ISO 17664-1

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices

Body

ISO

Number

ISO 17664-1

Editions

2021

FDA recognition no.

14-578

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 6.6.1.1 At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue. Clause 6.7.1.1 If the medical device is intended to be disinfected, at least one validated automated disinfection method shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue. Clause 6.8 Drying: Where drying is necessary, at least one verified drying method shall be specified. If a drying method is specified, the following information shall be included, where applicable: Clause 6.11.3 i) the pressure required for the sterilization process;

Scope source: FDA 认可共识标准库

Laboratories covering this standard