REGULATORY OUTLOOK
New Deviations
The additional deviations that will likely be published early next year include the following:
Return to story : A New U.S. National Standard for Medical Devices
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• Clause 6: NFPA 70 includes a classification for x-ray systems as long-time operation (>5 minutes) or momentary operation (<5 seconds). Clause 7 will likely be modified to require that the appropriate rating be disclosed.
• Clause 7: Unfortunately, NFPA 99 has long specified different colors for indicating the types of medical gases (different from those specified for indication of gases, and specifically gas cylinders, in ISO standards). Although the 60601-1 standard does not specify the colors used to indicate gases, the committee may decide to specify that the NFPA colors be used in the United States.
• Clause 8.6: Requirements for protective earthing of enclosures of some types of x-ray equipment will be added to comply with NFPA 99.
• Clause 8.7.3: The Electrical Safety Committee had intended to request modifications to NFPA 99 that would harmonize its requirements for leakage currents with the IEC standard. Unfortunately, miscommunication between the committee and NFPA resulted in missing the three-year cycle for revisions in NFPA 99, meaning these changes may not be introduced until 2008.
• Clause 8.11: NFPA 99 includes several requirements related to wiring of the mains connection. These include requirements to use or specify hospital-grade plugs and to attach a label to the cord or plug stating that it should be connected only to hospital-grade outlets. The NFPA also includes several requirements and deviations to those requirements for large x-ray equipment. These deviations will likely be incorporated in the amendment of ANSI/AAMI 60601-1 as well.
