Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019)

Dieses Dokument legt Anforderungen an und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Es erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungssysteme für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.
Es beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.
Es gilt nicht für Verpackungsmaterialien und/oder  systeme, die dazu verwendet werden, ein verunreinigtes Medizinprodukt während des Transports zur Wiederaufbereitung oder Entsorgung aufzunehmen.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2019)

Le présent document spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés de façon terminale jusqu'au point d'utilisation.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où des dispositifs médicaux sont insérés dans des systèmes de barrière stérile et stérilisés.
Il ne couvre pas toutes les exigences relatives aux systèmes de barrière stérile et systèmes d'emballage pour les dispositifs médicaux fabriqués de manière aseptique. Dans ce cas, des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Il ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.
Il ne s'applique pas aux matériaux d'emballage et/ou systèmes utilisés pour contenir un dispositif médical contaminé pendant le transport du dispositif vers le site de retraitement ou d'élimination.

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)

Ta dokument določa zahteve in preskusne metode za materiale, izvedene sterilne pregradne sisteme, sterilne pregradne sisteme in sisteme embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih. Ne zajema vseh zahtev za sterilne pregradne sisteme in sisteme embalaže medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve. Ne opisuje sistema zagotavljanja kakovosti za nadzor vseh faz proizvodnje. Ne uporablja se za embalažo in/ali sisteme, ki se uporabljajo za hrambo kontaminiranega medicinskega pripomočka med prevozom elementa na mesto predelave ali odstranjevanja.

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 11607-1:2020
01-marec-2020
Nadomešča:
SIST EN ISO 11607-1:2017
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)

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

sterile barrier systems and packaging systems (ISO 11607-1:2019)

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

Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019)

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences

relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage

(ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11607-1:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 11607-1:2020
EN ISO 11607-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-1:2017
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)

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

terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:

aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme

d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This European Standard was approved by CEN on 3 November 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 12 February 2020.

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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
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 11607-1:2020 E

worldwide for CEN national Members.
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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
Contents Page

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

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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
European foreword

This document (EN ISO 11607-1:2020) 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 11607-1:2017.

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 11607-1:2019 has been approved by CEN as EN ISO 11607-1:2020 without any

modification.
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL ISO
STANDARD 11607-1
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière
stérile et aux systèmes d'emballage
Reference number
ISO 11607-1:2019(E)
ISO 2019
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(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
---------------------- Page: 8 ----------------------
SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
Contents Page

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

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

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

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

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

4 General requirements ..................................................................................................................................................................................... 6

4.1 Quality systems ....................................................................................................................................................................................... 6

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

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

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

4.5 Documentation ....................................................................................................................................................................................... 7

5 Materials, preformed sterile barrier systems and sterile barrier systems .............................................7

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

5.2 Microbial barrier properties ....................................................................................................................................................10

5.3 Compatibility with the sterilization process ..............................................................................................................11

5.4 Labelling system .................................................................................................................................................................................11

5.5 Storage and transport of materials and preformed sterile barrier systems ...................................11

6 Design and development for packaging systems .............................................................................................................12

6.1 General ........................................................................................................................................................................................................12

6.2 Design ..........................................................................................................................................................................................................12

7 Usability evaluation for aseptic presentation .....................................................................................................................13

8 Packaging system performance and stability .....................................................................................................................14

8.1 General ........................................................................................................................................................................................................14

8.2 Packaging system performance testing ..........................................................................................................................14

8.3 Stability testing ....................................................................................................................................................................................15

9 Packaging system validation and changes ..............................................................................................................................15

10 Inspection immediately prior to aseptic presentation ..............................................................................................16

11 Information to be provided ....................................................................................................................................................................16

Annex A (informative) Guidance on medical packaging ...............................................................................................................17

Annex B (informative) Standardized test methods, guides and procedures that can be used

to demonstrate conformity with the requirements of this document .......................................................20

Annex C (normative) Test method for resistance of impermeable materials to the passage of air .31

Annex D (informative) Environmental aspects .......................................................................................................................................32

Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from

protective packaging .....................................................................................................................................................................................33

Bibliography .............................................................................................................................................................................................................................38

