BS EN 455-4:2009 - Medical gloves for single use. Requirements and testing for shelf life determination

BS EN 455-4:2009

Medical gloves for single use. Requirements and testing for shelf life determination

Status : Current, Under review   Published : August 2009

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HARDCOPY



for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.




Standard NumberBS EN 455-4:2009
TitleMedical gloves for single use. Requirements and testing for shelf life determination
StatusCurrent, Under review
Publication Date31 August 2009
Normative References(Required to achieve compliance to this standard)EN 1041, EN 455, EN 455-1, EN ISO 11607
Informative References(Provided for Information)EN ISO 2578, EN ISO 291, 93/42/EEC, ISO 11346, EN 455-2, ISO 2578:1993
International RelationshipsEN 455-4:2009
DescriptorsGloves, Surgical equipment, Life (durability), Endurance testing, Estimation, Plastics, Storage, Protective clothing, Protective gloves, Sterile equipment, Disposable, Rubber, Medical equipment
ICS11.140
Title in FrenchGants médicaux non réutilisables. Exigences et essais relatifs à la détermination de la durée de conservation
Title in GermanMedizinische Handschuhe zum einmaligen Gebrauch. Anforderungen und Prüfung zur Bestimmung der Mindesthaltbarkeit
CommitteeCH/205/3
ISBN978 0 580 58298 1
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size343 KB
Price£130.00


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