BS ISO 8009:2014
Current
The latest, up-to-date edition.
Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests
Hardcopy , PDF
English
30-11-2014
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sampling
5 Classification
6 Materials
7 Design
8 Dimensions
9 Tensile properties of the dome
10 Mechanical properties of rim and spring - Type 1 and
Type 2 diaphragms
11 Freedom from visible defects
12 Test report
13 Packaging, labelling, and storage
Annex A (normative) - Determination of size
Annex B (normative) - Determination of dome thickness
Annex C (normative) - Determination of tensile properties
Annex D (normative) - Determination of deterioration
after accelerated ageing by oven treatment
Annex E (normative) - Determination of compression
and fatigue resistances of coil-spring and
flat-spring diaphragms
Annex F (normative) - Determination of twisting during
compression of coil-spring and flat spring
diaphragms
Annex G (normative) - Determination of visible defects
Annex H (normative) - Test report
Annex I (normative) - Instructions for care and use
of reusable rubber contraceptive diaphragms
Bibliography
Defines the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber.
| Committee |
CH/157
|
| DevelopmentNote |
Supersedes 09/30210725 DC. (11/2014)
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use.
This International Standard is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges, and vaginal sheaths.
| Standards | Relationship |
| ISO 8009:2014 | Identical |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 188:2011 | Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests |
| ISO 2230:2002 | Rubber products — Guidelines for storage |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 463:2006 | Geometrical Product Specifications (GPS) — Dimensional measuring equipment — Design and metrological characteristics of mechanical dial gauges |
| ISO/IEC Guide 7:1994 | Guidelines for drafting of standards suitable for use for conformity assessment |
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