ANSIAAMI ST91

Flexible and semi-rigid endoscope processing in health care facilities

Body: ANSIAAMI
Number: ANSIAAMI ST91
Editions: 2021
FDA recognition no.: 14-572

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 8.2.5 Endoscope drying (Sections referencing drying verification and methods for assessing drying in endoscopes in Annex K) Clause 13.5.3 Cleaning verification tests for users (Sections referencing cleaning verification tests for endoscopes in Annex F)

Scope source: FDA 认可共识标准库

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