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IEC 61010-1 ( 3rd Edition) EU Compliance

Discussion in 'IEC 60601 - Medical Electrical Equipment Safety' started by QAengineer13, Nov 17, 2015.

  1. QAengineer13

    QAengineer13 Member

    Aug 3, 2015
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    Like 60601-1 before it, CENELEC and IEC 61010-1: 2010 – along with CSA and UL 61010-1 Third Edition, 2012 – are moving to Third Edition. 61010-1 is the internationally harmonized safety standard for laboratory, process control, and test & measurement equipment. Products sold into the EU must comply with the 3rd edition of EN 61010-1 by October 2013.

    These are Key Changes
    Following is a summary of the most significant changes in EN 61010-1, 3rd Edition.

    Clause 5
    • Introduces the requirement for red pushbuttons and indictors
    Clause 6
    • New allowance for products with permanent supply cords
    • New test for transformers with a protective bonding screen
    • New requirements for layered PWBs, molded and potted parts, and thin-film insulation
    • With Annex K, covers the new requirements for insulation, including air clearance and creepage distances
    • Test voltages are no longer based on clearance distances, thus interpolation is no longer needed
    • Voltage tests on solid insulation are now 1 minute, up from 5 seconds
    • New standard for impulse test is now EN 61180-1 (formerly EN 60060), and requires 5 impulses instead of 3
    Clause 7
    • Requirements for sharp edges were added
    • Introduces the new requirements for moving parts, which include risk assessment requirements
    • New requirements for gaps between moving parts, and limiting forces and pressures
    • New requirement for load testing on parts supporting heavy loads
    • New requirement for support feet and castors
    Clause 8

    • Introduces risk assessment as a means of identifying the levels of energy the equipment must resist during mechanical stress testing
    • Added the IK rating as a means to identify the degree of protection required for the enclosure, referencing EN 62262
    Clause 10
    • Surface temperature limits were modified to align with EN 563
    Clause 11
    • Leakage and rupture at high pressure is checked by inspection
    • Fluids now defined as including both liquids and gases
    • Spillage test now includes aggressive substances (as for IVD equipment in EN 61010-2-101)
    Clause 12
    • Radiation requirements have been modified to include intended and unintended emission
    Clause 16
    • New requirements for reasonably foreseeable misuse and ergonomic aspects
    Clause 17 (New)
    • Added to deal with hazards and environments not covered by the standard, along with the new Annex J dealing with risk assessment
    • Requires a review of the manufacturer’s risk assessment file as part of the overall evaluation of the product

    Is there anything other than this ? please share with me your experience in implementation. Also when is the target compliance completion date for USA, Canada etc