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09/30195717 DC : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS

Available format(s)

Hardcopy , PDF

Superseded date

07-31-2011

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Design
6 Barrier properties
7 Biocompatibility
8 Surface finish
9 Tensile properties
10 Tests for stability and shelf life
11 Freedom from holes
12 Visible defects
13 Packaging and labelling
14 Data sheets
Annex A (normative) - Sampling plans intended for assessing
        compliance of a continuing series of lots of
        sufficient number to allow the switching rules to be
        applied
Annex B (normative) - Sampling plans intended for assessing
        compliance of isolated lots
Annex C (normative) - Determination of length and width
Annex D (normative) - Determination of dam thickness
Annex E (normative) - Guidance for risk assessment
Annex F (normative) - Determination of barrier properties
        using the bacteriophage method
Annex G (normative) - Determination of tensile properties
Annex H (normative) - Oven conditioning
Annex I (normative) - Determination of shelf life by real-time
        stability studies
Annex J (normative) - Guidance on conducting and analyzing
        accelerated ageing studies
Annex K (normative) - Testing for holes
Annex L (normative) - Testing for prophylactic dam package
        integrity
Bibliography

Committee
CH/157
DocumentType
Draft
Pages
39
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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 16038:2005 Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO/TR 8550:1994 Guide for the selection of an acceptance sampling system, scheme or plan for inspection of discrete items in lots
ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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