ISO 80601-2-55:2018
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Standard No.

ISO 80601-2-55:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Status

Be replaced 2023-12

Replace By

ISO 80601-2-55:2018/Amd 1:2023

Latest

ISO 80601-2-55:2018/Amd 1:2023

ISO 80601-2-55:2018 Referenced Document

• ASTM F1452-01 
• ASTM F2020-02 Standard Practice for Design, Construction, and Procurement of Emergency Medical Services Systems (EMSS) Ambulances
• ASTM F2761-09 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model*， 2023-12-23 Update
• EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
• IEC 60038:2009 IEC standard voltages
• IEC 60065:2014 Audio, video and similar electronic apparatus - Safety-requirements
• IEC 60068-1:2013 Environmental testing - Part 1: General and guidance
• IEC 60068-2-10:2005 Environmental testing - Part 2-10: Tests - Test J and guidance: Mould growth
• IEC 60068-2-11:1981 Basic environmental testing procedures. Part 2 : Tests. Test Ka: Salt mist
• IEC 60068-2-13:1983 Environmental testing. Part 2: Tests. Test M: Low air pressure
• IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
• IEC 60068-2-17:1994 Basic environmental testing procedures - Part 2: Tests - Test Q: Sealing
• IEC 60068-2-18:2017 Environmental testing - Part 2-18: Tests - Test R and guidance: Water
• IEC 60068-2-1:2007 Environmental testing - Part 2-1: Tests - Test A: Cold
• IEC 60068-2-20:2008 Environmental testing - Part 2: Tests - Test T: Test methods for soldeability and resistance to soldering heat of devices with leads
• IEC 60068-2-21:2006 Environmental testing - Part 2-21: Tests - Test U: Robustness of terminations and integral mounting devices
• IEC 60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B: Dry heat
• IEC 60068-2-5:2010 Environmental testing - Part 2-5: Tests - Test Sa: Simulated solar radiation at ground level and guidance for solar radiation testing
• IEC 60068-2-6:2007 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)
• IEC 60068-2-7:1983 Basic environmental testing procedures. Part 2 : Tests. Test Ga and guidance: Acceleration, steady state

ISO 80601-2-55:2018 history

• 2023 ISO 80601-2-55:2018/Amd 1:2023 Medical electrical equipment
• 2018 ISO 80601-2-55:2018 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
• 2011 ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors