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BS 6788-1:1986

BS 6788-1:1986

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Neurosurgical implants Specification for sterile, single-use hydrocephalus shunts and components

Available format(s)

Hardcopy , PDF

Superseded date

15-02-1998

Language(s)

English

Published date

31-12-1986

Publisher

British Standards Institution

Foreword
Committees responsible
Section one. General
1. Scope
2. Definitions
Section two. General requirements for complete shunts
and for components
3. Surface finish
4. Extractable materials
5. Type test for freedom from biological hazard
6. Packaging
7. Labelling
Section three. Additional requirements for complete
shunts
8. Type and size designation
9. Connectors
10. Pressure and flow characteristics
11. Freedom from reflux
12. Labelling
13. Accompanying documentation
Section four. Additional requirements for valves and
catheters with integral valves supplied as separate
components
14. Type and size designation
15. Pressure and flow characteristics
16. Freedom from reflux
17. Labelling
18. Accompanying documentation
Section five. Additional requirements for other
components supplied separately
19. Type and size designation
20. Labelling
Appendices
A. Guidance on materials
B. Suggested method of test for durability
C. Method of determination of acidity and alkalinity
D. Method for determination of pressure and flow
    characteristics
E. Method of test for reflux
Figures
1. Example of apparatus for evaluation of pressure and
    flow characteristics and durability of shunts and
    components
2. Configurations for testing valves for freedom from
    reflux

Requirements for shunts supplied complete or as separate components.

Committee
CH/150/2
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

BS 6788-2:1990 Neurosurgical implants Specification for marking and packaging of implantable neural stimulators

BS 5736-2:1981 Evaluation of medical devices for biological hazards Method of testing by tissue implantation
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 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 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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Hardcopy - English
PDF - English
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