SIST EN ISO 11607-2:2020
(Main)Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
This document specifies requirements for thedevelopment and validation of processes for packaging medical devices that areterminally sterilized. These processes include forming, sealing and assembly ofpreformed sterile barrier systems, sterile barrier systems and packagingsystems. It is applicable to industry, to health care facilities, and towherever medical devices are packaged and sterilized. It does not cover allrequirements for packaging medical devices that are manufactured aseptically.Additional requirements can be necessary for drug/device combinations .
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2019)
Dieses Dokument legt Anforderungen für die Entwicklung und Validierung von Verpackungsprozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Steril-barrieresystemen und Verpackungssystemen.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden.
Es deckt nicht alle Anforderungen an Verpackungen aseptisch hergestellter Medizinprodukte ab. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Le présent document spécifie les exigences pour la mise au point et la validation des procédés d'emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le formage, le scellage et l'assemblage de systèmes de barrière stérile préformés, de systèmes de barrière stérile et de systèmes d'emballage.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés.
Il ne couvre pas toutes les exigences relatives à l'emballage des dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2019)
Ta dokument podaja zahteve za razvoj in validacijo procesov za embalažo medicinskih pripomočkov, ki so končno sterilizirani. Ti procesi vključujejo oblikovanje, označevanje in sestavljanje izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani. Ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve
General Information
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Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11607-2:2020
01-marec-2020
Nadomešča:
SIST EN ISO 11607-2:2017
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11607-2:2020
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SIST EN ISO 11607-2:2020
EN ISO 11607-2
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-2:2017
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 2: Exigences de validation pour les sterilisierende Medizinprodukte - Teil 2:
procédés de formage, scellage et assemblage (ISO Validierungsanforderungen an Prozesse der
11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This European Standard was approved by CEN on 4 December 2019.
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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
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 11607-2:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11607-2:2020
EN ISO 11607-2:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11607-2:2020
EN ISO 11607-2:2020 (E)
European foreword
This document (EN ISO 11607-2:2020) 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 11607-2:2017.
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 11607-2:2019 has been approved by CEN as EN ISO 11607-2:2020 without any
modification.
3
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SIST EN ISO 11607-2:2020
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SIST EN ISO 11607-2:2020
INTERNATIONAL ISO
STANDARD 11607-2
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 2:
Validation requirements for forming,
sealing and assembly processes
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage,
scellage et assemblage
Reference number
ISO 11607-2:2019(E)
©
ISO 2019
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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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
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(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 Quality systems . 5
4.2 Risk management . 6
4.3 Sampling . 6
4.4 Test methods . 6
4.5 Documentation . 6
5 Validation of packaging processes . 7
5.1 General . 7
5.2 Installation qualification . 7
5.3 Operational qualification . 8
5.4 Performance qualification . 9
5.5 Formal approval of the process validation. 9
5.6 Process control and monitoring .10
5.7 Process changes and revalidation .10
6 Assembly .10
7 Use of reusable sterile barrier systems .11
8 Sterile fluid-path packaging .11
Annex A (informative) Process development .12
Bibliography .13
© ISO 2019 – All rights reserved iii
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(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 the following
URL: 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 11607-2:2006), which has been technically
revised. It also incorporates the amendment ISO 11607-2:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— terms and definitions for “process variable”, “process parameter” and “monitoring of processes”
have been added;
— various definitions have been aligned with the latest version of ISO 11139;
— the terminology of “critical” process parameters has been discontinued and the concept of a process
specification has been introduced to include all elements required to manufacture a product that
consistently meets specifications.
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
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
Introduction
Packaging for terminally sterilized medical devices should be designed and manufactured to ensure
that the medical device can be sterilized and remain sterile under documented storage and transport
conditions until the sterile barrier system is damaged or opened.
One of the most critical characteristics of a sterile barrier system and packaging system for sterile
medical devices is the assurance of sterility maintenance. Medical devices delivered in a sterile
state should have been manufactured, packed and sterilized by appropriate, validated methods. The
development and validation of packaging processes are crucial to ensure that sterile barrier system
integrity is attained and will remain so until opened by the users of sterile medical devices.
There should be a documented process validation programme demonstrating the efficacy and
reproducibility of all packaging and sterilization processes. Along with the sterilization process, some
of the packaging operations that can affect sterile barrier system integrity are sealing, capping or other
closure systems, cutting, form/fill/seal, assembly processes and subsequent handling. This document
provides the framework of activities and requirements to develop and validate the process used to
make and assemble the packaging system. Guidance for ISO 11607 series can be found in ISO/TS 16775.
