{"id":279869,"date":"2024-10-19T18:53:48","date_gmt":"2024-10-19T18:53:48","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11607-22017-tc\/"},"modified":"2024-10-25T15:28:30","modified_gmt":"2024-10-25T15:28:30","slug":"bs-en-iso-11607-22017-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11607-22017-tc\/","title":{"rendered":"BS EN ISO 11607-2:2017 – TC"},"content":{"rendered":"

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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\ncompares BS EN ISO 11607-2:2017 <\/td>\n<\/tr>\n
2<\/td>\nTRACKED CHANGES
Test example 1 <\/td>\n<\/tr>\n
3<\/td>\nBS EN ISO 11607-2:2017 to BS EN ISO 11607-2:2006 <\/td>\n<\/tr>\n
17<\/td>\nForeword <\/td>\n<\/tr>\n
18<\/td>\nIntroduction <\/td>\n<\/tr>\n
22<\/td>\n4.1 Quality systems
4.2 Sampling
4.3 Test methods <\/td>\n<\/tr>\n
23<\/td>\n4.4 Documentation
5.1 General <\/td>\n<\/tr>\n
24<\/td>\n5.2 Installation qualification (IQ) <\/td>\n<\/tr>\n
25<\/td>\n5.3 Operational qualification (OQ)
5.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
26<\/td>\n5.5 Formal approval of the process validation
5.6 Process control and monitoring
5.7 Process changes and revalidation <\/td>\n<\/tr>\n
29<\/td>\nTable ZA.1 \u2014 Correspondence between this International Standard and Directive 93\/42\/EEC on medical devices <\/td>\n<\/tr>\n
30<\/td>\nBibliography <\/td>\n<\/tr>\n
32<\/td>\nNational foreword <\/td>\n<\/tr>\n
36<\/td>\nAnnex\u00a0ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
38<\/td>\nAnnex\u00a0ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered <\/td>\n<\/tr>\n
40<\/td>\nAnnex\u00a0ZC (informative)Relationship between this European Standard and the essential requirements of Directive 98\/79\/EC [OJ L 331] aimed to be covered <\/td>\n<\/tr>\n
43<\/td>\nForeword <\/td>\n<\/tr>\n
44<\/td>\nIntroduction <\/td>\n<\/tr>\n
45<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
48<\/td>\n4 General requirements
4.1 Quality systems
4.2 Sampling
4.3 Test methods <\/td>\n<\/tr>\n
49<\/td>\n4.4 Documentation
5 Validation of packaging processes
5.1 General <\/td>\n<\/tr>\n
50<\/td>\n5.2 Installation qualification (IQ)
5.3 Operational qualification (OQ) <\/td>\n<\/tr>\n
51<\/td>\n5.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
52<\/td>\n5.5 Formal approval of the process validation
5.6 Process control and monitoring
5.7 Process changes and revalidation
6 Packaging system assembly <\/td>\n<\/tr>\n
53<\/td>\n7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging <\/td>\n<\/tr>\n
54<\/td>\nAnnex A (informative) Process development <\/td>\n<\/tr>\n
55<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and assembly processes<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n57<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279872,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[157,2641],"product_tag":[],"class_list":{"0":"post-279869","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-30","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\/279869","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\/279872"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279869"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279869"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279869"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}