SN EN ISO 17664-2:2024
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
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.
- Originator
- INB
- Published
- 2024-01-01
- ICS
- 11.080.01
SN EN ISO 17664-2:2024
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 2: Nicht kritische Medizinprodukte (ISO 17664-2:2021)
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
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.
Content pages for this standard
guide
Comprehensive Overview of SN EN ISO 17664-2:2024 - Medical Devices
Explore SN EN ISO 17664-2:2024, covering processing information for non-critical medical devices and its importance in healthcare technology.
ISO 17664-2:2021 Compliance Requirements for Medical Devices
Discover the ISO 17664-2:2021 compliance requirements for processing non-critical medical devices as per SN EN ISO 17664-2:2024.