Hrvatski normativni dokument

HRN EN ISO 23500-1:2024

Priprema i upravljanje kvalitetom tekućina za hemodijalizu i srodne terapije -- 1. dio: Opći zahtjevi (ISO 23500-1:2024; EN ISO 23500-1:2024)

Oznaka: HRN EN ISO 23500-1:2024
Naslov (HR): Priprema i upravljanje kvalitetom tekućina za hemodijalizu i srodne terapije -- 1. dio: Opći zahtjevi (ISO 23500-1:2024; EN ISO 23500-1:2024)
Naslov (EN): Preparation and quality management of fluids for haemodialysis and related therapies -- Part 1: General requirements (ISO 23500-1:2024; EN ISO 23500-1:2024)
Područje primjene (EN): 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.
Izdanje: 2
ICS: 11.040.40 Implantati za kirurgiju, protetiku i ortotiku
Tehnički odbor/pododbor: TU S1, Zdravlje, okoliš i medicinska oprema 1
Oznaka faze: 60.60 - HRN dostupan
Glasilo (rasprava): HZN e-Glasilo 12/2022 ()
Glasilo (objava): HZN e-Glasilo 9/2024 ()
Način prihvaćanja: pr - prihvaćanje strane norme u izvorniku
Cijena #1: Cijena: 69,00 € | Jezik: en | Cjenovni razred: O | Broj stranica: 108
Izvornik: EN ISO 23500-1:2024
Zamjenjuje: HRN EN ISO 23500-1:2019

Obrazac za naručivanje normativnih dokumenata i/ili publikacija (obrazac ob.025-2):

PREUZMITE (DOC)   PREUZMITE (PDF) 

Prijava korisnika

Mrežna stranica koristi kolačiće (cookies). Kolačiće upotrebljavamo kako bismo personalizirali sadržaj i oglase, omogućili značajke društvenih medija i analizirali promet. Isto tako, podatke o vašoj upotrebi naše web-lokacije dijelimo s partnerima za društvene medije, oglašavanje i analizu, a oni ih mogu kombinirati s drugim podacima koje ste im pružili ili koje su prikupili dok ste upotrebljavali njihove usluge. Nastavkom korištenja naših internetskih stranica vi prihvaćate našu upotrebu kolačića. Polica privatnosti.