The new CENELEC Amendment 1 to EN60601:2006 (3rd edition) includes all elements from the IEC Amendment 1 from 2012 and additional extra material has been published.
Medical Device Manufactures will find increased detail in the new Amendment. The relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices contains valuable and insightful material. The 18-page Annex describes how Essential Requirements outlined in the Medical Device Directive (MDD) are covered by means of the clauses in the EN60601-1 Standard or by other Standards. More importantly, when Essential Requirements of the MDD are not covered, the table includes comments specifically outlining that which is not Covered or not completely covered. Where requirements are mitigated by the EN60601-Standard, the table’s “coverage” contains reference clauses helpful in the understanding and implementation of the Amendment’s intent. The list can therefore be a good tool to supplement the Device Risk Management File, ensuring that none of the Essential Requirements are inadvertently overlooked.
The EN Amendment 1 is officially called EN 60601-1:2006/A1:2013 and has the following dates associated: (dor: 2013-09-24 doa: 2013-12-24 dop: 2014-06-24 dow: 2018-12-24 – This date information can be found on http://www.cenelec.org.
For more information, please contact G&M Compliance, Inc. at 714.628.1020