ISO/IEC Guide 63:2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
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1 Scope
2 Terms and definitions
3 Principles for preparing medical device safety standards
3.1 General considerations
3.2 Scope of safety standards
3.3 Types of standards
3.3.1 Product standards
3.3.2 Process standards
3.3.3 Installation and environmental standards
3.3.4 In-process standards
3.4 Taking a practical view of safety
3.5 Managing risks
3.6 Risk acceptability criteria
3.7 Risk control methods/methodology
3.8 Coordination of medical device safety standards
3.9 Regulatory implications
4 Risk-based framework for developing a medical device safety standard
4.1 General
4.2 Management of the risk-based framework
4.3 Application and characteristics
4.4 Identification of hazards and hazardous situations
4.5 Types of hazards and hazardous situations
4.5.1 General
4.5.2 Medical device-related hazards and hazardous situations
4.5.3 Patient-related hazards and hazardous situations
4.5.4 Use-related hazards and hazardous situations
4.5.5 Occupational exposure to hazards and hazardous situations
4.6 Systematic or random nature of risks
4.6.1 General
4.6.2 Risks arising from systematic events
4.6.3 Risks arising from random events
4.7 Risk estimation
4.7.1 General
4.7.2 Components of risk
4.7.3 Quantitative versus qualitative
4.8 Risk acceptability criteria
4.8.1 General
4.8.2 Establishing criteria
4.8.3 Generally accepted state of the art
4.8.4 Stakeholder concerns
4.8.5 Societal expectations
4.9 Risk evaluation
4.10 Risks to be controlled by the standard
4.10.1 General
4.10.2 Hierarchical approach to risk control
4.10.3 Residual risks
4.10.3.1 General
4.10.3.2 Verification of effectiveness
4.10.3.3 Validation that user needs are met
4.10.3.4 Impact of introduced risk control measures
4.11 Conclusion
5 Facilitating the implementation of ISO 14971 through product or process standards
5.1 Product standards
5.2 Process standards
5.3 Overview of the application of medical device safety standards in an ISO 14971 framework
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1 Scope
2 Terms and definitions
3 Principles for preparing medical device safety standards
3.1 General considerations
3.2 Scope of safety standards
3.3 Types of standards
3.3.1 Product standards
3.3.2 Process standards
3.3.3 Installation and environmental standards
3.3.4 In-process standards
3.4 Taking a practical view of safety
3.5 Managing risks
3.6 Risk acceptability criteria
3.7 Risk control methods/methodology
3.8 Coordination of medical device safety standards
3.9 Regulatory implications
4 Risk-based framework for developing a medical device safety standard
4.1 General
4.2 Management of the risk-based framework
4.3 Application and characteristics
4.4 Identification of hazards and hazardous situations
4.5 Types of hazards and hazardous situations
4.5.1 General
4.5.2 Medical device-related hazards and hazardous situations
4.5.3 Patient-related hazards and hazardous situations
4.5.4 Use-related hazards and hazardous situations
4.5.5 Occupational exposure to hazards and hazardous situations
4.6 Systematic or random nature of risks
4.6.1 General
4.6.2 Risks arising from systematic events
4.6.3 Risks arising from random events
4.7 Risk estimation
4.7.1 General
4.7.2 Components of risk
4.7.3 Quantitative versus qualitative
4.8 Risk acceptability criteria
4.8.1 General
4.8.2 Establishing criteria
4.8.3 Generally accepted state of the art
4.8.4 Stakeholder concerns
4.8.5 Societal expectations
4.9 Risk evaluation
4.10 Risks to be controlled by the standard
4.10.1 General
4.10.2 Hierarchical approach to risk control
4.10.3 Residual risks
4.10.3.1 General
4.10.3.2 Verification of effectiveness
4.10.3.3 Validation that user needs are met
4.10.3.4 Impact of introduced risk control measures
4.11 Conclusion
5 Facilitating the implementation of ISO 14971 through product or process standards
5.1 Product standards
5.2 Process standards
5.3 Overview of the application of medical device safety standards in an ISO 14971 framework