The work of ANSI C63 Subcommittee 6: Lab accreditation and conformity assessment and Subcommittee 8: Tests for electrical medical devices

Abstract

Subcommittee 6 of ANSI Accredited Standards Committee C63 is a technical committee which is developing documentation in the area of Laboratory Accreditation and Conformity Assessment. The Subcommittee has three working groups under its scope. It was formed to be able to respond to technical issues being created by the advancement of Mutual Recognition Agreements by the United States government as a means of lowering trade barriers. The first working group of the Subcommittee is developing checklists to be used by laboratory assessors when reviewing an EMC laboratory for conformance to "ISO/IEC Guide 25-General Requirements for Calibration and Testing Laboratories". The second working group of SC-6 has been looking at training aids for laboratory assessors. The third working group of SC-6 has been investigating proficiency testing using an "artifact". This group has been working with NVLAP and A2LA in formalizing a procedure to circulate the artifact to interested EMC laboratories for comparison purposes. Subcommittee 8 of the American National Standard Institute's Accredited Standards Committee C63 is devoted to developing standards in the area of EMC testing for electrical medical devices and has three working groups reporting to it. The first working group has developed ANSI C63.18 EMC Test Methods for hospitals. A second working group has been looking at patient connected equipment and their special situation as a recipient of electromagnetic energy. The third working group has been studying interference between cellular phones (wireless communication devices) and hearing aids.