Hivatkozási szám

MSZ EN ISO 26722:2016

Dokumentumazonosító

162844

Cím

Vízkezelő berendezések hemodialízishez és a kapcsolódó gyógykezelésekhez (ISO 26722:2014)

Angol cím

Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014)

Alkalmazási terület

1.1 General This International Standard is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies. 1.2 Inclusions This International Standard covers devices used to treat water intended for use in the delivery of haemodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; (3) the reprocessing of dialysers for multiple uses. Included within the scope of this International Standard are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of devices included within the scope of this International Standard are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water. 1.3 Exclusions Excluded from the scope of this International Standard are dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other International Standards. Also excluded from the scope of this International Standard are requirements for the ongoing monitoring of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing.

ICS

11.040.40 Sebészeti implantátumok, protézisek és ortézisek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-06-01

A visszavonás napja

2019-10-01

Forrás

idt EN ISO 26722:2015; idt ISO 26722:2014

Előd

Utód

MSZ EN ISO 23500-2:2019

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

A szabvány

kapható formátuma

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oldalszáma

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ára

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