{"id":445546,"date":"2024-10-20T08:42:21","date_gmt":"2024-10-20T08:42:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11607-22020a12023\/"},"modified":"2024-10-26T16:12:18","modified_gmt":"2024-10-26T16:12:18","slug":"bs-en-iso-11607-22020a12023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11607-22020a12023\/","title":{"rendered":"BS EN ISO 11607-2:2020+A1:2023"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
6<\/td>\nEuropean foreword
Anchor 5
European foreword to amendment A11 <\/td>\n<\/tr>\n
8<\/td>\nAnnex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
14<\/td>\nAnnex ZB (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/746 aimed to be covered <\/td>\n<\/tr>\n
19<\/td>\nAnnex ZC (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
22<\/td>\nForeword <\/td>\n<\/tr>\n
23<\/td>\nIntroduction <\/td>\n<\/tr>\n
25<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
29<\/td>\n4 General requirements
4.1 Quality systems <\/td>\n<\/tr>\n
30<\/td>\n4.2 Risk management
4.3 Sampling
4.4 Test methods
4.5 Documentation <\/td>\n<\/tr>\n
31<\/td>\n5 Validation of packaging processes
5.1 General
5.2 Installation qualification <\/td>\n<\/tr>\n
32<\/td>\n5.3 Operational qualification <\/td>\n<\/tr>\n
33<\/td>\n5.4 Performance qualification
5.5 Formal approval of the process validation <\/td>\n<\/tr>\n
34<\/td>\n5.6 Process control and monitoring
5.7 Process changes and revalidation
6 Assembly <\/td>\n<\/tr>\n
35<\/td>\n7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging <\/td>\n<\/tr>\n
36<\/td>\nAnnex A (informative) Process development <\/td>\n<\/tr>\n
37<\/td>\nAnnex sec_B
Annex sec_B.1
Annex sec_B.2 <\/td>\n<\/tr>\n
38<\/td>\nAnnex sec_B.3
Annex sec_B.3.1
Annex sec_B.3.2
Annex sec_B.4 <\/td>\n<\/tr>\n
39<\/td>\nTable tab_B.1
Annex sec_B.5
Annex sec_B.6
Annex sec_B.7 <\/td>\n<\/tr>\n
40<\/td>\nAnnex sec_B.8 <\/td>\n<\/tr>\n
41<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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>\n2023<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":445556,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[157,2641],"product_tag":[],"class_list":{"0":"post-445546","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\/445546","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\/445556"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=445546"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=445546"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=445546"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}