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 |