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ANSI/NEMA HN 1-2019

Manufacturer Disclosure Statement for Medical Device Security

Consists of the MDS2 form and instructions for completing it. Assists professionals responsible for security-risk assessment in the management of medical device security issues. The information on the MDS2 form is not intended, and may be inappropriate, for other purposes.


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NEMA: National Electrical Manufacturers Association [NEMA]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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