BS EN ISO 13408-3:2011 - Aseptic processing of health care products. Lyophilization

BS EN ISO 13408-3:2011

Aseptic processing of health care products. Lyophilization

Status : Current, Confirmed   Published : October 2011



Standard NumberBS EN ISO 13408-3:2011
TitleAseptic processing of health care products. Lyophilization
StatusCurrent, Confirmed
Publication Date31 October 2011
Confirm Date27 January 2016
Normative References(Required to achieve compliance to this standard)ISO 9001, ISO 13408-5, ISO 13408-1, ISO 13408-4
Informative References(Provided for Information)ISO/TS 11139:2006, 93/42/EEC, 90/385/EEC, 98/79/EC, ISO 9000, ISO 13485
ReplacesBS EN 13824:2004
International RelationshipsISO 13408-5:2006,ISO 13408-3:2006,EN ISO 13408-3:2011
DescriptorsSterilization (hygiene), Verification, Quality management, Environment (working), Quality control, Production, Freeze-drying, Drying, Personnel, Sterile equipment, Quality assurance systems, Medical equipment
Title in FrenchTraitement aseptique des produits de santé. Lyophilisation
Title in GermanAseptische Herstellung von Produkten für die Gesundheitsfürsorge. Gefriertrocknung
ISBN978 0 580 72610 1
File Size1.014 MB

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