Case scenario 1 :
Reliance on MedicalAC/DC adaptor with standard connector as means of protection against electrocution.
Problem:
Patient/operator uses standard ITE AC/DC adaptor.
ITE AC/DC adaptor does not provide medical grade protection thus no such reliance is accordable.
Possible solution:
Use of Medical AC/DC adaptor with unique connector.
Additional component providing separation of 1500Vac.
Case scenario:
Improper board design for medical device not providing sufficient clearance/creepage distances between parts.
Problem:
Requirements of IEC 60601-1(medical devices standard) Cl. 8.9 are not fulfilled, leading to fail verdict in the report.
Possible solution:
Employment of engineers with medical device design.
Following good engineering practices.
Pre-compliance testing.
Case scenario:
Improper board design not providing sufficient clearance/creepage distances between parts.
Problem:
Requirements of IEC 60601-1(medical devices standard)Cl. 8.9 are not fulfilled, leading to fail verdict in the report.
Possible solution:
Employment of engineers with medical device design.
Following good engineering practices.
Pre-compliance testing.
Case scenario:
F-type applied part not separated from SIP/SOP (I/O port) earth or any other part it must be separated from.
Problem:
Requirements of IEC 60601-1(medical devices standard)Cl. 8.5.2.1 are not fulfilled, leading to fail verdict in the report.
Possible solution:
Employment of engineers with medical device design.
Following good engineering practices.
Pre-compliance testing.
Case scenario:
Device not properly shielded or uses “noisy” cables.
Problem:
Requirements of IEC 60601-1-2(medical devices EMC standard) Cl. 7 or 8 are not fulfilled, leading to fail verdict in the report.
Possible solution:
Employment of engineers with medical device design.
Following good engineering practices.
Several tips:
Avoid HDMI ports if possible.
Graphics cards are a grate source of noise changing manufacturer can save the day.
Case scenario:
Rushed instructions to testing house regarding EMC Immunity setup.
Problem:
Setup or pass/fail criteria are not providing proper verification of essential performance during immunity testing. Such testing can be rejected by NB.
Possible solution:
Employment of engineers with medical device design.
Seek guidance from testing house.
Prepare detailed test plan and submit it for review to safety engineer
Case scenario:
Selection of approved FCC radio module with RED declaration.
Problem:
Integration inductions not properly followed. Required separation distance not taken in to account. Changed antenna. Spurious emission testing not performed.
Possible solution:
Reed the fine lines in FCC documentation preferably from FCC site.
Employment of engineers with medical device design.
Seek guidance from testing house.
Case scenario:
Device is not single fault safe. No redundant protections in relevant circuits.
Problem:
Requirements of IEC 60601-1(medical devices standard)CL. 4.7 are not fulfilled, leading to fail verdict in the report.
Possible solution:
Employment of engineers with medical device design.
Following good engineering practices.
Seek guidance from testing house.