{"id":278175,"date":"2024-10-19T18:44:41","date_gmt":"2024-10-19T18:44:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-146072018\/"},"modified":"2024-10-25T15:16:46","modified_gmt":"2024-10-25T15:16:46","slug":"bs-en-iso-146072018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-146072018\/","title":{"rendered":"BS EN ISO 14607:2018"},"content":{"rendered":"

This document specifies particular requirements for mammary implants.<\/p>\n

With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 Intended performance
5 Design attributes
6 Materials
6.1 General <\/td>\n<\/tr>\n
18<\/td>\n6.2 Cytotoxicity
6.3 Residual low molecular weight oligomers
6.4 Trace elements
6.5 Physico-mechanical properties and characterization
6.6 Documentation of materials <\/td>\n<\/tr>\n
19<\/td>\n7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.2.1 General
7.2.2 Mechanical tests <\/td>\n<\/tr>\n
20<\/td>\n7.2.3 Physical evaluation <\/td>\n<\/tr>\n
21<\/td>\n7.2.4 Chemical evaluation
7.2.5 Biological evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging <\/td>\n<\/tr>\n
22<\/td>\n11 Information supplied by the manufacturer
11.1 General
11.2 Product labelling
11.3 Information for the user
11.3.1 General
11.3.2 Resterilization
11.3.3 Effects on diagnostic techniques
11.4 Marking on implants
11.5 Filling materials
11.6 Information on expected lifetime <\/td>\n<\/tr>\n
23<\/td>\n11.7 Information for the patient
11.7.1 General
11.7.2 Patient record label
11.7.3 Patient card <\/td>\n<\/tr>\n
24<\/td>\nAnnex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels <\/td>\n<\/tr>\n
28<\/td>\nAnnex B (normative) Tests for shell integrity <\/td>\n<\/tr>\n
31<\/td>\nAnnex C (normative) Mechanical tests on a mammary implant in its implantable state <\/td>\n<\/tr>\n
37<\/td>\nAnnex D (normative) Test method for valve competence and injection site competence <\/td>\n<\/tr>\n
39<\/td>\nAnnex E (normative) Test for silicone gel cohesion (silicone filling materials only) <\/td>\n<\/tr>\n
41<\/td>\nAnnex F (normative) Test for silicone gel penetration (silicone filling materials only) <\/td>\n<\/tr>\n
46<\/td>\nAnnex G (informative) Assessment of silicone diffusion from mammary implants using an in vitro method <\/td>\n<\/tr>\n
50<\/td>\nAnnex H (informative) Test for surface characteristics <\/td>\n<\/tr>\n
53<\/td>\nAnnex I (normative) Information for the user <\/td>\n<\/tr>\n
54<\/td>\nAnnex J (normative) Information for the patient <\/td>\n<\/tr>\n
55<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Non-active surgical implants. Mammary implants. Particular requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2018<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278180,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-278175","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/278175","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\/278180"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278175"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278175"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}