4.2.2 |
Risk Management Result Form: Risk Management Process for Medical Electrical Equipment or Medical Electrical System
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YY/T 0316
article
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Risk Management Document References (Document and Paragraph Numbers) - The main heading of the article
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Results - Remarks
(What kind of objective evidence needs to be reflected in the cited documents)
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conclusion
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General program
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Special medical equipment
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3.1 |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 5
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Risk management process (except production and post-production information)
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3.2 |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 4.2
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Adequate resources
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3.2 |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 3
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Assign qualified personnel
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3.2 |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 1.3
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Determine risk acceptance guidelines
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3.3 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 3
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Personnel qualifications
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3.4a | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 4.1
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Risk management scope
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3.4b | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 3
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Assignment of responsibilities and authority
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3.4c | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 4.3
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Review requirements for risk management activities
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3.4d | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 1.3
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Risk Acceptance Criteria
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3.4e | — |
Risk Management Report: Document No. QC/7.1-02A/0& Chapter III
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Verify the activity
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3.5 | — |
Risk Management Report: Document No. QC/7.1-02A/0
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Risk management documentation
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4.1 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 2
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Risk analysis process
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4.2 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 2.2
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Identification of intended use and safety-related features
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4.3 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 2.2
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Identification of hazards (sources).
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4.4 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter III, Section 1.1
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Estimate the risk of each hazardous situation
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5 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter III, Section 1.1
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Risk assessment
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6.2 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter III, Section 1.1
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Risk control scheme analysis
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6.3 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 1.2
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Implementation of risk control measures
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6.4 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter IV
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Residual risk assessment
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6.5 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter V
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Risk/benefit analysis
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6.6a | — | — |
The introduction of a new hazard (source) or hazardous situation
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6.6b | — | — |
Whether the risk estimated by the previously identified hazardous situation has been affected by the introduction of risk control measures
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6.7 | — |
Risk Management Report: Document No. QC/7.1-02A/0& Chapter VII
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Integrity of risk controls
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7 | — |
Risk Management Report: Document No. QC/7.1-02A/0 & Chapter VII, Section 3
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Acceptability assessment of comprehensive residual risk
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8 | — |
Risk Management Report: Document No. QC/7.1-02A/0
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Risk management reporting
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Additional Information: Risk document references should be based on relevant policy/procedure documents and include specific output files.
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沉浸式翻译