Page 190 - Safety Risk Management for Medical Devices

Risk Controls 169

• Standard of care is to take the product out of sterile pack with sterile gloves in
the sterile field, in the OR
• Current leakage in the applied part is limited to 10 µA per IEC 60601-1

The Risk Control narratives in the Risk Assessment and Control Table (RACT)
must be traced to their implementation means, and to verifications of implementation
and effectiveness.

18.6 RISK CONTROLS AND SAFETY REQUIREMENTS

It is best to link Risk Controls to product requirements. This takes advantage of the
formality with which requirements are tracked, change-controlled, traced, and veri-
fied. This formality also assures that Risk Controls will be implemented and that if
any change to a requirement is contemplated, the impact of that change on the Risk
Control will be evaluated.
When a requirement is linked to a Risk Control, it becomes a safety requirement.It is
a good practice to tag safety requirements for ease of discernment by other parts of the
product development team such as: R&D, Quality, Test Engineering, and Regulatory.
The connection between safety requirements and risk management is maintained
via traceability. Fig. 25.1 depicts the connections between safety requirements and
Risk Controls.

18.7 COMPLETENESS OF RISK CONTROLS

ISO 14971 [3,7] requires that the manufacturer ensure that the risks from all identified
Hazardous Situations are considered and that the results of this activity are recorded in
the Risk Management File. To meet this requirement, it is important that the risk
analysis process is faithfully followed. This would ensure that all the relevant Hazards
and Hazardous Situations are identified. Recording all the relevant Hazards and
Hazardous Situations in the RACT, and logging their respective Risk Controls, residual
risks, and relevant Harms would demonstrate compliance with this requirement of
ISO 14971 [3,7].