IEC TR 80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities.

General Information

• Status: Published
• Publication Date: 22-Sep-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 3 - TC 62/SC 62A/JWG 3
• Current Stage: PPUB - Publication issued
• Start Date: 15-Dec-2009
• Completion Date: 23-Sep-2009

Standards Content (Sample)

IEC/TR 80002-1
Edition 1.0 2009-09
TECHNICAL
REPORT

colour
inside
Medical device software –
Part 1: Guidance on the application of ISO 14971 to medical device software



IEC/TR 80002-1:2009(E)

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IEC/TR 80002-1
Edition 1.0 2009-09
TECHNICAL
REPORT

colour
inside

Medical device software –
Part 1: Guidance on the application of ISO 14971 to medical device software


INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XB
ICS 11.040.01 ISBN 978-2-88910-779-7

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– 2 – TR 80002-1 © IEC:2009(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 General .7
1.1 Scope.7
1.2 Normative references .7
2 Terms and definitions .8
3 General requirements for RISK MANAGEMENT.8
3.1 RISK MANAGEMENT PROCESS .8
3.2 Management responsibilities .11
3.3 Qualification of personnel.13
3.4 RISK MANAGEMENT plan .14
3.5 RISK MANAGEMENT FILE .16
4 RISK ANALYSIS .17
4.1 RISK ANALYSIS PROCESS.17
4.2 INTENDED USE and identification of characteristics related to the SAFETY of the
MEDICAL DEVICE .18
4.3 Identification of HAZARDS .20
4.4 Estimation of the RISK(S) for each HAZARDOUS SITUATION .22
5 RISK EVALUATION .25
6 R
...