Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

ISO 11607-1:2006 specifies the 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.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006)

Dieser Teil von ISO 11607 legt die Anforderungen und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme,
Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität
der in der Endverpackung zu sterilisierenden Medizinprodukte bis zum Anwendungszeitpunkt aufrechtzuerhalten.
Dieser Teil von ISO 11607 gilt für die Industrie, für Gesundheitseinrichtungen und alle anderen Einrichtungen,
in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Dieser Teil von ISO 11607 erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungssysteme
für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Arzneimitteln und Medizinprodukten
können auch zusätzliche Anforderungen erforderlich sein.
Dieser Teil von ISO 11607 beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.

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 11607-1:2006)

L'ISO 11607-1:2006 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 au stade terminal jusqu'au point d'utilisation.
L'ISO 11607-1:2006 s'applique à l'industrie, aux installations de santé et à tout lieu où les dispositifs médicaux se trouvent dans des systèmes de barrière stérile et stérilisés.
L'ISO 11607-1:2006 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 sont nécessaires pour garantir les combinaisons médicaments/dispositifs.
L'ISO 11607-1:2006 ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2006)

General Information

Status
Withdrawn
Publication Date
02-Jun-2009
Withdrawal Date
18-Jul-2017
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
19-Jul-2017

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SLOVENSKI STANDARD
SIST EN ISO 11607-1:2009
01-september-2009
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SIST EN ISO 11607-1:2006
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,

sterile barrier systems and packaging systems (ISO 11607-1:2006)

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

Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2006)

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 11607-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2009
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2009 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11607-1:2009
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SIST EN ISO 11607-1:2009
EUROPEAN STANDARD
EN ISO 11607-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.30 Supersedes EN ISO 11607-1:2006
English Version
Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2006)

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

terminal - Partie 1: Exigences relatives aux matériaux, aux Medizinprodukte - Teil 1: Anforderungen an Materialien,

systèmes de barrière stérile et aux systèmes d'emballage Sterilbarrieresysteme und Verpackungssysteme (ISO

(ISO 11607-1:2006) 11607-1:2006)
This European Standard was approved by CEN on 16 May 2009.

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 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 Management Centre has the same status as the

official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2009: E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11607-1:2009
EN ISO 11607-1:2009 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC ...........................................................................................4

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SIST EN ISO 11607-1:2009
EN ISO 11607-1:2009 (E)
Foreword

The text of ISO 11607-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health

care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO

11607-1:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” 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 December 2009, and conflicting national standards shall be withdrawn

at the latest by March 2010.

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

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11607-1:2006.

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

European Free Trade Association, and supports essential requirements of EC Directive.

For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.

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, Cyprus, Czech

Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
Endorsement notice

The text of ISO 11607-1:2006 has been approved by CEN as a EN ISO 11607-1:2009 without any

modification.
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SIST EN ISO 11607-1:2009
EN ISO 11607-1:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC

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

and the European Free Trade Association to provide a means of conforming to Essential Requirements of the

New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has

been implemented as a national standard in at least one Member State, compliance with the clauses of this

standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of

conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/Sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this International Standard (ERs) of EU Directive
93/42/EEC
4.1, 4.2 1, 2
4.3, 4.4, 4.5 3, 4, 5, 6
5.1.1 to 5.1.11 7.1, 7.3, 7.5, 7.6
5.1.9 9.1, 9.2
5.2 8.1
5.3 8.3, 8.6
5.4 8.6
5.5 5, 8.3
6.1 1,2, 6
6.2 3, 7.1, 7.3, 7.5, 7.6, 8.3, 8.6,
13.1, 13.5
6.3 8.1, 8.6
6.4 5
7 13 The applicable parts of the Essential
Requirement 13 are partly addressed
13.3 a) This relevant Essential Requirement is not
addressed in this European Standard
13.3 f) This relevant Essential Requirement is not
addressed in this European Standard
13.6 h) This relevant Essential Requirement is not
addressed in this European Standard
13.6 (q) This relevant Essential Requirement is not
addressed in this European Standard

