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IEC TR 80002-1:2009

Current
Current

The latest, up-to-date edition.

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

09-23-2009

FOREWORD
INTRODUCTION
1 General
  1.1 Scope
  1.2 Normative references
2 Terms and definitions
3 General requirements for RISK MANAGEMENT
  3.1 RISK MANAGEMENT PROCESS
  3.2 Management responsibilities
  3.3 Qualification of personnel
  3.4 RISK MANAGEMENT plan
  3.5 RISK MANAGEMENT FILE
4 RISK ANALYSIS
  4.1 RISK ANALYSIS PROCESS
  4.2 INTENDED USE and identification of characteristics
      related to the SAFETY of the MEDICAL DEVICE
  4.3 Identification of HAZARDS
  4.4 Estimation of the RISK(S) for each HAZARDOUS
      SITUATION
5 RISK EVALUATION
6 RISK CONTROL
  6.1 RISK reduction
  6.2 RISK CONTROL option analysis
  6.3 Implementation of RISK CONTROL measure(s)
  6.4 RESIDUAL RISK EVALUATION
  6.5 RISK/benefit analysis
  6.6 RISKS arising from RISK CONTROL measures
  6.7 Completeness of RISK CONTROL
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and POST-PRODUCTION information
Annex A (informative) - Discussion of definitions
Annex B (informative) - Examples of software causes
Annex C (informative) - Potential software-related pitfalls
Annex D (informative) - Life-cycle/risk management grid
Annex E (informative) - SAFETY cases
Bibliography
Index
Index of defined terms

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.

DevelopmentNote
Stability Date: 2019. (09/2017)
DocumentType
Technical Report
Pages
64
PublisherName
International Electrotechnical Committee
Status
Current

Standards Relationship
NEN NPR IEC/TR 80002-1 : 2009 Identical
PD IEC/TR 80002-1:2009 Identical
AAMI/IEC TIR80002-1:2009 Identical

I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
AAMI SW87 : 2012 APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS
15/30328959 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
16/30346073 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
AAMI TIR38 : 2015 MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE
ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
AAMI/ISO TIR 80002-2:2017 MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS
ISO 16142-1:2016 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
ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
NEMA CPSP 1 : 2015 SUPPLY CHAIN BEST PRACTICES
14/30290166 DC : 0 BS ISO 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
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
PD ISO/TR 80002-2:2017 Medical device software Validation of software for medical device quality systems
BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
AAMI TIR45 : 2012 GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview

IEC 61025:2006 Fault tree analysis (FTA)
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 14971:2007 Medical devices Application of risk management to medical devices

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