EN ISO 11607-1:2020

SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 11607-1:2017
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
(ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11607-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-1:2017
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This European Standard was approved by CEN on 3 November 2018.

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

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11607-1:2020) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11607-1:2017.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11607-1:2019 has been approved by CEN as EN ISO 11607-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 11607-1
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière
stérile et aux systèmes d'emballage
Reference number
ISO 11607-1:2019(E)
©
ISO 2019
ISO 11607-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 11607-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 6
4.1 Quality systems . 6
4.2 Risk management . 6
4.3 Sampling . 6
4.4 Test methods . 6
4.5 Documentation . 7
5 Materials, preformed sterile barrier systems and sterile barrier systems .7
5.1 General requirements . 7
5.2 Microbial barrier properties .10
5.3 Compatibility with the sterilization process .11
5.4 Labelling system .11
5.5 Storage and transport of materials and preformed sterile barrier systems .11
6 Design and development for packaging systems .12
6.1 General .12
6.2 Design .12
7 Usability evaluation for aseptic presentation .13
8 Packaging system performance and stability .14
8.1 General .14
8.2 Packaging system performance testing .14
8.3 Stability testing .15
9 Packaging system validation and changes .15
10 Inspection immediately prior to aseptic presentation .16
11 Information to be provided .16
Annex A (informative) Guidance on medical packaging .17
Annex B (informative) Standardized test methods, guides and procedures that can be used
to demonstrate conformity with the requirements of this document .20
Annex C (normative) Test method for resistance of impermeable materials to the passage of air .31
Annex D (informative) Environmental aspects .32
Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from
protective packaging .33
Bibliography .38
ISO 11607-1:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11607-1:2006), which has been technically
revised. It also incorporates the amendment ISO 11607-1:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— the definitions have been aligned with the latest version of ISO 11139;
— new requirements for the evaluation of usability for aseptic presentation have been added;
— new requirements for the inspection of sterile barrier system integrity prior to use have been added;
— a new subclause with requirements for revalidation in accordance with ISO 11607-2 has been added;
— Annex B has been updated and various national, international and European test methods have
been added or deleted;
— a new Annex D has been added with environmental considerations;
— a new Annex E has been added with draft guidance on ways to differentiate a sterile barrier system
from protective packaging.
A list of all parts in the ISO 11607 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

ISO 11607-1:2019(E)
Introduction
The process of designing and developing a packaging system for terminally sterilized medical devices
is a complicated and critical endeavour. The device components and the packaging system should be
combined to create a sterile medical device that performs efficiently, safely and effectively in the hands
of the user.
This document specifies requirements for the design of sterile barrier systems and packaging systems
for terminally sterilized medical devices, the basic attributes required of materials and preformed
sterile barrier systems, and design validation requirements. This document is written as a general
(horizontal) standard considering a wide range of potential materials, medical devices, packaging
system designs and sterilization methods. It can be applied by suppliers of materials or of preformed
sterile barrier systems, by medical device manufacturers or health care facilities. ISO 11607-2 describes
the process development and validation requirements for forming, sealing and assembly processes and
addresses controls during normal operations.
Guidance for ISO 11607 series can be found in ISO/TS 16775.
European standards that provide requirements for particular materials and preformed sterile barrier
systems are available and known as the EN 868 series. Conformity with the EN 868 series can be used
to demonstrate conformity with one or more of the requirements of this document.
The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide
physical protection, maintain sterility up to the point of use and allow aseptic presentation. The
specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry
date, transport and storage all influence the packaging system design and choice of materials.
The term “sterile barrier system” was introduced in ISO 11607-1:2006 to describe the minimum
packaging required to perform the unique functions required of medical packaging: to allow sterilization,
to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging”
protects the sterile barrier system, and together they form the packaging system. “Preformed sterile
barrier systems” would include any partially assembled sterile barrier systems such as pouches, header
bags or hospital packaging reels. An overview of sterile barrier systems is given in Annex A.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices.
Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as
an accessory or a component of a medical device. Preformed sterile barrier systems sold to health care
facilities for use in internal sterilization are considered medical devices in many parts of the world.
INTERNATIONAL STANDARD ISO 11607-1:2019(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope
This document specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile
barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical
devices that are manufactured aseptically. Additional requirements can be necessary for drug/device
combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device
during transportation of the item to the site of reprocessing or disposal.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5636-5, Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
aseptic presentation
transfer of sterile contents from its sterile barrier system using conditions and procedures that
minimize the risk of microbial contamination
[SOURCE: ISO 11139:2018, 3.13]
ISO 11607-1:2019(E)
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.3
closure
means used to complete a sterile barrier system where no seal is formed
EXAMPLE By a reusable container gasket or sequential folding to construct a tortuous path.
[SOURCE: ISO 11139:2018, 3.51, modified — The example has been added.]
3.4
closure integrity
characteristics of a closure to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.52]
3.5
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.6
expiry date
date by which product should be used
Note 1 to entry: For the purpose of this document and ISO 11607-2, expiry date refers to the medical device in a
sterile barrier system. The term “use by date” (3.29) is used to describe the shelf life of packaging materials and
preformed sterile barrier systems prior to assembly into a sterile barrier system.
[SOURCE: ISO 11139:2018, 3.110, modified — Note 1 to entry has been added.]
3.7
labelling
label, instructions for use and any other information that is related to identification, technical
description, intended purpose and proper use of the health care product, but excluding shipping
documents
[SOURCE: ISO 13485:2016, 3.8, modified — The term “medical device” has been replaced by “health
care product”.]
3.8
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
2 © ISO 2019 – All rights reserved