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the

scope of this standard.
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SIST EN ISO 11607-1:2009
INTERNATIONAL ISO
STANDARD 11607-1
First edition
2006-04-15
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 11607-1:2006(E)
ISO 2006
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(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 General................................................................................................................................................... 5

4.2 Quality systems .................................................................................................................................... 5

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

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

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

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

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

5.2 Microbial barrier properties ................................................................................................................. 9

5.3 Compatibility with the sterilization process..................................................................................... 10

5.4 Compatibility with the labelling system ........................................................................................... 10

5.5 Storage and transport ........................................................................................................................ 10

6 Design and development requirements for packaging systems ................................................... 11

6.1 General................................................................................................................................................. 11

6.2 Design .................................................................................................................................................. 11

6.3 Packaging-system performance testing........................................................................................... 12

6.4 Stability testing ................................................................................................................................... 12

7 Information to be provided ................................................................................................................ 13

Annex A (informative) Guidance on medical packaging.............................................................................. 14

Annex B (informative) Standardized test methods and procedures that may be used to

demonstrate compliance with the requirements of this part of ISO 11607 .................................. 17

Annex C (normative) Test method for resistance of impermeable materials to the passage of air........ 21

Bibliography ..................................................................................................................................................... 22

© ISO 2006 – All rights reserved iii
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 11607-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

ISO 11607-1 and ISO 11607-2 cancel and replace ISO 11607:2003, which has been technically revised.

ISO 11607 consists of the following parts, under the general title Packaging for terminally sterilized medical

devices:

⎯ Part 1: Requirements for materials, sterile barrier systems and packaging systems

⎯ Part 2: Validation requirements for forming, sealing and assembly processes
iv © ISO 2006 – All rights reserved
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(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 product that performs efficiently, safely, and effectively in the hands of the user.

This part of ISO 11607 specifies the basic attributes required of materials and pre-formed systems intended

for use in packaging systems for terminally sterilized medical devices, while considering the wide range of

potential materials, medical devices, packaging system designs, and sterilization methods. ISO 11607-2

describes the validation requirements for forming, sealing and assembly processes. This part of ISO 11607 is

harmonized with EN 868-1 and specifies general requirements for all packaging materials whereas EN 868

Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of ISO 11607

were designed to meet the Essential Requirements of the European Medical Device Directives.

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

are available and known as the EN 868 series. This part of ISO 11607 has been developed as a means to

show compliance with the relevant Essential Requirements of the European Directives concerning medical

devices. Compliance with EN 868 Parts 2 to 10 can be used to demonstrate compliance with one or more of

the requirements of this part of ISO 11607.

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.

One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”,

“primary pack”, and “primary package” all have different connotations around the globe, and choosing one of

these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful

completion of this document. As a result, the term “sterile barrier system” was introduced 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 can be found 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 healthcare facilities for use in

internal sterilization are considered as medical devices in many parts of the world.

© ISO 2006 – All rights reserved v
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SIST EN ISO 11607-1:2009
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SIST EN ISO 11607-1:2009
INTERNATIONAL STANDARD ISO 11607-1:2006(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope

This part of ISO 11607 specifies the 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.

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are

placed in sterile barrier systems and sterilized.

This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for

medical devices that are manufactured aseptically. Additional requirements might also be necessary for

drug/device combinations.

This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

2 Normative references

The following referenced documents are indispensable for the application 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 5636-5:2003, Paper and board — Determination of air permeance and air resistance (medium range) —

Part 5: Gurley method
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aseptic presentation

introduction and transfer of a sterile product using conditions and procedures that exclude microbial

contamination
3.2
bioburden
population of viable microorganisms on or in a product or sterile barrier system
[ISO/TS 11139:2006]
© ISO 2006 – All rights reserved 1
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(E)
3.3
closure
means used to close a sterile barrier system where no seal is formed

