Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2019)

Dieses Dokument legt Anforderungen für die Entwicklung und Validierung von Verpackungsprozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Steril-barrieresystemen und Verpackungssystemen.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden.
Es deckt nicht alle Anforderungen an Verpackungen aseptisch hergestellter Medizinprodukte ab. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)

Le présent document spécifie les exigences pour la mise au point et la validation des procédés d'emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le formage, le scellage et l'assemblage de systèmes de barrière stérile préformés, de systèmes de barrière stérile et de systèmes d'emballage.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés.
Il ne couvre pas toutes les exigences relatives à l'emballage des dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.

Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2019)

Ta dokument podaja zahteve za razvoj in validacijo procesov za embalažo medicinskih pripomočkov, ki so končno sterilizirani. Ti procesi vključujejo oblikovanje, označevanje in sestavljanje izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani. Ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve

General Information

Status
Published
Publication Date
14-Jan-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Jan-2020
Completion Date
15-Jan-2020

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SLOVENSKI STANDARD
SIST EN ISO 11607-2:2020
01-marec-2020
Nadomešča:
SIST EN ISO 11607-2:2017
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za

validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2019)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for

forming, sealing and assembly processes (ISO 11607-2:2019)

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:

Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2019)

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de

validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)

Ta slovenski standard je istoveten z: EN ISO 11607-2:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2020 en

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

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SIST EN ISO 11607-2:2020
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SIST EN ISO 11607-2:2020
EN ISO 11607-2
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-2:2017
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)

Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu

terminal - Partie 2: Exigences de validation pour les sterilisierende Medizinprodukte - Teil 2:

procédés de formage, scellage et assemblage (ISO Validierungsanforderungen an Prozesse der

11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This European Standard was approved by CEN on 4 December 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a 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 European Standard 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, Turkey 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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2020 E

worldwide for CEN national Members.
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SIST EN ISO 11607-2:2020
EN ISO 11607-2:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11607-2:2020
EN ISO 11607-2:2020 (E)
European foreword

This document (EN ISO 11607-2:2020) 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 European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by July 2020, and conflicting national standards shall be

withdrawn at the latest by July 2020.

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 supersedes EN ISO 11607-2:2017.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 11607-2:2019 has been approved by CEN as EN ISO 11607-2:2020 without any

modification.
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SIST EN ISO 11607-2:2020
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SIST EN ISO 11607-2:2020
INTERNATIONAL ISO
STANDARD 11607-2
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 2:
Validation requirements for forming,
sealing and assembly processes
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage,
scellage et assemblage
Reference number
ISO 11607-2:2019(E)
ISO 2019
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General requirements ..................................................................................................................................................................................... 5

4.1 Quality systems ....................................................................................................................................................................................... 5

4.2 Risk management ................................................................................................................................................................................. 6

4.3 Sampling ....................................................................................................................................................................................................... 6

4.4 Test methods ............................................................................................................................................................................................. 6

4.5 Documentation ....................................................................................................................................................................................... 6

5 Validation of packaging processes ..................................................................................................................................................... 7

5.1 General ........................................................................................................................................................................................................... 7

5.2 Installation qualification ................................................................................................................................................................ 7

5.3 Operational qualification ............................................................................................................................................................... 8

5.4 Performance qualification ............................................................................................................................................................. 9

5.5 Formal approval of the process validation...................................................................................................................... 9

5.6 Process control and monitoring ............................................................................................................................................10

5.7 Process changes and revalidation .......................................................................................................................................10

6 Assembly ....................................................................................................................................................................................................................10

7 Use of reusable sterile barrier systems .....................................................................................................................................11

8 Sterile fluid-path packaging ..................................................................................................................................................................11

Annex A (informative) Process development ...........................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................13

© ISO 2019 – All rights reserved iii
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(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 the following

URL: www .iso .org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This second edition cancels and replaces the first edition (ISO 11607-2:2006), which has been technically

revised. It also incorporates the amendment ISO 11607-2:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:

— terms and definitions for “process variable”, “process parameter” and “monitoring of processes”

have been added;
— various definitions have been aligned with the latest version of ISO 11139;

— the terminology of “critical” process parameters has been discontinued and the concept of a process

specification has been introduced to include all elements required to manufacture a product that

consistently meets specifications.
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.
iv © ISO 2019 – All rights reserved
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
Introduction

Packaging for terminally sterilized medical devices should be designed and manufactured to ensure

that the medical device can be sterilized and remain sterile under documented storage and transport

conditions until the sterile barrier system is damaged or opened.

