Standard Swedish standard · SS-EN 13824:2005

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Status: Withdrawn

· Replaced by: 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
Scope
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.

Subjects

Sterilization and disinfection in general (11.080.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-39609

Edition: 1

Approved: 5/4/2005

No of pages: 62

Replaced by: 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