scope:

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.

This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:

a) initial treatment at the point of use;

b) preparation before cleaning;

c) cleaning;

d) disinfection;

e) drying;

f) inspection and maintenance;

g) packaging;

h) sterilization;

i) storage;

j) transportation.

This document excludes processing of the following:

- non-critical medical devices not intended for direct patient contact;

- textile devices used in patient draping systems or surgical clothing;

- medical devices specified by the manufacturer for single-use only and supplied ready for use.