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15/30303073 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
Available format(s)

Hardcopy , PDF

Superseded date

09-30-2017

Language(s)

English

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Superseded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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