99.60 Withdrawal effective Feb 19, 2020
CEN
CEN/TC 215 Respiratory and anaesthetic equipment
European Norm
11.040.10 Anaesthetic, respiratory and reanimation equipment
Withdrawn
ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995.
ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It 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.
ISO 8185:2007 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. It 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, ISO 8185:2007 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.
ISO 8185:2007 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.
ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 8185:2007
WITHDRAWN
EN ISO 8185:2009
99.60
Withdrawal effective
Feb 19, 2020
WITHDRAWN
EN ISO 80601-2-74:2020
