ISO 25841:2017
Female condoms — Requirements and test methods
ISO 25841:2017 specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Design
6.1 General
6.2 Product insertion feature
6.3 Retention features
6.4 Lubrication
6.5 Dimensions
6.5.1 Length
6.5.2 Width
6.5.3 Thickness
6.6 Risk assessment
7 Barrier properties
8 Biocompatibility
9 Clinical (human use) investigations
10 Microbial contamination
11 Bursting volume and pressure
11.1 Minimum values
11.2 Sampling and requirements
12 Tests for stability and shelf life
12.1 General
12.2 Procedure for determining shelf life by real-time stability studies
12.3 Procedure for estimating shelf life based upon accelerated stability studies
13 Freedom from holes
14 Visible defects
15 Packaging and labelling
15.1 Individual container integrity
15.2 Packaging
15.3 Labelling
15.3.1 Symbols
15.3.2 Individual containers
15.3.3 Consumer packages
15.3.4 Additional information for the consumer
15.3.5 Female condoms not distributed in consumer packages
15.4 Inspection
16 Data sheets
Annex A (normative) Sampling plans intended for assessing conformity 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 conformity 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
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Design
6.1 General
6.2 Product insertion feature
6.3 Retention features
6.4 Lubrication
6.5 Dimensions
6.5.1 Length
6.5.2 Width
6.5.3 Thickness
6.6 Risk assessment
7 Barrier properties
8 Biocompatibility
9 Clinical (human use) investigations
10 Microbial contamination
11 Bursting volume and pressure
11.1 Minimum values
11.2 Sampling and requirements
12 Tests for stability and shelf life
12.1 General
12.2 Procedure for determining shelf life by real-time stability studies
12.3 Procedure for estimating shelf life based upon accelerated stability studies
13 Freedom from holes
14 Visible defects
15 Packaging and labelling
15.1 Individual container integrity
15.2 Packaging
15.3 Labelling
15.3.1 Symbols
15.3.2 Individual containers
15.3.3 Consumer packages
15.3.4 Additional information for the consumer
15.3.5 Female condoms not distributed in consumer packages
15.4 Inspection
16 Data sheets
Annex A (normative) Sampling plans intended for assessing conformity 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 conformity 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