15/30303073 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
30-09-2017
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Barrier properties
6 Biocompatibility
7 Clinical (human use) investigations
8 Microbial contamination
9 Bursting volume and pressure
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 (informative) - Sampling plans intended for
assessing compliance of isolated lots
Annex C (normative) - Determination of lubricant mass
for individual female condom containers
Annex D (normative) - Determination of female condom
length
Annex E (normative) Determination of female condom width
Annex F (normative) - Determination of female condom
thickness
Annex G (normative) - Testing for female condom individual
container integrity
Annex H (normative) - Determination of barrier properties
using the bacteriophage method
Annex I (informative) - Determination of microbial contamination
Annex J (normative) - Determination of bursting volume
and bursting pressure
Annex K (normative) - Testing for holes
Annex L (normative) - Determination of shelf life by real-time
stability studies
Annex M (informative) - Guidance on conducting and analysing
accelerated ageing studies
Bibliography
BS ISO 25841.
| Committee |
CH/157
|
| DocumentType |
Draft
|
| Pages |
71
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 11346:2014 | Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use |
| 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 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 4074:2015 | Natural rubber latex male condoms Requirements and test methods |
| 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 Guide 7:1994 | Guidelines for drafting of standards suitable for use for conformity assessment |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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