IEC 60601-1 provides general requirements, in a series of standards, that address the basic safety and essential performance requirements of medical electrical equipment. ...
What is the IEC 60601-1 standard?
the IEC 60601-1 (Edition 3.2) Standard IEC 60601-1 (Edition 3.2) 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.
What is IEC compliance?
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.
Is IEC 60601 mandatory?
IEC 60601-1 is continually reviewed, and standards may be added or changed through amendments. It is considered mandatory for most markets, including the EU, the US, and Canada to show evidence of safety and performance.
What is the latest version of IEC 60601-1 2?
The most recent addition of IEC 60601-1-2 has been released. The IEC 60601-1-2:2020 (ed4. 1) features some new tests as well as some modifications to some existing tests.Sep 29, 2020
Does FDA require 60601?
For years the US Food and Drug Administration has mandated that medical devices comply with 60601 standards for near-patient safety, and while that's great for patients, it can be a difficult or frustrating road to navigate for medical device manufacturers.Jul 16, 2019
How long does 60601 testing take?
6-12 weeks
What are IEC standards?
The International Electrotechnical Commission (IEC) authors international standards for all electrical, electronic and related technologies. This standards collection addresses product development, performance, compatibility and related topics in order to ensure product compatibility and environmental safety.
How do I access IEC standards?
- If you go to the IEC or ISO homepages you can search for a standard and see a preview which includes the table of contents. ...
- If you work for a big company you can get your IT department to a buy a multi-user version of the standard and perhaps have it hosted on a company like IHS or similar.
What are the types of IEC?
What is the difference between IEC 60601 and IEC 62353?
Using IEC 60601-1 repeatedly can shorten the life of the medical device (Tests like the 25A PE resistance and/or 110% mains on applied parts testing). Choosing IEC 62353 will shorten the amount of testing while providing the minimum accepted electrical safety tests.
What IEC 62353?
As its full name implies, IEC 62353 Medical Electrical Equipment - recurrent test and test after repair of ME equipment, defines the requirements for electrical safety testing of medical electrical (ME) equipment and systems during routine intervals.Nov 19, 2019