Case scenario:

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 protectionthus 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.

Examples of CoMedical-Devices-Development

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 EMCstandard) 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.

Pre-compliance testing.

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.

 

 

 

 

 

 

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