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STN EN ISO 17664-2

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Name: STN EN ISO 17664-2
Validity: Valid
Number of pages: 36
Language:
EN
Paper: 17,20€
Electronic version a) Only read (without ability to print and copy) 15,48€
b) Without ability to print, with ability to copy (printscreen) 17,20€
c) With ability to print and copy (printscreen) 22,36€
Slovak title Úprava výrobkov na zdravotnú starostlivosť. Informácie poskytované výrobcom zdravotníckych pomôcok na úpravu zdravotníckych pomôcok. Časť 2: Nekritické zdravotnícke pomôcky (ISO 17664-2: 2021)
English title 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)
Release Date: 01. 05. 2024
Date of withdrawal:
ICS: 11.080.01
Sorting character/National clasification code 85 6536
Level of incorporation: idt ISO 17664-2:2021, idt EN ISO 17664-2:2023
Official Journal 04/24
Amendments
Replaced by:
Repleces:
Note in Official Journal:
Subject of the standard: 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.
Preview: Náhľad normy (PDF)