Recognition of the increasing use of medical devices in the home environment led to the establishment in 2006 of the International Electrotechnical Commission (IEC)Technical Committee 62A(IEC62A)-International Organization for Standardization (ISO)Technical Committee 121, Subcommittee 3: Anaesthetic and Respiratory Equipment, Lung Ventilators and Related Devices, (ISO/TC121/SC3), Joint Working Group 6 (JWG6) on medical electrical equipment and medical electrical systems used in the home healthcare environment. Publication of IEC Collateral Standard 60601-1-11 on home healthcare environment followed in June 2010, 1,2 with recognition in the Official Journal of the European Union as of Jan. 18, 2011. 3 This International Standard is also used to demonstrate the presumption of conformity with the Essential Requirements in the framework of the European Medical Device Directive, the precondition to enter the European market. Subsequently, the leadership of ISO/TC121/SC3 reviewed its Work Programme to identify respiratory care devices commonly used in the home. Existing standards covering those devices were also identified (Table 1).
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