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BSI - BS EN ISO 23500-4 - TC

Tracked Changes (Redline) - Preparation and quality management of fluids for haemodialysis and related therapies Part 4: Concentrates for haemodialysis and related therapies

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Organization: BSI
Publication Date: 28 February 2020
Status: active
Page Count: 84
ICS Code (Other standards related to pharmaceutics): 11.120.99
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN ISO 23500-4 - TC
February 28, 2020
Tracked Changes (Redline) - Preparation and quality management of fluids for haemodialysis and related therapies Part 4: Concentrates for haemodialysis and related therapies
A description is not available for this item.

References

This document references:
IEC 60601-2-16 - Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Published by IEC on April 1, 2018
Clause 1 of the general standard1 applies, except as follows: Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
Published by IEC on January 1, 2017
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
This document references:
ISO 15223-2 - Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
Published by ISO on January 15, 2010
This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this part of ISO 15223 is to ensure that symbols included in...
This document references:
15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by ISO on July 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
Published by IEC on January 1, 2017
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
This document references:
15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by ISO on July 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
ISO 15223-2 - Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
Published by ISO on January 15, 2010
This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this part of ISO 15223 is to ensure that symbols included in...
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