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The Regulatory and Recommending Associations and Agencies in the Industry

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1. Agencies and Associations  AAMI – Association for the Advancement of Medical Instrumentation – T he primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.  ACGIH – American Conference of Government Industrial Hygienists – S cientific organization that advances occupational and environmental health, publishes Threshold Limit Values annually.  EPA – Environmental Protection Agency – Is responsible for creating standards and laws that promote the health of individuals and the environment. • FDA – Food and Drug Administration – Is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. • NIOSH – National Institute of Occupational Safety and Hea lth – Is responsible for conducting research and making recommendations for the prevention of work - related injury and illness.  OSHA – Occupational Safety and Health Administration – A ssures safe and healthful conditions for working men and women by settin g and enforcing standards and providing training, outreach, education and compliance assistance.


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