Just search on electrical connectors, scan the headlines, and you see these devices are available to do nearly everything. Some are small, or hold many connectors, work reliably after many connections and disconnections, and stay connected and disconnect easily when necessary. Some come with electronics for several functions, such as the prevention of short circuits. Plug arrangements must prevent misconnections, tolerate sterilizations, come with the right wires, be long and short, and lots more.
A few significant standards guide the designs of connectors:
ISO 13485 helps maintain the good quality and design of medical connectors (as well as other medical devices). This regulation helps ensure product safety and puts in place specific requirements for inspection, documentation, validation, and verification for medical connectors. It is considered a standard requirement for medical devices, with its guidelines slowly becoming universal.
IEC 60601 is a series of medical connector standards that require medical device companies to check the safety and risk potential that electrical connectors pose to patients and healthcare workers. To comply, companies must examine their products using an approved process and give every device a risk-management file. Manufacturers must be able to specify which connectors comply with technical requirements, and which satisfy the required performance characteristics. Furthermore, any found with an unacceptable risk level must be eliminated.
Medical equipment is further governed by IEC/UL 60601-1, which harmonizes safety requirements from North America and Europe. An important recent addition to this basic standard for medical devices is IEC/UL 60601-1-11, for protection in a Class II environment. The safety requirements in the -11 standard place additional restrictions on in-home medical equipment, such as:
- Altered ambient conditions (storable at -25ºC – 70ºC and operable at 5ºC – 40ºC at 93% relative humidity)
- Protection Class II (permitting no protective ground connection)
- Enclosure protection from water and dust must be at least IP 21 (light rain)
- Stricter shock and vibration tests (30 min random vibration test per axis)
Devices certified to Protection Class II have double insulation between the main circuit and the output voltage or metal enclosure. Even when they have electrically conductive surfaces, they are protected against contact with other live parts through the double insulation.
IEC standard 60320 describes requirements for detachable plug connections. Depending on the application, it is recommended to include a mechanism to protect against any unintentional plug removal from the equipment’s power socket.