One of the most critical characteristics of a sterile barrier system and packaging system for sterile

medical devices is the assurance of sterility maintenance. Medical devices delivered in a sterile

state should have been manufactured, packed and sterilized by appropriate, validated methods. The

development and validation of packaging processes are crucial to ensure that sterile barrier system

integrity is attained and will remain so until opened by the users of sterile medical devices.

There should be a documented process validation programme demonstrating the efficacy and

reproducibility of all packaging and sterilization processes. Along with the sterilization process, some

of the packaging operations that can affect sterile barrier system integrity are sealing, capping or other

closure systems, cutting, form/fill/seal, assembly processes and subsequent handling. This document

provides the framework of activities and requirements to develop and validate the process used to

make and assemble the packaging system. Guidance for ISO 11607 series can be found in ISO/TS 16775.

The term “sterile barrier system” was introduced in 2006 to describe the minimum packaging required

to perform the unique functions required of medical packaging: to allow sterilization, to provide an

acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects

the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier

systems” would include any partially assembled sterile barrier systems such as pouches, header bags

or hospital packaging reels.

The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices.

Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as

an accessory or a component of a medical device. Preformed sterile barrier systems sold to health care

facilities for use in internal sterilization are considered medical devices in many parts of the world.

© ISO 2019 – All rights reserved v
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SIST EN ISO 11607-2:2020
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SIST EN ISO 11607-2:2020
INTERNATIONAL STANDARD ISO 11607-2:2019(E)
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
1 Scope

This document specifies requirements for the development and validation of processes for packaging

medical devices that are terminally sterilized. These processes include forming, sealing and assembly

of preformed sterile barrier systems, sterile barrier systems and packaging systems.

It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and

sterilized.

It does not cover all requirements for packaging medical devices that are manufactured aseptically.

Additional requirements can be necessary for drug/device combinations.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 11607-1:2018, Packaging for terminally sterilized medical devices — Part 1: Requirements for

materials, sterile barrier systems and packaging systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
aseptic presentation

transfer of sterile contents from its sterile barrier system using conditions and procedures that

minimize the risk of microbial contamination
[SOURCE: ISO 11139:2018, 3.13]
3.2
closure

means used to complete a sterile barrier system where no seal is formed

EXAMPLE By a reusable container gasket or sequential folding to construct a tortuous path.

[SOURCE: ISO 11139:2018, 3.51, modified — The example has been added.]
© ISO 2019 – All rights reserved 1
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
3.3
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.4
expiry date
date by which product should be used

Note 1 to entry: For the purpose of this document and ISO 11607-1, expiry date refers to the medical device

in a sterile barrier system. The term “use by date” is used to describe the shelf life of packaging materials and

preformed sterile barrier systems (3.13) prior to assembly into a sterile barrier system (3.25).

[SOURCE: ISO 11139:2018, 3.110, modified — The Note 1 to entry has been added.]
3.5
installation qualification

process of establishing by objective evidence that all key aspects of the process equipment and ancillary

system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.6
labelling

label, instructions for use and any other information that is related to identification, technical

description, intended purpose and proper use of the health care product but excluding shipping

documents

[SOURCE: ISO 13485:2016, 3.8, modified — The term “medical device” has been replaced by “health

care product”.]
3.7
medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,

material or other similar or related article, intended by the manufacturer to be used, alone or in

combination, for human beings, for one or more of the specific medical purpose(s) of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease;

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

— investigation, replacement, modification, or support of the anatomy or of a physiological process;

— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;

— providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic

means, in or on the human body, but which may be assisted in its intended function by such means

Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others

include:
— items specifically intended for cleaning or sterilization of medical devices;

— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for

sterilization;
2 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.

[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been added.]

3.8
microbial barrier

property of a sterile barrier system to minimize the risk of ingress of microorganisms

[SOURCE: ISO 11139:2018, 3.169]
3.9
monitoring

continual checking, supervising, critically observing or determining the status in order to identify

change from the performance level required or expected
[SOURCE: ISO Guide 73:2009, 3.8.2.1, modified — The note has been deleted.]
3.10
operational qualification

process of obtaining and documenting evidence that installed equipment operates within predetermined

limits when used in accordance with its operational procedures
[SOURCE: ISO 11139:2018, 3.220.3]
3.11
packaging system
combination of a sterile barrier system (3.25) and protective packaging (3.18)
[SOURCE: ISO 11139:2018, 3.192]
3.12
performance qualification

process of establishing by objective evidence that the process, under anticipated conditions, consistently

produces a product (3.17) which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.13
preformed sterile barrier system

sterile barrier system (3.25) that is supplied partially assembled for filling and final closure or sealing

EXAMPLE Pouches, bags and open reusable containers (3.21).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.14
process parameter
specified value for a process variable (3.16)

Note 1 to entry: The specification for a process includes the process parameters and their tolerances.

