ISO 23500-1

Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements

Body

ISO

Number

ISO 23500-1

Editions

2019、2024

FDA recognition no.

9-133

FDA recognition no.

9-152

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 7.6 Surveillance of concentrate distribution - Third paragraph, first sentence "There are no published reports of acid concentrate supporting bacterial growth; therefore, it is not necessary to perform routine testing for total viable microbial count and endotoxins on those systems." Section 8.2.3.4 Concentrate distribution systems - Second paragraph, third sentence "As there are no published reports of acid concentrate supporting bacterial growth, the disinfection of acid concentrate distribution systems is not normally required." Section B.5.3.1 Acid concentrate distribution systems - Last two sentences "Even though there are no published reports of acid concentrate supporting microbial growth, every effort should be made to keep the system closed to prevent contamination and evaporation. If the acid system remains intact, no rinsing or disinfection is necessary."

Scope source: FDA 认可共识标准库

Laboratories covering this standard