Article | REF: TE7504 V2

International Regulation and Standardisation in bodies of e-Health equipments

Author: Daniel BATTU

Publication date: February 10, 2020

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3. Health-related international standards bodies

3.1 World Standards Organization (ISO)

ISO, founded in 1947, coordinates a worldwide network of national standards institutes in 165 countries. Its standards are voluntary. In 2019, ISO is collaborating with more than 700 international, national and regional organizations, including AFNOR in France, ANSI (American National Standards Institute) in the United States, and others. The 22,800 International Standards currently published by ISO are based on a double level of consensus, between stakeholders and between countries. ISO has no certification body.

Standardization in the field of healthcare information and communication technologies (ICT) aims to promote interoperability between independent systems, to ensure the compatibility and consistency of healthcare...

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