The term “sterile barrier system” was introduced in 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.
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.
© ISO 2019 – All rights reserved v
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SIST EN ISO 11607-2:2020
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SIST EN ISO 11607-2:2020
INTERNATIONAL STANDARD ISO 11607-2:2019(E)
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
1 Scope
This document specifies requirements for the development and validation of processes for packaging
medical devices that are terminally sterilized. These processes include forming, sealing and assembly
of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and
sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically.
Additional requirements can be necessary for drug/device combinations.
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 11607-1:2018, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems
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 http: //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]
3.2
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.]
© ISO 2019 – All rights reserved 1
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
3.3
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.4
expiry date
date by which product should be used
Note 1 to entry: For the purpose of this document and ISO 11607-1, expiry date refers to the medical device
in a sterile barrier system. The term “use by date” is used to describe the shelf life of packaging materials and
preformed sterile barrier systems (3.13) prior to assembly into a sterile barrier system (3.25).
[SOURCE: ISO 11139:2018, 3.110, modified — The Note 1 to entry has been added.]
3.5
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.6
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”.]
3.7
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;
— 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;
2 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
— 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.]
3.8
microbial barrier
property of a sterile barrier system to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.169]
3.9
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.]
3.10
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
[SOURCE: ISO 11139:2018, 3.220.3]
3.11
packaging system
combination of a sterile barrier system (3.25) and protective packaging (3.18)
[SOURCE: ISO 11139:2018, 3.192]
3.12
performance qualification
PQ
process of establishing by objective evidence that the process, under anticipated conditions, consistently
produces a product (3.17) which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.13
preformed sterile barrier system
sterile barrier system (3.25) that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers (3.21).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.14
process parameter
specified value for a process variable (3.16)
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
[SOURCE: ISO 11139:2018, 3.211]
© ISO 2019 – All rights reserved 3
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
3.15
process specification
documented procedure that includes all equipment, process parameters, monitors and materials
required to manufacture a product that consistently meets requirements
3.16
process variable
chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process,
changes in which can alter its effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: ISO 11139:2018, 3.213]
3.17
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), healthcare product(s).
Note 1 to entry: For the purposes of this document and ISO 11607-1, products include preformed sterile barrier
systems (3.13), sterile barrier systems (3.25) and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
3.18
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.25) and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.19
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.]
3.20
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 has been simplified.]
3.21
reusable container
rigid sterile barrier system (3.25) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.22
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.
4 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
[SOURCE: ISO 11139:2018, 3.244 modified — The Note 1 to entry has been added.]
3.23
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.24
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.25
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]
3.26
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]
3.27
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]
3.28
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.
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.]
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.
© ISO 2019 – All rights reserved 5
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SIST EN ISO 11607-2:2020
ISO 11607-2:2019(E)
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 of ISO 11607-1 contains a list of test methods. Publication of a method by a standards body
does not make it validated in any laboratory.
4.4.4 The test method validation shall demonstrate the suitability of th
...
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01-januar-2018
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO/DIS 11607-2)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO/DIS 11607-2:2017)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO/DIS 11607-
2:2017)
Ta slovenski standard je istoveten z: prEN ISO 11607-2
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN ISO 11607-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11607-2:2018
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oSIST prEN ISO 11607-2:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11607-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-09-18 2017-12-11
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage
ICS: 11.080.30
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
4.1 General . 4
4.2 Quality systems . 4
4.3 Sampling . 4
4.4 Test methods . 4
4.5 Documentation . 5
5 Validation of packaging processing . 5
5.1 General . 5
5.2 Installation qualification (IQ) . 6
5.3 Operational qualification (OQ) . 7
5.4 Performance qualification (PQ) . 7
5.5 Formal approval of the process validation. 8
5.6 Process control and monitoring . 8
5.7 Process changes and revalidation . 8
6 Packaging system assembly . 9
7 Use of reusable sterile barrier systems . 9
8 Sterile fluid-path packaging . 9
Annex A (informative) Process development .10
Annex B (informative) Draft guidance on the relationship between this standard and the
general safety and performance requirements of Regulation (EU) 2017/745 of
the European Parliament and of the Council of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC .11
Annex C (informative) Draft guidance on the relationship between this standard and
general safety and performance requirements of Regulation (EU) 2017/746 of
the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and Commission Decision
2010/227/EU .14
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .16
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered .18
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered .19
Bibliography .21
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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 on 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 the following URL: www . i so .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.
The main changes compared to the previous edition are as follows:
— New definitions for process variable, process parameter and monitoring of processes.
— Alignments of various definitions with ISO 11139 to ensure harmonization throughout the standards
under ISO/TC 198.
