Abstract
Over twenty years ago, an international effort to address the problems relating to visual and auditory alarm signals in operating rooms and intensive care units began.1,2,3 International Organization for Standardization (ISO) Technical Committee (TC) 121, Anaesthetic and Respiratory Equipment, Subcommittee 3, Lung Ventilators and Related Devices (ISO/TC121/ Subcommitee [SC] 3), chaired by John HedleyWhyte, MD, developed Anaesthesia and respiratory care alarm signals—Part 1: Visual alarm signals (ISO 9703-1:1992), Part 2: Auditory alarm signals (ISO 9703-2:1994), and Part 3: Guidance on application of alarms (ISO 9703-3:1998). Recognizing the need to harmonize alarm systems for all medical electrical equipment, in 1998, Hedley-Whyte and ISO/TC121/SC 3 Secretary David Osborn issued a call for experts in both the International Electrotechnical Commission Technical Committee 62A, Some Aspects of Electromedical Equipment (IEC TC/ SC62A) and ISO/TC121/SC3, and convened the ISO/TC121/SC3-IEC/TC/SC62A/Joint Working Group 2 on Medical Alarm Systems (JWG2). This joint working group held its first meeting at the British Standards Institution (BSI) in London in June of that year. The efforts of clinicians, engineers and regulatory authorities’ representatives culminated in publication of IEC 60601-1-8, Medical electrical equipment— Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, as an IEC-ISO dual logo standard in 2003.4 This standard was replaced by the second edition in 2006, which aligned it with the 2005 edition of IEC 60601-15 and made the clause numbering adhere to that specified in ISO/IEC Directives Part 2:2004.4,6 In 2010, JWG2 reconvened under the same leadership to revise IEC 60601-1-8 and further address distributed alarm systems, the electronic health record and related concerns. Early this year, ISO will publish the first edition of ISO 80601-2-12, Medical electrical equipment—Part 2-12: Particular requirements for About the Authors
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