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
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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-
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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 will consistently yield product complying with predetermined specifications.
- Validation is considered to be a total process that includes written protocol, evidence that the equipment as installed
NOTE
meets design criteria and specifications (equipment qualification), use of calibrated instruments to collect data, and evidence
that the equipment can deliver the process within specified tolerances under established operating conditions and is
reproducible as demonstrated by replicate runs and process challenges (process performance qualification).
4 Packaging materials
4.1 Requirements
4.1 .l Quality systems
The activities described within this and subsequent clauses of this International Standard shall be carried out within
a formal quality system.
NOTE - IS0 9001 and IS0 9002 specify requirements for suitable quality systems (see annex D). It is not necessary to
obtain third-party certification of the quality system to fulfil the requirements of this International Standard.
4.1.2 Sampling
The sampling plans used for selection and testing of packaging materials shall be chosen by agreement between
the producer and manufacturer, e.g. acceptable quality level (AQL) in accordance with IS0 2859-l or IS0 186, or
statistical process control (SPC). For each plan chosen, a rationale shall be documented.
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4.1.3 General requirements
4.1.3.1 The intention of packaging for terminally sterilized medical devices is to maintain the sterility of the product
with respect to its intended use, shelf life, transport and storage conditions.
4.1.3.2 Raw materials used for the manufacture of packaging materials may be virgin or reclaimed materials
provided that the source, history and traceability of all raw materials, especially recycled materials, are known and
controlled to ensure that the finished product will consistently meet the requirements of this International Standard.
NOTE - With current commercial technologies, it is unlikely that reclaimed material other than manufacturing waste will be
sufficiently controlled to allow its safe use for packaging for terminally sterilized medical devices.
4.1.3.3 The packaging design and processing requirements shall be reviewed and applied against the material
chosen. This should include effects of the sterilization process Clauses 5 and 6 of this International Standard
provide relevant performance criteria.
4.1.3.4 All test methods used to show compliance with this International Standard shall be validated and
documented.
4.1.3.5 The following material properties shall be evaluated with appropriate test methods agreed by the producer
and manufacturer:
microbial barrier;
a>
b) toxicological attribute;
C) physical and chemical properties;
compatibility with respect to sterilization processes with which the material is intended to be used;
d)
e) compatibility with respect to forming and sealing processes (see clause 5);
f) any shelf-life limitations for presterilization and poststerilization storage of the packaging material.
4.1.3.6 Listed in 4.1.4 through 4.1.7 are some essential performance requirements that shall be considered for
packaging for terminally sterilized medical devices. This list is not intended to be all-inclusive. The manufacturer
shall decide the material characteristics that are necessary for each particular application. Materials which have
characteristics not listed in clause 4 can be evaluated using the penormance criteria given in clauses 5 and 6.
4.1.4 General performance requirements
General packaging materials, e.g. wrapping materials, paper, plastic film or nonwoven high density polyethylene
(HDPE), shall meet the following requirements.
Materials shall be nonleaching, nontoxic and odourless to such an extent that neither performance nor safety is
a)
impaired and the medical devices with which they are in contact are not adversely affected.
b) Materials shall be free of holes, cracks, tears, creases or localized thickening and/or thinning sufficient to impair
functioning.
C) Basis weight shall be consistent with the producer’s stated value.
Materials shall exhibit an acceptable level of cleanliness;
d)
e) Specific or minimum physical properties, such as tensile strength, thickness variation, tear resistance, air
permeance and burst strength, shall be established to meet the requirements of the medical device, packaging
or sterilization process or final package.
f) Specific chemical properties, such as pH value, chloride and sulfate content, shall be established to meet the
requirements of the medical device, packaging or sterilization process.

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4.1.5 Additional requirements for adhesive-coated materials
In addition to the requirements given in 4.1.4, adhesive-coated materials shall meet the requirements listed below.
a) Coating patterns shall be continuous without skips or breaks in the pattern sufficient to cause a discontinuity in
the seal.
Coating mass shall be consistent with the producer’s stated value.
b)
C) Materials shall demonstrate a minimum specified seal strength.
4.1.6 Additional requirements for formed packages
4.1.6.1 Components, e.g. materials, adhesive coating, ink or chemical indicators, shall not react with, contaminate,
transfer to or adversely affect the product before, during or after sterilization.
4.1.6.2 In addition to meeting the materials requirements given in 4.1.4 and, if appropriate, 4.1.5, formed
packaging (e.g. paper bags, heat-sealable pouches and reels) shall comply with the requirements listed below.
a) Packages shall meet producer’s and manufacturer’s specifications for seal width, burst and/or seal strength.
b) Process indicators printed on packages shall comply with IS0 11140-I.
Packages that have peel-open characteristics shall have a peel that is continuous and homogeneous without
C)
delamination or tearing of the material which can affect aseptic presentation.
Paper bags and heat-sealable pouches and reels have construction and package design requirements as well as
NOTE -
performance requirements.
4.1.7 Additional requirements for reusable containers
In addition to the general materials requirements given in 4.1.4 and, if appropriate, 4.1.5, reusable containers shall
meet the requirements given below.
Each container shall be fitted with a tamper-evident system to provide a clear indication when the closure
a>
integrity has been compromised.
b) The sterilant port shall provide a barrier to microorganisms during removal from the sterilizer, transport and
storage (see 4.1.3).