[SOURCE: ISO 11139:2018, 3.211]
© ISO 2019 – All rights reserved 3
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
3.15
process specification

documented procedure that includes all equipment, process parameters, monitors and materials

required to manufacture a product that consistently meets requirements
3.16
process variable

chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process,

changes in which can alter its effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: ISO 11139:2018, 3.213]
3.17
product
tangible result of a process

EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), healthcare product(s).

Note 1 to entry: For the purposes of this document and ISO 11607-1, products include preformed sterile barrier

systems (3.13), sterile barrier systems (3.25) and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
3.18
protective packaging

configuration of materials designed to prevent damage to the sterile barrier system (3.25) and its

contents from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.19
repeatability

condition of measurement, out of a set of conditions that includes the same measurement procedure,

same operators, same measuring system, same operating conditions and same location, and replicate

measurements on the same or similar objects over a short period of time

[SOURCE: ISO/IEC Guide 99:2007, 2.20, modified — The term name has been simplified and the notes

omitted.]
3.20
reproducibility

condition of measurement, out of a set of conditions that includes different locations, processors,

measuring systems, and replicate measurements on the same or similar objects

Note 1 to entry: The different measuring systems may use different measurement procedures.

Note 2 to entry: A specification should give the conditions changed and unchanged to the extent practical.

[SOURCE: ISO/IEC Guide 99:2007, 2.24, modified — The term has been simplified.]
3.21
reusable container
rigid sterile barrier system (3.25) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.22
seal

result of joining surfaces together by fusion to form a microbial barrier

Note 1 to entry: Surfaces can be joined together by, for example, adhesives or thermal fusion.

4 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
[SOURCE: ISO 11139:2018, 3.244 modified — The Note 1 to entry has been added.]
3.23
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.24
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.25
sterile barrier system
SBS

minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation

of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.26
sterile fluid-path packaging

system of protective port covers and/or packaging designed to ensure sterility of the portion of the

medical device intended for contact with fluids
EXAMPLE The interior of the tubing for administration of an intravenous fluid.
[SOURCE: ISO 11139:2018, 3.273]
3.27
terminally sterilized

condition of a product that has been exposed to a sterilization process in its sterile barrier system

[SOURCE: ISO 11139:2018, 3.296]
3.28
validation

confirmation process, through the provision of objective evidence, that the requirements for a specific

intended use or application have been fulfilled

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination

such as performing alternative calculations or reviewing documents.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

[SOURCE: ISO 9000:2015, 3.8.13, modified — “process” has been added to the definition.]

4 General requirements
4.1 Quality systems

The activities described within this document shall be carried out within a formal quality system.

NOTE ISO 9001, ISO 13485, and ANSI/AAMI ST90 contain requirements for suitable quality systems.

Additional requirements can be specified by a country or region.
© ISO 2019 – All rights reserved 5
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
4.2 Risk management

The activities described within this document shall consider risk management to medical devices.

NOTE ISO 14971 contains requirements for risk management to medical devices. Additional requirements

can be specified by a country or region.
4.3 Sampling

The sampling plans used for testing of materials, sterile barrier systems or packaging systems shall be

applicable to materials, sterile barrier systems or packaging systems being evaluated. Sampling plans

shall be based upon statistically valid rationale.

NOTE Common statistically based sampling plans as given, for example, in ISO 2859-1 or ISO 186 (with

appropriate modifications if necessary) can be applied to materials, sterile barrier systems or packaging systems.

Additional sampling plans can be specified by countries or regions. For further guidance, see ISO/TS 16775.

4.4 Test methods

4.4.1 A rationale for the selection of appropriate tests for the packaging system shall be established

and recorded.
4.4.2 A rationale for acceptance criteria shall be established and recorded.
NOTE Pass/fail is a type of acceptance criterion.

4.4.3 All test methods used to show conformity to this document shall be validated and documented

by the laboratory performing the test.

NOTE Annex B of ISO 11607-1 contains a list of test methods. Publication of a method by a standards body

does not make it validated in any laboratory.
4.4.4 The test method validation shall demonstrate the suitability of th
...

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