Standards are freely accessible to support COVID-19 responseS. Himmelstein | April 27, 2020
To help support a rapid COVID-19 response, many accredited code and standards developers are providing complimentary access to resources relevant to the design and manufacture of medical equipment, health facilities management and other supply chain issues brought to light by the pandemic.
The Canadian Standards Association (CSA Group) is offering no-fee view access to selected standards, including: CAN/CSA-Z94.4-18, Selection, use, and care of respirators; CSA Z8002:19, Operation and maintenance of health care facilities; and CSA Z317.2:19, Special requirements for heating, ventilation, and air-conditioning (HVAC) systems in health care facilities.
Documents covering medical device/equipment and 3D printing can be obtained from IEEE, such as 11073-10421-2010 — Health informatics — Personal health device communication Part 10421: Device specialization — Peak expiratory flow monitor (peak flow), and 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling.
Requirements for lung ventilators for medical use, general requirements for protective clothing and other standards are now available from ISO. Similarly, ASTM International is providing no-cost public access to standards used in the production and testing of personal protective equipment, including face masks, medical gowns and gloves, to support manufacturers and healthcare professionals.
The National Fire Protection Association (NFPA) offers standards and codes covering emergency planning, fire and life safety issues while the American National Standards Institute (ANSI) is granting access to standards supporting biological evaluation of medical devices; protective clothing used in healthcare settings; and business continuity management, security and resilience.
Standards and technical information reports from the Association for the Advancement of Medical Instrumentation (AAMI) address the production, selection and use of personal protective equipment and surgical drapes for the healthcare environment and the effective disinfection of medical devices, patient-care equipment and sterile processing environmental surfaces.
Installation requirements for plumbing and mechanical systems, personnel qualification standards for infection control risk assessment for all building systems and other documents are freely available from the International Association of Plumbing and Mechanical Officials (IAPMO).
The British Standards Institution (BSI Group) is also providing access to ventilator and medical electrical equipment standards, including a specification for ventilators to be used in U.K. hospitals during the coronavirus outbreak. This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of anesthesia and intensive care medicine professionals and medical device regulators.