09/30195717 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
31-07-2011
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Superseded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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