Standard Svensk standard · SS-EN 13824:2005

Sterilisering av medicintekniska produkter - Aseptisk hantering av vätskeformiga medicintekniska produkter - Krav

Status: Upphävd · Ersätts av: SS-EN ISO 13408-2:2011 , SS-EN ISO 13408-6:2011 , SS-EN ISO 13408-3:2011 , SS-EN ISO 13408-4:2011 , SS-EN ISO 13408-5:2011 , SS-EN ISO 13408-1:2011

Omfattning
This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable. NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.

Ämnesområden

Sterilisering och desinficering allmänt (11.080.01)


Produktinformation

Språk: Engelska

Framtagen av: SIS - Hälso- och sjukvård

Internationell titel: Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Artikelnummer: STD-39609

Utgåva: 1

Fastställd: 2005-05-04

Antal sidor: 62

Ersätts av: SS-EN ISO 13408-2:2011 , SS-EN ISO 13408-6:2011 , SS-EN ISO 13408-3:2011 , SS-EN ISO 13408-4:2011 , SS-EN ISO 13408-5:2011 , SS-EN ISO 13408-1:2011