International Standard
ISO 23500-1:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
Reference number
ISO 23500-1:2024
Edition 2
2024-08
© ISO 2024
Preview
недоступно на русском языке
Опубликовано (Версия 2, 2024)

ISO 23500-1:2024

Язык
Формат
CHF 216
Пересчитать швейцарские франки (CHF) в ваша валюта

Тезис

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.

This document is applicable to

—     the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused.

—     the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and

—     the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.

This document does not apply to

—     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.

This document does not address clinical issues associated with inappropriate usage of such fluids.

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2024-08
    Этап
    : Опубликование международного стандарта [60.60]
  • Версия
     : 2
  • Технический комитет :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS обновления

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
Хорошее здоровье и благополучие

Появились вопросы?

Ознакомьтесь с FAQ

  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO 23500-1:2024