ISO 8637-1

Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Body

ISO

Number

ISO 8637-1

Editions

2017

FDA recognition no.

9-118

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 6.2h Labelling on unit containers - a statement of sterility and non-pyrogenicity.

Scope source: FDA 认可共识标准库

Laboratories covering this standard