BS EN ISO 10993-4:2002 - Biological evaluation of medical devices. Selection of tests for interactions with blood – BSI British Standards
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BS EN ISO 10993-4:2002

Biological evaluation of medical devices. Selection of tests for interactions with blood

Status : Superseded, Withdrawn   Published : November 2002 Replaced By : BS EN ISO 10993-4:2009, BS EN ISO 10993-4:2017

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BS EN ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood. It describes a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in BS EN ISO 10993-1; the fundamental principles governing the evaluation of the interaction of devices with blood; the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.

This international standard describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.




Standard NumberBS EN ISO 10993-4:2002
TitleBiological evaluation of medical devices. Selection of tests for interactions with blood
StatusSuperseded, Withdrawn
Publication Date14 November 2002
Withdrawn Date28 February 2010
Normative References(Required to achieve compliance to this standard)ISO 10993-2:1992, ISO 10993-1:1997
Informative References(Provided for Information)ASTM F 1984-99, ISO 5841-3, ISO 3826, AANSI/AAMI CVP3-1981, ASTM F 756-00, ISO 10993-12, NF 90-300:1981, DIN 58361-4:1980, GB/T 16175-1996, ISO 7198, ISO 7199, ASTM F 2065-00, ANSI/AAMI VP20-1986, ISO 5840:1996, ISO 5841-1, BS 5736-11:1990
Replaced ByBS EN ISO 10993-4:2009, BS EN ISO 10993-4:2017
ReplacesBS EN ISO 10993-4:2002
International RelationshipsEN ISO 10993-4:2002/A1:2006,ISO 10993-4:2002/Amd 1:2006
Amended ByAMD 14295
Amendment, September 2006; Corrigendum, January 2003
DescriptorsDental materials, Blood coagulation, Dental equipment, Biological hazards, Blood, Medical instruments, Haematology, Medical equipment, Medical technology, Biological analysis and testing
ICS11.100.20
Title in FrenchEvaluation biologique des dispositifs medicaux. Choix des essais concernant les interactions avec le sang
Title in GermanBiologische Beurteilung von Medizinprodukten. Auswahl von Pruefungen zur Wechselwirkung mit Blut
CommitteeCH/194
ISBN0 580 40720 9
PublisherBSI
FormatA4
DeliveryNo
Pages48
File Size1.497 MB
Price£246.00


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