Publication

PD IEC/TR 80002-1:2009

Medical device software - Guidance on the application of ISO 14971 to medical device software

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Product Details

Descriptors

Computer software

Quality management

Design

Electrical medical equipment

Medical equipment

Risk assessment

Maintenance

Safety measures

Software engineering techniques

Quality assurance systems

Life cycle

Equipment safety

Computer technology

Electrical equipment

Hazards

Life (durability)

ICS Codes

11.040.01 Medical equipment in general

35.240.80 IT applications in health care technology

Committee

CH/62/1

International relationships

Identical to:

IEC TR 80002-1:2009

ISBN

978 0 580 58674 3

Publisher

BSI