BSB Edge

Standards on COVID-19


The COVID-19 pandemic had a huge impact on Business and communities, and organizations are facing disruptions and challenges which need to be managed and responded to with quick actions. COVID-19 is testing the preparedness for business continuity management. BSB Edge is here to help your organisation to accelerate your organization’s response to the global pandemic, COVID-19 and to maintain business continuity before, during and after such times in the future.


ISO Standards


ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risk


ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators


ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators


ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators


ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process


ISO 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes


ISO 13688:2013, Protective clothing – General requirements


ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories


ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1]


ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process


ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter


ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)


ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate


ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics


ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR


ISO 22301:2019, Security and resilience – Business continuity management systems –Requirements


ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency


ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management


ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes


ISO 31000:2018, Risk management – Guidelines


ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets


ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators


ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]


ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment


ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment


ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment


ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency


ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors


ASTM Standards


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


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 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


ASTM F1494-14 Standard Terminology Relating to Protective Clothing


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


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


ASTM F3387-19 Standard Practice for Respiratory Protection


ASTM E1104-98 Standard Specification for Clinical Thermometer Probe Covers and Sheaths



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