IEC 60601 services
Many manufacturers have questions about the impact of the IEC 60601-1:2005 3rd edition. This revised standard houses many changes with regard to the 2nd edition. These changes can be become clear by grouping them into following subjects:
Risk assessment
The most prominent change is the risk assessment. Although risk assessment is already and integral part of Design and Development for medical device manufacturers (i.e. ISO 14971:2009 Medical devices - Application of risk management to medical devices), However now also in relation to IEC 60601-1:2006. The manufacturer must determine the essential performance of the medical device, in order to implement risk control during design and development and safeguard the essential performance of the device. Subsequently verification and validation plans need to be rolled out to provide proof of adequate control measures.
Verification of Basic Safety
In terms of electrical safety testing, changes are limited and therefore the impact on electrical requirements is small. The majority of changes with respect to basic safety are mechanical safety tests. Mechanical safety has been brought in line with other IEC standards such as IEC 60950-1(Information technology equipment - Safety - Part 1: General requirements). For example changes included to requirements such as impact test, drop test and test instability.
Currently Qserve provides services for different manufacturers how to ensure compliance to the IEC 60601-1:2006 3rd Edition. If you seek assistance on the subject IEC 60601 compliance of Medical Electrical Equipment please do not hesitate to Contact us.
Our IEC 60601 services
Regulatory Strategy
- IEC 62304 Medical device software, Software life-cycle processes
- ISO 14971 Medical Devices - Application of Risk Management to medical devices
- IEC 62366 Medical devices - Application of usability engineering to medical devices
- ISO 13485 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- Medical Devices Directives
- FDA Regulations AAMI / ANSI ES IEC 60601-1
- China SFDA GB9706.1
- Health Canada IEC 60601-1
- more
Design control
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Determine the (gap between 2nd and 3rd edition) requirements of the applicable standards for the product development process Divide the product development process in phases, ensuring design review(s) and tune input- and output requirements.
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Determine requirements for risk assessment and define verification and validation activities.
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Determine Essential Performance as an integral part of risk management.
- In house testing of IEC 60601-1 basic safety (if applicable), Electrical safety testing, Mechanical safety testing etc.
- Determine the required Design and Technical Documentation.
- Preparing of accompanying documents and marking.
Technical writing
- Risk Management Plan
- Integration of Essential performance(s) into the Risk management files
- FMEA analysis report(s)
- IEC 60601 parts of risk assesment checklists (TRF)
- Risk Management Report
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Electrical safety, Mechanical safety, Radiation safety, Usability, Software verification and validation
Quality systems
- IEC 60601-1 / IEC 62304 / ISO 14971 / IEC 62366
- Applicable Collaterals and Particulars
- Basic Safety design and testing, electrical safety, mechanical safety, radiation safety