17/30321193 DC : 0
NA
Status of Standard is Unknown
BS ISO 23500-1 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 1. GENERAL REQUIREMENTS
Hardcopy , PDF
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of quality requirements of
ISO 23500-4, ISO 23500-3 and ISO 23500-5
5 Critical aspects of system design
6 Validation of system performance
7 Quality management
8 Strategies for microbiological control
9 Location of and access to water treatment system
10 Personnel
Annex A (informative) - Rationale for the
development and provisions of this
International Standard
Annex B (informative) - Equipment
Annex C (informative) - Monitoring guidelines
for water treatment equipment, distribution
systems, and dialysis fluid
Annex D (informative) - Strategies for microbiological
control
Annex E (informative) - Validation
Annex F (informative) - Special considerations for
home haemodialysis
Annex G (informative) - Special considerations for
acute haemodialysis
Bibliography
BS ISO 23500-1.
| Committee |
CH/150/2
|
| DocumentType |
Draft
|
| Pages |
107
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
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