BS 5736-4:1981
Withdrawn
Evaluation of medical devices for biological hazards Method of test for intracutaneous reactivity of extracts from medical devices
Hardcopy , PDF
English
11-30-1981
11-15-2001
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
Table
1 Classification system for tissue reaction
Figure
1 Arrangement of injection sites for a single extract
Describes the method of test designed to assess the localized reaction of tissue to leachable inherent or extraneous substances present in or on a medical device. Use with the guidance of Part 1.
| Committee |
CH/194
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Standards | Relationship |
| UNE-CEN/TS 16272-7:2015 | Identical |
| 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 1695-1:1990 | Urological catheters Specification for sterile, single-use urethral catheters of the Nélaton and Foley types |
| BS 6155:1990 | Specification for tracheal tubes for large animals in veterinary anaesthesia |
| 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 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 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 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 1695-2:1990 | Urological catheters Specification for sterile, single-use urethral catheters of the Tiemann, whistle tip, 3-way and haematuria types |
| BS 5736-1:1989 | Evaluation of medical devices for biological hazards Guide for the selection of biological methods of test |
| 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 |
| 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 |
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