ISO 11607-1:2019(E)
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been added.]
3.9
microbial barrier
property of a sterile barrier system to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.169]
3.10
monitoring
continual checking, supervising, critically observing, or determining the status, in order to identify
change from the performance level required or expected
[SOURCE: ISO Guide 73:2009, 3.8.2.1, modified — The note has been deleted.]
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
preformed sterile barrier system
sterile barrier system (3.23) that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers (3.17).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.13
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), health care product(s).
Note 1 to entry: For the purpose of this document and ISO 11607-2, products include preformed sterile barrier
systems, sterile barrier systems, and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
ISO 11607-1:2019(E)
3.14
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.15
repeatability
condition of measurement, out of a set of conditions that includes the same measurement procedure,
same operators, same measuring system, same operating conditions and same location, and replicate
measurements on the same or similar objects over a short period of time
[SOURCE: ISO/IEC Guide 99:2007, 2.20, modified — The term name has been simplified and the notes
omitted.]
3.16
reproducibility
condition of measurement, out of a set of conditions that includes different locations, processors,
measuring systems, and replicate measurements on the same or similar objects
Note 1 to entry: The different measuring systems may use different measurement procedures.
Note 2 to entry: A specification should give the conditions changed and unchanged to the extent practical.
[SOURCE: ISO/IEC Guide 99:2007, 2.24, modified — The term name has been simplified.]
3.17
reusable container
rigid sterile barrier system (3.23) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.18
seal
result of joining surfaces together by fusion to form a microbial barrier
Note 1 to entry: Surfaces can be joined together by, for example, adhesives or thermal fusion.
[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.19
seal integrity
characteristics of a seal to minimize the ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.245]
3.20
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.21
service life
number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and
safe for its intended use when used according to the labelling
[SOURCE: ISO 11139:2018, 3.251]
4 © ISO 2019 – All rights reserved

