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11.040.01: Medical equipment in general

Items to be displayed:

Standard and/or projectStage TC
ISO/DIS 13485
Medical devices -- Quality management systems -- Requirements for regulatory purposes
40.20 ISO/TC 210
ISO 13485:2003
Medical devices -- Quality management systems -- Requirements for regulatory purposes
90.92 ISO/TC 210
ISO 13485:2003/Cor 1:2009
60.60 ISO/TC 210
ISO/TR 14969:2004
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
90.93 ISO/TC 210
ISO 14971:2007
Medical devices -- Application of risk management to medical devices
90.93 ISO/TC 210
ISO 15223-1:2012
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
60.60 ISO/TC 210
ISO 15223-2:2010
Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
60.60 ISO/TC 210
ISO 15225:2010
Medical devices -- Quality management -- Medical device nomenclature data structure
90.92 ISO/TC 210
ISO/DIS 15378
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
40.20 ISO/TC 76
ISO 15378:2011
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
90.92 ISO/TC 76
ISO/TR 16142:2006
Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
90.92 ISO/TC 210
ISO/DIS 16142-1
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
40.00 ISO/TC 210
ISO/PAS 18761:2013
Use and handling of medical devices covered by the scope of ISO/TC 84 -- Risk assessment on mucocutaneous blood exposure
60.60 ISO/TC 84
ISO/TS 19218-1:2011
Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
90.20 ISO/TC 210
ISO/TS 19218-1:2011/Amd 1:2013
60.60 ISO/TC 210
ISO/TS 19218-2:2012
Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
60.60 ISO/TC 210
ISO/TR 19244
Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and intravascular catheters
60.00 ISO/TC 84
ISO/TR 24971:2013
Medical devices -- Guidance on the application of ISO 14971
60.60 ISO/TC 210
IEC 62304:2006
Medical device software -- Software life cycle processes
90.92 ISO/TC 210
IEC/CD 62304
Medical device software -- Software life cycle processes
30.99 ISO/TC 210
IEC 62304:2006/DAmd 1
40.20 ISO/TC 210
IEC 62366:2007
Medical devices -- Application of usability engineering to medical devices
90.92 ISO/TC 210
IEC 62366:2007/Amd 1:2014
60.60 ISO/TC 210
IEC/DIS 62366-1
Medical devices -- Part 1: Application of usability engineering to medical devices
40.60 ISO/TC 210
IEC 80001-1:2010
Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities
60.60 ISO/TC 215
IEC/WD 80001-2
Application of risk management for IT-networks incorporating medical devices -- Part 2: Guidance on distributed alarm systems
20.20 ISO/TC 215
IEC/TR 80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples
60.60 ISO/TC 215
IEC/TR 80001-2-2:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-2: Guidance for the communication of medical device security needs, risks and controls
60.60 ISO/TC 215
IEC/TR 80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-3: Guidance for wireless networks
60.60 ISO/TC 215
IEC/TR 80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for Healthcare Delivery Organizations
60.60 ISO/TC 215
IEC/DTR 80001-2-5
Application of risk management for IT-networks incorporating medical devices -- Part 2-5: Application guidance -- Guidance for distributed alarm systems
30.60 ISO/TC 215
ISO/DTR 80001-2-6
Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
30.99 ISO/TC 215
IEC/DTR 80001-2-7
Application of risk management for IT-networks incorporating medical devices -- Part 2-7: Application guidance -- Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
30.60 ISO/TC 215
IEC/TR 80002-1:2009
Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 ISO/TC 210
IEC/DTR 80002-3
Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
30.60 ISO/TC 210