En 60601 or iec 60601 is the european harmonized standard to meet the medical device directive. As from 1 january 1997 all iec publications are issued with a designation in the 60000 series. Meca provides highquality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the iec 60601 1 and iec 61010 1 series of standards. The standard spells out a riskbased decision model on when the use of soup is acceptable, and defines testing requirements for soup to support a rationale on why such software should be u. It is harmonized by the european union eu and the united states us, and therefore can be used as a benchmark to comply with regulatory requirements from both.
This second edition cancels and replaces the first edition published in 1990, amendment 1 1992 and amendment 2 1995. Tag iec 610101 software in medical devices, by md101. Ul 610101 ul standard for safety electrical equipment. Commission iec, iec 610101 is an international standard that. General requirements by bureau of indian standards. And invitro diagnosis devices ivd with electric or electronic components are in the scope of iec 61010 1. For harmonized standards, check the eu site to confirm.
The evaluation package is a summary of the iec 606011. We are accredited to iso 17025, are a certified body testing laboratory cbtl under the iecee cb scheme and participate in the ul data. Letter symbols iec 60027 used p graphic symbols iec 610101. Electrical safety in low voltage distribution systems up to v ac and 1500 v dc equipment for testing, measuring or monitoring of protective measures, part 1.
F2 labs can assist you in testing your electrical products to the applicable iec standards. General requirements, ul 609501 second edition, dated march 27, 2007 summary of topics this is the second edition of the binational standard and is based on iec 609501, second edition. We are accredited to iso 17025, are a certified body testing laboratory cbtl under the iecee cb scheme and participate in the ul data acceptance program dap, intertek recognized. Iec 614396 en 614396 busbar distributorsbusbar distributors iects 614397 distributor for camping, market places, marinas and charging stations for electric vehicles distributoror for camping, markett iectr 614390 planning guide for lowvoltage switchgear assemblies iec 614391 en 614391. Do md and ivd that embed software, fall in the scope of iec 62304. This document is available in either paper or pdf format.
Mecamedical equipment compliance iec 606011 franklin. For example, iec 341 is now referred to as iec 600341. Iec 614396 en 614396 busbar distributorsbusbar distributors iec ts 614397 distributor for camping, market places, marinas and charging stations for electric vehicles distributoror for camping, markett iec tr 614390 planning guide for lowvoltage switchgear assemblies iec 61439 1 en 61439 1. International standard iec 61010 1 has been prepared by iec technical committee 66. Iec610101am1 amendment 1 safety requirements for electrical equipment for measurement, control, and laboratory use part 1. X the product fulfils the requirements of iec 610101. This is an incomplete list of standards published by the international electrotechnical commission iec the numbers of older iec standards were converted in 1997 by adding 60000. Iec 610101 iec 6261 iec 6155712 iec 6205211 iec 6205311 iec 6205322 iec 6205323 iec 6205324 iec 625862 ieee 519 ul 610101 pm8000 series advanced metering functions and characteristics version. Jul 24, 20 iec61010 1, the comprehensive standard for test, measurement and laboratory equipment, is changing. Digital isolators compliance to iec 610101 edition 3. It covers the entire lifecycle including design, development, validation. The eu date of cessation for iec 61010 1 2nd edition is in october 2012.
International standard iec 610101 has been prepared by iec technical committee 66. Apr 12, 20 the relationship between iec 60601 1 and iec 62304, on the one hand, and iec 61010 1 and iec 62304, on the other hand, is not based on the same criteria. Ul standard for safety for information technology equipment safety part 1. This part of iec 61010 specifies general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used. The iec 62304 standard calls out certain cautions on using software, particularly soup software of unknown pedigree or provenance. Ul 610101 ul standard for safety electrical equipment for. Metsepm5100 pm5100 meter, without communication, up to.
Ul 610101 safety requirements for electrical equipment. General requirements equipment included in scope this part of iec 61010 specifies general safety requirements for electrical equipment intended for professional, industrial process, and educational use, any of which may. Guide design and assembly according to iec 61439 en 61439. January 2017 safety requirements for electrical equipment for measurement, control, and laboratory use part 1.
The eu date of cessation for iec 610101 2nd edition is. Iec 61557 electrical safety in low voltage distribution systems up to 1 000 v a. Having done several assessments of the 61010 standard including the harmonized versions, there are a few things to note. Iec610101 safety requirements for electrical equipment. En 60601 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. Or download the pdf of the directive or of the official journal for free. It has the status of a group safety publication, as specified in iec guide 104. Safety requirements for electrical equipment for measurement. Equipment for testing, measuring or monitoring of protective measures iec 61558 safety of power transformers, power supplies, reactors and similar products.
Iec 610102051 part of iec 61010, this is a part 2 standard with safety reqiurements for laboratory equipment for mixing and stirring. Our breadth, established objectivity and proven history mean we are a symbol of trust, enabling us to help provide peace of mind to all. This is equipment which by electromagnetic means tests, measures, indicates or records one or more electrical or physical. The international standard iec 62304 medical device software software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. Meca provides highquality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the iec 606011 and iec 610101 series of standards. Hazards arising from software is the most important criteria to apply iec 62304, iec 60601 1 adds the notion of software complexity in its informative section.
Consolidated editions the iec is now publishing consolidated versions of its publications. Iec 62304 medical device software development life cycle. Safety of measuring, control and laboratory equipment. We can provide you with the necessary iec 606011, iec 6060112, and more testing and certifications to. List of international electrotechnical commission standards.
Safety requirements for electrical equipment for measurement, control, and laboratory use part 1. Iec standards often have multiple subpart documents. The iec is the worlds leading organization for the preparation and publication of international standards for all electrical, electronic and related technologies. Or download the pdf of the directive or of the official journal for free this website uses cookies to ensure you get the best experience on our website.
Pm5100 meter, without communication, up to 15th h, 1do 33 alarms. Ul standard for safety electrical equipment for measurement, control, and laboratory use. All bsi british standards available online in electronic and print formats. Handheld probe assemblies are no longer covered iec 610101. Pm8000 series technical datasheet schneider electric. Safety terms of general use are defined in iec 610101. Test report iec 610101 safety requirements for electrical.
Ul 610101 safety requirements for electrical equipment for. In north america, ul has announced that the effective date for 61010 1 third edition is january 1, 2018. Iec610101, the comprehensive standard for test, measurement and laboratory equipment, is changing. Safety terms of general use are defined in iec 61010 1. Obviously, medical devices md with electric or electronic components are in the scope of iec 60601 1. Compliance with cenelec en 61010 3rd edition will be mandatory for products needing to comply with the low voltage directive for ce marking in accordance with the european union. Csa currently has not announced an effective date for 61010 1 third edition.