Inspections, Compliance, Enforcement, and Criminal Investigations
GUIDE TO INSPECTIONS OF ELECTROMAGNETIC
COMPATIBILITY ASPECTS OF MEDICAL DEVICE
They are not ideal, but when used, they certainly increase product safety. Appendix B lists examples of available standards.
CDRH encourages manufacturers of electromedical equipment to use the IEC 60601-1-2 standard, a widely recognized standard issued by the International Electrotechnical Commission, Geneva, Switzerland. [NOTE: IEC recently renumbered the standards, adding 60000 to all previous numbers, so investigators may know it as IEC 601-1-2.] It is a collateral standard to IEC 60601-1, which is a horizontal (product family) standard intended to apply across many medical disciplines. Other standards such as MIL-STDs or some industry standards may be appropriate as well. It is the manufacturer's responsibility to determine the most appropriate specifications and requirements for their devices. If conformance claims have been made in a PMA or the labeling, however, the GMP documents should contain documented evidence consistent with and supporting those claims.
The IEC 60601 series currently includes a general safety standard, four collateral standards (systems, EMC, diagnostic x-ray protection, and programmable electrical medical systems), and over 40 particular, or product specific standards that adapt the general and collateral standards. Related international standards contain details of the IEC 60601-1-2 requirements and test methods (e.g., International Special Committee on Radio Interference (CISPR) standards CISPR 11 and CISPR 16, and IEC 61000-4-x which supersedes the obsolete IEC 801-x series). FDA investigators may be aware of IEC 801-2, since many firms have used it to determine requirements for controlling ESD during manufacturing.
These standards are subject to frequent revisions and many documents have to be reviewed simultaneously to determine the current requirements. Hence, manufacturers of the same device, claiming to meet the same standard, may have differing specifications. Firms may claim partial or complete conformance to IEC 60601-1-2 or may have alternate test methods or parameters. Partial conformance may be adequate if the firm substantiates and/or justifies the deviations.
The IEC 60601-1-2 standard provides various limits on emissions and immunity. While these limits are clear, the pass/fail criteria are not. Therefore, CDRH encourages manufacturers to clearly specify all deviations from the standard, their specific pass/fail criteria, and justifications as part of their GMP documentation.
(NOTE that IEC 60601-1-2 is not applicable to in vitro diagnostic devices or sterilizers but may be used.)
FDA investigators should assess a firm's EMC activities while conducting an overall inspection of their Quality System/Good Manufacturing Practices (QS/GMP). This guidance is not intended for separate inspections.
Manufacturers of electrical products may have included EMC requirements in parts of the QS/GMP process when:
- FDA required safety and effectiveness data on emissions and immunity in a premarket approval application (PMA),
- FDA requested information in the premarket notification (510(k)) submissions due to a history of interference issues or recent significant EMI concerns, or
- a firm has voluntarily, or based on complaints, begun to address some EMC issues.
EMC generally needs to be designed into the product. Therefore, the following questions regarding EMC are included in the Design Control Inspectional Strategy (DCIS), dated March 1997:
"820.30(c) Design input"
For an electrically powered device, where electromagnetic compatibility (EMC) should have been considered in the design, determine the following:
- How has EMC been addressed with regard to the device use environment? For