{"id":445613,"date":"2024-10-20T08:42:41","date_gmt":"2024-10-20T08:42:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11607-12020a12023\/"},"modified":"2024-10-26T16:13:01","modified_gmt":"2024-10-26T16:13:01","slug":"bs-en-iso-11607-12020a12023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11607-12020a12023\/","title":{"rendered":"BS EN ISO 11607-1:2020+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\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
5<\/td>\nBlank Page <\/td>\n<\/tr>\n
6<\/td>\nBlank Page <\/td>\n<\/tr>\n
9<\/td>\nBlank Page <\/td>\n<\/tr>\n
10<\/td>\nAnnex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] (as amended) aimed to be covered <\/td>\n<\/tr>\n
13<\/td>\nBlank Page <\/td>\n<\/tr>\n
14<\/td>\nBlank Page <\/td>\n<\/tr>\n
15<\/td>\nAnnex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] (as amended) aimed to be covered <\/td>\n<\/tr>\n
17<\/td>\nAnnex ZC (informative)Relationship between this European Standard and the essential requirements of Directive 98\/79\/EC [OJ L 331] (as amended) aimed to be covered <\/td>\n<\/tr>\n
19<\/td>\nBlank Page <\/td>\n<\/tr>\n
20<\/td>\nBlank Page <\/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>\nBlank Page <\/td>\n<\/tr>\n
30<\/td>\nBlank Page <\/td>\n<\/tr>\n
31<\/td>\nBlank Page <\/td>\n<\/tr>\n
32<\/td>\n4.5 Documentation
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements <\/td>\n<\/tr>\n
35<\/td>\n5.2 Microbial barrier properties <\/td>\n<\/tr>\n
36<\/td>\n5.3 Compatibility with the sterilization process
5.4 Labelling system
5.5 Storage and transport of materials and preformed sterile barrier systems <\/td>\n<\/tr>\n
37<\/td>\n6 Design and development for packaging systems
6.1 General
6.2 Design <\/td>\n<\/tr>\n
38<\/td>\n7 Usability evaluation for aseptic presentation <\/td>\n<\/tr>\n
39<\/td>\n8 Packaging system performance and stability
8.1 General
8.2 Packaging system performance testing <\/td>\n<\/tr>\n
40<\/td>\n8.3 Stability testing
9 Packaging system validation and changes <\/td>\n<\/tr>\n
41<\/td>\n10 Inspection immediately prior to aseptic presentation
11 Information to be provided <\/td>\n<\/tr>\n
42<\/td>\nAnnex A (informative) Guidance on medical packaging <\/td>\n<\/tr>\n
45<\/td>\nAnnex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document <\/td>\n<\/tr>\n
56<\/td>\nAnnex C (normative) Test method for resistance of impermeable materials to the passage of air <\/td>\n<\/tr>\n
57<\/td>\nAnnex D (informative) Environmental aspects <\/td>\n<\/tr>\n
58<\/td>\nAnnex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging <\/td>\n<\/tr>\n
63<\/td>\nBlank Page <\/td>\n<\/tr>\n
64<\/td>\nBlank Page <\/td>\n<\/tr>\n
65<\/td>\nBlank Page <\/td>\n<\/tr>\n
66<\/td>\nBlank Page <\/td>\n<\/tr>\n
67<\/td>\nBlank Page <\/td>\n<\/tr>\n
68<\/td>\nBlank Page <\/td>\n<\/tr>\n
69<\/td>\nBlank Page <\/td>\n<\/tr>\n
70<\/td>\nBlank Page <\/td>\n<\/tr>\n
71<\/td>\nBlank Page <\/td>\n<\/tr>\n
72<\/td>\nBlank Page <\/td>\n<\/tr>\n
73<\/td>\nBlank Page <\/td>\n<\/tr>\n
74<\/td>\nBlank Page <\/td>\n<\/tr>\n
75<\/td>\nBlank Page <\/td>\n<\/tr>\n
76<\/td>\nBlank Page <\/td>\n<\/tr>\n
77<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems and packaging systems<\/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>\n84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":445623,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[157,2641],"product_tag":[],"class_list":{"0":"post-445613","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\/445613","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\/445623"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=445613"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=445613"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=445613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}