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New Standard IEC 60601-1-11 Valid for Devices in Home Healthcare Environment
Along with other applicable standards in the IEC 60601 3rd edition series, IEC 60601-1-11 (2010) outlines new mandatory requirements for the design and verification of a wide range of home use and point of care medical devices.
The IEC 60601-1-11 standard defines the Home Healthcare Environment as:
“…dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.” Although the IEC standard includes nursing homes within its definition, the US national version of the standard – ANSI/AAMI HA60601-1-11 – does not specify the nursing home environment as applicable due to nursing facilities in the US being considered professional healthcare environments. The US version also differs by placing greater emphasis on a requirement that states: “inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use.”
The European EN and Canadian CSA versions are both identical to the IEC standard 60601-1-11 (http://webstore.iec.ch/
Medical Devices covered by IEC 60601-1-11
Medical devices typically mandated to use the new standard include:
• Oxygen concentrators
• Body-worn nerve and muscle stimulators
• Sleep apnea monitors
• Battery chargers prescribed for use at home
In-vitro diagnostic devices (i.e. blood glucose meters for home use) do not apply as these devices are covered by the more lenient IEC 61010 series.
Protecting the device and the user
The new standard differs from the general IEC 60601-1 in relation to the requirements for construction and testing. For construction, the standard requires the use of a two-prong (unearthed) plug, water-resistant casings, and that parts to be applied by a patient be isolated from other parts of the device. Devices are also tested to ensure no damage from:
• Mechanical shock
• Impact from dropping
• Wider range of environmental conditions (i.e. temperature, humidity, pressure, etc.)
These requirements go beyond the general 60601-1 standard. A design review is recommended to ensure compliance across the entire range of new requirements. Simply addressing the very general risk concerns of ISO 14971, Application of risk management to medical devices, is no longer adequate to comply with the specific hardware-related aspects of IEC 60601.
IEC 60601 3rd edition series has, and still is, undergoing change with a recent amendment to the general requirements standard IEC 60601-1 which modifies and clarifies some of the existing requirements. A thorough review of any new, or existing, devices intended for the European or North American markets is highly recommended.
About SGS Medical Devices Services
SGS is one of the premiere organizations accredited for the certification of electro-medical equipment. SGS experts can help executive level management, engineering professionals, compliance executives, legal departments, and medical professionals to better understand and comply with recent changes to standards and directives on medical device safety. SGS’ Medical Services (http://www.sgs.com/
For more information about IEC 60601, please contact the SGS experts.
SGS Consumer Testing Services
Global Medical Device Technical Manager
SGS North America, Inc.
620 Old Peachtree Road, Suite 100
Suwanee GA 30024
t: +1 770-570-1824
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.