ISO 8637-2

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters

Body

ISO

Number

ISO 8637-2

Editions

2018

FDA recognition no.

9-140

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: The following part(s) of the standard is (are) not recognized: - Clause 4.4.9.1 Integral transducer protectors - Clause 4.4.9.2 Non-integral transducer protectors - Clause 5.5.6.1 Needle access ports - Clause 5.5.9 Transducer protectors - Clause 5.5.10 Blood pathway flow dynamics - Clause 5.5.11 Pump segment performance

Scope source: FDA 认可共识标准库

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