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EVS-EN ISO 13408-1:2024

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

General information

Valid from 02.05.2024
Base Documents
ISO 13408-1:2023; EN ISO 13408-1:2024
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
2017/745 Medical devices (MDR) 2017/746 In vitro diagnostic medical devices (IVDMDR)

Standard history

Status
Date
Type
Name
02.05.2024
Main
EVS-EN ISO 13408-1:2024
02.07.2015
Main
EVS-EN ISO 13408-1:2015
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

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Standard monitoring
English (PDF 772 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