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Standards

A guide to engineering standards at CSULB

Relevant Standards for PPE

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