© ISO 2019 – All rights reserved iii
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(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 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 11607-1:2006), which has been technically

revised. It also incorporates the amendment ISO 11607-1:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— the definitions have been aligned with the latest version of ISO 11139;

— new requirements for the evaluation of usability for aseptic presentation have been added;

— new requirements for the inspection of sterile barrier system integrity prior to use have been added;

— a new subclause with requirements for revalidation in accordance with ISO 11607-2 has been added;

— Annex B has been updated and various national, international and European test methods have

been added or deleted;
— a new Annex D has been added with environmental considerations;

— a new Annex E has been added with draft guidance on ways to differentiate a sterile barrier system

from protective packaging.
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 11607-1:2020
ISO 11607-1:2019(E)
Introduction

The process of designing and developing a packaging system for terminally sterilized medical devices

is a complicated and critical endeavour. The device components and the packaging system should be

combined to create a sterile medical device that performs efficiently, safely and effectively in the hands

of the user.

This document specifies requirements for the design of sterile barrier systems and packaging systems

for terminally sterilized medical devices, the basic attributes required of materials and preformed

sterile barrier systems, and design validation requirements. This document is written as a general

(horizontal) standard considering a wide range of potential materials, medical devices, packaging

system designs and sterilization methods. It can be applied by suppliers of materials or of preformed

sterile barrier systems, by medical device manufacturers or health care facilities. ISO 11607-2 describes

the process development and validation requirements for forming, sealing and assembly processes and

addresses controls during normal operations.
Guidance for ISO 11607 series can be found in ISO/TS 16775.

European standards that provide requirements for particular materials and preformed sterile barrier

systems are available and known as the EN 868 series. Conformity with the EN 868 series can be used

to demonstrate conformity with one or more of the requirements of this document.

The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide

physical protection, maintain sterility up to the point of use and allow aseptic presentation. The

specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry

date, transport and storage all influence the packaging system design and choice of materials.

The term “sterile barrier system” was introduced in ISO 11607-1:2006 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. An overview of sterile barrier systems is given in Annex A.

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 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL STANDARD ISO 11607-1:2019(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope

This document specifies requirements and test methods for materials, preformed sterile barrier

systems, sterile barrier systems and packaging systems that are intended to maintain sterility of

terminally sterilized medical devices until the point of use.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile

barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical

devices that are manufactured aseptically. Additional requirements can be necessary for drug/device

combinations.

It does not describe a quality assurance system for control of all stages of manufacture.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device

during transportation of the item to the site of reprocessing or disposal.
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 5636-5, Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method

ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for

forming, sealing and assembly processes
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 https: //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]
© ISO 2019 – All rights reserved 1
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.2
bioburden

population of viable microorganisms on or in product and/or sterile barrier system

[SOURCE: ISO 11139:2018, 3.23]
3.3
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.]
3.4
closure integrity

characteristics of a closure to minimize the risk of ingress of microorganisms

[SOURCE: ISO 11139:2018, 3.52]
3.5
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.6
expiry date
date by which product should be used

Note 1 to entry: For the purpose of this document and ISO 11607-2, expiry date refers to the medical device in a

sterile barrier system. The term “use by date” (3.29) is used to describe the shelf life of packaging materials and

preformed sterile barrier systems prior to assembly into a sterile barrier system.

[SOURCE: ISO 11139:2018, 3.110, modified — Note 1 to entry has been added.]
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 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”.]
3.8
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;
2 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)

— 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;
— 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.]

3.9
microbial barrier

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

[SOURCE: ISO 11139:2018, 3.169]
3.10
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.]
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
preformed sterile barrier system

sterile barrier system (3.23) that is supplied partially assembled for filling and final closure or sealing

EXAMPLE Pouches, bags and open reusable containers (3.17).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.13
product
tangible result of a process

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

Note 1 to entry: For the purpose of this document and ISO 11607-2, products include preformed sterile barrier

systems, sterile barrier systems, and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
© ISO 2019 – All rights reserved 3
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.14
protective packaging

configuration of materials designed to prevent damage to the sterile barrier system and its contents

from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.15
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.]
3.16
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 name has been simplified.]

