• BS ISO 8009:2014

    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

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    Defines the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/157
    Development Note Supersedes 09/30210725 DC. (11/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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