Standards

Medical devices, personal protective equipment, ventilators, masks, gowns and other medical supplies should meet manufacturing and testing standards to ensure they are safe for use. Below, you will find a select list of standards.  ASTM and IEEE standards are available for the CSULB community - search by standard number or title from here. ISO and other standards standards can be searched in Techstreet, and if a CSULB member would like access, please contact me to request purchase.

If you are NOT a member of CSULB you can check out the free resources page.

This is not an exhaustive list, and you may need to consult other resources. 

Note: Please ensure that the standards you are using are appropriate for the geographic area you are designing for, as different jurisdictions have different requirements. FDA regulationsM

MASKS:

• ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Peration by Particulates Using Latex Spheres

• ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• ASTM F1494-14 Standard Terminology Relating to Protective Clothing

HAND SANITIZERS:

• ASTM E2755-15 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults
• ASTM E1174-13 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
• ASTM E3058-16 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations

VENTILATORS:

You may also want to visit this page from the Government of Canada about the expedited review of of veNtilators during the COVID-19 crisis: 

Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order

• ISO 80601-2-12:2020 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• IEC 60601-1 Ed. 3.1 b:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance CONSOLIDATED EDITION
• IEC 60601-1-2: 2014: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC 62366-1: 2014: Medical devices – Application of usability engineering to medical devices
• IEC 60601-1-8: 2006+A1:2012: Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and...
• AAMI/IEC 62304:2006 & A1:2016 Medical device software - Software life cycle processes - Consolidated Text
• IEC 60601-1-6: 2013-Ed.3.1: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
• ISO 10993-1: 2009: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• ISO 80601-2-12:2011: Medical electrical equipment – Part 2-12 Particular requirements for the safety of lung ventilators – Critical care ventilators.
• ISO 80601-2-55:2011: Medical electrical equipment – Part 2-55 Particular requirements for the safety – Respiratory gas monitors
• ISO 80601-2-61:2011: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
• ISO 80601-2-72: 2015: Medical electrical equipment – Part 2-72 Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients.
• EN 13544-1: 2007+ A1:2009: Respiratory therapy equipment – Part 1: Nebulizing Systems and their components
• ISO 17664: 2004: Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices
• ISO 14971: 2007: Medical devices – Application of risk management to medical devices
• ISO 13485: 2016: Medical devices – Quality management systems - Requirements for regulatory purposes
• EN 1041: 2008 + A1:2013: Information supplied by the manufacturer of medical devices
• ISO 15223-1:2016: Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
• ISO 18562-1 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 1: Evaluation and Testing Within a Risk Management Process
• ISO 10651-5 First Edition 2006-02-01: Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
• ISO 80601-2-74 First Edition 2017-05: Medical Electrical Equipment - Part 2-74: Particular Requirements for Basic Safety and Essential Performance of Respiratory Humidifying Equipment

RESPIRATORS:

ASTM F3387-19 Standard Practice for Respiratory Protection

GLOVES:

• ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D3578-19 Standard Specification for Rubber Examination Gloves
• ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
• ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
• ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
• ISO 10282:2014 Single-use sterile rubber surgical gloves – Specification

GOWNS/PROTECTIVE CLOTHING:

• ISO 13688:2013 Protective clothing - General requirements

There is a flow chart in "Annex B" of this document that may be particularly useful.

• ASTM F1494-14 Standard Terminology Relating to Protective Clothing
• ASTM F2407 - 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• ASTM F1671 / F1671M - 13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
• ASTM F1868 - 17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
• ASTM D751 - 19 Standard Test Methods for Coated Fabrics
• ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• ASTM D1776/D1776M-20 Standard Practice for Conditioning and Testing Textiles
• ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
• ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• ASTM D6701-16 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers