Inspections, Compliance, Enforcement, and Criminal Investigations
GUIDE TO INSPECTIONS OF ELECTROMAGNETIC
COMPATIBILITY ASPECTS OF MEDICAL DEVICE
The following questions may be used to assess the EMC aspects of a firm's quality system or GMPs. These questions are to be used as a guide during an inspection and in preparing the EIR, not as a reporting form.
The first section expands the Design Control Inspectional Strategy questions to aid the investigator in understanding how EMC might be addressed throughout the design controls. If there is no additional guidance relating to EMC, the number is followed by "No comment." The second section suggests questions for reviewing other GMP areas such as complaint handling or corrective actions where EMC may be addressed.
21 CFR 820.30(a) General No comment.
21 CFR 820.30(b) Design and Development Planning No comment.
21 CFR 820.30(c) Design Input
1. Identify sources (standards, complaints, users, etc.) for EMC design input requirements.
2. No comment.
3. How were EMC design input requirements (such as which standards or deviations, interpretations or variances from standards) identified, reviewed for adequacy, and documented?
4. Identify and describe any incomplete, ambiguous or conflicting EMC requirements and how they were resolved. What criteria were used to decide when and how EMC will be addressed in labeling instead of or in addition to product design?
5. Summarize how general input information and requirements are translated to specific EMCrequirements.
6. Summarize how the design input addresses the user interface in regard to EMC, if applicable.
7. In summarizing the methods used for any risk analysis done at the design input stage, please address EMC.
8. How has EMC been addressed with regard to the device use environment, including EMI resulting from expected EMD from other devices, EMD(emissions) affecting other devices expected to be used nearby, and EMI resulting from expected EMD from such sources as consumer electronic products?
Identify applicable standards and requirements chosen to address EMC and to which the design/device must conform. Because there is some latitude and decision-making in applying IEC 60601-1-2, identify the specific sections to which the design/device must conform, and the options chosen (e.g., immunity pass/fail criteria, modulation frequencies, test levels for patient- coupled devices).
Identify any additional EMC design input requirements for the device which are not specified in IEC 60601-1-2.
9. No comment.
21 CFR 820.30(d) Design Output
1. How does the design system identify and define the design output in regard to EMC? What EMCspecifications and performance requirements have been determined for components, sub-assemblies and the finished device?
2. Explain how design outputs are expressed in terms which allow comparison to design inputs including those for EMC.
3. How are EMC characteristics identified in the design output?
4. Provide examples of acceptance criteria for EMC-related design output.
5. No comment.
21 CFR 820.30(e) Design Review
1.-4. No comment.
5. Summarize the disposition of any EMI-related problem or action item identified during a formal design review.
6.-8. No comment.