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SSH EN ISO 13408-1:2015

Trajtimi antimikrobik ndaj produkteve të kujdesit shëndetësor - Pjesa 1: Kërkesa të përgjithshme (ISO 13408-1:2008, përfshirë Amd 1:2013)

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
29 mar 2016

General information

60.60     29 mar 2016

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

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Scope

ISO 13408-1:2008 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.
ISO 13408-1:2008 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.

Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara
90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara

Life cycle

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PUBLISHED
SSH EN ISO 13408-1:2015
60.60 Standard published
29 mar 2016

Related project

Adopted from EN ISO 13408-1:2015