Tagasi

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

Üldinfo
Kehtiv alates 25.02.2021
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
25.02.2021
Põhitekst
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.
*
*
*
PDF
131,11 € koos KM-ga
Paber
131,11 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst

EVS-EN ISO 20417:2021

Meditsiiniseadmed. Tootja esitatav teave
Uusim versioon Kehtiv alates 17.05.2021
Põhitekst

EVS-EN ISO 80000-3:2020

Quantities and units - Part 3: Space and time (ISO 80000-3:2019)
Uusim versioon Kehtiv alates 16.11.2020
Põhitekst

EVS-EN ISO 80000-1:2013

Quantities and units - Part 1: General (ISO 80000-1:2009 + Cor 1:2011)
Uusim versioon Kehtiv alates 06.05.2013
Põhitekst

EVS-EN ISO 80000-4:2019

Quantities and units - Part 4: Mechanics (ISO 80000-4:2019)
Uusim versioon Kehtiv alates 01.11.2019