ISO 11607-1:2019(E)
3.22
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.23
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.24
sterile fluid-path packaging
system of protective port covers and/or packaging designed to ensure sterility of the portion of the
medical device intended for contact with fluids
EXAMPLE The interior of the tubing for administration of an intravenous fluid.
[SOURCE: ISO 11139:2018, 3.273]
3.25
sterilization compatibility
attributes of the packaging material and/or system that allow it both to withstand the
sterilization process and attain the required conditions for sterilization within the packaging system
[SOURCE: ISO 11139:2018, 3.278]
3.26
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbiocidal activity to
achieve sterility under specified conditions
[SOURCE: ISO 11139:2018, 3.288]
3.27
terminal sterilization
process whereby a product is sterilized within its sterile barrier system
[SOURCE: ISO 11139:2018, 3.295]
3.28
terminally sterilized
condition of a product that has been exposed to a sterilization process in its sterile barrier system
[SOURCE: ISO 11139:2018, 3.296]
3.29
use by date
upper limit of the time interval during which the performance characteristics of a material and/or
preformed sterile barrier system, stored under the specified conditions, have been demonstrated
3.30
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination
such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
ISO 11607-1:2019(E)
Note 3 to entry: The use conditions for validation can be real or simulated.
[SOURCE: ISO 9000:2015, 3.8.13, modified — “process” has been added to the definition.]
3.31
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12, modified — The original Note 2 to entry has been deleted and Note 3
has been renumbered as Note 2 accordingly.]
4 General requirements
4.1 Quality systems
The activities described within this document shall be carried out within a formal quality system.
NOTE ISO 9001, ISO 13485, and ANSI/AAMI ST90 contain requirements for suitable quality systems.
Additional requirements can be specified by a country or region.
4.2 Risk management
The activities described within this document shall consider risk management to medical devices.
NOTE ISO 14971 contains requirements for risk management to medical devices. Additional requirements
can be specified by a country or region.
4.3 Sampling
The sampling plans used for testing of materials, sterile barrier systems or packaging systems shall be
applicable to materials, sterile barrier systems or packaging systems being evaluated. Sampling plans
shall be based upon statistically valid rationale.
NOTE Common statistically based sampling plans as given, for example, in ISO 2859-1 or ISO 186 (with
appropriate modifications if necessary) can be applied to materials, sterile barrier systems or packaging systems.
Additional sampling plans can be specified by countries or regions. For further guidance, see ISO/TS 16775.
4.4 Test methods
4.4.1 A rationale for the selection of appropriate tests for the packaging system shall be established
and recorded.
4.4.2 A rationale for acceptance criteria shall be established and recorded.
NOTE Pass/fail is a type of acceptance criterion.
4.4.3 All test methods used to show conformity to this document shall be validated and documented
by the laboratory performing the test.
NOTE Annex B contains a list of test methods. Publication of a method by a standards body does not make it
validated in any laboratory.
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ISO 11607-1:2019(E)
4.4.4 The test method validation shall demonstrate the suitability of the method as used. The following
elements shall be included:
— determination of test method repeatability;
— determination of test method reproducibility;
— establishment of test method sensitivity for integrity tests.
4.5 Documentation
4.5.1 Demonstration of conformity with the requirements of this document shall be recorded.
4.5.2 All records shall be retained for a specified period of time. The retention period shall consider
factors such as applicable requirements, expiry date and traceability of the medical device or sterile
barrier system.
4.5.3 Records of conformity with the requirements shall include, but is not limited to, performance
data, specifications and test results from validated test methods as well as validation protocols,
conclusions and any necessary actions.
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
remain legible, readily identifiable and retrievable.
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements
5.1.1 Materials and/or preformed sterile barrier systems shall be selected to fulfil the goals of a
terminally sterilized medical device packaging system.
NOTE 1 Conformity with one or more requirements of this document can be demonstrated by using one or
more parts of the EN 868 series.
NOTE 2 A confirmation of conformity to a part of the EN 868 series is not sufficient to be in full conformity
with this document.
NOTE 3 Guidance on sustainability aspects is given in Annex D.
The requirements on materials shall apply to those used in preformed sterile barrier systems, as well
as sterile barrier systems.
5.1.2 The requirements listed in 5.1 are not intended to be all-inclusive. Characteristics not listed in
this subclause may be evaluated using the usability and performance criteria given in Clauses 7 and 8.
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 the following:
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;
c) the material and/or sterile barrier meets the specification.
ISO 11607-1:2019(E)
5.1.4 As applicable, the influences of the following shall be evaluated and recorded:
a) temperature range;
b) pressure range;
c) humidity range;
d) maximum rate of change of the above, where necessary;
e) exposure to sunlight or UV light;
f) cleanliness;
g) bioburden;
h) electrostatic properties.
5.1.5 The source, history and traceability of all materials, especially recycled materials, shall be known
and controlled to ensure that the preformed sterile barrier system and/or sterile barrier system will
consistently meet the requirements of this document.
NOTE With current commercial technologies, it is unlikely that anything other than virgin manufacturing
waste will be used in recycled materials, due to insufficient controls to allow the safe use of other recycled
material in sterile barrier systems.
5.1.6 The following properties shall be evaluated:
a) microbial barrier (see 5.2);
b) biocompatibility and toxicological attributes;
NOTE This is usually restricted to material in contact with the device. Guidance on biocompatibility is
given in ISO 10993-1. For further guidance, see ISO/TS 16775.
c) physical and chemical properties;
d) compatibility with respect to forming, sealing and assembly processes;
e) compatibility with respect to the intended sterilization process(es) (see 5.3);
