Getting IEC 60601-1 3rd Edition Certification
The IEC 60601-1 Third Edition has a major clause. This is an addition to the existing regulation. Accordingly, an electronic medical device has to conform to the ISO14971 regulations, which relate to risk management. According to this regulation, a medical device manufacturer has to implement risk management during the product life cycle to ensure the product’s safety.
In order to ensure that medical devices are safe and effective for use and performs to prescribed standards in bringing about the desired therapeutic effect; the IEC 60601-1, 3rd Edition has also updated many other regulations in relation to the following:
- general requirements for medical devices;
- standards for identification, marking and providing accompanying documents; hazards (electrical, mechanical, radiation, temperature and fire, accuracy, etc.)
- hazardous situations and fault conditions.
Getting IEC 60601-1 Certification
Since Risk Management through the product lifecycle is mandatory; a medical device company has to have a Risk Management File (RMF) in order to obtain IEC 60601-1 3rd Edition certification. This is how the process goes:
– Step 1: To gain education on how to ensure compliance with the 3rd Edition
– Step 2: ISO 14971 audit, which should increase the Risk Management pass rate up to 80 percent
– Step 3: Preliminary Design Package, which includes preliminary reviews of the product and the Risk Management File, a critical document
– Step 4: Testing, the final stage to certification of IEC 60601-1 3rd Edition
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