{"id":464813,"date":"2024-10-20T10:37:04","date_gmt":"2024-10-20T10:37:04","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-258412017a12020\/"},"modified":"2024-10-26T19:34:38","modified_gmt":"2024-10-26T19:34:38","slug":"bs-iso-258412017a12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-258412017a12020\/","title":{"rendered":"BS ISO 25841:2017+A1:2020"},"content":{"rendered":"

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).<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n3.1 General terms <\/td>\n<\/tr>\n
13<\/td>\n3.2 Terms related to female condom failure modes <\/td>\n<\/tr>\n
15<\/td>\n4 Quality verification <\/td>\n<\/tr>\n
16<\/td>\n5 Lot size
6 Design
6.1 General <\/td>\n<\/tr>\n
17<\/td>\n6.2 Product insertion feature
6.3 Retention features <\/td>\n<\/tr>\n
18<\/td>\n6.4 Lubrication
6.5 Dimensions
6.5.1 Length
6.5.2 Width <\/td>\n<\/tr>\n
19<\/td>\n6.5.3 Thickness
6.6 Risk assessment
7 Barrier properties
8 Biocompatibility <\/td>\n<\/tr>\n
20<\/td>\n9 Clinical (human use) investigations <\/td>\n<\/tr>\n
21<\/td>\n10 Microbial contamination
11 Bursting volume and pressure
11.1 Minimum values <\/td>\n<\/tr>\n
22<\/td>\n11.2 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 <\/td>\n<\/tr>\n
23<\/td>\n12.3 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 <\/td>\n<\/tr>\n
24<\/td>\n15.3 Labelling
15.3.1 Symbols
15.3.2 Individual containers
15.3.3 Consumer packages <\/td>\n<\/tr>\n
25<\/td>\n15.3.4 Additional information for the consumer <\/td>\n<\/tr>\n
26<\/td>\n15.3.5 Female condoms not distributed in consumer packages
15.4 Inspection <\/td>\n<\/tr>\n
27<\/td>\n16 Data sheets <\/td>\n<\/tr>\n
28<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
29<\/td>\nAnnex B (informative) Sampling plans intended for assessing conformity of isolated lots <\/td>\n<\/tr>\n
30<\/td>\nAnnex C (normative) Determination of lubricant mass for individual female condom containers <\/td>\n<\/tr>\n
32<\/td>\nAnnex D (normative) Determination of female condom length <\/td>\n<\/tr>\n
33<\/td>\nAnnex E (normative) Determination of female condom width <\/td>\n<\/tr>\n
34<\/td>\nAnnex F (normative) Determination of female condom thickness <\/td>\n<\/tr>\n
36<\/td>\nAnnex G (normative) Testing for female condom individual container integrity <\/td>\n<\/tr>\n
38<\/td>\nAnnex H (normative) Determination of barrier properties using the bacteriophage method <\/td>\n<\/tr>\n
43<\/td>\nAnnex I (informative) Determination of microbial contamination <\/td>\n<\/tr>\n
48<\/td>\nAnnex J (normative) Determination of bursting volume and bursting pressure <\/td>\n<\/tr>\n
50<\/td>\nAnnex K (normative) Testing for holes <\/td>\n<\/tr>\n
58<\/td>\nAnnex L (normative) Determination of shelf life by real-time stability studies <\/td>\n<\/tr>\n
60<\/td>\nAnnex M (informative) Guidance on conducting and analysing accelerated ageing studies <\/td>\n<\/tr>\n
63<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Female condoms. Requirements and test methods<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n66<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464822,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-464813","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/464813","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/464822"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464813"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464813"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464813"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}