BS EN ISO 13408-1:2011+A1:2013 - Aseptic processing of health care products. General requirements

BS EN ISO 13408-1:2011+A1:2013

Aseptic processing of health care products. General requirements

Status : Revised, Superseded, Withdrawn   Published : October 2011 Replaced By : BS EN ISO 13408-1:2015

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Standard NumberBS EN ISO 13408-1:2011+A1:2013
TitleAseptic processing of health care products. General requirements
StatusRevised, Superseded, Withdrawn
Publication Date31 October 2011
Withdrawn Date31 August 2015
Normative References(Required to achieve compliance to this standard)ISO 13408-2:2018, ISO 14644-3:2019, ISO 14644-1:1999, ISO 17665-1, BS EN ISO 14644-3:2019, ISO 14644-7, ISO 14160, ISO 11137-2, ISO 11135-1, ISO 14644-4, ISO 13408-3, ISO 14644-2, ISO 13485, ICH Guidance for Industry - Q9 Quality Risk Management, ISO 14698-1, ISO 20857, ISO 9001, ISO 13408-6, ISO 14937, ISO 14971, ISO 14644-5, ISO 14698-2, ISO 14644-1, ISO 13408-4, ISO 11137-1, ISO 13408-5
Informative References(Provided for Information)ISO 11137-3:2017, IEC 60812, EN 1822-1, ISO 9000:2005, 90/385/EEC, ISO 13408, ANSI/AAMI ST67:2003, ISO 13485:2003, 98/79/EC, ISO 9004, ISO/TS 11139, 93/42/EEC, EN 556-2, ISO/TR 14969, ISO 15223
Replaced ByBS EN ISO 13408-1:2015
ReplacesBS EN 13824:2004
International RelationshipsISO 13408-1:2008/Amd 1:2013,ISO 13408-1:2008,EN ISO 13408-1:2011/A1:2013
Amended ByAmendment, June 2013
Draft Superseded By11/30250157 DC
DescriptorsSterile equipment, Medical equipment, Environmental cleanliness, Cleaning, Production, Quality assurance systems, Verification, Sterilization (hygiene), Quality control, Personnel, Quality management, Environment (working), Clean rooms, Performance testing
ICS11.080.01
Title in FrenchTraitement aseptique des produits de santé. Exigences générales
Title in GermanAseptische Herstellung von Produkten für die Gesundheitsfürsorge. Allgemeine Anforderungen
CommitteeCH/198
ISBN978 0 580 76083 9
PublisherBSI
FormatA4
DeliveryNo
Pages60
File Size2.05 MB
Price£254.00


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