ISO 11607:1997

INTERNATIONAL IS0
STANDARD 11607
First edition
1997-02-15
Packaging for terminally sterilized medical
devices
Emballages pour dispositifs mgdicaux enti&rement st&ilis&
Reference number
IS0 11607: 1997(E)
IS0 11607:1997(E)
Contents
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.~.~.~.~.~. 1
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.~.~.~.~.~.~.~~.
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4 Packaging materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Package forming and sealing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 8
6 Final (product) package . . . . . .*.*. 10
Annex A (normative) Test method for resistance of impermeable materials to the passage of air . .15
Annex B (informative) Evaluating package performance in distribution, storage and handling
systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Annex C (informative) Dye penetration test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Annex D (informative) Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 18
0 IS0 1997
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ii
0 IS0 ISO11607:1997(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0
member bodies). The work of preparing International Standards is normally carried out through IS0 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. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
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.
International Standard IS0 II 607 was prepared by Technical Committee lSO/TC 198, Sterilizat;on of health care
products.
Annex A forms an integral part of this International Standard. Annexes B, C and D are for information only.
. . .
III
0 IS0
ISO11607:1997(E)
Introduction
The process of designing and developing a package for terminally sterilized medical devices is a complicated and
critical endeavour. The device components and the package system should combine to create a total product
which performs efficiently, safely and effectively in the hands of the user.
The specific nature of the medical device; the intended sterilization method(s); and the intended use, shelf life,
transport and storage all influence the package design and choice of packaging materials.
Clause 4 of this International Standard specifies the basic attributes required of materials intended for use in
packaging for terminally sterilized medical devices while considering the wide range of potential materials, medical
devices, packaging designs and sterilization methods that are available.
Based upon the complexities outlined above, determination that a material is appropriate for packaging of terminally
sterilized medical devices should not be made without reference to all parts of this document. European standards
providing specifications for particular materials are currently under development as the EN 868 series (see annex
.
D)
The basic requirements described in this International Standard allow either the producer or the manufacturer to
conduct a formal qualification to determine if a potential packaging material meets the performance requirements.
Once a material has been determined to adequately meet the performance requirements, product specifications
may be established by the producer, manufacturer or a regulatory body. From that point in time, compliance
qualification of the material can be conducted to demonstrate that the material meets these stated specifications.
The development and validation of packaging operations are crucial to assure package integrity to the users of
sterile medical devices. There should be a documented process validation programme demonstrating the efficacy
and reproducibility of all sterilization and packaging processes. Along with the sterilization process, some of the
packaging operations that can affect package integrity are forming, sealing, capping or other closure systems,
cutting and process handling. Clause 5 provides manufacturers with a framework of activities to validate the
process used to make and assemble the package.
The microbial barrier properties of packaging materials, together with suitable forming and sealing, are critical for
assuring package integrity and product safety. As long as no validated final package challenge method is available
or applicable, the barrier properties of materials should be evaluated separately from the effectiveness of forming
and sealing.
Clause 6 is intended to assist in the selection of tests and to provide criteria that can be used to evaluate the
performance of packages for terminally sterilized medical devices.
It is intended that historical data and supporting rationale are acceptable for use in the verification of requirements
of this International Standard.
iv
INTERNATIONAL STANDARD o IS0 IS0 11607: 1997(E)
Packaging for terminally sterilized medical devices
1 Scope
1 .l Inclusions
1.1.1 This International Standard specifies the requirements for single-use materials and reusable containers used
for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities (see
clause 4).
1 .1.2 This International Standard outlines principal requirements for packaging process development and
validation for the manufacturer of terminally sterilized medical devices (see clause 5).
Forming and sealing are considered to be the most critical processes. It is recognized that there are other process
operations that can affect the final package, and these are addressed also. Guidelines are provided for the most
common practices and techniques.
- For the purposes of this International Standard, hospitals or other organizations that package medical devices are
NOTE
considered to be manufacturers.
performance of
1.1.3 This International Standard specifies requirements for essential criteria used to evaluate the
packages for sterile medical devices (see clause 6).
devices with a
The intent of this International Standard is to provide designers and manufacturers of medical
framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package
used to protect device components during handling, distribution and storage.
