ISO 25841:2011
Female condoms — Requirements and test methods
ISO 25841:2011 specifies the minimum requirements and test methods for female condoms, which are supplied to consumers for contraceptive purposes assisting in the prevention of sexually transmitted infections.
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Scope
Normative references
Terms and definitions
Quality verification
Design
General
Product insertion feature
Retention features
Lubrication
Dimensions
Length
Width
Thickness
Risk assessment
Barrier properties
Biocompatibility
Clinical (human use) investigations
Bursting volume and pressure
Minimum values
Sampling and requirements
Tests for stability and shelf-life
General
Procedure for determining shelf-life by real-time stability
Procedure for estimating shelf-life based upon accelerated s
Freedom from holes
Visible defects
Packaging and labelling
Package integrity
Packaging
Labelling
Symbols
Individual containers
Consumer packages
General
Additional information for the consumer
Female condoms not distributed in consumer packages
Inspection
Data sheets
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Scope
Normative references
Terms and definitions
Quality verification
Design
General
Product insertion feature
Retention features
Lubrication
Dimensions
Length
Width
Thickness
Risk assessment
Barrier properties
Biocompatibility
Clinical (human use) investigations
Bursting volume and pressure
Minimum values
Sampling and requirements
Tests for stability and shelf-life
General
Procedure for determining shelf-life by real-time stability
Procedure for estimating shelf-life based upon accelerated s
Freedom from holes
Visible defects
Packaging and labelling
Package integrity
Packaging
Labelling
Symbols
Individual containers
Consumer packages
General
Additional information for the consumer
Female condoms not distributed in consumer packages
Inspection
Data sheets