ISO 8185:2007
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems

Standard No.

ISO 8185:2007

Release Date

2007

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 8185:2007/Amd 1:2008

Latest

ISO 8185:2007/Amd 1:2008

Scope

IEC 60601-1:1988, Clause 1, applies, except as follows: Amendment (add at the end of 1.1): This International Standard includes requirements for the basic safety and essential performance of humidification systems, as defined in 3.6. This International Standard also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes. NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1. * This International Standard also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This International Standard is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance. Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, this International Standard has been prepared as a Particular Standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. Where this International Standard specifies that a Clause of IEC 60601-1 applies, it means that the Clause applies only if the requirement is relevant to the humidification system under consideration. This International Standard is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. This International Standard is not applicable to nebulizers used for the delivery of drugs to patients. In the planning and design of products within the scope of this International Standard, it is advisable to give due consideration to the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex GG. NOTE Additional aspects of environmental impact are addressed in ISO 14971.

ISO 8185:2007 Referenced Document

• IEC 60079-4:1975 Electrical apparatus for explosive gas atmospheres. Part 4 : Method of test for ignition temperature
• IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests
• IEC 60601-1-6:2004 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
• IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• IEC 60601-2-19:1990 Medical electrical equipment; part 2: particular requirements for safety of baby incubators
• ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
• ISO 3744:1994 Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane
• ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
• ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 5367:2000 Breathing tubes intended for use with anaesthetic apparatus and ventilators
• ISO 7396-1:2002 Medical gas pipeline systems - Part 1: Pipelines for compressed medical gases and vacuum
• 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 8185:2007 history

• 2007 ISO 8185:2007/Amd 1:2008 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
• 2007 ISO 8185:2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
• 2001 ISO 8185:1997/Cor 1:2001 Humidifiers for medical use - General requirements for humidification systems; Technical Corrigendum 1
• 1997 ISO 8185:1997 Humidifiers for medical use - General requirements for humidification systems
• 1988 ISO 8185:1988 Humidifiers for medical use; safety requirements