— The terminology of “critical” process parameters is discontinued and the concept of a process
specification is introduced to include all elements required to manufacture a product that
consistently meets specifications.
A list of all parts in the ISO 11607 series can be found on the ISO website.
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Introduction
Packaging for medical devices which shall be terminally sterilized should be designed and manufactured
to ensure that the medical device can be sterilized and remain sterile under documented storage and
transport conditions until the sterile barrier system is damaged or opened.
One of the most critical characteristics of a sterile barrier system and packaging system for sterile
medical devices is the assurance of sterility maintenance. Medical devices delivered in a sterile
state should have been manufactured, packed and sterilized by appropriate, validated methods. The
development and validation of packaging processes are crucial to ensure that sterile barrier system
integrity is attained and will remain so until opened by the users of sterile medical devices.
There should be a documented process validation program demonstrating the efficacy and
reproducibility of all packaging and sterilization processes. Along with the sterilization process,
some of the packaging operations that can affect sterile barrier system integrity are sealing, capping
or other closure systems, cutting, form/fill/seal, assembly processes and subsequent handling. This
part of ISO 11607 provides the framework of activities and requirements to develop and validate the
process used to make and assemble the packaging system. Both parts of ISO 11607 were designed
to meet the selected Essential Requirements of the European Medical Device Directives. During the
revision of ISO 11607-1 and -2, the European Commission published the drafts and final versions of
the European Medical Device Regulations (MDR) and the In Vitro Diagnostics Regulation (IVDR). The
committee responsible for ISO 11607-1 and -2 incorporated changes in this revision to meet the specific
requirements of the MDR and IVDR.
The term “sterile barrier system” was introduced in 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.
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 regulated as medical devices in many parts of the world.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 11607-2:2017(E)
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
1 Scope
This part of ISO 11607 specifies the requirements for development and validation of processes for
packaging medical devices that are terminally sterilized. These processes include forming, sealing, and
assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices
are packaged and sterilized.
This part of ISO 11607 does not cover all requirements for packaging medical devices that are
manufactured aseptically. Additional requirements may also be necessary for drug/device
combinations.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
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 http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
control
regulation of variables within specified limits
[SOURCE: ISO/DIS 11139:2017]
3.2
expiry date
indication of the date by which the product should be used
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3.3
installation qualification
IQ
Process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation adhere to the approved specification
[SOURCE: ISO/DIS 11139:2017]
3.4
labelling
label, instructions for use, and any other information that is related to identification, technical
description, intended purpose and proper use of the medical device but excluding shipping documents
[SOURCE: ISO/DIS 11139:2017]
3.5
monitoring
continual checking, supervising, critically observing or determining the status in order to identify
change from the performance level required or expected
[SOURCE: ISO/DIS 11139:2017]
3.6
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
[SOURCE: ISO/DIS 11139:2017]
3.7
packaging system
combination of the sterile barrier system and protective packaging
[SOURCE: ISO/DIS 11139:2017]
3.8
process parameter
specified value for a process variable
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
3.9
performance qualification
PQ
process of establishing by objective evidence that the process, under anticipated conditions, consistently
produces a product which meets all predetermined requirements
[SOURCE: ISO/DIS 11139:2017]
3.10
preformed sterile barrier system
sterile barrier system that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers
[SOURCE: ISO/DIS 11139:2017]
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3.11
process parameter
specified value for a process variable
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
[SOURCE: ISO/DIS 11139:2017]
3.12
process variable
chemical or physical properties attribute within a cleaning, disinfection, packaging, or sterilization
process, changes in which can alter its effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength
[SOURCE: ISO/DIS 11139:2017]
3.13
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), healthcare product(s)
Note 1 to entry: For the purposes of ISO 11607-1 and ISO 11607-2, product includes preformed sterile barrier
systems, sterile barrier systems, and contents within them.
[SOURCE: Modified from ISO/DIS 11139:2017]
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
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
[SOURCE: ISO/DIS 11139:2017]
3.16
reproducibility
condition of measurement, out of a set of conditions that includes different locations, operators,
measuring systems, and replicate measurements on the same or similar objects
[SOURCE: ISO/DIS 11139:2017]
3.17
reusable container
rigid sterile barrier system designed to be repeatedly used
3.18
sterile barrier system
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
3.19
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 1 to entry: An example of sterile fluid-path packaging would be the interior of the tubing for administration
of an intravenous fluid.
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3.20
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.
