Is IEC 60601 mandatory?
IEC 60601 series is published by the International Electrical Commission and establishes standards for the basic safety and essential performance of medical electrical equipment. It is considered mandatory for most markets, including the EU, the US, and Canada to show evidence of safety and performance.
What is the IEC 60601-1 standard?
IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment.
What is the latest version of 60601-1?
Edition 3.1
IEC 60601-1 (Edition 3.1) is the newest published general standard with around 1500 single specific requirements. The requirements are often recognized as State-Of- The-Art (SOTA), and are required to be met in different markets around the globe.
Is 60601 required by FDA?
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 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.
What is IEC standard for medical devices?
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, thermal or functional failure shall pose an unacceptable risk to patients and/or operators.
What IEC 62353?
IEC 62353: 2014 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.
What is a single fault condition?
The Single Fault Condition IEC 60601-1 defines Single Fault Condition as a condition in which a single means for reducing a risk is defective, or a single abnormal condition is present.
How do you define essential design outputs?
Design outputs are the work products or deliverables of a design stage. Examples include, diagrams, drawings, specifications and procedures. The outputs from one stage may become inputs to the next stage. The total finished design output consists of the device, its packaging and labeling, and the device master record.
What IEC 3?
IE3 – Premium Efficiency. Motors that fall witin the EI2 efficiency class have the following specifications: Output is 0.75kW to 355kW. Poles are 2, 4 and 6 and 8. Speed range is from 750 rpm to 3600 rpm.
What is the IEC 61131 3 standard protocol?
IEC 61131-3 is the international standard for programmable controller programming languages. As such, it specifies the syntax, semantics and display for the following suite of PLC programming languages: Ladder diagram (LD) Sequential Function Charts (SFC)
What are the changes in IEC 60601-1 3rd edition?
The 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, including a greater emphasis on risk management and essential performance. As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting your device to market.
Which is the collateral standard for IEC 60601-9?
For example, IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment published July 2007 is a collateral standard to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Healthineers.
When is IEC 60601 merged to Medical Device Directive 93 / 42?
IEC 60601-1 merged to medical device directive 93/42/EEC which covers all IEC standard of electromedical & electrical safety so it is clear that EC cover all Previous IEC standard to medical device directive 93/42/EEC The mandatory date for implementation of the EN European version of the standard is June 1, 2012.
Are there National deviations from the IEC standard?
National deviations of this series of standards exist which include country specific requirements; see e.g. UL or AAMI for US specifics. The European EN and Canadian CSA versions of the standard are identical to the IEC standard.