{"id":279865,"date":"2024-10-19T18:53:47","date_gmt":"2024-10-19T18:53:47","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11607-12017-tc\/"},"modified":"2024-10-25T15:28:30","modified_gmt":"2024-10-25T15:28:30","slug":"bs-en-iso-11607-12017-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11607-12017-tc\/","title":{"rendered":"BS EN ISO 11607-1:2017 – 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\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 11607-1:2017 <\/td>\n<\/tr>\n
2<\/td>\nTRACKED CHANGES
Test example 1 <\/td>\n<\/tr>\n
3<\/td>\nBS EN ISO 11607-1:2017 to BS EN ISO 11607-1:2009 <\/td>\n<\/tr>\n
5<\/td>\nNational foreword
Compliance with a British Standard cannot confer immunity from legal obligations.
Amendments\/corrigenda issued since publication <\/td>\n<\/tr>\n
7<\/td>\nForewordEuropean foreword
Table \u2014 Correlation between normative references and dated EN and ISO standards <\/td>\n<\/tr>\n
9<\/td>\nAnnex ZA
(informative) <\/td>\n<\/tr>\n
10<\/td>\nTable ZA.1 \u2014 Correspondence between this European Standard and Annex I of Directive 93\/42\/EEC [OJ L 169] <\/td>\n<\/tr>\n
12<\/td>\nAnnex ZB
(informative)
Table ZB.1 \u2014 Correspondence between this European Standard and Annex I of Directive 90\/385\/EEC [OJ L 189] <\/td>\n<\/tr>\n
14<\/td>\nAnnex ZC
(informative)
Table ZC.1 \u2014 Correspondence between this European Standard and Annex I of Directive 98\/79\/EC [OJ L 331] <\/td>\n<\/tr>\n
17<\/td>\nForeword <\/td>\n<\/tr>\n
18<\/td>\nIntroduction <\/td>\n<\/tr>\n
19<\/td>\nPackaging for terminally sterilized medical devices \u2014
1 Scope
2 Normative references
3 Terms and definitions
3.1
aseptic presentation
introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination
3.2
bioburden
population of viable microorganisms on or in a product or sterile barrier system
[SOURCE: ISO\/TS 11139:2006] <\/td>\n<\/tr>\n
20<\/td>\n3.3
3.4
3.5
3.6
3.7
3.8 <\/td>\n<\/tr>\n
21<\/td>\n3.9
3.10
3.11
3.12
3.13
3.14
3.15 <\/td>\n<\/tr>\n
22<\/td>\n3.16
3.17
3.18
3.19
3.20
3.21
3.22 <\/td>\n<\/tr>\n
23<\/td>\n3.23
3.24
3.25
3.26
3.27
3.28
3.29
4 General requirements
4.1 General
4.2 Quality systems <\/td>\n<\/tr>\n
24<\/td>\n4.3 Sampling
4.4 Test methods
4.5 Documentation <\/td>\n<\/tr>\n
25<\/td>\n5 Materials and preformed sterile barrier systems
5.1 General requirements <\/td>\n<\/tr>\n
27<\/td>\n5.2 Microbial barrier properties <\/td>\n<\/tr>\n
28<\/td>\n5.3 Compatibility with the sterilization process
5.4 Compatibility with the labelling system <\/td>\n<\/tr>\n
29<\/td>\n5.5 Storage and transport
6 Design and development requirements for packaging systems
6.1 General
6.2 Design <\/td>\n<\/tr>\n
30<\/td>\n6.3 Packaging-system performance testing <\/td>\n<\/tr>\n
31<\/td>\n6.4 Stability testing
7 Information to be provided <\/td>\n<\/tr>\n
32<\/td>\n(informative)
A.1 Factors influencing the choice of the materials and design of the packaging system
Figure A.1 \u2014 Interrelationships influencing the choice of appropriate materials for terminally sterilized medical packaging systems
A.3 Sterile barrier systems <\/td>\n<\/tr>\n
35<\/td>\nAnnex B
(informative)
B.1 General
B.2 Packaging materials and preformed sterile barrier systems
Table B.1 \u2014 Test methods and their status <\/td>\n<\/tr>\n
47<\/td>\nAnnex C
(normative) <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n
52<\/td>\nundefined <\/td>\n<\/tr>\n
56<\/td>\nAnnex ZA (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
58<\/td>\nAnnex ZB (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
60<\/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
63<\/td>\nundefined <\/td>\n<\/tr>\n
64<\/td>\nundefined <\/td>\n<\/tr>\n
65<\/td>\nundefined
undefined
undefined <\/td>\n<\/tr>\n
69<\/td>\nundefined
undefined
undefined <\/td>\n<\/tr>\n
70<\/td>\nundefined
undefined
undefined <\/td>\n<\/tr>\n
71<\/td>\nundefined
undefined <\/td>\n<\/tr>\n
73<\/td>\nundefined <\/td>\n<\/tr>\n
74<\/td>\nundefined
undefined <\/td>\n<\/tr>\n
75<\/td>\nundefined
undefined
undefined
undefined <\/td>\n<\/tr>\n
76<\/td>\nundefined <\/td>\n<\/tr>\n
77<\/td>\nundefined
undefined <\/td>\n<\/tr>\n
78<\/td>\nundefined <\/td>\n<\/tr>\n
81<\/td>\nundefined <\/td>\n<\/tr>\n
90<\/td>\nundefined <\/td>\n<\/tr>\n
91<\/td>\nundefined <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. 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>\n2019<\/td>\n94<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279868,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[157,2641],"product_tag":[],"class_list":{"0":"post-279865","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\/279865","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\/279868"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279865"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279865"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279865"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}