NOTE For example, a sterile barrier system can be closed by a reusable container gasket or sequential folding to

construct a tortuous path.
3.4
closure integrity

characteristics of the closure, which ensures that it prevents the ingress of microorganisms under specified

conditions
NOTE See also 3.8.
3.5
expiry date

indication of the date, by which the product should be used, expressed at least as the year and month

3.6
labelling

written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or

accompanying a medical device

NOTE Labelling is related to identification, technical description and use of the medical device but excludes shipping

documents.
3.7
medical device

any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,

material or other related article, intended by the manufacturer to be used, alone or in combination, for human

beings for one or more of the specific 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 for medical purposes by means of in vitro examination of specimens derived from

the human body;

and which does not achieve its primary intended action in or on the human body by pharmacological,

immunological or metabolic means, but which may be assisted in its function by such means

[ISO 13485:2003]

NOTE This definition from ISO 13485:2003 has been developed by the Global Harmonization Task Force

(GHTF 2002).
3.8
microbial barrier

property of the sterile barrier system that prevents the ingress of microorganisms under specified conditions

3.9
packaging material
any material used in the fabrication or sealing of a packaging system
2 © ISO 2006 – All rights reserved
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(E)
3.10
packaging system
combination of the sterile barrier system and protective packaging
[ISO/TS 11139:2006]
3.11
preformed sterile barrier system

sterile barrier system (3.22) that is supplied partially assembled for filling and final closure or sealing

EXAMPLE Pouches, bags, and open reusable containers.
[ISO/TS 11139:2006]
3.12
product
result of a process
[ISO 9000:2000]

NOTE For the purpose of sterilization standards, product is tangible and can be raw material(s), intermediate(s),

sub-assembly(ies) and health care product(s).
[ISO/TS 11139:2006]
3.13
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
NOTE Adapted from ISO/TS 11139:2006.
3.14
recycled material

material that has been reprocessed through a production process of waste materials for their original purpose

or for other purposes
3.15
repeatability

closeness of the agreement between the results of successive measurements of the same particular quantity

subject to measurement (measurand) carried out under the same conditions of measurement

NOTE 1 These conditions are called repeatability conditions.
NOTE 2 Repeatability conditions can include the following:
⎯ the same measurement procedure;
⎯ the same observer;
⎯ the same measuring instrument, used under the same conditions;
⎯ the same location;
⎯ repetition over a short period of time.

NOTE 3 Repeatability may be expressed quantitatively in terms of the dispersion characteristics of the results.

NOTE 4 Adapted from International Vocabulary of Basic and General Terms in Metrology, 1993, definition 3.6.

© ISO 2006 – All rights reserved 3
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(E)
3.16
reproducibility

closeness of the agreement between the results of measurements of the same particular quantity subject to

measurement (measurand) carried out under changed conditions of measurement

NOTE 1 A valid statement of reproducibility requires specification of the conditions changed.

NOTE 2 The changed conditions can include:
⎯ principle of measurement;
⎯ method of measurement;
⎯ observer;
⎯ measuring instrument;
⎯ reference standard;
⎯ location;
⎯ conditions of use;
⎯ time.

NOTE 3 Reproducibility may be expressed quantitatively in terms of the dispersion characteristics of the results.

NOTE 4 Adapted from International Vocabulary of Basic and General Terms in Metrology, 1993, definition 3.7.

3.17
reusable container
rigid sterile barrier system designed to be repeatedly used
3.18
seal
result of joining surfaces together

NOTE For example, surfaces can be jointed together by use of adhesives or thermal fusion.

