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Biomedical Engineering: STANDARDS

This guide provides a set of resources, available through the CCNY's Library for beginning biomedical engineering research. This list is not exhaustive or comprehensive. Visit our home page for additional resources.


In the United States, responsibility for setting product and process standards rests almost exclusively with the private sector. Government agencies rely heavily on voluntary standards, which they often incorporate into regulatory and procurement requirements. The International Organization for Standardization (ISO) Guide 2: 2004 defines a standard as a "document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities of their results, aimed at the achievement of the optimum degree of order in a given context."  Standards can serve many purposes, including: fitness for purpose, compatibility, interchangeability, variety control, safety, protection of the environment, and product protection against climatic or other adverse conditions.

ASTM 13.02: Medical and Surgical Materials and Devices; Anesthetic and Respiratory Equipment CALL NUMBER:  SCI/ REF TA401.A653. 2005  


Standards.Gov offers background materials and useful links for locating information about the use of standards in government.

Standards.Gov supports the requirements ofThe National Technology Transfer and Advancement Act (NTTAA), which directs Federal agencies with respect to their use of private sector standards and conformity assessment practices. The objective is for Federal agencies to adopt private sector standards, wherever possible, in lieu of creating proprietary, non-consensus standards. The Act directs the National Institute of Standards and Technology (NIST) to bring together Federal agencies, as well as State and local governments, to achieve greater reliance on voluntary standards and decreased dependence on in-house standards.

Progress toward accomplishing NTTAA aims is summarized in annual reports prepared by NIST, in collaboration with the Interagency Committee on Standards Policy (ICSP).

NTTAA Annual Reports

IEEE Standards