เครื่องช่วยหายใจ

มาตรฐานเกี่ยวกับเครื่องช่วยหายใจ

  Title Standard No. หมายเหตุ
1 Standard Practice for Respiratory Protection ASTM F3387-19  
2 Medical Devices - Anesthesiology Devices  21 CFR 868  
3 Medical device software - Software life-cycle processes BS EN 62304:2006+A1:2015  
4 Particular requirements for emergency and transport ventilators BS EN 794-3:1998+A2:2009  
5 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ISO 14971:2012  
6 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests BS EN ISO 60601-1-2:2015  
7 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators BS EN ISO 60601-2-12:2020  
8 Lung ventilators and related equipment. Vocabulary and semantics BS ISO 19223:2019  
9 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Corrigendum 1 - Amendment 1 IEC 60601-1:2005/AMD1:2012/COR1:2014  
10 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-2:2014  
11 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2010  
12 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 medical electrical systems IEC 60601-1-8:2006  
13 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment IEC 62353:2014  
14 Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015  
15 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices IEC/TR 62366-2:2016  
16 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices ISO 10524-1:2018  
17 Lung ventilators for medical use - Part 1: Requirements ISO 10651-1:1993  
18 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients ISO 10651-2:2004  
19 Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators ISO 10651-3:1997  
20 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14937:2009  
21 Medical devices — Application of risk management to medical devices ISO 14971:2019  
22 Lung ventilators and related equipment — Vocabulary and semantics ISO 19223:2019  
23 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance ISO 23328-1:2003  
24 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects ISO 23328-2:2002  
25 Medical electrical equipment – Part 1: General requirements for safety ISO 601-1:1975  
26 Medical electrical equipment – Part 1: General requirements for safety – Electromagnetic compatibility – Requirements and tests  ISO 601-1-2:1993  
27 Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators ISO 80601-2-12:2020  
28 Medical electrical equipment — Part 2-84: Particular requirements for basic safety and essential performance of ventilators for the emergency medical services environment ISO 80601-2-84:2018  
29 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
ISO 8185:2007 wd