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 Standard, 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.
[ISO/IEC Guide 51:1999, definition 3.3]
2.3
Hazard
Potential source of harm.
[ISO/IEC Guide 51:1999, definition 3.5]
2.4
Hazardous situation
Circumstance in which people, property, or the environment are exposed to one or more hazard(s).
[ISO/IEC Guide 51:1999, definition 3.6]
Note: See Appendix 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
Medical device intended by the manufacturer for the examination of specimens derived from the human body to provide information for diagnostic, monitoring or compatibility purposes.
Examples: Reagents, calibrators, specimen collection and storage devices, control materials and related instruments, apparatus or articles.
Note 1: Can be used alone or in combination with accessories or other medical devices.
Note 2: Adapted from ISO 18113-1:—, definition 3.29.
2.7
Life-cycle
All phases in the life of a medical device, from the initial conception to final decommissioning and disposal.
2.8
Manufacturer
Natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a medical device, assembling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party
Note 1: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer.
Note 2: For a definition of labelling, see ISO 13485:2003, definition 3.6.
2.9
Medical device
Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information for medical purposes by means of in vitro examination of specimens derived from the human body;
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
Contents
Foreword II
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
Appendix A (Informative) Rationale for Requirements
Appendix B (Informative) Overview of the Risk Management Process for Medical Devices
Appendix C (Informative) Questions that Can Be Used to Identify Medical Device Characteristics that Could Impact on Safety
Appendix D (Informative) Risk Concepts Applied to Medical Devices
Appendix E (Informative) Examples of Hazards, Foreseeable Sequences of Events and Hazardous Situations
Appendix F (Informative) Risk Management Plan
Appendix G (Informative) Information on Risk Management Techniques
Appendix H (Informative) Guidance on Risk Management for in Vitro Diagnostic Medical Devices
Appendix I (Informative) Guidance on Risk Analysis Process for Biological Hazards
Appendix J (Informative) Information for Safety and Information about Residual Risk
Bibliography
