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SSH EN ISO 13408-6:2011

Trajtimi antimikrobik ndaj produkteve të kujdesit shëndetësor - Pjesa 6: Sistemet e izoluesve (ISO 13408-6:2005)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
26 mar 2012
95.99 Withdrawal of Standard   21 dhj 2021

General information

95.99     21 dhj 2021

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

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Scope

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

Related directives

Directives related to this standards.

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara
98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara

Life cycle

NOW

WITHDRAWN
SSH EN ISO 13408-6:2011
95.99 Withdrawal of Standard
21 dhj 2021

REVISED BY

PUBLISHED
SSH EN ISO 13408-6:2021

Related project

Adopted from EN ISO 13408-6:2011