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17/30321193 DC : 0

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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
Available format(s)

Hardcopy , PDF

Language(s)

English

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 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)

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