3.17
reusable container
rigid sterile barrier system (3.23) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.18
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.

[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.19
seal integrity
characteristics of a seal to minimize the ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.245]
3.20
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.21
service life

number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and

safe for its intended use when used according to the labelling
[SOURCE: ISO 11139:2018, 3.251]
4 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.22
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.23
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]
3.24
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]
3.25
sterilization compatibility

attributes of the packaging material and/or system that allow it both to withstand the

sterilization process and attain the required conditions for sterilization within the packaging system

[SOURCE: ISO 11139:2018, 3.278]
3.26
sterilizing agent

physical or chemical entity, or combination of entities, having sufficient microbiocidal activity to

achieve sterility under specified conditions
[SOURCE: ISO 11139:2018, 3.288]
3.27
terminal steril
...

SLOVENSKI STANDARD
SIST EN ISO 11607-1:2020
01-marec-2020
Nadomešča:
SIST EN ISO 11607-1:2017
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)

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

sterile barrier systems and packaging systems (ISO 11607-1:2019)

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

Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019)

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences

relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage

(ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020 en

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

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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
EN ISO 11607-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-1:2009
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)

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

terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:

aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme

d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This European Standard was approved by CEN on 3 November 2018.

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 11607-1:2020 E

worldwide for CEN national Members.
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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
Contents Page

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

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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
European foreword

This document (EN ISO 11607-1:2020) 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 11607-1:2009.

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 11607-1:2019 has been approved by CEN as EN ISO 11607-1:2020 without any

modification.
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL ISO
STANDARD 11607-1
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière
stérile et aux systèmes d'emballage
Reference number
ISO 11607-1:2019(E)
ISO 2019
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(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.
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
Contents Page

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

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

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

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

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

4 General requirements ..................................................................................................................................................................................... 6

4.1 Quality systems ....................................................................................................................................................................................... 6

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

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

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

4.5 Documentation ....................................................................................................................................................................................... 7

5 Materials, preformed sterile barrier systems and sterile barrier systems .............................................7

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

5.2 Microbial barrier properties ....................................................................................................................................................10

5.3 Compatibility with the sterilization process ..............................................................................................................11

5.4 Labelling system .................................................................................................................................................................................11

5.5 Storage and transport of materials and preformed sterile barrier systems ...................................11

6 Design and development for packaging systems .............................................................................................................12

6.1 General ........................................................................................................................................................................................................12

6.2 Design ..........................................................................................................................................................................................................12

7 Usability evaluation for aseptic presentation .....................................................................................................................13

8 Packaging system performance and stability .....................................................................................................................14

8.1 General ........................................................................................................................................................................................................14

8.2 Packaging system performance testing ..........................................................................................................................14

8.3 Stability testing ....................................................................................................................................................................................15

9 Packaging system validation and changes ..............................................................................................................................15

10 Inspection immediately prior to aseptic presentation ..............................................................................................16

11 Information to be provided ....................................................................................................................................................................16

Annex A (informative) Guidance on medical packaging ...............................................................................................................17

Annex B (informative) Standardized test methods, guides and procedures that can be used

to demonstrate conformity with the requirements of this document .......................................................20

Annex C (normative) Test method for resistance of impermeable materials to the passage of air .31

Annex D (informative) Environmental aspects .......................................................................................................................................32

Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from

protective packaging .....................................................................................................................................................................................33

Bibliography .............................................................................................................................................................................................................................38

© ISO 2019 – All rights reserved iii
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(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 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 11607-1:2006), which has been technically

revised. It also incorporates the amendment ISO 11607-1:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— the definitions have been aligned with the latest version of ISO 11139;

— new requirements for the evaluation of usability for aseptic presentation have been added;

— new requirements for the inspection of sterile barrier system integrity prior to use have been added;

— a new subclause with requirements for revalidation in accordance with ISO 11607-2 has been added;

— Annex B has been updated and various national, international and European test methods have

been added or deleted;
— a new Annex D has been added with environmental considerations;

— a new Annex E has been added with draft guidance on ways to differentiate a sterile barrier system

from protective packaging.
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 11607-1:2020
ISO 11607-1:2019(E)
Introduction

The process of designing and developing a packaging system for terminally sterilized medical devices

is a complicated and critical endeavour. The device components and the packaging system should be

combined to create a sterile medical device that performs efficiently, safely and effectively in the hands

of the user.

