contamination;
— Chemical contamination;
— Adverse environmental, processing and use conditions;
— Misleading information.
See Table B.1 for examples of hazards and contributing factors:
© ISO 2022 – All rights reserved
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)
Table B.1 — Hazards and contributing factors
Hazard Possible contributing factors
Microbial contami-
Airborne, surface or material microbial contamination
nation
Chemical contami-
process residuals (e.g. EO residual), cleaning agents,
nation
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
Adverse environmen-
environment and human factors
tal, processing and
use conditions
Labeling / printing application inadequate
Misleading informa-
tion
Misallocation (incorrect label, information, data, etc.)
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 of that hazardous

situation 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 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 or reduce risks as far as possible through use of validated and controlled processes for

forming, assembly and sealing;

b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to

risks that cannot be eliminated;

c) provide information and training on risk control measures performed by process operators (e. g.

inspections, maintenance, monitoring, etc).
© ISO 2022 – All rights reserved
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(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 validation

activities, the effectiveness of risk controls is then verified.
© ISO 2022 – All rights reserved
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SIST EN ISO 11607-2:2020/oprA1:2022
ISO 11607-2:2019/DAM 1:2022(E)
Annex ZA
(informative)
Relationship between this European Standard 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 are 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 referenc
...