BS ISO 18362:2016 - Manufacture of cell-based health care products. Control of microbial risks during processing

BS ISO 18362:2016

Manufacture of cell-based health care products. Control of microbial risks during processing

Status : Current, Under review   Published : January 2016

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Format
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Standard NumberBS ISO 18362:2016
TitleManufacture of cell-based health care products. Control of microbial risks during processing
StatusCurrent, Under review
Publication Date31 January 2016
Normative References(Required to achieve compliance to this standard)ISO 17665-1, ISO 14937, ISO 14644-4, ISO 13408-1:2008, ISO 14160, ISO 25424, ISO 20857, ISO 11137, ISO 13408-7:2012, ISO 14971, ISO 22442, ISO 13022:2012, ICH Q7, ISO 11135, ISO 13408-1:2008/Amd.1:2013, ICH Q9
Informative References(Provided for Information)ISO 29463-1, ISO/TS 11139, 2003/94/EC, ISO 14161:2009, ISO/TS 17665-2, FDA 21 CFR Part 1271, ISO 13485:2003, ICH Q5A(R1), ISO 9004, 2009/41/EC, ICH Q8, ISO/TR 14969, AAMI TIR 37, ISO 13408-2:2018, 2001/83/EC, ISO 11737-1:2018
International RelationshipsISO 18362:2016
Draft Superseded By14/30266295 DC
DescriptorsCells (biology), Contamination, Sterilization (hygiene), Microbiology, Human biology, Risk assessment, Sterile equipment, Health services
ICS11.080.01
Title in FrenchManufacture de produits de soins de santé fondés sur les cellules. Contrôle des risques microbiaux durant le processus
CommitteeCH/198
ISBN978 0 580 79537 4
PublisherBSI
FormatA4
DeliveryYes
Pages46
File Size1.494 MB
Price£240.00


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