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Risk Stethoscope
Risk Stethoscope
Issued By:王运良
Table of Contents
1. Scope
2. Definition
3. General requirements for risk management
3.1 Risk management process
3.2 Responsibilities and authority
4. Risk analysis
4.1 Intended use/ intended purpose and identification of characteristics related to
the safety of the medical devices.
4.2 Identification of hazards
4.3. Estimation of the risks 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 measures
6.4 Residual risk evaluation
6.5 Risk/benefit analysis
6.6 Risk 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
1、Scope
This risk management is carried out for Stethoscope to identify the hazards
associated with medical devices, to estimate and evaluate the associated
risks, to control these risks, and to monitor the effectiveness of controls. This
report is applicable to all stages of the life-cycle of a medical device in
accordance with ISO 14971:2012.
2、Definition
2.1 Harm: Physical injury and/or damage to health or property.
2.2 Hazard: A potential source of harm.
2.3 Hazardous situation: Circumstance in which people, property, or the
environment are exposed to on or more hazard(s).
2.4 Risk: The probable rate of occurrence of a hazard causing harm and the
degree of severity of the harm.
2.5 Post-production: Part of the life-cycle of the product after the design
has been completed and medical device has been manufactured.
2.6 Residual risk: Risk remaining after risk control measures have been taken.
2.7 Risk Analysis: The investigation of available information to identify hazards
and to estimate risks.
2.8 Risk assessment: Overall process comprising a risk analysis and a risk
evaluation.
2.9 Risk assessment: Overall process comprising a risk analysis and a risk
evaluation.
2.10 Risk estimation: Process used to assign values to the probability of
occurrence of harm and the severity of that harm.
2.11 Risk evaluation: Process of comparing the estimated risk against given risk
criteria to determine the acceptability of the risk.
2.12 Risk management: Systematic application of management policies,
procedures and practices to the tasks of analyzing, evaluating, controlling
and monitoring risk.
2.13 Safety: Freedom from unacceptable risk of harm.
2.14 Risk evaluation: Process of comparing the estimated risk against given risk
criteria to determine the acceptability of the risk.
2.15 Risk management: Systematic application of management policies,
procedures and practices to the tasks of analyzing, evaluating, controlling
and monitoring risk.
2.16 Safety: Freedom from unacceptable risk of harm.
2.17 Severity: Measure of the possible consequences of a hazard.
2.18 Verification: Confirmation, through the provision of objective evidence,
that specified requirements have been fulfilled.
4、Risk analysis
4.1 Risk analysis process
C OPERATIONAL HAZARDS
D. INFOMATION HAZARDS
D.1 LABELING Y N Hazard
D.1.1 Incomplete instructions for use V H09
D.1.2 Inadequate description of performance characteristics V H09
D.1.3 Inadequate specification of intended use V
D.1.4 Inadequate disclosure of limitations V
D.2 OPERATATING INSTRUCTIONS Y N Hazard
D.2.1 Inadequate specification of accessories to be used with the device V H10
D.2.2 Inadequate specification of pre-use checks V H11
D.2.3 Over-complicated operating instructions V
D.3 WARNINGS Y N Hazard
D.3.1 Warnings of side effects V
D.3.2 Warnings of hazards likely with re-use of single-use devices V
D.4 SPECIFICATION OF SERVICE AND MAINTENANCE Y N Hazard
D.4.1 Inadequate specification of when service and maintenance is required V H12
Conclusion:
It has been concluded through the process of risk analysis that this is a low risk device
and any risks that existed were eliminated or reduced through safety testing, proper
choice of materials, sterilization validation, and thorough instructions for use. The risk
analysis was evaluated in regarding the European Medical Device Directives (MDD),
Annex 1, Chapter 1, point 1 and 2.”
2、Risk Evaluation
Step 4. Risk Evaluation
From the estimated hazard data at step 3, we can decide if risk reduction is needed
or not.
Where the level is under 4, BAR, it can go step 9 directly. However, the possible
risk reduction can be adopted.
3、Risk Control
3.1 Risk reduction
When risk reduction is required, risk control activities shall be performed as
follows,
3.2 Option analysis (Step 5)
The risk control measures shall be used one or more of the followings in the
priority order listed.
3.2.1 Inherent safety by design
3.2.2 Protective measures in the medical devices itself or in the manufacturing
process
3.2.3 Information for safety
3.3 Implementation of risk control measures (Step 6)
The risk control measures adopted at stage5 shall be implemented and verified.
3.4 Residual risk evaluation (Step 7)
After the risk control measures are applied, the residual risk evaluation shall
be performed in accordance with the same criteria as in step 3.
3.5 Risk/benefit analysis (Step 8)
Decide if the overall residual risks posed by the medical devices are
acceptable.
3.6 Other generated hazards (Step 9)
Risk control measures taken in step 5 may have inherent hazard. If any new
hazards are introduced by any risk control measures, the associated risk(s)
shall be assessed.
6.3 Incident
Year Incidents Reported
2013 0
Total 0
Signature / Name