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EN 60601-1:2006

01 June 2012

EN 60601-1:2006 (the 3rd edition standard) is now the oldest version of the standard which can be used to provide a presumption of conformity with the essential requirements of the Medical Devices Directive.

EN 60601-1:2006 is significantly different to the EN 60601-1:1990 2nd edition version since the 3rd edition standard makes the manufacturer responsible for maintaining the policy that is used to determine acceptable risk.

Compliance is checked by inspection of the Risk Management File. The requirements of the 3rd edition standard are considered to be satisfied if the manufacturer has:

The 3rd edition standard requires the risk management process to be carried out in accordance with EN ISO 14971:2009. Most manufacturers are likely to operate the risk management process within an EN ISO 13485:2003 quality management system.

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