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BS 5736-3:1981

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

15-05-1996

Language(s)

English

Published date

30-11-1981

Foreword
Cooperating organizations
Method
1 Scope
2 References
3 Definitions
4 Animals and husbandry
5 Preparation of extracts
6 Test procedure
7 Presentation of results
8 Assessment of results

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.

Committee
CH/194
DocumentType
Standard
Pages
10
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

BS 5736-6:1983 Evaluation of medical devices for biological hazards Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis
BS 6788-1:1986 Neurosurgical implants Specification for sterile, single-use hydrocephalus shunts and components
BS 5736-1:1979 Evaluation of medical devices for biological hazards Guide for the selection of biological methods of test
BS 2463-1:1990 Transfusion equipment for medical use Specification for collapsible containers for blood and blood components
BS 5736-7:1983 Evaluation of medical devices for biological hazards Method of test for skin irritation of extracts from medical devices
BS 5736-2:1990 Evaluation of medical devices for biological hazards Methods of testing by tissue implantation
BS 4843:1987 Specification for sterile intravascular cannula units for single use
BS 5736-4:1981 Evaluation of medical devices for biological hazards Method of test for intracutaneous reactivity of extracts from medical devices
BS 2463-2:1989 Transfusion equipment for medical use Specification for administration sets
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 7253-3:1990 Non-metallic materials for surgical implants Specification for surgical implants made of heat-vulcanized silicone elastomer
BS 3531-16:1985 Surgical implants Specification for surgical implants made of heat-vulcanized silicone elastomer
BS 5736-1:1989 Evaluation of medical devices for biological hazards Guide for the selection of biological methods of test

BS 5736-4:1981 Evaluation of medical devices for biological hazards Method of test for intracutaneous reactivity of extracts from medical devices
BS 5736-1:1979 Evaluation of medical devices for biological hazards Guide for the selection of biological methods of test
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

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