Note 3 to entry: The use conditions for validation can be real or simulated
[SOURCE: ISO/DIS 11139:2017]
4 General requirements
4.1 General
Practices in 4.2, 4.3, 4.4 and 4.5 are a fundamental prerequisite of demonstrating compliance to
ISO 11607-2.
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
might be specified by a country or region.
4.2.2 It shall not be necessary to obtain third-party certification of the quality system to fulfil the
requirements of this part of ISO 11607.
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 might be specified by countries or regions. For further guidance, see
ISO/TS 16775:2014, Annex L.
4.4 Test methods
4.4.1 A rationale for the selection of appropriate tests for the packaging system shall be established
and documented.
4.4.2 A rationale for acceptance criteria shall be established and documented.
NOTE Pass/fail is a type of acceptance criterion.
4.4.3 All test methods used to show compliance with this part of ISO 11607 shall be validated and
documented by the laboratory performing the test.
NOTE ISO 11607-1, 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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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; and
— establishment of test method sensitivity for integrity tests.
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 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 Validation of packaging processing
5.1 General
5.1.1 Preformed sterile barrier systems and sterile barrier system manufacturing processes shall be
validated.
NOTE Examples of these processes include, but are not limited to:
— pouch, reel, or bag forming and sealing;
— form/fill/seal automated processes;
— kit assembly and wrapping, including application of tape;
— assembly of sterile fluid-path products ;
— tray/lid sealing;
— filling and closing of reusable containers;
— sterilization sheets folding and wrapping.
5.1.2 Process validation shall include, at a minimum, an installation qualification, an operational
qualification, and a performance qualification in this order.
5.1.3 A process specification shall be established for forming, assembly and sealing processes,
including, but not limited to, the following elements:
— the required process output;
— the process parameters for control to produce the specified process output; and
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— the process variables and process (and/or product) attributes to be monitored in order to maintain
the process in a state of control and capability.
NOTE 1 Process development, while not formally part of process validation, is considered an integral part of
forming and sealing (see Annex A).
NOTE 2 Validation of existing products can rely on data from previous validations of existing products. That
data can be used for determination of the tolerances for process parameters.
5.1.4 When similar preformed sterile barrier systems and sterile barrier system manufacturing
processes are validated, a rationale for establishing similarities and identifying the worst case
configuration shall be documented. As a minimum, the worst case configuration shall be validated to
determine compliance with this part of ISO 11607.
NOTE For example, similarity could be established by different sizes of preformed sterile barrier systems
made of the same or comparable raw materials.
5.2 Installation qualification (IQ)
5.2.1 Installation qualification shall be performed including as minimum all elements listed in the
process specification.
The following shall be considered:
— equipment design features;
— installation conditions such as wiring, utilities, functionality, etc.;
— safety features;
— equipment operating within the stated design parameters;
— supplier documentation, prints, drawings and manuals;
— spare-parts lists;
— software validation;
— environmental conditions such as cleanliness, temperature, humidity;
— documented operator training;
— operating manual or procedure.
5.2.2 Tests shall be performed to confirm that process variables can be controlled as specified.
5.2.3 Functions that allow process variable monitoring shall be checked.
5.2.4 Alarms, warning systems, or machine stops shall be challenged in the event that process variables
exceed predetermined limits.
5.2.5 Specified instruments, sensors, displays, controllers, etc. shall be documented as calibrated and
have written calibration schedules.
5.2.6 There shall be written preventive maintenance and cleaning schedules.
5.2.7 The application of software systems shall be validated.
[17]
NOTE For software validation see also ISO 13485:2015, 7.5.6 and GAMP 5 .
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5.3 Operational qualification (OQ)
5.3.1 Process variables shall be challenged to determine the upper and lower parameter limits that
produce preformed sterile barrier systems and/or sterile barrier systems that meet all predetermined
specifications.
NOTE See Annex A.
5.3.2 As a minimum, preformed sterile barrier systems and sterile barrier systems shall be produced
at both the upper and lower parameter limits (see 5.3.1) and exhibit the properties that meet predefined
specifications.
The following quality properties shall be considered:
a) For forming/assembly:
— sterile barrier system completely formed/assembled;
— product fits into the sterile barrier system;
— essential dimensions are met.
b) For sealing:
— intact seal for a specified seal width;
— absence of channels or open seals;
— absence of punctures or tears;
— absence of material delamination or separation.
c) For other closure systems:
— continuous closure;
— absence of punctures or tears;
— absence of material delamination or separation.
5.4 Performance qualification (PQ)
5.4.1 The performance qualification shall demonstrate that the process will consistently produce
preformed sterile barrier systems, and sterile barrier systems, that meet predetermined requirements
under anticip
...
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