ISO 17664-1:2021

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
Autor: ISO
Código ICS: 11.080.01
Vigente
$101.000

Alcance

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.This document excludes processing of the following:—    non-critical medical devices unless they are intended to be sterilized;—    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.NOTE       See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.

Especificaciones de la Norma
Fecha de Publicación 06/07/2021
Título Secundario Traitement de produits de soins de santé -- Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif -- Partie 1: Dispositifs médicaux critiques et semi-critiques
Páginas Técnicas 23
Idioma Inglés