SS-EN-13824 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

SS-EN-13824 - 2005 EDITION - SUPERSEDED
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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.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Designation Name

SS-EN 13824:2005

Revision Level

2005 EDITION

Status

Superseded

Publication Date

May 4, 2005

Language(s)

English

Page Count

62

International Equivalent

EN 13824:2004(IDT)