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BS ISO 25841:2017+A1:2020

BS ISO 25841:2017+A1:2020

$198.66

Female condoms. Requirements and test methods

Published By Publication Date Number of Pages
BSI 2020 66
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This document 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).

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
12 3.1 General terms
13 3.2 Terms related to female condom failure modes
15 4 Quality verification
16 5 Lot size
6 Design
6.1 General
17 6.2 Product insertion feature
6.3 Retention features
18 6.4 Lubrication
6.5 Dimensions
6.5.1 Length
6.5.2 Width
19 6.5.3 Thickness
6.6 Risk assessment
7 Barrier properties
8 Biocompatibility
20 9 Clinical (human use) investigations
21 10 Microbial contamination
11 Bursting volume and pressure
11.1 Minimum values
22 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
23 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
24 15.3 Labelling
15.3.1 Symbols
15.3.2 Individual containers
15.3.3 Consumer packages
25 15.3.4 Additional information for the consumer
26 15.3.5 Female condoms not distributed in consumer packages
15.4 Inspection
27 16 Data sheets
28 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
29 Annex B (informative) Sampling plans intended for assessing conformity of isolated lots
30 Annex C (normative) Determination of lubricant mass for individual female condom containers
32 Annex D (normative) Determination of female condom length
33 Annex E (normative) Determination of female condom width
34 Annex F (normative) Determination of female condom thickness
36 Annex G (normative) Testing for female condom individual container integrity
38 Annex H (normative) Determination of barrier properties using the bacteriophage method
43 Annex I (informative) Determination of microbial contamination
48 Annex J (normative) Determination of bursting volume and bursting pressure
50 Annex K (normative) Testing for holes
58 Annex L (normative) Determination of shelf life by real-time stability studies
60 Annex M (informative) Guidance on conducting and analysing accelerated ageing studies
63 Bibliography

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BS ISO 25841:2017+A1:2020
$198.66