1.2 Exclusions
1.2.1 This International Standard does not necessarily apply to packaging for products manufactured aseptically; in
such cases, additional requirements are necessary to ensure that the packaging and packaging process do not
present a source of contamination of the product.
1.2.2 This International Standard does not define sampling plans or the number and duration of replicate runs.
NOTE - Such protocols should be developed by the producer and manufacturer based on the requirements for the particular
medical device(s).
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
Sampling to determine average quality.
IS0 186:1994, Paper and board-
0 IS0
ISO11607:1997(E)
Sampling procedures for inspection by attributes - Par% 1: Sampling plans indexed by quality level
IS0 2859-I:” ,
(AQL) for lot-by-lot inspection.
Determination of air permeance (medium range) - Parf 5: Gurley method.
IS0 5636-5: 1986, Paper and board -
IS0 11140-l :I 995, Sterilization of health care products - Chemical indicators - Par? 1: General requirements.
3 Definitions
For the purposes of this International Standard, the following definitions apply:
3.1 closure: Means used to close a package where no seal is formed; for example, by repeated folding to
construct a tortuous path.
3.2 closure integrity: Condition of the closure which ensures that the closure presents a microbial barrier to at
least the same extent as the rest of the packaging.
3.3 compliance qualification: Documented evidence that packaging meets the requirements for packaging for
terminally sterilized medical devices based on testing for conformity to an agreed material specification.
3.4 development: Process of refining a prototype design or process to meet established product criteria.
3.5 failure: Event in which a component of the package does not perform one or more of its required functions
within the specified limits under specified conditions.
3.6 failure analysis: Logical, systematic examination of an item to identify and analyze the probability, causes
and consequences of potential and real failures.
3.7 final package: Primary containment system in which the product is sterilized (excluding shelf cartons and
shipping containers) that protects contents to the intended level over a specific period of time (i.e. a barrier to
physical, microbial or chemical challenges).
3.8 manufacturer: Natural or legal person, individual or organization with the responsibility for packaging and/or
sterilizing the medical device.
3.9 medical device: Any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, including the software necessary for its proper application, intended by the manufacturer to be used
for human beings for the purposes of
diagnosis, prevention, monitoring, treatment or alleviation of disease;
-
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
investigation, replacement or modification of the anatomy or of a physiological process;
control of conception;
and which does not achieve its principal 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.
3.10 microbial barrier: Attribute of the packaging system that prevents the ingress of microorganisms under
specified conditions.
l) To be published. (Revision of IS0 2859-i :1989)

0 IS0 IS0 11607: 1997(E)
3.11 labelling system: Assembly of the package label and any supplied information on usage that is included
within or in contact with the final package.
3.12 packaging compatibility: Attribute of the packaging material and/or system to allow it to achieve the required
performance without detrimental effect on the medical device.
3.13 package integrity: Unimpaired physical condition of a final package.
3.14 performance qualification: Documented evidence that packaging meets the appropriate requirements for
sterile packaging based on testing of the particular packaging material for compliance with the applicable
requirements of this International Standard.
3.15 producer: Natural or legal person, individual or organization with the responsibility for manufacturing the
packaging material and/or system.
3.16 product: Combination of both the medical device and/or additional components with the final package.
3.17 qualification: Documented evidence that all specified design and performance requirements are met.
3.18 revalidation: Documented procedure to reconfirm an established validation.
3.19 seal: Result of joining of the layers, e.g. by use of adhesives or thermal fusion.
3.20 seal integrity: Condition of the seal which ensures that it presents a microbial barrier to at least the same
extent as the rest of the packaging.
3.21 seal strength: Mechanical strength of the seal.
3.22 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.
3.23 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 final package.
3.24 user: Natural or legal person, individual or organization with the responsibility for making use of the product,
3.25 validation: Documented procedure for obtaining and interpreting the results required to establish that a
process wi
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