Evaluation based on IEC60601-1 Third Edition and JIST0601-1:2012 (based on IEC60601-1 Third Edition) is possible.
The EN60601-1 Third Edition became mandatory on June 1, 2012. The JIST0601-1 Third Edition was published on June 1, 2012! Safety evaluations and testing can be conducted according to IEC60601-1:2005 Third Edition and JIST0601-1:2012 (based on IEC60601-1 Third Edition). NEMKO, as a National Certification Body (NCB) under the IECEE-CB scheme (an international mutual recognition scheme for test results), is also capable of compliance with IEC60601-1 Third Edition as a CB testing laboratory (CBTL). While the requirements for medical devices in various countries generally refer to IEC60601-1 Second Edition A1/A2, the transition to IEC60601-1 Third Edition is also progressing.
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basic information
Europe: Mandatory from June 1, 2012 Japan: Issued on June 1, 2012, with a transitional period until May 31, 2017. Mandatory from June 1, 2017 The third edition introduces significant differences from the second edition, such as the introduction of risk management evaluations. For customers struggling to comply with the third edition, Cosmos offers evaluation services for products transitioning from IEC 60601-1 second edition to third edition. Please take advantage of this service to identify issues with the IEC 60601-1 third edition in current products and ensure that new products can obtain certification without delaying their sales launch.
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For customers struggling with the transition to the 3rd edition, Cosmos also conducts product evaluation services related to the transition from IEC 60601-1 2nd edition to 3rd edition. Please take advantage of this service, which allows for certification of new products without delaying their sales timing.
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You can outsource tasks such as medical device certification, radio law certification, terminal equipment certification, electrical appliance safety law, consumer equipment EMC testing, automotive equipment EMC testing, product safety testing, overseas application agency, and domestic application agency. There are four testing facilities, including one in Matsusaka City, Mie Prefecture. If you have any questions about testing content or testing locations, please feel free to contact us.