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

Standard No.

ISO 80601-2-79:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 80601-2-79:2018

ISO 80601-2-79:2018 Referenced Document

• EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
• 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 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
• 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 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 17510:2015 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
• 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 23328-1:2003 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
• 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 4871:1996 Acoustics - Declaration and verification of noise emission values of machinery and equipment
• 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 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 8836:2014 Suction catheters for use in the respiratory tract
• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
• ISO 9360-1:2000 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
• ISO 9360-2:2001 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
• ISO/DIS 80601 Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

ISO 80601-2-79:2018 history

• 2018 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