This document specifies requirements for the design of sterile barrier systems and packaging systems

for terminally sterilized medical devices, the basic attributes required of materials and preformed

sterile barrier systems, and design validation requirements. This document is written as a general

(horizontal) standard considering a wide range of potential materials, medical devices, packaging

system designs and sterilization methods. It can be applied by suppliers of materials or of preformed

sterile barrier systems, by medical device manufacturers or health care facilities. ISO 11607-2 describes

the process development and validation requirements for forming, sealing and assembly processes and

addresses controls during normal operations.
Guidance for ISO 11607 series can be found in ISO/TS 16775.

European standards that provide requirements for particular materials and preformed sterile barrier

systems are available and known as the EN 868 series. Conformity with the EN 868 series can be used

to demonstrate conformity with one or more of the requirements of this document.

The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide

physical protection, maintain sterility up to the point of use and allow aseptic presentation. The

specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry

date, transport and storage all influence the packaging system design and choice of materials.

The term “sterile barrier system” was introduced in ISO 11607-1:2006 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. An overview of sterile barrier systems is given in Annex A.

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 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL STANDARD ISO 11607-1:2019(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope

This document specifies requirements and test methods for materials, preformed sterile barrier

systems, sterile barrier systems and packaging systems that are intended to maintain sterility of

terminally sterilized medical devices until the point of use.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile

barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical

devices that are manufactured aseptically. Additional requirements can be necessary for drug/device

combinations.

It does not describe a quality assurance system for control of all stages of manufacture.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device

during transportation of the item to the site of reprocessing or disposal.
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 5636-5, Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method

ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for

forming, sealing and assembly processes
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 https: //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]
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.2
bioburden

population of viable microorganisms on or in product and/or sterile barrier system

[SOURCE: ISO 11139:2018, 3.23]
3.3
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.]
3.4
closure integrity

characteristics of a closure to minimize the risk of ingress of microorganisms

[SOURCE: ISO 11139:2018, 3.52]
3.5
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.6
expiry date
date by which product should be used

Note 1 to entry: For the purpose of this document and ISO 11607-2, expiry date refers to the medical device in a

sterile barrier system. The term “use by date” (3.29) is used to describe the shelf life of packaging materials and

preformed sterile barrier systems prior to assembly into a sterile barrier system.

[SOURCE: ISO 11139:2018, 3.110, modified — Note 1 to entry has been added.]
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 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”.]
3.8
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;
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)

— 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;
— 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.]

3.9
microbial barrier

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

[SOURCE: ISO 11139:2018, 3.169]
3.10
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.]
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
preformed sterile barrier system

sterile barrier system (3.23) that is supplied partially assembled for filling and final closure or sealing

EXAMPLE Pouches, bags and open reusable containers (3.17).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.13
product
tangible result of a process

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

Note 1 to entry: For the purpose of this document and ISO 11607-2, products include preformed sterile barrier

systems, sterile barrier systems, and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.14
protective packaging

configuration of materials designed to prevent damage to the sterile barrier system and its contents

from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.15
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.]
3.16
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 name has been simplified.]

3.17
reusable container
rigid sterile barrier system (3.23) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.18
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.

[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.19
seal integrity
characteristics of a seal to minimize the ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.245]
3.20
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.21
service life

number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and

safe for its intended use when used according to the labelling
[SOURCE: ISO 11139:2018, 3.251]
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.22
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.23
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]
3.24
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]
3.25
sterilization compatibility

attributes of the packaging material and/or system that allow it both to withstand the

sterilization process and attain the required conditions for sterilization within the packaging system

[SOURCE: ISO 11139:2018, 3.278]
3.26
sterilizing agent

physical or chemical entity, or combination of entities, having sufficient microbiocidal activity to

achieve sterility under specified conditions
[SOURCE: ISO 11139:2018, 3.288]
3.27
terminal sterilization
process whereby a product is sterilized within its sterile barrier system
[SOURCE: ISO 11139:2018, 3.295]
3.28
termina
...

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