Avoiding last minute design changes to meet safety requirements

M. L. Marcus, B. R. Biersach

Research output: Contribution to specialist publicationArticle

Abstract

The importance of being aware of product safety certification requirements both in the US and internationally to avoid last minute design changes to meet safety requirements is discussed. When dealing with Medical Equipment for the US and Canada, FDA recognizes consensus safety standards as a means to support a declaration of conformity under the 510(k) paradigm. Many authorities in the US and Canada require a safety certification mark on certain equipment. Product safety certification agencies employ standards to examine a wide range of product types. The second edition of IEC 60601-1 contains two amendments that were published in 1991 and 1995, which are additions and corrections to the base standard. he standard also has collateral standards, numbered IEC 60601-1-x, and particular standards, numbered IEC 60601-2-xx. The standard requires two levels of protection against excessive unintentional current, defined as leakage current, passing through the patient or operator.

Original languageEnglish (US)
NoMAR.
Specialist publicationMedical Device and Diagnostic Industry
StatePublished - Dec 1 2003

All Science Journal Classification (ASJC) codes

  • Materials Science(all)
  • Mechanical Engineering

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