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ISO 13408-1:2023

Aseptic processing of health care products — Part 1: General requirements
15. 8. 2023.

Опште информације

60.60     15. 8. 2023.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 13408-1:2008

POVUČEN
ISO 13408-1:2008/Amd 1:2013

TRENUTNO

OBJAVLJEN
ISO 13408-1:2023
60.60 Standard objavljen
15. 8. 2023.

Nacionalna preuzimanja

SRPS EN ISO 13408-1:2024  
ISS

Aseptična obrada proizvoda za zaštitu zdravlja – Deo 1: Opšti zahtevi

60.60   Standard objavljen

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