12/30251858 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
30-11-2015
Foreword
Introduction
1 Scope
2 Normative references
2 Terms and definitions
3 Quality verification
4 Lot size
5 Biocompatibility
6 Microbial contamination
7 Product claims
8 Design
9 Bursting volume and pressure
10 Stability and shelf life
11 Freedom from holes
12 Visible defects
13 Package integrity of individual container
14 Packaging and labelling
15 Test report
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 (informative) - Sampling plans intended for
assessing compliance of isolated lots
Annex C (normative) - Determination of total lubricant
for condoms in individual containers
Annex D (normative) - Determination of length
Annex E (normative) - Method for the determination of
width
Annex F (normative) - Determination of thickness
Annex G (informative) - Determination of microbial
contamination
Annex H (normative) - Determination of bursting volume
and pressure
Annex I (normative) - Oven treatment for condoms
Annex J (informative) - Determination of force and elongation
at break of test pieces of condoms
Annex K (normative) - Determination of shelf life by real-time
stability studies
Annex L (informative) - Guidance on conducting and
analysing accelerated ageing studies
Annex M (normative) - Testing for holes
Annex N (normative) - Testing for package integrity
Annex O (informative) - Calibration of air inflation
equipment for determination of bursting
volume and pressure
Annex P (informative) - Recommendations for testing
condoms that fall outside of the size ranges
specified in ISO 4074
Bibliography
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directives 93/42/EEC
BS ISO 4074
| Committee |
CH/157
|
| DocumentType |
Draft
|
| Pages |
69
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| ISO 11346:2014 | Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use |
| ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 2230:2002 | Rubber products — Guidelines for storage |
| ISO 16038:2005 | Rubber condoms — Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms |
| ISO 16037:2002 | Rubber condoms for clinical trials — Measurement of physical properties |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| 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 5893:2002 | Rubber and plastics test equipment — Tensile, flexural and compression types (constant rate of traverse) — Specification |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO/IEC 17007:2009 | Conformity assessment — Guidance for drafting normative documents suitable for use for conformity assessment |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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