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BME 3300: Biomedical Engineering Design: Standards & Regulations


What Are Standards?

A standard is a document that contains technical specifications or other precise criteria to be used consistently as a rule, guideline, or definition of characteristics, to ensure that materials, products, processes, personnel or services are competent and/or fit for their intended purpose(s). - The National Institute of Standards and Technology

Types of Standards:

  • Voluntary/consensus standards are developed through cooperation of stakeholders and impose no obligations regarding use.
  • De facto standards become standards from public acceptance and market forces, rather than official approval.
  • Regulatory standards or codes are written or adopted by government agencies and are mandatory.