What are some new medical devices

IEC publishes changes to essential standards for medical devices

Protect operators and patients

Medical electrical devices, such as heart monitors, syringe pumps, and ventilators, are connected to or used in the vicinity of patients. IEC 60601-1 sets different requirements that medical devices must take into account in order to protect operators and patients from many types of hazards, including a fatal electric shock. Examples of basic electrical safety requirements are

  • a certain creepage distance,
  • protective insulation,
  • an air gap or
  • Combinations of these.

Manufacturers of medical electrical devices (ME devices) must determine the likelihood that a patient is exposed to many hazards and hazardous situations through a formal risk assessment process using the ISO 14971 standard, Medical devices - Application of risk management to medical devices establish. The IEC 60601 series of standards defines many of these hazards and hazardous situations and provides generally recognized methods for controlling the risk to operators and patients.

One of the most important changes in the change is the introduction of IEC 62368-1, Audio / video, information and communication technology equipment - Part 1: Safety requirements, which combines the security aspects of information technology, sound and video in a single standard. The IEC 62368-1 standard can be used as an alternative to IEC 60950-1 with regard to protective measures for operator protection.

In edition 3 of IEC 60601, work was carried out on harmonizing the requirements for operator protection with the requirements in IEC 60950-1. This really had advantages, as ME equipment manufacturers were allowed to use components and power supplies that were mass-produced for IT equipment, as long as they had appropriate insulation and operator protection. With the introduction of IEC 62368-1, additions to the standard were developed so that components, power supply units and the like certified according to IEC 62368-1 can be used safely and IEC 60601 offers operator protection.