magnifying icon Basket
1 item ^

Basket is empty
Login

Login

LOGGED AS

Help

Satisfaction enquiry

SATISFACTION ENQUIRY

Newsletter

Free of charge lifelong learning "Standardization"

FREE OF CHARGE LIFELONG LEARNING "STANDARDIZATION"

Standardisation

Draft standards in public enquiry

DRAFT STANDARDS IN PUBLIC ENQUIRY

Standards organizations

STANDARDS ORGANIZATIONS

  • National standards

  • European standards

  • International standards


Deliverable

 
Free preview
Price
Language
 
ILNAS-EN ISO 13408-1:2024 Edition 04/2024
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
  •   
  •   
  •  
  • 91.8 / copy
  •  
 

Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 204 : Sterilization of medical devices

Implementation

start of the vote on the project    16/12/2021   date of ratification (dor)    02/07/2023
end of the vote on the project    19/03/2022   date of anouncement (doa)    31/07/2024
start of the vote on the final project    06/04/2023   date of publication (dop)    31/10/2024
end of the vote on the final project    01/06/2023   date of withdrawal (dow)    31/10/2024


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ILNAS-EN ISO 13408-1:2015

Relations to international standards
ISO 13408-1 
ISO 13408-1:2023 

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

magnifying icon Basket
1 item ^

Basket is empty


Warning:
DIN standards can be downloaded only once! After downloading, they are no longer available in the eLibrary.
Begin download?