ISO 23500-4

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies

Body

ISO

Number

ISO 23500-4

Editions

2019、2024

FDA recognition no.

9-136

FDA recognition no.

9-155

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 4.1.3.1 Bacteriology of acid concentrates Section 4.3.7 Piping systems - Last sentence "The disinfection of piping systems for acid concentrate is normally not necessary because acid concentrates are typically bacteriostatic."

Scope source: FDA 认可共识标准库

Laboratories covering this standard