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

Available format(s)

Hardcopy

Language(s)

English

Published date

06-05-2024

Publisher

Norwegian Standards (Norges Standardiseringsforbund)

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.

Committee	CEN/TC 204
DocumentType	Standard
Pages	0
PublisherName	Norwegian Standards (Norges Standardiseringsforbund)
Status	Current
Supersedes	NS EN ISO 13408-1 : 2015

Standards	Relationship
ISO 13408-1:2023	Identical
EN ISO 13408-1:2024	Identical

EN 556-2:2015	Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
ISO/TS 19930:2017	Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

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NS-EN ISO 13408-1:2024

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

Abstract

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