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EVS-EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

General information

Valid from 03.08.2011
Base Documents
ISO 13408-3:2006; EN ISO 13408-3:2011
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
90/385/EEC Active implantable medical devices 93/42/EEC Medical devices (MDD) 98/79/EC In vitro diagnostic medical devices

Standard history

Status
Date
Type
Name
03.08.2011
Main
EVS-EN ISO 13408-3:2011
Main
EVS-EN 13824:2005
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

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English (PDF 349 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English