BS EN 868-2:2017 - Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods

BS EN 868-2:2017

Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods

Status : Current   Published : February 2017



This draft European Standard provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in to of this part of EN 868 are intended for single use, the materials specified in are intended for reuse.

Standard NumberBS EN 868-2:2017
TitlePackaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
Publication Date28 February 2017
Normative References(Required to achieve compliance to this standard)ISO 5636-3, ISO 187, ISO 1974, ISO 2758, ISO 535, ISO 811:1981, ISO 9073-3, ISO 6588-2:2012, ISO 8601, ISO 3781, EN ISO 535, EN ISO 13938-1, ISO 13937-1, EN ISO 536, ISO 2470-2, EN 20811, EN 20187, ISO 9198, ISO 1924-2, EN ISO 11607-1:2009+A1:2014, ISO 9197, EN ISO 2758, ISO 11607-1:2006, ISO 13938-1, ISO 11607-1:2006/A1:2014, EN ISO 13937-1, EN ISO 9237, EN ISO 1974, ISO 536, ISO 3689, ISO 9237, EN ISO 1924-2, EN 29073-3
Informative References(Provided for Information)ISO 5725-2, ISO 15223-1, EN ISO 15223-1, EN 13795, EN 1149–1, ISO 9073-9, EN ISO 9073-9, EN ISO 11607-2, ISO 11607-2, 93/42/EEC, EN 1041
ReplacesBS EN 868-2:2009
International RelationshipsEN 868-2:2017
Draft Superseded By15/30325855 DC
DescriptorsTear strength, Air permeability, Drape determination (textiles), Marking, Optical properties of materials, Packaging, Woven fabrics, Water-resistance tests, Crepe paper, pH, Medical instruments, Porosity, Performance, Tensile strength, Sterile equipment, Porosity measurement, Paper, Weight (mass), Packaging materials, Wrapping paper, Elongation at fracture, Medical equipment, Sterilization (hygiene)
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Enveloppe de stérilisation. Exigences et méthodes d'essai
Title in GermanVerpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte. Sterilisierverpackung. Anforderungen und Prüfverfahren
ISBN978 0 580 90656 5
File Size558 KB

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