BS EN ISO 23500:2015
$215.11
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 96 |
ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice. ISO 23500:2014 addresses the user’s responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user’s facility, as well as concentrates and the final dialysis fluid and substitution fluid.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Foreword |
| 7 | Introduction |
| 9 | Section sec_1 Section sec_1.1 Section sec_1.2 Section sec_1.3 Section sec_2 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references |
| 10 | Section sec_3 Section sec_3.1 Section sec_3.2 Section sec_3.3 Section sec_3.4 Section sec_3.5 3 Terms and definitions |
| 11 | Section sec_3.6 Section sec_3.7 Section sec_3.8 Section sec_3.9 Section sec_3.10 Section sec_3.11 Section sec_3.12 |
| 12 | Section sec_3.13 Section sec_3.14 Section sec_3.15 Section sec_3.16 Section sec_3.17 |
| 13 | Section sec_3.18 Section sec_3.19 Section sec_3.20 Section sec_3.21 Section sec_3.22 Section sec_3.23 |
| 14 | Section sec_3.24 Section sec_3.25 Section sec_3.26 Section sec_3.27 Section sec_3.28 Section sec_3.29 Section sec_3.30 |
| 15 | Section sec_3.31 Section sec_3.32 Section sec_3.33 Section sec_3.34 Section sec_3.35 Section sec_3.36 Section sec_3.37 Section sec_3.38 |
| 16 | Section sec_3.39 Section sec_3.40 Section sec_3.41 Section sec_3.42 Section sec_3.43 Section sec_3.44 Section sec_3.45 |
| 17 | Section sec_3.46 Section sec_4 Section sec_4.1 Section sec_4.1.1 Section sec_4.1.2 Table tab_1 4 Summary of quality requirements of ISO 13958, ISO 13959 and ISO 11663 4.1 Dialysis water |
| 18 | Table tab_2 Section sec_4.1.3 |
| 19 | Table tab_3 Section sec_4.2 Section sec_4.2.1 Section sec_4.2.2 Section sec_4.3 Section sec_4.3.1 Section sec_4.3.2 4.2 Requirements for concentrate 4.3 Requirements for dialysis fluid |
| 20 | Table tab_4 Section sec_4.3.3 Section sec_4.3.4 Section sec_4.4 Section sec_5 4.4 Record retention 5 Critical aspects of system design |
| 21 | Section sec_5.1 Section sec_5.2 5.1 Technical aspects 5.2 Microbiological aspects |
| 22 | Section sec_6 Section sec_6.1 6 Validation of system performance 6.1 Validation plan |
| 23 | Table tab_b Figure fig_1 Section sec_6.2 6.2 Installation and operational qualification |
| 24 | Section sec_6.3 Section sec_6.4 6.3 Performance qualification 6.4 Routine monitoring and revalidation |
| 25 | Section sec_7 Section sec_7.1 Section sec_7.2 Section sec_7.2.1 Section sec_7.2.2 7 Quality management 7.1 General 7.2 Monitoring of fluid quality |
| 26 | Section sec_7.2.3 Section sec_7.3 Section sec_7.3.1 Section sec_7.3.2 Section sec_7.3.3 Section sec_7.3.4 7.3 Monitoring of water treatment equipment |
| 27 | Section sec_7.3.5 Section sec_7.3.6 |
| 28 | Section sec_7.3.7 |
| 29 | Section sec_7.3.8 Section sec_7.3.9 Section sec_7.4 Section sec_7.4.1 7.4 Monitoring of dialysis water storage and distribution |
| 30 | Section sec_7.4.2 Section sec_7.4.3 Section sec_7.4.3.1 Section sec_7.4.3.2 Section sec_7.4.3.3 |
| 31 | Section sec_7.5 Section sec_7.5.1 Section sec_7.5.2 Section sec_7.6 Section sec_7.7 7.5 Monitoring of concentrate preparation 7.6 Monitoring of concentrate distribution 7.7 Monitoring of dialysis fluid proportioning |
| 32 | Section sec_8 Section sec_8.1 Section sec_8.2 Section sec_8.2.1 8 Strategies for microbiological control 8.1 General 8.2 Disinfection |
