BS EN ISO 11607-1:2006 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems – BSI British Standards
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BS EN ISO 11607-1:2006

Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

Status : Revised, Superseded, Withdrawn   Published : May 2006 Replaced By : BS EN ISO 11607-1:2009+A1:2014

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The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a product that performs efficiently, safely and effectively in the hands of the user.

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.

BS EN ISO 11607-1 specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs and sterilization methods. The standard describes the validation requirements for forming, sealing and assembly processes. BS EN ISO 11607-1 specifies general requirements for all packaging materials whereas BS EN 868 Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of BS EN ISO 11607 were designed to meet the Essential Requirements of the European Medical Device Directives.

European standards that provide requirements for particular materials and preformed sterile barrier systems are available and known as the BS EN 868 series. BS EN ISO 11607-1 has been developed as a means to show compliance with the relevant Essential Requirements of the European Directives concerning medical devices. Compliance with EN 868 Parts 2 to 10 can be used to demonstrate compliance with one or more of the requirements of BS EN ISO 11607-1..

The specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials. One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”, “primary pack”, and “primary package” all have different connotations around the globe, and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document. As a result, the term “sterile barrier system” was introduced to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags or hospital packaging reels.

The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare facilities for use in internal sterilization are considered as medical devices in many parts of the world.

BS EN ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. An overview of sterile barrier systems can be found in Annex A.

It is applicable to industry, health care facilities and 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 might also be necessary for drug/device combinations. Nor does it describe a quality assurance system for control of all stages of manufacture.

BS EN ISO 11607-1:2006 supersedes BS EN 868-1:1997, which has been withdrawn.




Standard NumberBS EN ISO 11607-1:2006
TitlePackaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
StatusRevised, Superseded, Withdrawn
Publication Date31 May 2006
Withdrawn Date28 February 2010
Normative References(Required to achieve compliance to this standard)ISO 5636-5:2003
Informative References(Provided for Information)ASTM F88:2000, EN 554:1994, IST 80-8, EN 20535:1994, ISO 14937:2000, ASTM D882:2002, ASTM F1929:1998, ASTM D1938:2002, ASTM D1709:2001, ASTM D4169:2001, ISO 6588-1:2005, 93/42/EEC, ISO 534:2005, ISO 11137-2:2006, ASTM F1608:2000, ISO 9198:2001, ANSI/AAMI ST65:2000, ASTM F1980:2002, ASTM F1306:1998, ASTM D3078:1994, ISO 10993-1:2003, ISO 4180-1:1980, ISO 3781:1983, ASTM F2101:2001, ASTM F2251:2003, ISO 11607-2:2006, ASTM F2203:2002, ISO 2233:2000, TAPPI T 437-OM-96, ISO 13485:2003, BS 6524:1989, ASTM F1140:2000, ISO 186:2002, ISO 11137-1:2006, ASTM D3776:1996, ASTM D1922:2000, ASTM F2227:2002, ISO 811:1981, ASTM D4332:2001, DIN 58953-6:1987, ASTM D645:1997, DIN 53121:1978, ASTM F2054:2000, VIM:1993, ISO 3689:1983, EDANA 170-1-02, EN 552:1994, ASTM D4321:1999, ASTM F2338:2003, ASTM F2252:2003, ISO 6588-2:2005, ISO 9001:2000, EN 868-8:1999, EN 13795-1:2002, BS 6256:1989, ISO 13683:1997, EN 14180:2003, ISO 2493:1992, EN 868-10:2000, EN 868-7:1999, ISO 5636-3:1992, ISO 9073-9:1995, ISO 536:1995, ISO 2859-1:1999, ISO 187:1990, EN 868-3:1999, EN 285:1996, EN 868-1:1997, ISO 1974:199
Replaced ByBS EN ISO 11607-1:2009+A1:2014
ReplacesBS EN 868-1:1997
International RelationshipsEN ISO 11607-1:2006,ISO 11607-1:2006
Draft Superseded By04/30101211 DC
DescriptorsTest methods, Seals, Packaging materials, Medical equipment, Design, Performance, Quality assurance systems, Sterile equipment, Medical instruments, Compatibility, Performance testing, Packaging, Wrapping, Quality, Sterilization (hygiene), Packages
ICS11.080.30
Title in FrenchEmballages des dispositifs medicaux sterilises au stade terminal. Exigences relatives aux materiaux, aux systemes de barriere sterile et aux systemes d'emballage
Title in GermanVerpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte. Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme
CommitteeCH/198
ISBN0 580 48311 8
PublisherBSI
FormatA4
DeliveryNo
Pages36
File Size787 KB
Price£218.00


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