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STANDARD

Current

ÖNORM EN ISO 23500-5

Issue date: 2024 10 01

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)

This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies. This document applies to - dialysis fluids used for haemodialysis and haemodiafiltration, - substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid This document does not apply to - the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid - sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, - systems for continuous renal replacement therapy that use pre-packaged solutions, and - systems and solutions for peritoneal dialysis. The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.

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General information on ÖNORM EN ISO 23500-5

Format

Digital | 21 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 23500-5 from 2016 til today.

• ÖNORM EN ISO 23500-5

  2024 10 01 Standard ÖNORM EN ISO 23500-5, Edition: 2024 10 01

  Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quali...
• ÖNORM EN ISO 23500-5

  2019 09 15 Standard ÖNORM EN ISO 23500-5, Edition: 2019 09 15

  Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quali...
• ÖNORM EN ISO 11663

  2016 02 01 Standard ÖNORM EN ISO 11663, Edition: 2016 02 01

  Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 23500-1:2019	Titel Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements	Ausgabedatum 2019 02 15	Art Standard	Zur Produktseite
Dokumentnummer ISO 23500-3:2019	Titel Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies	Ausgabedatum 2019 02 15	Art Standard	Zur Produktseite
Dokumentnummer ISO 23500-4:2019	Titel Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies	Ausgabedatum 2019 02 15	Art Standard	Zur Produktseite

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