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. Author manuscript; available in PMC: 2020 Feb 1.
Published in final edited form as: Hypertension. 2019 Feb;73(2):258–264. doi: 10.1161/HYPERTENSIONAHA.118.11990

Table 2:

Proposed Entry Criteria for the American Medical Association Validated Device Listing

Criteria
A validation study performed according to one of the following 85-subject protocols*:
  1. ANSI/AAMI/ISO 81060–2:2013
  2. AAMI/ISO 81060–2:2009
  3. ANSI/AAMI SP10:2002
  4. BHS Revised Protocol 1993
One of the following methods of summarizing validation data (listed in order of preference):
  1. Peer-reviewed publication.
  2. Independent third party validation testing by a qualified entity. These may include academic institutions or credible research entities with expertise in BP measurement and knowledge of validation protocols and validation study requirements.
*

The European Society of Hypertension International Protocol18 alone is not considered acceptable

Abbreviations: AAMI = Association for the Advancement of Medical Instrumentation; ANSI = American National Standards Institute; ISO = International Standards Organization; BHS = British Hypertension Society