27 Jul ISO Standard related with Covid19
รายชื่อมาตรฐาน ISO ที่เกี่ยวข้องกับ Covid19
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รายชื่อมาตรฐาน ISO ที่สามารถเข้าถึงได้ในรูปแบบอ่านได้อย่างเดียว (Read Format)
เพื่อสนับสนุนการป้องกันโรค COVID-19
• ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms – Part 5:
Terminology and performance requirements for micro-organisms risks
• ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process
• ISO 13688:2013, Protective clothing – General requirements
• 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 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 13485:2016, Medical devices — Quality management systems – Requirements for
regulatory purposes
• 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 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
หมายเหตุ: ผู้ที่สนใจสามารถเข้าถึงเอกสารดังกล่าวข้างต้นได้ที่เว็บไซต์ www.iso.org/covid19
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