ANSI AAMI ISO 17664-2017 pdf free download – Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.
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.
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1 4971, Medical devices—Application of risk management to medical devices
3 Terms and definitions For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1 cleaning removal of contaminants to the extent necessary for further processing or for intended use Note 1 to entry: Cleaning consists of the removal, usually with detergent and water, of adherent soil (e.g. blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated process that prepares the items for safe handling and/or further processing.
3.2 disinfecting agent physical or chemical agent that is able to reduce the number of viable microorganisms
3.3 disinfection process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose
3.4 manual cleaning removal of contaminants from an item to the extent necessary for further processing or for intended use without the use of an automated process
3.5 manufacturer natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer.
[SOURCE: ISO 1 3485:201 6, 3.1 0, modified – notes to entry not included].ANSI AAMI ISO 17664 pdf download.