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4.2.2


Risk Management Result Form: Risk Management Process for Medical Electrical Equipment or Medical Electrical System

YY/T 0316


article


Risk Management Document References (Document and Paragraph Numbers) - The main heading of the article


Results - Remarks


(What kind of objective evidence needs to be reflected in the cited documents)


conclusion


General program


Special medical equipment

3.1


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 5


Risk management process (except production and post-production information)

3.2


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 4.2


Adequate resources

3.2


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 3


Assign qualified personnel

3.2


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 1.3


Determine risk acceptance guidelines

3.3


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 3


Personnel qualifications

3.4a


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 4.1


Risk management scope

3.4b


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 3


Assignment of responsibilities and authority

3.4c


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter I, Section 4.3


Review requirements for risk management activities

3.4d


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 1.3


Risk Acceptance Criteria

3.4e


Risk Management Report: Document No. QC/7.1-02A/0& Chapter III


Verify the activity

3.5


Risk Management Report: Document No. QC/7.1-02A/0


Risk management documentation

4.1


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 2


Risk analysis process

4.2


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 2.2


Identification of intended use and safety-related features

4.3


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 2.2


Identification of hazards (sources).

4.4


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter III, Section 1.1


Estimate the risk of each hazardous situation

5


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter III, Section 1.1


Risk assessment

6.2


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter III, Section 1.1


Risk control scheme analysis

6.3


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter II, Section 1.2


Implementation of risk control measures

6.4


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter IV


Residual risk assessment

6.5


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter V


Risk/benefit analysis

6.6a


The introduction of a new hazard (source) or hazardous situation

6.6b


Whether the risk estimated by the previously identified hazardous situation has been affected by the introduction of risk control measures

6.7


Risk Management Report: Document No. QC/7.1-02A/0& Chapter VII


Integrity of risk controls

7


Risk Management Report: Document No. QC/7.1-02A/0 & Chapter VII, Section 3


Acceptability assessment of comprehensive residual risk

8


Risk Management Report: Document No. QC/7.1-02A/0


Risk management reporting


Additional Information: Risk document references should be based on relevant policy/procedure documents and include specific output files.