3.19
seal integrity

characteristics of the seal, which ensures that it prevents the ingress of microorganisms under specified

conditions
NOTE See also 3.8.
3.20
seal strength
mechanical strength of the seal
3.21
sterile
free from viable microorganisms
[ISO/TS 11139:2006]
3.22
sterile barrier system

minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at

the point of use
[ISO/TS 11139:2006]
4 © ISO 2006 – All rights reserved
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(E)
3.23
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

NOTE An example of sterile fluid-path packaging would be the interior of the tubing for administration of an

intravenous fluid.
3.24
sterilization compatibility

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

attain the required conditions for sterilization within the packaging system
3.25
sterilizing agent

physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility

under defined conditions
[ISO/TS 11139:2006]
3.26
terminal sterilization
process whereby product is sterilized within its sterile barrier system
3.27
useful life
the time period during which all the performance requirements are met
3.28
validation

〈general〉 confirmation by examination and provision of objective evidence that the particular requirement for a

specific intended use can be consistently fulfilled
NOTE This definition is applicable to validation of test methods and design.
3.29
validation

〈process〉 documented procedure for obtaining, recording and interpreting the results required to establish that

a process will consistently yield product complying with predetermined specifications

NOTE Adapted from ISO/TS 11139:2006.
4 General requirements
4.1 General

Compliance with one or more requirements of this part of ISO 11607 may be demonstrated by using one or

more parts of the series EN 868-2 to EN 868-10.
4.2 Quality systems

4.2.1 The activities described within this part of ISO 11607 shall be carried out within a formal quality

system.

NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirements may be

specified by a country or region.
© ISO 2006 – All rights reserved 5
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SIST EN ISO 11607-1:2009
ISO 11607-1:2006(E)

4.2.2 It is not necessary to obtain third-party certification of the quality system to fulfil the requirements of

this part of ISO 11607.

4.2.3 Health care facilities may use the quality system required by their country or region.

4.3 Sampling

The sampling plans used for selection and testing of packaging systems shall be applicable to packaging

systems being evaluated. Sampling plans shall be based upon statistically valid rationale.

NOTE Examples of suitable sampling plans are given in ISO 2859-1 or ISO 186. Additional sampling plans may be

specified by countries or regions.
4.4 Test methods

4.4.1 All test methods used to show compliance with this part of ISO 11607 shall be validated and

documented.
NOTE Annex B contains a list of suitable test methods.

4.4.2 The test method validation shall demonstrate the suitability of the method as used. The following

elements shall be included:
⎯ establishment of a r
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006)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 11607-1:2006)Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)11.080.30Sterilizirana embalažaSterilized packagingICS:Ta slovenski standard je istoveten z:prEN ISO 11607-1kSIST prEN ISO 11607-1:2009en,fr,dekSIST prEN ISO 11607-1:2009SLOVENSKI

STANDARD
kSIST prEN ISO 11607-1:2009

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 11607-1January 2009ICS 11.080.30Will supersede EN ISO 11607-1:2006

English VersionPackaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems andpackaging systems (ISO 11607-1:2006)Emballages des dispositifs médicaux stérilisés au stadeterminal - Partie 1: Exigences relatives aux matériaux, auxsystèmes de barrière stérile et aux systèmes d'emballage(ISO 11607-1:2006)Verpackungen für in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 1: Anforderungen an Materialien,Sterilbarrieresysteme und Verpackungssysteme (ISO11607-1:2006)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 102.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:

Avenue Marnix 17,

B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 11607-1:2009: EkSIST prEN ISO 11607-1:2009

prEN ISO 11607-1:2009 (E) 2 Contents Page Foreword ..............................................................................................................................................................3Annex ZA (informative)

Relationship between this
European
Standard and the Essential Requirements

of EU Directive 93/42/EEC ...........................................................................................4 kSIST prEN ISO 11607-1:2009

prEN ISO 11607-1:2009 (E) 3 Foreword The text of ISO 11607-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 11607-1:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 11607-1:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 11607-1:2006 has been approved by CEN as a prEN ISO 11607-1:2009 without any modification. kSIST prEN ISO 11607-1:2009

prEN ISO 11607-1:2009 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements

of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 — Correspondence between this

European

Standard and Directive 93/42/EEC Clause(s)/Sub-clause(s) of this International Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4.1, 4.2 1, 2

