BS EN ISO 13408-1:2015 - Aseptic processing of health care products. General requirements

BS EN ISO 13408-1:2015

Aseptic processing of health care products. General requirements

Status : Current   Published : August 2015
Conformity to regulation : Designated



ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Standard NumberBS EN ISO 13408-1:2015
TitleAseptic processing of health care products. General requirements
Publication Date31 August 2015
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)BS EN ISO 14644-3:2019, ISO 14644-1:1999, ISO 17665-1, ISO 13408-2:2018, ISO 14644-3:2019, ISO 14160, ISO 14644-7, ISO 14971, ISO 11137-1, ISO 13408-6, ISO 14937, ISO 14644-4, ISO 11135-1, ISO 13408-5, ISO 13408-4, ISO 14644-5, ISO 13485, ISO 11137-2, ISO 14644-2, ISO 20857, ISO 14698-2, ISO 13408-3, ISO 14698-1
Informative References(Provided for Information)ISO 9001, ANSI/AAMI ST67:2003, ISO 9000:2005, EN 556-2, 98/79/EC, ISO 9004, ISO 15223, ISO/TS 11139, EN 1822-1, 90/385/EEC, ISO/TR 14969, 93/42/EEC, IEC 60812, ISO 11137-3:2017
ReplacesBS EN ISO 13408-1:2011+A1:2013
International RelationshipsEN ISO 13408-1:2015,ISO 13408-1:2015
DescriptorsEnvironmental cleanliness, Sterilization (hygiene), Quality management, Verification, Performance testing, Cleaning, Quality control, Sterile equipment, Medical equipment, Clean rooms, Production, Environment (working), Personnel, Quality assurance systems
Title in FrenchTraitement aseptique des produits de santé. Exigences générales
Title in GermanAseptische Herstellung von Produkten für die Gesundheitsfürsorge. Allgemeine Anforderungen
ISBN978 0 580 90760 9
File Size2.283 MB

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