BS 5736-3:1981 - Evaluation of medical devices for biological hazards. Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices

BS 5736-3:1981

Evaluation of medical devices for biological hazards. Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices

Status : Withdrawn, Superseded   Published : November 1981 Replaced By : BS EN ISO 10993-11:1996

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Describes the method of test designed to provide information on the acute toxic effects attributable to leachable inherent or extraneous substances present in or on a medical device using a polar and non-polar solvent to obtain extracts that are administered as a parenteral dose to mice. Use with the guidance of Part 1.




Standard NumberBS 5736-3:1981
TitleEvaluation of medical devices for biological hazards. Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
StatusWithdrawn, Superseded
Publication Date30 November 1981
Confirm Date15 April 1994
Withdrawn Date15 May 1996
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 10993-11:1996
Amended ByAMD 6208
Draft Superseded By79/64281 DC88/54616
DescriptorsBiological analysis and testing, Biological hazards, Medical equipment, Medical instruments, Extraction, Leaching, Laboratory animals, Toxicity, Containers
ICS11.100.20
Title in FrenchEvaluation des risques biologiques présentés par les appareils médicaux. Méthode d'essai de toxicité systémique; évaluation de la toxicité aiguë d'extraits d'appareils médicaux
Title in GermanAuswertung der biologischen Gefahren von medizinischen Einrichtungen. Pruefverfahren fuer Systemtoxizitaet; Bewertung akuter Toxizitaet von Extrakten von medizinischen Einrichtungen
CommitteeCH/194
ISBN0 580 12459 2
PublisherBSI
FormatA4
DeliveryNo
Pages10
File Size675.5 KB
Price£110.00


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