This International Standard specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
ISO 27427:2013 Referenced Document
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10524-1 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices — Amendment 1*, 2014-06-01 Update
ISO 10524-3 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRs)*, 2019-01-17 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*, 2022-06-13 Update
ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*, 2017-06-01 Update
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 14971 Medical devices - Application of risk management to medical devices*, 2019-12-01 Update
ISO 15001 Anaesthetic and respiratory equipment - Compatibility with oxygen
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 23328-1 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets*, 2015-03-01 Update
ISO 5356-2 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors AMENDMENT 1
ISO 5367 Anaesthetic and respiratory equipment — Breathing sets and connectors*, 2023-07-01 Update
ISO 7396-1 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum AMENDMENT 1*, 2016-01-01 Update
ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements*, 2018-11-05 Update
ISO 9170-1 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum*, 2017-07-01 Update
ISO 27427:2013 history
2023ISO 27427:2023 Anaesthetic and respiratory equipment — Nebulizing systems and components
2013ISO 27427:2013 Anaesthetic and respiratory equipment - Nebulizing systems and components
2010ISO 27427:2010 Anaesthetic and respiratory equipment — Nebulizing systems and components
2009ISO 27427:2009 Anaesthetic and respiratory equipment - Nebulizing systems and components