Research Guides: Standards and Codes: Medical

Medical Device Standards

FDA Recognized Consensus Standards
This database consists of those national and international standards recognized by the U.S. Food and Drug Administration (FDA).
Health Canada Medical Device Standards
List of national and international medical device standards recognized by Health Canada and related information.

The following organizations have made selected standards related to the pandemic available to view/download at no cost.

AAMI (Association for the Advancement of Medical Instrumentation)
Standards and guidelines related to masks, gowns and surgical drapes, gloves, ventilators, sterilization and disinfection.
ANSI (American National Standards Institute)
The ANSI portal, Freely Available ISO and IEC Standards to Help Address COVID-19 Crisis, provides access to 39 international standards.
ASHRAE
Air quality and ventilation standards.
ASTM
Standards related to masks, medical gowns, gloves, hand sanitizers, and respirators.
BSI (British Standards Instituteion)
Pandemic-related guides and standards.
CSA (Canadian Standards Association)
A collection of CSA standards and handbooks.
IEC
See ANSI.
IEEE
Standards related to medical devices, medical modelling, and personal protective equipment.
ISEA (International Safety Equipment Association)
ANSI/ISEA Z87.1-2010, American National Standard for Occupational and Educational Personal Eye and Face Protection
ISO (International Standards Organization)
See ANSI.
UL (Underwriters' Laboratories)
UL is providing view-only access to several relevant standards relating to healthcare facilities and workers, laboratory testing, manufacturers, and building materials and air ventilation for temporary housing of patients.