STN EN ISO 17664-1
| Name: | STN EN ISO 17664-1 |
| 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 1: Zdravotnícke pomôcky na intenzívnu a polointenzívnu starostlivosť (ISO 17664-1: 2021) |
| English title | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
| Release Date: | 01. 01. 2022 |
| Date of withdrawal: | |
| ICS: | 11.080.01 |
| Sorting character/National clasification code | 85 6536 |
| Level of incorporation: | idt EN ISO 17664-1:2021, idt ISO 17664-1:2021 |
| Official Journal | 12/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 17664:2018-12 (85 6536) |
| 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 critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. 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) 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. |
| Preview: | Náhľad normy (PDF) |