The general requirements of 60601-1 apply to all medical electrical equipment and part 2 standards apply to specific categories of medical electrical equipment. However, there is another level in this hierarchy of standards: the collateral standards. These are applied more selectively than the general requirements, either in terms of the topic they cover or the type of equipment, but they are not as specific as the part 2 standards. In standards jargon they are referred to as semi-horizontal standards.
60601-1-1 Medical Electrical Systems. The document is discontinued as a stand-alone document and is now incorporated into the third edition.
60601-1-2:2007 Electromagnetic Compatibility (EMC). Compliance means that the equipment will neither generate unwanted electromagnetic radiation nor be unduly affected by it. Compliance with 60601-1-2 also means that the requirements of the EMC Directive are met.
60601-1-3:2008 Radiation Protection for Diagnostic X-ray Systems. The purpose of this standard is to ensure that stray radiation is kept to a minimum for the safety of patient and operator.
60601-1-4 Programmable Electrical Medical Systems (PEMS). This is a collateral standard for software. It has been discontinued as a stand-alone document and is now incorporated into the third edition.
60601-1-6:2007 Usability. Increases emphasis on ergonomics. Manufacturers must take the requirements into account during the design phase. Many adverse incidents in the past have been traced to use error; equipment should be as intuitive and easy to use as possible.
60601-1-8:2007 Medical Alarms. Gives guidance in the prioritizing and management of alarm functions in medical equipment. Alarms can be chaotic if the user does not know what is going off and whether the alarm is trivial or serious.
60601-1-9:2008 Environmentally Conscious Design. The designer should consider contamination of the air, water, and biosphere, the use of raw materials, and transport and packaging in the design of new products.
60601-1-10:2008 Physiologic Closed Loop Controllers. This is design criteria that should be considered when designing medical devices that are used to control the parameters they are measuring. For example, a device can measure the insulin level of a patient and automatically infuse insulin. Such systems have to be stable, reliable, and fault tolerant. Software must be designed methodically and validated comprehensively.
60601-1-11:2010 Home Healthcare Equipment. Puts considerable emphasis on the use of home healthcare equipment by nonspecialist users. Electrical safety is also a factor here and the equipment must be tolerant of poor wiring in the building.
Other aspects covered are the likelihood that the device will be handled roughly, the possibility of it getting wet or dirty, and the ingress of objects into the equipment. Instructions for use must be very clear.
In general, but with significant exceptions, these collateral standards are not pass-or-fail—rather they are concepts to be taken into account in the device design. In all cases the concepts or requirements may be overridden by requirements in the particular part 2 standards for specific equipment categories.
Furthermore, in nearly all cases there are other more-detailed or specific standards that cover the same topics (EMC, software, radiation protection, ergonomics and environmental design), a number of which are referenced in the collaterals. Therefore the collaterals should be read in conjunction with these additional standards.
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