SIST EN ISO 11607-1:2006

SLOVENSKI STANDARD
SIST EN ISO 11607-1:2006
01-julij-2006
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SIST EN 868-1:2000
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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 systemes de barriere stérile et aux systemes d'emballage
(ISO 11607-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2006
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11607-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.30 Supersedes EN 868-1:1997
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 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2006: E
worldwide for CEN national Members.

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EN ISO 11607-1:2006 (E)





Foreword


This document (EN ISO 11607-1:2006) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with 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 October 2006, and conflicting national standards
shall be withdrawn at the latest by April 2007.

This document supersedes EN 868-1:1997.

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 EU Directive(s).

For relationship with EU Directive(s), 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, 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.


Endorsement notice

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

2

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EN ISO 11607-1:2006 (E)



ANNEX ZA
(informative)

Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices


This International 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 normative 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 International Standard and Directive 93/42/EEC
on medical devices

Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this International Standard 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 (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

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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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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ISO 11607-1:2006(E)
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ii © ISO 2006 – All rights reserved

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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

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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

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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.

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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]
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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
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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.
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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]
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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.
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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 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.
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ISO 11607-1:2006(E)
5 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
...