Skip to main content

Regulatory Affairs for Drugs, Biologics and Medical Devices: Medical Devices - Standards

A guide to resources and research in regulatory affairs for drugs, biologics and medical devices.

Medical Devices Standards - overview

Overview of International Medical Device Human Factors Standards/Ed Israelski PhD. Abbott Abbott Park, IL, USA

Standards Agencies - Medical Devices


Access to Standards

ASTM Standards and Engineering Digital Library (SEDL) A vast online collection of industry-leading standards and technical engineering information. The Library covers a broad range of engineering disciplines.

Annual book of ASTM standards (American Society for Testing and Materials) available in paper in Snell Reference  Call # TA401.A653.

IHS Engineering Resource Center Provides access to standards, specifications and related technical documents from military, commercial, national and international standards organizations. To view and print a complete standard:Register in IHS using an e-mail address for free document delivery of specs & standards (except ASTM)

Electronic version must be requested when available

All requests reviewed and approved by the library;  allow 2 business days for processing.

LIbrary user must view and print standard within 48 hours after approval.

For questions contact Joan Omoruyi(617-373-2806).

[More Info]

IEEE Standards This gives the citation and abstract of IEEE standards. Standards may be ordered through IHS Engineering Resource Center.

National Institute of Standards and Technology (NIST)