Meet the Connector: IEC 60601-Compliant Connectors

What are IEC 60601-compliant connectors?

IEC 60601 is a technical standard that ensures the basic safety and essential performance of electrical medical equipment and systems for use in the home healthcare environment. IEC 60601-compliant connectors adhere to a specific pin layout, meet insulation requirements, feature specific grounding measures, as well as protect against electrical hazards to patients and medical staff. IEC 60601-1 is the third edition of this standard. It is reviewed every five years and will undergo review in 2025.

As essential components that are part of the medical device, IEC 60601-1 compliant connectors regulate the interfaces that enable smooth communication between different components. Medical devices are usually connected to the general power supply network and thus pose potential danger to patients and operators. IEC 60601-1 defines clear requirements to ensure that such devices function reliably under the intended conditions of use while minimizing potential hazards.

Four core requirements apply to interconnects:

• Electrical safety and isolation (IEC 60601-1): Creepage and clearance distances, leakage current limits, touch-proof design, and IP rating
• Electromagnetic compatibility (IEC 60601-1-2): Shielding and EMI protection and EMI filters
• Mechanical requirements (IEC 60601-1 & IEC 60601-1-11 for home use devices): Durability and mating cycles, misconnection prevention, and mechanical strength
• Usability and human factors (IEC 60601-1-6 & IEC 62366): Ease of Use

Patient considerations: MOPP and MOOP

The 60601-1 standard specifies means of patient protection (MOPP) and means of operator protection (MOOP) for devices that have contact with a patient or operator. These protection ratings specify stringent creepage and clearance distances. (Clearance is the shortest distance through air between two conductive parts, such as pins. Creepage is the shortest distance between two pins along the insulating material between them.) These distances are meant to ensure that no arcing can occur between pins, causing potential harm to patients and device handlers.

The standard also specifies a maximum leakage current that flows from the probe contact to ground through the patient. The latest revision increased protections by raising the ESD protection threshold from 8 kV to 15 kV; increasing MOPP/MOOP values and re-definition of clearance and creepage requirements.

Most commercial interconnects cannot meet the strict requirements of 60601-1. Connector suppliers that offer compliant components work closely with regulatory bodies to design products that meet the highest levels of compliance for safety, performance, and reliability to prevent risks such as electrical shock, misconnection, or electromagnetic interference.

Design Notes

Standardization: The first edition of IEC 60601 was published in 2010. The current version of the standard, IEC 60601-1-11:2015, was issued in 2015 and amended in 2020. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. It is subject to review every five years and is up for review in 2025.

The most significant changes in the latest edition include:
– Correction of test method for relative humidity control at temperatures above 35 °C
– Redrafting of subclauses that altered instead of adding to the general standard or other collateral standards
– Harmonizing with the changes to the amendments to the general standard and other collateral standards

IEC 60601 has collateral (IEC 60601-1-X) and particular standards (IEC 60601-2-X) for specific device types, such as:

• IEC 60601-2-24 for infusion pumps
• IEC 60601-2-22 for laser equipment
• IEC 60601-2-37 for ultrasound diagnostic systems

By specifying products that meet 60601-1 requirements, designers can simplify the associated necessary risk analysis.

Markets, Sectors, and Applications

Medical, Test & Measurement

The 60601-1 standard applies to a wide range of medical devices. Three classifications address cardiac contact: Type B devices have no contact with a patient’s heart (hospital beds, surgical lights, infusion pumps). Type BF devices have direct patient contact but not heart contact (endoscopes, ultrasound equipment, transesophageal echocardiogram, probes). Type CF devices have direct contact with the patient’s heart (heart monitors, electrocardiogram machines)

Author: Amy Goetzman

Link: https://connectorsupplier.com/meet-the-connector-iec-60601-compliant-connectors/