PD ISO/TS 19930:2017 - Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

PD ISO/TS 19930:2017

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

Status : Current   Published : December 2017

Format
PDF

Format
HARDCOPY






Standard NumberPD ISO/TS 19930:2017
TitleGuidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
StatusCurrent
Publication Date01 December 2017
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO 14040, ICH Q1A(R2), EN 556-1, ISO 22442-1, ISO 20857, ISO 9001, ISO 14161, ISO 9004, ISO 11137-1, ANSI/AAMI ST67, ISO 10993, ISO 22442-2, ISO 11137-2, ISO 14971, ISO 14937, ISO/IEC Guide 51, AAMI TIR17, ISO 22442-3, ISO 11607-2, ISO 11135-1, ISO 13408, ISO 14160, ISO 90003, ISO 17665-1, ISO 14001, ISO 11607-1, ISO 9000:2005 (R09) Ed 3, ISO 25424:2009 Ed 1, ISO/TS 13004:2013, ASTM F1980 - 07
International RelationshipsISO/TS 19930:2017
DescriptorsVerification, Certification (approval), Sterilization (hygiene), Disposable, Maintenance, Compatibility, Quality control, Medical equipment, Microbiological analysis, Performance, Personnel, Animal products, Sterile equipment, Liquids, Medical instruments, Microorganisms
ICS11.080.01
Title in FrenchDocument d'orientation sur les aspects d'une approche, fondée sur l'appréciation du risque, permettant d'assurer la stérilité des produits de santé à usage unique, soumis à une stérilisation terminale y compris ceux ne pouvant pas supporter un traitement
CommitteeCH/198
ISBN978 0 580 95161 9
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size796 KB
Price£182.00


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