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.
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 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 are collateral standards?
Collateral standards (IEC 60601-1-x) are standards about board subjects which are applicable 1 - to all MEE (for example, IEC 60601-1-6 - usability) or 2 - a group of MEE which shares some characteristics as described in the collateral (for example, IEC 60601-1-8 is applicable to all MEE with contains alarms).
What is the latest version of AS 60601-1?
Edition 3.2
What is IEC standard for medical devices?
IEC 60601 is actually a series of standards for the safety and essential performance of medical electrical equipment and is a widely accepted benchmark for electronic medical devices. IEC 60601-1 is the general safety standard and there are multiple collateral and particular standards.Jul 4, 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.
Is IEC 62353 mandatory?
Short answer: no. IEC 62353 does not apply to manufacturers and cannot be referred to in medical device regulation. IEC 62354 is a guide only, a technical report, and again cannot be referred to in regulation.Apr 9, 2014
What is IEC 60601 standards?
IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission.
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.
What is the latest version of IEC 60601-1 2?
In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances - Requirements and tests”. At the end of 2020, a new version of this “EMC standard” modified by Amendment 1 and called Edition 4.1 was published.