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BS ISO 8009:2014

Current
Current

The latest, up-to-date edition.

Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2014

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.

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.

Committee
CH/157
DevelopmentNote
Supersedes 09/30210725 DC. (11/2014)
DocumentType
Standard
Pages
38
PublisherName
British Standards Institution
Status
Current
Supersedes

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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