DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

SSH EN ISO 13408-2:2011

Trajtimi i proçesit të përpunimit antimikrobik ndaj produkteve të kujdesit për shëndetin- Pjesa 2: Filtrimi (ISO 13408-2:2003)

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
26 mar 2012
95.99 Withdrawal of Standard   22 dhj 2018

General information

95.99     22 dhj 2018

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

Buying

Shfuqizuar

Language in which you want to receive the document.

Scope

ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

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

NOW

WITHDRAWN
SSH EN ISO 13408-2:2011
95.99 Withdrawal of Standard
22 dhj 2018

REVISED BY

PUBLISHED
SSH EN ISO 13408-2:2018

Related project

Adopted from EN ISO 13408-2:2011