f) any use by date limitations for pre-sterilization storage and shelf-life limitations for post-
sterilization storage.
5.1.7 Materials, e.g. wrapping materials, paper, plastic film, nonwovens or reusable fabrics, shall meet
the following general performance requirements.
a) Materials shall be non-leaching and odourless under specified conditions of use, to such an extent
that neither performance nor safety is impaired and the medical devices with which they are in
contact are not adversely affected.
NOTE Odour determination does not require a standardized test method, since odours are readily
evident.
b) Materials shall be free of holes, cracks, tears, creases or localized thickening and/or thinning
sufficient to impair functioning.
c) Materials shall have a basis weight (mass per unit area) which is consistent with the specified value.
d) Materials shall exhibit acceptable levels of cleanliness, particulate matter and linting.
e) Materials shall conform to established specific or minimum physical properties, such as tensile
strength, thickness variation, tear resistance, air permeance and burst strength.
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ISO 11607-1:2019(E)
f) Materials shall conform to established specific chemical characteristics (e.g. pH value, chloride, and
sulfate content) to meet the requirements of the medical device, packaging system or sterilization
process.
g) Materials shall not contain or release substances known to be toxic in sufficient quantity to cause a
health hazard either before, during or after sterilization under the conditions of use.
h) Materials shall have microbial barrier properties which are consistent with the specified acceptance
criteria unless they meet the criterion of impermeability when evaluated as per Annex C.
5.1.8 In addition to the requirements given in 5.1.1 through 5.1.7, 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.
b) Coating mass shall be consistent with the stated value.
c) Materials shall demonstrate minimum specified seal strength when a seal is formed with another
specified material under specified conditions.
5.1.9 In addition to the requirements given in 5.1.1 through 5.1.7 and, if appropriate, 5.1.8, sterile
barrier systems and preformed sterile barrier systems shall meet the requirements listed below.
a) Sterile barrier systems and preformed sterile barrier systems shall meet the requirements of
ISO 11607-2.
b) Materials and components, e.g. coatings, ink or chemical indicators, shall not adversely affect the
medical device by reaction, contamination and/or transfer before, during or after the defined
sterilization process.
c) If formed by sealing, the specified requirements for seal width and seal strength shall be met.
d) Peel-open characteristics shall be continuous and homogeneous, without delamination or tearing
of the material that can affect aseptic opening and presentation.
NOTE If seals are not intended to be opened for aseptic presentation, a maximum seal strength limit is
usually not necessary.
e) Once formed, the sterile barrier system shall provide seal integrity and/or closure integrity until it
is opened at the point of use.
f) Opening a seal or a closure should be irreversible or destructive. If the open seal or closure is
reversible, it shall be clearly evident that the seal or closure has been opened.
5.1.10 For reusable sterile barrier systems, e.g. containers and woven textile wraps, it shall be
determined if processing in accordance with the provided instruction leads to a degradation that will
limit the service life.
a) If degradation is anticipated, the labelling shall state the number of reprocessing cycles that can
be tolerated, unless the end of the service life is detectable. This can be done in the form of stating
how many times the sterile barrier system can be reused based on testing, or in the form of stating
a performance test method prior to use, or in the form of stating a recommended visual inspection
along with acceptance or failure criteria (e.g. unacceptable deterioration such as corrosion,
discoloration, pitting, cracked seals).
b) It shall be determined that the minimum performance characteristics are maintained throughout
the stated service life of the reusable sterile barrier system when following the recommended
processing and sterilization instructions.
ISO 11607-1:2019(E)
5.1.11 In addition to the requirements given in 5.1.1 through 5.1.7 and 5.1.10, reusable containers shall
meet the requirements given below.
a) The container shall be fitted with a tamper-evident system to provide a clear indication when the
closure integrity has been compromised.
b) The sterilizing agent port shall provide a barrier to microorganisms during removal from the
sterilizer, transport and storage (see 5.2).
c) After forming the sterile barrier system, the closure shall provide a barrier to microorganisms
until it is opened at the point of use.
d) The container shall be constructed to facilitate inspection of all essential parts.
e) Acceptance criteria shall be established for inspection prior to each reuse.
NOTE 1 Visual inspection is the most common procedure.
f) Individual components of the same container models shall be either completely interchangeable or
designed such that the components cannot be interchanged.
NOTE 2 Suitable coding and/or labelling can address this design requirement.
g) Service, cleaning procedures and the manner of inspection, maintenance and replacement of
components shall be specified.
NOTE 3 For additional guidance on reusable containers, see EN 868-8, ANSI/AAMI ST77 and ISO/
TS 16775.
5.1.12 In addition to the requirements given in 5.1.1 through 5.1.7 and, if appropriate, 5.1.8, reusable
woven textile wraps shall meet the requirements given below.
a) Performance requirements shall be met after any repairs to the material including qualifying the
compatibility of the repair to the recommended processing and sterilization instructions.
b) Processing procedures for laundering and refurbishing shall be established and documented and
ensure that performance requirements shall continue to be met.
NOTE Visual inspection is the most common procedure.
c) Processing procedures shall conform to the product labelling.
5.2 Microbial barrier properties
5.2.1 If not a declared porous material, the impermeability shall be determined in accordance with
Annex C.
NOTE The microbial barrier properties of materials used in the construction of sterile barrier systems
are critical for ensuring integrity and product safety. The methods used for evaluation of the microbial barrier
properties are divided into two categories: those that are appropriate for impermeable materials, and those that
are appropriate for porous materials.
5.2.2 A demonstration that the material is impermeable shall satisfy the microbial barrier requirement.
5.2.3 Porous materials shall provide an adequate microbial barrier to microorganisms.
10 © ISO 2019 – All rights reserved

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