CEN/TC 204/WG 12 - Annex Z reviews

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
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)   preparation before processing;
b)   cleaning;
c)   disinfection;
d)   drying;
e)   inspection and maintenance;
f)    packaging;
g)   storage;
h)   transportation.
This document excludes processing of:
1)   critical and semi-critical medical devices;
2)   medical devices intended to be sterilized;
3)   textile medical devices used in patient draping systems or surgical clothing;
4)   medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE     See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

This document specifies general criteria to be applied in the determination of
bacterial endotoxins on or in health care products, components or raw materials
using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.
This document is not applicable to the evaluation of pyrogens other than
bacterial endotoxins. Other endotoxin detection methodologies are not included.
This document does not address setting specific endotoxin limit specifications.