1 Scope
This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this standard are applicable to all stages of the life-cycle of a medical device.
This standard does not apply to clinical decision making.
This standard does not specify acceptable risk levels.
This standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
2.1
accompanying document
document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the medical device, the operator or the user, particularly regarding safety
Note: Adapted from IEC 60601-1:2005, definition 3.4.
2.2
harm
physical injury or damage to the health of people, or damage to property or the environment
[GB/T 20000.4-2003, definition 3.3]
2.3
hazard
potential source of harm
[GB/T 20000.4-2003, definition 3.5]
2.4
hazardous situation
circumstance in which people, property, or the environment are exposed to one or more hazard(s)
[GB/T 20000.4-2003, definition 3.6]
Note: See Annex E for an explanation of the relationship between “hazard” and “hazardous situation”.
2.5
intended use
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer
2.6
in vitro diagnostic medical device
IVD medical device
Foreword i
Introduction iii
1 Scope
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) Rationale for requirements
Annex B (Informative) Overview of the risk management process for medical devices
Annex C (Informative) Questions that can be used to identify medical device characteristics that could impact on safety
Annex D (Informative) Risk concepts applied to medical devices
Annex E (Informative) Examples of hazards, foreseeable sequences of events and hazardous situations
Annex F (Informative) Risk management plan
Annex G (Informative) Information on risk management techniques
Annex H (Informative) Guidance on risk management for in vitro diagnostic medical devices
Annex I (Informative) Guidance on risk analysis process for biological hazards
Annex J (Informative) Information for safety and information about residual risk
Bibliography