4.3, 4.4, 4.5 3, 4, 5, 6
5.1.1 to 5.1.11 (except 5.1.10) 7.1, 7.3, 7.5, 7.6, 8.5
5.1.9 9.1, 9.2
5.2 8.1
5.3 8.3, 8.6
5.4 8.6
5.5 5, 8.3
6.1 1,2, 6
6.2 3, 7.1, 7.3, 7.5, 7.6, 8.3, 8.6, 13.1, 13.5
6.3 8.1, 8.6
6.4 5
7 13 The applicable parts of the Essential Requirement 13 are partly addressed

13.3 a) This relevant Essential Requirement is not addressed in this European Standard

13.3 f) This relevant Essential Requirement is not addressed in this European Standard

13.6 h) This relevant Essential Requirement is not addressed in this European Standard

13.6 (q) This relevant Essential Requirement is not addressed in this European Standard WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

kSIST prEN ISO 11607-1:2009
Reference numberISO 11607-1:2006(E)© ISO 2006

INTERNATIONAL STANDARD ISO11607-1First edition2006-04-15Packaging 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

kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.

+ 41 22 749 01 11 Fax
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copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2006 – All rights reserved
kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) © ISO 2006 – All rights reserved iiiContents Page Foreword............................................................................................................................................................iv Introduction........................................................................................................................................................v 1 Scope.....................................................................................................................................................1 2 Normative references...........................................................................................................................1 3 Terms and definitions...........................................................................................................................1 4 General requirements...........................................................................................................................5 4.1 General...................................................................................................................................................5 4.2 Quality systems....................................................................................................................................5 4.3 Sampling................................................................................................................................................6 4.4 Test methods.........................................................................................................................................6 4.5 Documentation......................................................................................................................................6 5 Materials and preformed sterile barrier systems..............................................................................7 5.1 General requirements...........................................................................................................................7 5.2 Microbial barrier properties.................................................................................................................9 5.3 Compatibility with the sterilization process.....................................................................................10 5.4 Compatibility with the labelling system...........................................................................................10 5.5 Storage and transport........................................................................................................................10 6 Design and development requirements for packaging systems...................................................11 6.1 General.................................................................................................................................................11 6.2 Design..................................................................................................................................................11 6.3 Packaging-system performance testing...........................................................................................12 6.4 Stability testing...................................................................................................................................12 7 Information to be provided................................................................................................................13 Annex A (informative)

Guidance on medical packaging..............................................................................14 Annex B (informative)

Standardized test methods and procedures that may be used to demonstrate compliance with the requirements of this part of ISO 11607..................................17 Annex C (normative)

Test method for resistance of impermeable materials to the passage of air........21 Bibliography.....................................................................................................................................................22

kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) iv © ISO 2006 – All rights reserved 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 11607-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 11607-1 and ISO 11607-2 cancel and replace ISO 11607:2003, which has been technically revised. ISO 11607 consists of the following parts, under the general title Packaging for terminally sterilized medical devices: ⎯ Part 1: Requirements for materials, sterile barrier systems and packaging systems ⎯ Part 2: Validation requirements for forming, sealing and assembly processes

kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) © ISO 2006 – All rights reserved vIntroduction 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 product that performs efficiently, safely, and effectively in the hands of the user. This part of ISO 11607 specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs, and sterilization methods. ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. This part of ISO 11607 is harmonized with EN 868-1 and specifies general requirements for all packaging materials whereas EN 868 Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of ISO 11607 were designed to meet the Essential Requirements of the European Medical Device Directives. European standards that provide requirements for particular materials and preformed sterile barrier systems are available and known as the EN 868 series. This part of ISO 11607 has been developed as a means to show compliance with the relevant Essential Requirements of the European Directives concerning medical devices. Compliance with EN 868 Parts 2 to 10 can be used to demonstrate compliance with one or more of the requirements of this part of ISO 11607. 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. One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”, “primary pack”, and “primary package” all have different connotations around the globe, and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document. As a result, the term “sterile barrier system” was introduced 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 can be found 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 healthcare facilities for use in internal sterilization are considered as medical devices in many parts of the world.

