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.
The Impact of the IEC 60601 Standard on the Healthcare Industry
August 6, 2015
IEC 60601-1 is the primary standard governing the design of medical devices. While not all countries have adopted IEC 60601-1 as the standard, globally it has become the de facto international benchmark for the design of electronic medical devices. [...]
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IEC 60601-1: Addressing Hazards in the Healthcare Field
August 27, 2015
The concept of using electronic devices that are designed with the concept of safety in mind is a primary concern for professionals who operate in the medical industry. In an attempt to increase the level of safety when an electronic medical device is used, a set of standards was created. The IEC 60601-1 standard is a set of documentation that was made to address the risks that are associated with the use of electronic medical equipment. It is in the manufacturer’s best interest to ensure that each device they design and release for purchase is compliant with this set of standards. Ensuring that an electronic medical device adheres to IEC 60601-1 can be an extremely complex task. There are a variety of concerns that need to be addressed before a device can be categorized as “safe” for use in medical working environments. [...]
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Why a Long Product Life Cycle Matters in Healthcare
March 16, 2021
Regular readers of this blog will know that medical computers offer healthcare facilities many benefits over consumer-grade units. Beyond the advantages of their industry-specific features, one edge that medical computers have over the alternatives is their long life cycle. A product’s life cycle refers to the “commercialization steps that each product goes through as it penetrates the market,” from research and development, through its introduction into the marketplace, market share growth, and maturity, to its decline and eventual discontinuation. [...]
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