{"id":277886,"date":"2024-10-19T18:43:11","date_gmt":"2024-10-19T18:43:11","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-139582015\/"},"modified":"2024-10-25T15:14:41","modified_gmt":"2024-10-25T15:14:41","slug":"bs-en-iso-139582015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-139582015\/","title":{"rendered":"BS EN ISO 13958:2015"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Table 1 \u2014 Correlation between normative references and dated EN and ISO standards Endorsement notice <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on medical devices Table ZA.1 \u2014 Correspondence between this European Standard and Directive 93\/42\/EEC on medical devices <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Section sec_1 Section sec_2 Section sec_3 1\tScope 2\tNormative references 3\tTerms and definitions <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | Section sec_3.1 Section sec_3.2 Section sec_3.3 Section sec_3.4 Section sec_3.5 Section sec_3.6 Section sec_3.7 <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | Section sec_3.8 Section sec_3.9 Section sec_3.10 Section sec_3.11 Section sec_3.12 Section sec_3.13 Section sec_3.14 <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | Section sec_3.15 Section sec_3.16 Section sec_3.17 Section sec_3.18 Section sec_3.19 Section sec_3.20 <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | Section sec_3.21 Section sec_3.22 Section sec_3.23 Section sec_3.24 Section sec_3.25 Section sec_3.26 <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | Section sec_3.27 Section sec_3.28 Section sec_3.29 Section sec_3.30 Section sec_3.31 Section sec_3.32 Section sec_3.33 <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Section sec_3.34 Section sec_3.35 Section sec_4 Section sec_4.1 Section sec_4.1.1 Section sec_4.1.2 Section sec_4.1.2.1 Section sec_4.1.2.2 Section sec_4.1.3 4\tRequirements 4.1\tConcentrates <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | Section sec_4.1.4 Section sec_4.1.4.1 Section sec_4.1.4.2 Section sec_4.1.5 Section sec_4.1.6 Section sec_4.1.7 Section sec_4.1.8 Section sec_4.1.9 Section sec_4.1.10 <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | Section sec_4.1.11 Section sec_4.1.12 Section sec_4.2 Section sec_4.3 Section sec_4.3.1 Section sec_4.3.2 Section sec_4.3.3 Section sec_4.3.3.1 4.2\tManufacturing equipment 4.3\tSystems for mixing concentrate at a dialysis facility <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | Section sec_4.3.3.2 Section sec_4.3.4 Section sec_4.3.5 Section sec_4.3.6 <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Section sec_4.3.7 Section sec_4.3.8 Section sec_5 Section sec_5.1 Section sec_5.2 Section sec_5.2.1 Section sec_5.2.2 Section sec_5.2.2.1 5\tTests 5.1\tGeneral 5.2\tConcentrates <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | Table tab_1 Section sec_5.2.2.2 Section sec_5.2.3 Section sec_5.2.4 Section sec_5.2.5 Section sec_5.2.6 Section sec_5.2.7 <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | Section sec_5.2.8 Section sec_5.2.9 Section sec_5.2.10 Section sec_5.2.11 Section sec_5.2.12 Section sec_5.3 Section sec_5.4 Section sec_5.4.1 Section sec_5.4.2 5.3\tManufacturing equipment 5.4\tSystems for mixing concentrate at a dialysis facility <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Section sec_5.4.3 Section sec_5.4.3.1 Section sec_5.4.3.2 Section sec_5.4.4 Section sec_5.4.5 Section sec_5.4.6 Section sec_5.4.7 Section sec_5.4.8 Section sec_6 Section sec_6.1 6\tLabelling 6.1\tGeneral <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | Section sec_6.2 6.2\tGeneral labelling requirements for concentrates <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | Section sec_6.3 Section sec_6.4 6.3\tLabelling requirements for liquid concentrate 6.4\tLabelling requirements for powder concentrate <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Section sec_6.5 Section sec_6.6 6.5\tAdditives 6.6\tLabelling requirements for concentrate generators <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | Table tab_2 Section sec_6.7 Section sec_6.7.1 Section sec_6.7.2 6.7\tLabelling for concentrate mixer systems <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | Annex sec_A Annex sec_A.1 Annex\u00a0A \n(informative)<\/p>\n Rationale for the development and provisions of this International Standard <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | Annex sec_A.2 Annex sec_A.2.1 Annex sec_A.2.1.1 Annex sec_A.2.1.2 Annex sec_A.2.1.3 <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | Annex sec_A.2.1.4 Annex sec_A.2.1.5 Annex sec_A.2.1.6 Annex sec_A.2.1.7 Annex sec_A.2.1.8 Annex sec_A.2.1.9 <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | Annex sec_A.2.1.10 Annex sec_A.2.1.11 Annex sec_A.2.1.12 Annex sec_A.2.2 Annex sec_A.2.2.1 <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | Annex sec_A.2.2.2 Annex sec_A.3 Annex sec_A.3.1 Annex sec_A.3.2 Annex sec_A.3.3 <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | Reference ref_1 Reference ref_2 Reference ref_3 Reference ref_4 Reference ref_5 Reference ref_6 Reference ref_7 Reference ref_8 Reference ref_9 Reference ref_10 Reference ref_11 Reference ref_12 Reference ref_13 Reference ref_14 Reference ref_15 Bibliography <\/td>\n<\/tr>\n | ||||||
37<\/td>\n | Reference ref_16 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Concentrates for haemodialysis and related therapies<\/b><\/p>\n |