BS ISO 8009-1:1997
Withdrawn
Reusable rubber contraceptive diaphragms Classification, sampling and requirements
Hardcopy , PDF
English
08-15-1997
08-01-2014
1 Scope
2 Normative references
3 Definitions
4 Sampling
5 Classification
6 Materials
7 Design
8 Dimensions
9 Tensile properties of the rubber dome
10 Mechanical properties of rim and spring in type 1
and type 2 diaphragms
11 Freedom from visible defects
12 Packaging and labelling
13 Recommendations for storage
Annex
A Bibliography
Provides a classification of and requirements for resuable rubber diaphragms supplied in consumer packaging for contraceptive use. Does not include other vaginal contraceptive barriers (cervical caps, vaginal sponges and vaginal sheaths).
| Committee |
CH/157
|
| DevelopmentNote |
Supersedes 88/55978 DC and BS 4028(1989). (07/2005)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 8009-1:1997 | Identical |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| ISO 8009-2:1985 | Reusable rubber contraceptive diaphragms — Part 2: Determination of size |
| ISO 8009-10:1985 | Reusable rubber contraceptive diaphragms — Part 10: Recommendations for storage |
| ISO 8009-9:1985 | Reusable rubber contraceptive diaphragms — Part 9: Packaging and labelling |
| ISO 8009-7:1985 | Reusable rubber contraceptive diaphragms — Part 7: Determination of compression resistance of coil spring and flat spring diaphragms |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 2230:2002 | Rubber products — Guidelines for storage |
| ISO 8009-3:1985 | Reusable rubber contraceptive diaphragms — Part 3: Determination of dome thickness |
| ISO 8009-4:1996 | Reusable rubber contraceptive diaphragms — Part 4: Freedom from visible defects |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 8009-5:1996 | Reusable rubber contraceptive diaphragms — Part 5: Determination of tensile properties |
| ISO 8009-6:1985 | Reusable rubber contraceptive diaphragms — Part 6: Determination of deterioration after accelerated ageing |
| ISO 8009-8:1985 | Reusable rubber contraceptive diaphragms — Part 8: Determination of twisting during compression of coil spring and flat spring diaphragms |