| 33 | Section sec_8.2.2 Section sec_8.2.2.1 Section sec_8.2.2.2 Section sec_8.2.2.3 |
| 34 | Section sec_8.2.2.4 Section sec_8.3 Section sec_8.3.1 Section sec_8.3.2 Section sec_8.3.2.1 8.3 Microbiological monitoring methods |
| 35 | Section sec_8.3.2.2 Section sec_8.3.3 Section sec_8.3.3.1 Section sec_8.3.3.2 Section sec_8.3.3.2.1 Section sec_8.3.3.2.2 Section sec_8.3.3.2.3 |
| 36 | Section sec_8.3.3.2.4 Section sec_8.3.3.3 Table tab_5 Section sec_8.3.4 Section sec_9 9 Environment |
| 37 | Section sec_10 10 Personnel |
| 38 | Annex sec_A Annex sec_A.1 Annex sec_A.2 Annex sec_A.3 Annex sec_A.4 Annex A (informative) Rationale for the development and provisions of this International Standard |
| 39 | Annex sec_A.5 Annex sec_A.6 Annex sec_A.7 |
| 40 | Annex sec_A.8 |
| 41 | Annex sec_A.9 Annex sec_A.10 |
| 42 | Annex sec_B Annex sec_B.1 Annex sec_B.2 Annex sec_B.2.1 Annex B (informative) Equipment |
| 43 | Annex sec_B.2.2 Annex sec_B.2.3 Annex sec_B.2.4 |
| 44 | Annex sec_B.2.5 |
| 45 | Annex sec_B.2.6 |
| 46 | Annex sec_B.2.7 |
| 47 | Annex sec_B.2.8 |
| 48 | Annex sec_B.2.9 Annex sec_B.3 Annex sec_B.3.1 |
| 49 | Annex sec_B.3.2 Annex sec_B.3.3 |
| 50 | Table tab_B.1 Annex sec_B.3.4 Annex sec_B.3.4.1 Annex sec_B.3.4.2 |
| 51 | Annex sec_B.3.4.3 Annex sec_B.3.4.4 |
| 52 | Annex sec_B.4 Annex sec_B.4.1 Annex sec_B.4.2 |
| 53 | Annex sec_B.4.3 Annex sec_B.4.3.1 Annex sec_B.4.3.2 Annex sec_B.4.3.3 Annex sec_B.4.3.4 Annex sec_B.4.4 Annex sec_B.4.4.1 |
| 54 | Annex sec_B.4.4.2 Annex sec_B.4.4.3 Annex sec_B.4.5 |
| 55 | Annex sec_B.5 Annex sec_B.5.1 Annex sec_B.5.2 Annex sec_B.5.3 Annex sec_B.5.3.1 Annex sec_B.5.3.2 |
| 56 | Annex sec_B.5.3.3 |
| 57 | Annex sec_B.6 Table tab_B.2 |
| 58 | Annex sec_B.7 Annex sec_B.7.1 Annex sec_B.7.2 |
| 59 | Annex sec_B.7.3 Annex sec_B.7.4 |
| 60 | Annex sec_C Annex sec_C.1 Table tab_C.1 Annex C (informative) Monitoring guidelines for water treatment equipment, distribution systems, and dialysis fluid |
| 63 | Annex sec_C.2 |
| 64 | Table tab_C.2 |
| 65 | Annex sec_D Annex sec_D.1 Annex D (informative) Strategies for microbiological control Strategies for microbiological control |
| 67 | Annex sec_D.2 Annex sec_D.2.1 Annex sec_D.2.2 |
| 68 | Annex sec_D.2.3 Annex sec_D.2.4 |
| 69 | Annex sec_D.3 |
| 70 | Annex sec_E Annex sec_E.1 Annex sec_E.2 Annex sec_E.2.1 Annex sec_E.2.2 Annex E (informative) Validation Validation |
| 71 | Annex sec_E.2.3 Annex sec_E.2.4 |
| 72 | Annex sec_E.3 |
| 73 | Annex sec_F Annex sec_F.1 Annex sec_F.2 Annex sec_F.3 Annex sec_F.3.1 Annex F (informative) Special considerations for home haemodialysis Special considerations for home haemodialysis |
| 74 | Annex sec_F.3.2 Annex sec_F.3.3 |
| 75 | Annex sec_F.4 Annex sec_F.5 Annex sec_F.5.1 Annex sec_F.5.2 Annex sec_F.5.3 |
| 76 | Annex sec_F.5.4 Annex sec_F.5.5 Annex sec_F.5.6 Annex sec_F.6 Annex sec_F.6.1 Annex sec_F.6.2 |
| 77 | Annex sec_F.7 Annex sec_F.7.1 Annex sec_F.7.2 Annex sec_F.7.2.1 Annex sec_F.7.2.2 Annex sec_F.7.2.3 |
| 78 | Annex sec_F.7.2.4 Annex sec_F.7.2.5 |
| 79 | Annex sec_G Annex sec_G.1 Annex sec_G.2 Annex sec_G.3 Annex sec_G.3.1 Annex G (informative) Special considerations for acute haemodialysis Special considerations for acute haemodialysis |
| 80 | Annex sec_G.3.2 Annex sec_G.3.3 Annex sec_G.3.4 |
| 81 | Annex sec_G.3.5 Annex sec_G.3.5.1 Annex sec_G.3.5.2 |
| 82 | Annex sec_G.3.6 Annex sec_G.3.7 Annex sec_G.4 |
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