DD CEN/TS 15260:2006 - Health informatics. Classification of safety risks from health informatics products

DD CEN/TS 15260:2006

Health informatics. Classification of safety risks from health informatics products

Status : Current   Published : July 2006

Format
PDF

Format
HARDCOPY



This Technical Specification is concerned with the safety of patients and gives guidance on the analysis and categorisation of hazards and risks to patients from health informatics products, to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient. This Technical Specification applies to any health informatics product whether or not it is placed on the market and whether or not it is for sale or free of charge. Examples of the application of the classification scheme are given. This Technical Specification does not apply to any software which is encompassed within EU Medical Devices Directives [7] [8] [9].




Standard NumberDD CEN/TS 15260:2006
TitleHealth informatics. Classification of safety risks from health informatics products
StatusCurrent
Publication Date31 July 2006
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)IEC 61508-1, IEC 61508-2, IEC 61508-3, IEC 61508-4, IEC 61508-5, IEC 61508-6, IEC 61508-7, ISO/IEC 17799, AS/NZS 4360:1999, ISO/IEC Guide 73, IEC 60601-1-4, EN ISO 14971, ISO 14971:2000, ISO/IEC Guide 51, 90/385/EEC, 93/42/EEC, 98/79/EC
International RelationshipsCEN/TS 15260:2006
DescriptorsMedical sciences, Health services, Computer software, Classification systems, Safety measures, Hazards, Risk assessment, Patients, Data processing, Data processing equipment
ICS35.240.80
Title in FrenchInformatique de sante. Classification des risques de surete des produits d'information de sante
CommitteeIST/35
ISBN0 580 48892 6
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size474.8 KB
Price£214.00


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