kSIST prEN ISO 11607-1:2009
kSIST prEN ISO 11607-1:2009

INTERNATIONAL STANDARD ISO 11607-1:2006(E) © ISO 2006 – All rights reserved 1Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems 1 Scope This part of ISO 11607 specifies the 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture. 2 Normative references The following referenced documents are indispensable for the application 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 5636-5:2003, Paper and board — Determination of air permeance and air resistance (medium range) — Part 5: Gurley method 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 aseptic presentation introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination 3.2 bioburden population of viable microorganisms on or in a product or sterile barrier system [ISO/TS 11139:2006] kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) 2 © ISO 2006 – All rights reserved 3.3 closure means used to close a sterile barrier system where no seal is formed NOTE For example, a sterile barrier system can be closed by a reusable container gasket or sequential folding to construct a tortuous path. 3.4 closure integrity characteristics of the closure, which ensures that it prevents the ingress of microorganisms under specified conditions NOTE See also 3.8. 3.5 expiry date indication of the date, by which the product should be used, expressed at least as the year and month 3.6 labelling written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or accompanying a medical device NOTE Labelling is related to identification, technical description and use of the medical device but excludes shipping documents. 3.7 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific 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 for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [ISO 13485:2003] NOTE This definition from ISO 13485:2003 has been developed by the Global Harmonization Task Force (GHTF 2002). 3.8 microbial barrier property of the sterile barrier system that prevents the ingress of microorganisms under specified conditions 3.9 packaging material any material used in the fabrication or sealing of a packaging system kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) © ISO 2006 – All rights reserved 33.10 packaging system combination of the sterile barrier system and protective packaging [ISO/TS 11139:2006] 3.11 preformed sterile barrier system sterile barrier system (3.22) that is supplied partially assembled for filling and final closure or sealing EXAMPLE Pouches, bags, and open reusable containers. [ISO/TS 11139:2006] 3.12 product result of a process [ISO 9000:2000] NOTE For the purpose of sterilization standards, product is tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and health care product(s). [ISO/TS 11139:2006] 3.13 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 NOTE Adapted from ISO/TS 11139:2006. 3.14 recycled material material that has been reprocessed through a production process of waste materials for their original purpose or for other purposes 3.15 repeatability closeness of the agreement between the results of successive measurements of the same particular quantity subject to measurement (measurand) carried out under the same conditions of measurement NOTE 1 These conditions are called repeatability conditions. NOTE 2 Repeatability conditions can include the following:

⎯ the same measurement procedure; ⎯ the same observer; ⎯ the same measuring instrument, used under the same conditions; ⎯ the same location; ⎯ repetition over a short period of time. NOTE 3 Repeatability may be expressed quantitatively in terms of the dispersion characteristics of the results. NOTE 4 Adapted from International Vocabulary of Basic and General Terms in Metrology, 1993, definition 3.6. kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) 4 © ISO 2006 – All rights reserved 3.16 reproducibility closeness of the agreement between the results of measurements of the same particular quantity subject to measurement (measurand) carried out under changed conditions of measurement NOTE 1 A valid statement of reproducibility requires specification of the conditions changed. NOTE 2 The changed conditions can include: ⎯ principle of measurement; ⎯ method of measurement; ⎯ observer; ⎯ measuring instrument; ⎯ reference standard; ⎯ location; ⎯ conditions of use; ⎯ time. NOTE 3 Reproducibility may be expressed quantitatively in terms of the dispersion characteristics of the results. NOTE 4 Adapted from International Vocabulary of Basic and General Terms in Metrology, 1993, definition 3.7. 3.17 reusable container rigid sterile barrier system designed to be repeatedly used 3.18 seal result of joining surfaces together NOTE For example, surfaces can be jointed together by use of adhesives or thermal fusion.

