BS 5736-5:1982 - Evaluation of medical devices for biological hazards. Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices

BS 5736-5:1982

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

Status : Withdrawn, Superseded   Published : November 1982 Replaced By : BS EN ISO 10993-11:1996

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Method specifies measurement of the rise in body temperature of rabbits during a period of 3 hours following an intravenous injection of an extract of the device prepared with pyrogen-free saline. Method intended to identify the presence of pyrogenic materials in, or on, a medical device.




Standard NumberBS 5736-5:1982
TitleEvaluation of medical devices for biological hazards. Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
StatusWithdrawn, Superseded
Publication Date30 November 1982
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Withdrawn Date15 May 1996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 6210
Draft Superseded By80/62086 DC88/54616
DescriptorsBiological analysis and testing, Biological hazards, Medical equipment, Medical instruments, Leaching, Extraction, Toxicity, Laboratory animals, Containers, Temperature measurement
ICS11.100.20
Title in FrenchEvaluation des risques biologiques du matériel médical. Méthode d'essai de la toxicité systémique: évaluation de l'action pyrogène du matériel médical sur le lapin
Title in GermanBewertung der medizinischen Geraeten ausgehenden biologischen Gefahren. Verfahren zur Pruefung auf Systemtoxizitaet; Bestimmung der Pyrogenizitaet an Kaninchen mit Hilfe von Extrakten aus medizinischen Geraeten
CommitteeCH/194
ISBN0 580 12920 9
PublisherBSI
FormatA4
DeliveryNo
Pages12
File Size664.4 KB
Price£110.00


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