ANSI AAMI ISO 17664:2017 pdf download – Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices
1 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.
6.1.1 The information specified in this clause shall take into account the nature of the medical device and its intended use.
6.1.2 Where disinfection is the terminal process, the medical device manufacturer shall specify validated method(s) to reduce the risk of transmission of infectious agents to a level appropriate for the intended use of the medical device. Medical device manufacturers shall specify in their processing instructions any special techniques and accessories that will enable the processor to provide a medical device that is suitable for its intended use.
6.1.3 Where sterilization is the terminal process, the medical device manufacturer shall specify validated method(s) to achieve the required sterility assurance level. Medical device manufacturers shall specify in their processing instructions any specific requirements that will enable the processor to provide a medical device that is suitable for its intended use.
6.3.1 If processing of a medical device in accordance with the medical device manufacturer’s instructions is known to lead to degradation that might limit the service life of the medical device, e.g. functionality, biocompatibility or suitability for effective processing, then the medical device manufacturer shall provide such information regarding limitations and restrictions to the processor.
6.3.2 If the service life of the medical device is limited by the number of processing cycles or some other end of life indicator(s) this information shall also be provided. NOTE For example, this information if applicable, can provide a method to monitor the actual number of processing cycles.
6.3.3 Where an incompatibility of the medical device with a substance(s) or processing condition(s) is known, this information shall be provided.