C) Gaskets/seals shall provide a barrier to microorganisms as specified in 4.1.3.
The container shall be constructed to facilitate visual inspection of all essential parts. The producer shall
d)
specify the acceptance criteria to be used on visual inspection prior to each reuse.
e) The producer shall specify the service, cleaning procedures and the manner of inspection, maintenance and
replacement of components.
4.1.8 Responsibilities for package validation and for compliance and performance qualification
4.1.8.1 It shall be the responsibility of the manufacturer to ensure that the final package is validated in accordance
with this International Standard.
4.1.8.2 The responsibility for conducting compliance qualification tests on materials shall rest with the producer.
NOTE - This does not exclude voluntary assumption of this responsibility by the manufacturer.
4.1.8.3 The responsibility for conducting performance qualification tests shall rest with the manufacturer.
4.1.9 Records
All validation procedures and results shall be fully documented and retained in accordance with a formal quality
system.
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4.2 Validation requirements
4.2.1 Compatibility with the sterilization process
4.2.1.1 The sterilization compatibility of the material shall be determined for the sterilization processes to be used.
This shall include determination that the packaging is sufficiently permeable to all the physical and chemical agents
which affect the efficacy of the particular sterilization process (e.g. for ethylene oxide sterilization this would include
permeability to ethylene oxide gas, water vapour and air), and that the physical properties of the material are not
adversely affected over time by the sterilization process.
NOTES
1 Different limits on material properties may be set for inner and outer layers of packaging where the product is enclosed by
multiple wrappings.
2 Determination of suitability may be carried out concurrently with validation of the sterilization process(es) to be used.
4.2.1.2 In specific cases where multiple sterilization cycles are required, the performance of the packaging
materials shall be evaluated to ensure that the material performance remains within specified limits. This shall be
the responsibility of the manufacturer.
4.2.1.3 Determination of suitability for the intended purpose shall include consideration of material variations which
will occur during normal routine supply.
NOTE - Testing of materials should assess the effect which the random variation of essential attributes can have on the
performance of the material (e.g. thickness and/or pore size of porous materials).
4.2.1.4 Means shall be provided to ensure that all packaging used in routine production is within the limits
determined to be suitable for the sterilization process.
4.2.2 Compatibility with the product to be packaged
4.2.2.1 The suitability of the packaging for use with the particular medical device shall be determined by the
manufacturer.
This should include determination of the resistance to puncture and resistance to tear (both with and without prior
initiation of a tear) and, if applicable, determination of the effects of heat, light, moisture, air, etc.
Historical evidence may be used for materials which have previously been used satisfactorily.
4.2.2.2 The determination of limiting values for physical and chemical characteristics shall include consideration of
both the adverse interactions that can occur between the packaging and the medical device, and the stresses which
will be imposed during sterilization and subsequent transport and storage.
Examples of such adverse physical interactions can include effects of the mass, the medical device or the presence
of sharp edges, and chemical interactions which can include possible migration of plasticizers, either from
packaging to medical device or vice versa.
4.2.2.3 The manufacturer shall be responsible for ensuring that the packaging materials in combination with the
specified sterilization and packaging processes do not adversely affect the safety and efficacy of the medical
device.
4.2.2.4 The suitability of the packaging for use in protecting the particular medical device shall be determined by
the manufacturer.
This shall include consideration of particular protection required by the medical device (e.g. protection against static
discharge for electronic components) as well as the stresses which will be imposed during sterilization and
subsequent transport and storage.

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4.2.2.5 The suitability of the packaging for use with the intended labelling system shall be determined by the
manufacturer.
This shall include documented evidence that:
a) the labelling system is not adversely affected by the sterilization process and/or subsequent transport and
storage;
b) the sterilization process and/or subsequent transport and storage is not adversely affected by the labelling
system;
cj for printed labels, there is no strike-through, bleed or fading of ink which would adversely affect the medical
device or product identification;
for adhesive labels, there is adequate adhesive retention.
4.2.3 Microbial barrier properties
4.2.3.1 General
The microbial barrier properties of packaging materials are critical for assuring package integrity and product safety.
The methods used for evaluation of the microbial barrier properties are divided into two categories: those which are
appropriate for impermeable materials and methods appropriate for porous materials.
4.2.3.2 Impermeable materials
The impermeability of a material shall be determined according to annex A. Demonstrating that the material is
impermeable shall satisfy the microbial barrier requirement.
4.2.3.3 Porous materials
4.2.3.3.1 Porous materials shall provide an adequate microbial barrier to microorganisms in order to provide sterile
package integrity and product safety.
- There is no universally applicable method of demonstrating microbial barrier properties. Evaluation of the microbial
NOTE
barrier properties of porous materials is typically conducted by challenging samples with an aerosol of bacterial spores or
particulates under a set of test conditions which specify the flowrate through the material, microbial challenge to the sample,
and duration of the test. The microbial barrier properties of the material under these specified test conditions are determined by
comparing the extent of bacterial or particulate penetration through the material with the original challenge. These methods
provide a relative ranking of materials and do not predict performance under conditions other than the specified test conditions.
4.2.3.3.2 The producer of the material shall determine if the microbial barrier properties are adequate for sterile
packaging for the intended use.
4.2.3.3.3 The manufacturer shall de
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