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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Page 18

 

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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC

COMPATIBILITY ASPECTS OF MEDICAL DEVICE

QUALITY SYSTEMS

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21 CFR 820.30(f) Design Verification

 

1. Summarize high (general) and low level (details) documents used in regard to EMC.

 

2. If verification activities for EMC were performed on non-production devices, then how were the tested devices shown to be equivalent to production devices?

 

3. No comment.

 

4. Describe verification methods and activities used to confirm that input requirements for EMC have been fulfilled by design output. What sections of IEC 60601-1-2 (or other EMC standard) were applied in certifying conformance?

 

5. Address EMC, if it is an issue with user interface.

 

6. Describe how verification that EMC output meets EMC input is decided and achieved.

 

7. If IEC 60601-1-2 is part of the design input, who certified conformance to this standard? If additional EMC requirements over and above those in IEC 60601-1-2 were identified in the design input, who tested the design output for conformance to these requirements?

 

21 CFR 820.30(g) Design Validation

 

1. Summarize at least one written device design validation procedure relating to EMC.

 

2. Summarize at least one validation activity relating to EMC, if any, performed on devices that were produced using the same methods and procedures as those to be used in routine production.

 

3. If validation activities for EMC were performed on non-production devices, then how were the tested devices shown to be equivalent to production devices? If validation on non-production devices was for purposes other than EMC, state this and summarize at least one.

 

4. What evaluations relating to EMC (clinical and other activities) were performed to assist in validating that the device design meets defined user needs and intended uses?

 

5. Describe the actual or simulated use conditions under which the finished device was tested for EMC.

 

6. If discrepancies relating to EMC were identified during validation activities, how were they resolved?

 

7. Did software validation address EMI?

 

8. If risks related to EMC or EMI were identified and analyzed, provide examples.

 

9. No comment.

 

21 CFR 820.30(h) Design Transfer

 

1. No comment.

 

2. Review the transfer process(es) for an EMC design feature to confirm that procedures for design transfer were followed.

 

21 CFR 820.30(i) Design Changes

 

1. For devices in production, when are design changes considered

 

?

2. For devices in production, what criteria are used to determine that an EMI complaint or service report is sufficient to warrant a design change?

 

3. When a design change is made for a device in production, what is the criteria for a complete EMC laboratory verification test? What is the criteria for a partial EMC test based on a previous type-testing and how is its adequacy determined? How is the firm assured that the design changes do not introduce new EMI or electrical safety problems?

 

4.-5. No comment.

 

21 CFR 820.30(j) Design History File No comment.

 

OTHER GMP AREAS

 

Complaint Files: Is there evidence to suggest intermittent or spurious device malfunctions, faults, or failures? Request copies of the suspect reports and the firm's investigations of each.

 

Use Environment: Are the devices used in environments where other electronic instruments might exist? These other instruments can be medical devices, the same or totally different devices, machines incorporating high voltage power supplies, computer equipment,

 

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