{"id":431456,"date":"2024-10-20T07:28:20","date_gmt":"2024-10-20T07:28:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-74392023-2\/"},"modified":"2024-10-26T14:12:14","modified_gmt":"2024-10-26T14:12:14","slug":"bs-en-iso-74392023-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-74392023-2\/","title":{"rendered":"BS EN ISO 7439:2023"},"content":{"rendered":"

This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. NOTE       Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
6<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4 Quality verification <\/td>\n<\/tr>\n
13<\/td>\n5 Intended clinical performance
5.1 General
5.2 Clinical performance
5.2.1 General
5.2.2 Study duration
5.2.3 Study population <\/td>\n<\/tr>\n
14<\/td>\n5.2.4 Sample size
5.2.5 Contraceptive performance
5.2.6 Expulsion rate
5.2.7 Discontinuation rate
5.2.8 Investigation report <\/td>\n<\/tr>\n
15<\/td>\n5.2.9 Labelling
6 Design attributes
6.1 General <\/td>\n<\/tr>\n
16<\/td>\n6.2 Shape
6.3 Dimensions
6.3.1 IUD
6.3.2 Copper components
6.3.3 Thread
6.3.4 Insertion instrument
6.4 Tensile force <\/td>\n<\/tr>\n
17<\/td>\n6.5 Stability
6.5.1 Shelf-life stability
6.6 Viscoelastic property
6.7 Detection by X-ray
7 Materials
8 Design evaluation
8.1 General <\/td>\n<\/tr>\n
18<\/td>\n8.2 Determination of dimensions
8.3 Determination of tensile force
8.3.1 Principle
8.3.2 Apparatus
8.3.3 Procedure
8.3.4 Test report <\/td>\n<\/tr>\n
19<\/td>\n8.4 Test of elastic recovery (memory test)
8.4.1 Principle
8.4.2 Procedure
8.4.3 Test report
8.5 Determination of barium sulfate content and identification of barium and sulfate
8.5.1 Ash content test
8.5.2 Identity test
8.6 Pre-clinical evaluation <\/td>\n<\/tr>\n
20<\/td>\n9 Manufacturing and inspection
10 Sterilization
11 Packaging
12 Information to be supplied by the manufacturer
12.1 General <\/td>\n<\/tr>\n
21<\/td>\n12.2 Labelling of the primary container
12.3 Labelling of the secondary container
12.4 Instructions for the health care providers <\/td>\n<\/tr>\n
22<\/td>\n12.5 Information intended for the client after insertion of the IUD <\/td>\n<\/tr>\n
23<\/td>\n12.6 Written information intended for the client <\/td>\n<\/tr>\n
24<\/td>\nAnnex A (normative) Sampling requirements for testing copper bearing IUDs <\/td>\n<\/tr>\n
26<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Copper-bearing contraceptive intrauterine devices. Requirements and tests<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":431466,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-431456","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\/431456","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\/431466"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=431456"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=431456"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=431456"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}