Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ANSI/AAMI/ISO 17664:2017

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices. Supersedes ST81

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 standard are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this standard. Rather, this standard specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities where applicable: a) Pre-treatment at the point of use before processing; b) Preparation before cleaning; c) Cleaning; d) Disinfection; e) Drying; f) Inspection, maintenance and functionality testing; g) Packaging; h) Sterilization; i) Storage; j) Transportation.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought

ANSI/AAMI ES60601-1:2005 (R2012) with amendments
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, ...
ANSI/AAMI/ISO 10993-5:2009 (R2014)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI/AAMI/ISO 17665-1:2006 (R2013)
Sterilization of health care products - Moist heat - Part1: Requirements for the development, validation, and routine ...

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.