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EVS-EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

General information
Valid from 02.07.2015
Base Documents
ISO 13408-1:2008; ISO 13408-1:2008/Amd 1:2013; EN ISO 13408-1:2015
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
Main
prEN ISO 13408-1
02.07.2015
Main
EVS-EN ISO 13408-1:2015
04.06.2013
Amendment
EVS-EN ISO 13408-1:2011/A1:2013
03.08.2011
Main
EVS-EN ISO 13408-1:2011
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. 1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
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Standard monitoring
English

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EVS-EN ISO 13408-2:2018

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EVS-EN ISO 13408-4:2011

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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

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Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
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