BS EN ISO 13958:2015
$167.15
Concentrates for haemodialysis and related therapies
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 40 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | European foreword |
| 5 | Table 1 — Correlation between normative references and dated EN and ISO standards Endorsement notice |
| 6 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices |
| 9 | Foreword |
| 10 | Introduction |
| 12 | Section sec_1 Section sec_2 Section sec_3 1 Scope 2 Normative references 3 Terms and definitions |
| 13 | 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 |
| 14 | 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 |
| 15 | Section sec_3.15 Section sec_3.16 Section sec_3.17 Section sec_3.18 Section sec_3.19 Section sec_3.20 |
| 16 | Section sec_3.21 Section sec_3.22 Section sec_3.23 Section sec_3.24 Section sec_3.25 Section sec_3.26 |
| 17 | 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 |
| 18 | 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 Requirements 4.1 Concentrates |
| 19 | 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 |
| 20 | 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 Manufacturing equipment 4.3 Systems for mixing concentrate at a dialysis facility |
| 21 | Section sec_4.3.3.2 Section sec_4.3.4 Section sec_4.3.5 Section sec_4.3.6 |
| 22 | 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 Tests 5.1 General 5.2 Concentrates |
| 23 | 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 |
| 24 | 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 Manufacturing equipment 5.4 Systems for mixing concentrate at a dialysis facility |
| 25 | 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 Labelling 6.1 General |
| 26 | Section sec_6.2 6.2 General labelling requirements for concentrates |
| 27 | Section sec_6.3 Section sec_6.4 6.3 Labelling requirements for liquid concentrate 6.4 Labelling requirements for powder concentrate |
| 28 | Section sec_6.5 Section sec_6.6 6.5 Additives 6.6 Labelling requirements for concentrate generators |
| 29 | Table tab_2 Section sec_6.7 Section sec_6.7.1 Section sec_6.7.2 6.7 Labelling for concentrate mixer systems |
| 31 | Annex sec_A Annex sec_A.1 Annex A (informative) Rationale for the development and provisions of this International Standard |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | Reference ref_16 |
