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.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$503.38 NZD
|
|
| HardCopy |
$503.38 NZD
|
|
| Networkable PDF |
Price varies
|
CONTENTS
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
Figures
Figure 1 – Pictorial representation of the relationship of hazard, sequence of events, hazardous situation and harm – from ISO 14971:2007 Annex E
Figure 2 – FTA showing risk control measure which prevents incorrect software outputs from causing harm
Figure A.1 – Relationship between sequence of events, harm and hazard
Tables
Table 1 – Requirements for documentation to be included in the risk management file in addition to ISO 14971:2007 requirements
Table A.1 – Relationship between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
Table B.1 – Examples of causes by software function area
Table B.2 – Examples of software causes that can introduce side-effects
Table B.3 – Methods to facilitate assurance that risk control methods are likely to perform as intended
Table C.1 – Potential software-related pitfalls to avoid
Table D.1 – Life-cycle/risk management grid
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 2500:2020
Safe use of medical electrical equipment in health care -
AS/NZS 3200.1.2:2005
Medical electrical equipment - Part 1.2: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests -
AS/NZS 3200.1.8:2005
Medical electrical equipment - Part 1.8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems -
AS/NZS 3200.2.23:2001
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
CONTENTS
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
Figures
Figure 1 – Pictorial representation of the relationship of hazard, sequence of events, hazardous situation and harm – from ISO 14971:2007 Annex E
Figure 2 – FTA showing risk control measure which prevents incorrect software outputs from causing harm
Figure A.1 – Relationship between sequence of events, harm and hazard
Tables
Table 1 – Requirements for documentation to be included in the risk management file in addition to ISO 14971:2007 requirements
Table A.1 – Relationship between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
Table B.1 – Examples of causes by software function area
Table B.2 – Examples of software causes that can introduce side-effects
Table B.3 – Methods to facilitate assurance that risk control methods are likely to perform as intended
Table C.1 – Potential software-related pitfalls to avoid
Table D.1 – Life-cycle/risk management grid