BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

BS EN ISO 11607-1:2017

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

Status : Superseded, Withdrawn   Published : May 2018 Replaced By : BS EN ISO 11607-1:2020

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What is this standard about?

This part of 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.

Who is this standard for?

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 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. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture. This part of ISO 11607 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.




Standard NumberBS EN ISO 11607-1:2017
TitlePackaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
StatusSuperseded, Withdrawn
Publication Date15 May 2018
Withdrawn Date20 January 2020
Normative References(Required to achieve compliance to this standard)ISO 5636-5:2003, ISO 5636-5, ISO 11607-2
Informative References(Provided for Information)TAPPI T564, TAPPI T536, ASTM F2217, ISO 18606, ISO 14040, ASTM F2638, ASTM F2096, ASTM F99, ISO 4180, ASTM D257, TAPPI T456, ISO 2493-1, EN 13430, TAPPI T255, ASTM F2475, ISO 15223-1, EN 13429, ISO 6588-2, ISO 14045, ISO 11135, ASTM D1709, JIS T 0993-1, ISO 7000, AAMI TIR 65, ISO 1924-2, ASTM F2252, ISO 14025, ASTM F1140, IEC 62366 (all parts), ASTM F2203, ASTM F3004, EN 13427, ISO 3781, TAPPI T441, ANSI/AAMI ST77, ISO 535, ASTM F1886/F1886M, ISO 187, BS 6256, ASTM F2981, ASTM F1307, TAPPI T494, ISO 186, ISO 2493-2, ASTM D737, ISO 14024, ASTM F2391, ASTM F392, ASTM F2559/2559F, ASTM F1306, ASTM D3420, ASTM F1927, TAPPI T410, ISO 18601, ISO 536, ISO 18602, JIS P-8117, ISO 13485, EN 13060, ISO 14021, JIS P-8124, ASTM F2054, JIS P 8133, ASTM D3776?6M, ASTM F1929, DIN 53121, ASTM F2250, ISO 2758, TAPPI T489, JIS P-8135, ANSI/AAMI ST90, EDANA 170-1, BS 6524, ASTM D5034, TAPPI T437, ISO/TS 16775, ASTM F2101, ASTM D882, JIS P-8118, EN 13431, ASTM D1922, ISO 1974, ASTM F2095, ISO 18603, ASTM F2251, TAPPI T256, ISO 9001, ASTM F2097, JIS P-8144, ISO 18604, ISO 11607-2, ANSI/AAMI ST79, ASTM F2622, JIS P-8111, TA
Replaced ByBS EN ISO 11607-1:2020
ReplacesBS EN ISO 11607-1:2009+A1:2014
International RelationshipsENISO 11607-1,ISO 11607-1,ISO 11607-1:2006,EN ISO 11607-1:2017
Draft Superseded By17/30351717 DC18/30377581DC
DescriptorsPerformance testing, Quality, Performance, Sterile equipment, Packaging materials, Compatibility, Medical instruments, Packages, Wrapping, Medical equipment, Sterilization (hygiene), Quality assurance systems, Seals, Packaging, Test methods, Design
ICS11.080.30
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme
CommitteeCH/198
ISBN978 0 580 96433 6
PublisherBSI
FormatA4
DeliveryYes
Pages44
File Size1.176 MB
Price£214.00


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