EN ISO 11607-1:2020/prA1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/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 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme - Änderung 1 (ISO 11607-1:2019/DAM 1:2022)

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 (ISO 11607-1:2019/DAM 1:2022)

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A1 (ISO 11607-1:2019/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: 05-Apr-2023
• Completion Date: 05-Apr-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 11607-1:2020/oprA1:2022 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)

Relations

• Amends: EN ISO 11607-1:2020 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
• Effective Date: 10-Jun-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11607-1:2020/oprA1:2022
01-oktober-2022
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A1 (ISO
11607-1:2019/DAM 1:2022)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,

sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM

1:2022)

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:

Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme -
Änderung 1 (ISO 11607-1:2019/DAM 1:2022)

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 (ISO 11607-1:2019/DAM 1:2022)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020/prA1
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020/oprA1:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
DRAFT AMENDMENT
ISO 11607-1:2019/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 1:
Requirements for materials, sterile barrier systems and
packaging systems
AMENDMENT 1
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
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 11607-1:2019/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
---------------------- Page: 3 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)
DRAFT AMENDMENT
ISO 11607-1:2019/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
AMENDMENT 1
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
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 11607-1:2019/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
---------------------- Page: 4 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/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 to ISO 11607-1:2019 revises the introduction, Clause 3, 4.2 and 6.1.1 and adds a

normative Annex F on risk management as well as an informative annex G with guidance on packaging

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.
Introduction
Add the following as the last paragraph:
iii
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
AMENDMENT 1

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 3
3.7

Replace term and definition with the definition from ISO 13485:2016, 3.8 as follows:

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]
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]
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)
3.xx
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 are deleted]
3.xx
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.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 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

[1]
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.
6.1.1
Replace the text with the following:
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)

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/purpose and/or reasonably foreseeable misuse.

NOTE 1 The requirement under 6.1.1 combines intended use as used in the United States and

intended purpose which is the term in the European Union. These terms have essentially the same

meaning.

NOTE 2 See also 4.2 as well as Annex G for guidance on packaging risk management.

Annex F, Annex G
Add the following annex F and annex G after Annex E.
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(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,

G.2.1, G.2.2, and G.2.3);

b) estimation (see F.5) and evaluation (see F.6) of the associated risks (see G.2.4 and G.2.5);

c) risk control (see F.7 and G.2.6);

d) monitoring of the effectiveness of the risk control measures (see F.8, G.2.7 and G.2.8).

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.

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, G.2.6.1, G.2.6.2, G.2.6.3 and G.2.7.2).

NOTE Sealing and assembly process development is addressed in G.2.6.4 and ISO 11607-2.

b) Validation phase
— Performance and stability testing (see Clause 8 and G.2.7.3);
— Usability evaluation (see Clause 7 and G.2.7.2).
NOTE Process validation is addressed in G.2.7.4 and ISO 11607-2.
c) Production phase
— Packaging system changes (see Clause 9 and G.2.9).

NOTE Process control and monitoring, assembly, use of reusable sterile barrier systems, process

changes and revalidation are addressed in ISO 11607-2 and G.2.8.
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.
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)
NOTE 1 This can include redesign, additional controls or revalidation.

NOTE 2 ISO 11607-1 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 as 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 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.2.5):

— aligned with the device to be packaged and its intended use;
— aligned 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).
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 contributing factors.
Table F.1 — Hazards and contributing factors
Hazard Possible contributing factors
Microbial contamination Airborne, surface or material microbial contamination
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)
Table F.1 (continued)
Hazard Possible contributing factors

Bio-incompatible or toxic materials or components, process residuals (e.g. EO residual),

Chemical contamination 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, etc.)
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
Misallocation (incorrect label, wrong file or information, data, etc.)

NOTE Table G.1 provides examples of 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 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.
NOTE See G.2.4 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 identify risks to be controlled.
NOTE See G.2.5 for guidance on risk estimation 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.
© ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(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 as far as possible through safe design. A packaging system, (inclusive of

sterile barrier system and protective packaging), is considered an inherently safe design when it

meets the requirements below without additional measures.
— Allow for sterilization (6.1.5).

— Provide physical protection to maintain SBS integrity (6.1.3) for expected conditions and hazards

during the specified processing, storage, handling, and distribution until that SBS is opened at the

point of use (6.1.6).

— Allow for the aseptic opening of the SBS and presentation of its contents (6.1.2).

b) Take adequate measures in relation to risks that cannot be eliminated, for example, shipping

controls.

NOTE An example of shipping controls would be the use of a temperature or humidity indicator for a

device and/or packaging that could be adversely affected by potential extreme temperature or high humidity

exposures in transport.

c) Provide information for safety (warnings/precautions/contra-indications) and, where appropriate,

training to users, for example, indication of opening location and sterile barrier system symbols.

F.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
---------------------- Page: 13 ----------------------
SIST EN ISO 11607-1:2020/oprA1:2022
ISO 11607-1:2019/DAM 1:2022(E)
Annex G
(informative)
Risk management for medical device packaging – rationale for
requirements
G.1 Objective of risk management for medical devices

The objective of risk management for medical devices is to control risks of hazards leading to patient

harm or, where applicable, risks of hazards that lead to harm of users and other persons during intended

use/purpose and/or reasonably foreseeable misuse of the medical device. The intent is to improve the

safety o
...