BS 7253-3:1990
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Non-metallic materials for surgical implants Specification for surgical implants made of heat-vulcanized silicone elastomer
Hardcopy , PDF
27-09-2012
English
31-05-1990
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Committees responsible
Specification
1. Scope
2. Definitions
3. Extraneous material
4. Chemical and biological properties
5. Sterility
6. Packaging and marking
Appendices
A. Guidance on materials used in the manufacture of
implants made of silicone elastomer
B. Method of measurement of extractable matter
C. Method of measurement of the buffering capacity of
an extract of an implant
D. Method of measurement of residual platinum
E. Method of measurement of residual peroxides
F. Method of measurement of ultraviolet absorbance of
extract of an implant
Tables
1. Maximum limits for extractable matter
2. Maximum limits for trace metal content of implant
Requirements for chemical and biological properties, sterility, marking and packaging of surgical implants consisting solely of silicone elastomer obtained after vulcanization by the application of heat and after post-curing if appropriate.
| Committee |
CH/150/1
|
| DevelopmentNote |
Supersedes 87/54939 DC and BS 3531-16(1985). (09/2005) Inactive for the new design. (12/2007)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| BS 7254-2:1990 | Orthopaedic implants Specification for general requirements for materials and finish |
| 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 1752:1983 | Specification for laboratory sintered or fritted filters including porosity grading |
| BS 6324-2:1983 | Terms relating to surgical implants Glossary of terms relating to mechanics |
| BS 5736-4:1981 | Evaluation of medical devices for biological hazards Method of test for intracutaneous reactivity 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 |
| BS 6324-1:1983 | Terms relating to surgical implants Glossary of general medical terms |
| 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 7254-1:1990 | Orthopaedic implants Specification for marking, packaging and labelling |
| BS 6324-4:1983 | Terms relating to surgical implants Glossary of orthopaedic surgical terms |
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