DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

Mar 26, 2012

General information

60.60     Mar 26, 2012

DPS

DPS/KT 316

European Norm

11.080.01  

English  

Buying

Published

Language in which you want to receive the document.

Scope

ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC

Life cycle

NOW

PUBLISHED
SSH EN ISO 13408-3:2011
60.60 Standard published
Mar 26, 2012

Related project

Adopted from EN ISO 13408-3:2011