What is the IEC 60601-1 standard?

October 23, 2020 Off By idswater

What is the IEC 60601-1 standard?

IEC 60601-1 (Edition 3.1) deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and/or operators.

Does FDA require 60601?

The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.

What is a collateral standard?

Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, e.g. Electromagnetic Compatibility (IEC 60601-1-2) or Protection for diagnostic use of X-rays (IEC 60601-1-3).

What is the latest edition of IEC 60601-1?

Edition 3.2
IEC 60601-1 (Edition 3.2) is the newest published general standard with around 1500 single specific requirements. The requirements are often recognised as State-Of-The-Art (SOTA), and are required to be met in different markets around the globe.

What is IEC testing?

IEC stands for International Electrotechnical Commission. IEC provides a standardized approach to testing and certification. IEC testing brings together the agreed upon set of rules, specifications, and terminology that allow manufacturers to have their devices tested for conformity.

How do you define essential performance?

Definition: Essential performance “Performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk.”

What is essential performance?

Essential performance are equipment specifications that, if one or more fail to be achieved during intended use, the result is the risk of patient harm.

What does IEC stand for?

the International Electrotechnical Commission
IEC stands for the International Electrotechnical Commission: An “organization that prepares and publishes international standards for all electrical, electronic and related technologies.”

WHO issues IEC?

Director General of Foreign Trade
It is issued by the DGFT (Director General of Foreign Trade). IEC is a 10-digit code which has a lifetime validity.