BS EN ISO 23500:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
Hardcopy , PDF
27-03-2019
English
31-10-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of quality requirements of ISO 13958,
ISO 13959 and ISO 11663
5 Critical aspects of system design
6 Validation of system performance
7 Quality management
8 Strategies for microbiological control
9 Environment
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
Gives 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.
Committee |
CH/150/2
|
DevelopmentNote |
Renumbers and supersedes BS ISO 23500. 2015 version incorporates corrigendum to BS ISO 23500. Supersedes 10/30201925 DC & 13/30270474 DC. (10/2015)
|
DocumentType |
Standard
|
Pages |
96
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
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.
Standards | Relationship |
EN ISO 23500:2015 | Identical |
ISO 23500:2014 | Identical |
ISO 11663:2014 | Quality of dialysis fluid for haemodialysis and related therapies |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
ISO 26722:2014 | Water treatment equipment for haemodialysis applications and related therapies |
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
ISO 13959:2014 | Water for haemodialysis and related therapies |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.