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, along with other applicable standards in the IEC 60601 3rd edition series.
2012 for EU & US FDA, 2013 for Health Canada
Since June 1, 2012, the EN 60601 3rd edition series became mandatory for most applicable devices placed on the EU market. The US FDA set the implementation of the standard from June 30, 2013, while Health Canada extended its implementation date for IEC 60601-1-11 from June 2012 to April 2013. The North American agencies require these standards only for new device submissions but the EU require all applicable devices being placed on the market to comply.
Differences in definition
The IEC 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.”
The IEC standard includes nursing homes within its definition; however, 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.
Devices covered by the new standard
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. Due to home-operators having varying levels of experience, and the uncontrolled home-environment, there is a need to safeguard the functioning and integrity of devices against unintentional or unauthorized damage or tampering.
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. It is recommended to review testing-laboratories 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.
To protect against unintentional improper use, the design and usability of the device (including any instructions and markings) assume a level of education of no more than eight years. Usability of the device is also dictated by the requirements of the collateral standard IEC 60601-1-6, with the third edition the preferred benchmark (and as of April 1, 2013, the third edition becomes mandatory in the EU).
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.