3.19 seal integrity characteristics of the seal, which ensures that it prevents the ingress of microorganisms under specified conditions NOTE See also 3.8. 3.20 seal strength mechanical strength of the seal 3.21 sterile free from viable microorganisms [ISO/TS 11139:2006] 3.22 sterile barrier system minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use

[ISO/TS 11139:2006] kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) © ISO 2006 – All rights reserved 53.23 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 NOTE An example of sterile fluid-path packaging would be the interior of the tubing for administration of an intravenous fluid.

3.24 sterilization compatibility attributes of the packaging material and/or system that allow it to both withstand the sterilization process and attain the required conditions for sterilization within the packaging system 3.25 sterilizing agent physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility under defined conditions [ISO/TS 11139:2006] 3.26 terminal sterilization process whereby product is sterilized within its sterile barrier system 3.27 useful life the time period during which all the performance requirements are met 3.28 validation 〈general〉 confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled NOTE This definition is applicable to validation of test methods and design. 3.29 validation 〈process〉 documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications NOTE Adapted from ISO/TS 11139:2006. 4 General requirements 4.1 General Compliance with one or more requirements of this part of ISO 11607 may be demonstrated by using one or more parts of the series EN 868-2 to EN 868-10. 4.2 Quality systems 4.2.1 The activities described within this part of ISO 11607 shall be carried out within a formal quality system. NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirements may be specified by a country or region.

kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) 6 © ISO 2006 – All rights reserved 4.2.2 It is not necessary to obtain third-party certification of the quality system to fulfil the requirements of this part of ISO 11607. 4.2.3 Health care facilities may use the quality system required by their country or region. 4.3 Sampling The sampling plans used for selection and testing of packaging systems shall be applicable to packaging systems being evaluated. Sampling plans shall be based upon statistically valid rationale. NOTE Examples of suitable sampling plans are given in ISO 2859-1 or ISO 186. Additional sampling plans may be specified by countries or regions. 4.4 Test methods 4.4.1 All test methods used to show compliance with this part of ISO 11607 shall be validated and documented. NOTE Annex B contains a list of suitable test methods.

4.4.2 The test method validation shall demonstrate the suitability of the method as used. The following elements shall be included: ⎯ establishment of a rationale for the selection of the appropriate tests for the packaging system; ⎯ establishment of acceptance criteria; NOTE Pass/fail is a type of acceptance criterion. ⎯ determination of test method repeatability; ⎯ determination of test method reproducibility; and ⎯ establishment of test method sensitivity for integrity tests. 4.4.3 Unless otherwise specified in the test methods, test samples shall be conditioned at (23 ± 1) °C and (50 ± 2) % relative humidity for a minimum of 24 h. 4.5 Documentation 4.5.1 Demonstration of compliance with the requirements of this part of ISO 11607 shall be documented. 4.5.2 All documentation shall be retained for a specified period of time. The retention period shall consider factors such as regulatory requirements, expiry date and traceability of the medical device or sterile barrier system. 4.5.3 Documentation of compliance with the requirements may include, but is not limited to, performance data, specifications and test results from validated test methods.

4.5.4 Electronic records, electronic signatures and handwritten signatures executed to electronic records that contribute to validation, process control or other quality decision-making processes shall be reliable. kSIST prEN ISO 11607-1:2009

ISO 11607-1:2006(E) © ISO 2006 – All rights reserved 75 Materials and preformed sterile barrier systems 5.1 General requirements 5.1.1 The requirements on materials referenced shall apply to those used in preformed sterile barrier systems, as well as sterile barrier systems. 5.1.2 The requirements listed in this subclause (5.1) are not intended to be all-inclusive. Materials which have characteristics not listed in this subclause may be evaluated using the performance criteria given in Clause 6. 5.1.3 The conditions under which the material and/or preformed sterile barrier system are produced and handled shall be established, controlled and recorded, if applicable, in order to ensure that: a) the conditions are compatible with the use for which the material and/or sterile barrier system is designed; b) the performance characteristics of the material and/or sterile barrier system are maintained. 5.1.4 As a minimum, the following shall be considered: a) temperature range; b) pressure range; c) humidity range; d) maximum rate of change of the above, w

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