GPTEK provide IEC60601-1 Tests

Great Partner Consulting Co., Ltd. GPTEK can assist you in determining what standards and collateral standards are required for testing and certifying your product in order to sell your medical device to global markets.

IEC 60601-1: 2nd or 3rd Edition

The 3rd Edition of IEC 60601-1 contains a shift in thinking from the 2nd Edition. There is more emphasis on the risk management file and process conforming to ISO 14971, as well as essential performance. As with any other standard change, failure to complete these new requirements in a timely manner could cause costly delays in getting your device to market. With the two editions of IEC 60601-1 still in use, it is often hard to determine which version should be used. F2 Labs can help.

Product such as: medical power supply, medical monitor, etc.

Safety standard:

IEC 60601-1 3rd edition Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

and IEC 60601-2 series standards

EMC standard:

IEC 60601-1-2 – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

Certain aspects of safety and performance are defined by the collateral standards numbered 60601-1-X. The revision dates for the Collaterals and Particulars standards may not be the same as that of the General Standard.

Definitions

 
• Essential performance – performance necessary to achieve freedom from unacceptable risk.  
• Risk Management – The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.  
• Usability – ensures that interactions between the operator and the medical device will occur safely and as intended.