ISO 20789:2018
Anaesthetic and respiratory equipment - Passive humidifiers

Standard No.

ISO 20789:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 20789:2018

ISO 20789:2018 Referenced Document

• EN 13544-2:2002 Respiratory therapy equipment - Part 2: Tubing and connectors (Incorporates Amendment A1: 2009)*， 2023-12-23 Update
• IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
• IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
• ISO 10993-1:2009 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 14937:2009 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 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
• ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
• ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
• ISO 3744:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane
• ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
• ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors
• ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
• ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
• ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• ISO 80601-2-74:2017 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

ISO 20789:2018 history

• 2018 ISO 20789:2018 Anaesthetic and respiratory equipment - Passive humidifiers