IEC 60601-1 Criteria for Product Classification

The purchase and use of electronic devices in the field of healthcare is a different proposition compared to the purchase of electronics designed for general use. Given the sensitive nature of the hospital working environment, the need for devices that comply with safety regulations is of paramount importance. This requirement has given birth to a set of standards that is designed to address the many risks associated with the use of electronic medical equipment. IEC 60601-1 was designed specifically to increase the level of safety when it comes to the use of electronic devices in the healthcare working environment. Simply put, devices that conform closely to IEC 60601-1 regulations mitigate the possibility of risks and accidents happening over the course of the use of electronic medical devices.

Product Classification and Criteria

A big part of IEC 60601-1 addresses the area of product classification. There are a number of criteria within the IEC60601-1 standard that determines the classification of a medical device employed in healthcare working environments. Once product classification has been determined, requirements are assigned to the device to ensure that it is designed with the concept of safety in mind. How a product is classified depends on criteria that cover how a device is intended for use and how the device responds to safety concerns.

Protection against Electric Shock

One of the criteria included in IEC 60601-1 deals with protection against electric shock. This criterion addresses protection against electric shock based on two instances. Devices that are powered by an external power source are either classified as Class I or Class II. Class I devices have a reliable protective earth. This product classification refers to devices with protective enclosures that are bound to the ground pin of a three-pronged power plug. In the event of a single fault, the exposed metal parts of Class I devices will not become live. In comparison, Class II products do not have a reliable protective earth. In place of a protective metal enclosure, Class II devices have reinforced insulation to act as a safeguard against the possibility of the device going live during a fault. Typically, Class II devices have an external brick power supply that provides protective double insulation.

Protection against Electric Shock (Applied Parts)

Another criterion in IEC 60601-1 still deals with the concept of electric shock but purely focuses on the concept of applied parts. Devices with circuitry or parts that come in direct contact with patients are covered in this product classification. The requirements stipulated in the product classification that deals with applied parts are categorized as B, BF, or CF. The classification is dependent on the amount of protection that the device provides a patient in the event of an electric shock.

Ingress of Liquids

The ingress of liquids in electronic medical devices poses a clear concern for healthcare professionals. Devices that do not have the safety measures required to operate in environments that expose them to liquids like water or bodily fluids pose a clear danger to healthcare professionals and patients alike. IEC 60601-1 classifies devices that are used in working environments where they may be exposed to liquids. Product classification in IEC 60601-1 that deals with the ingress of liquids is primarily concerned with the quality of the device’s construction.

Flammable Anesthetics

Another product classification deals with the use of flammable anesthetics in hospital working environments. This product classification may not attract as much attention as the others due to the fact that flammable anesthetics aren’t used in a pervasive manner. Still, devices that are used in conjunction with flammable anesthetics may be exposed to dangers associated with high-energy circuits, restricted ventilation, static discharge, etc. Under this product classification, devices are categorized under one of three sections depending on the quality of their interaction with flammable anesthetics.

Device Installation and Usage

The way the device is installed and used is another product classification included in IEC 60601-1. This product classification is divided into 7 different categories. The categories included in this product classification are stationary equipment, fixed equipment, permanently installed equipment, transportable equipment, handheld equipment, portable equipment, and mobile equipment. Ostensibly, a lot of these terms may seem synonymous but IEC 60601-1 clearly delineates distinctive differences to distinguish one category from the other.

Mode of Operation

The mode of operation by which a device functions is another product classification covered by IEC 60601-1. Most devices are classified under continuous operation but there are four other classifications covered. Short-time operation, intermittent operation, continuous operation with short-time loading, and continuous operation with intermittent loading are the remaining four categories covered by this product classification. The four categories mentioned aren’t as pervasive as the continuous mode of operation due to the fact that they limit the range in which the device in question can be utilized.

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