Medical devices regulators in most markets worldwide require that electrical medical devices comply with the international IEC 60601 family of standards for Medical Electrical Equipment and Systems, which is used to evaluate the electrical safety and effectiveness of medical electrical devices and equipment.
The national standards of most countries around the world, including the USA and Canada, are harmonized with the IEC60601 series standards, with some national differences. In North America, these standards are known as AAMI ES60601-1 (in the USA) and CAN/CSA C22.2 No 60601-1 (in Canada).
The standard’s current version is IEC 60601 3rd Edition, which, in addition to electrical safety, also contains requirements related to Electromagnetic Compatibility (EMC) and Risk Assessment.
EMC testing is required to ensure that electrical medical devices are not susceptible to electromagnetic interference from outside sources that may adversely affect the safe and effective use of the device. It also ensures that the device itself does not cause electromagnetic disturbances.
Risk assessment is a major requirement of the 3rd edition of IEC 60601-1, and is typically performed by the manufacturer and submitted to a test laboratory in the form of a Risk Management document. The document serves to provide evidence that the manufacturer has considered all potential hazards and mitigated associated risks to the highest degree possible.
The IEC 60601 standard family consists of more than 50 standards that apply to specific medical electrical equipment and systems. Some of these standards are:
- IEC 60601-1-6 Collateral Standard: Usability
- IEC 60601-1-8 Collateral Standard: Alarm Systems in Medical Electrical Equipment
- IEC 60601-1-11 Collateral Standard: Medical Electrical Equipment used in Home Care Applications
- IEC 60601-2-26 Particular Requirements for Electroencephalographs
- IEC 60601-2-52 Particular Requirements for Medical Beds
- IEC 60601-2-69 Particular Requirements for Oxygen Concentrator Equipment
Similarly, IEC 61010 standard series is commonly used around the world to evaluate equipment used in laboratories, test equipment, and industrial process control.
The national standards of most countries worldwide, including the USA and Canada, are harmonized with the IEC 61010 standard family, with some national differences. In North America, these standards for “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use” are known as UL 61010-1 (in the USA) and CAN/CSA C22.2 61010-1 (in Canada)
The standard’s current version is IEC 61010 3rd Edition, which, in addition to electrical safety, also contains requirements related to Risk Assessment.
The IEC 61010 standard family consists of more than 20 standards that apply to specific types of equipment. Some of these standards are:
- IEC 61010-2-011 Particular Requirements for Refrigerating Equipment
- IEC 61010-2-020 Particular Requirements for Laboratory Centrifuges
- IEC 61010-2-031 Particular Requirements for Hand-Held Probe Assemblies
- IEC 61010-2-040 Particular Requirements for Sterilizers and Washer-Disinfectors
- IEC 61010-2-061 Particular Requirements for Laboratory Atomic Spectrometers
- IEC 61010-2-081 Particular Requirements for Automatic Laboratory Equipment for Analysis
What should you do to ensure compliance with 60601 and 61010 standards?
It is very important that you have a full understanding of, and incorporate the requirements of the standard early during the design process. This helps you choose the appropriate components and build compliance into the product. Otherwise, you run the risk of costly design modifications later.
How can QPS Help?
To fully understand customers’ needs and help provide effective and value added support, we believe building relationships is very important. Throughout our interface with customers, we strive to foster relationships and build a reputation for dependability and trust.
Whether you are selling your medical and/or laboratory products locally or globally, steering through the maze of regulations and product compliance can be painful and time consuming. Let QPS be your partner on this journey and let our technical experts assist you in demystifying the complex regulatory requirements and help you speed the entry of your products to market.
Our technical experts average 10 plus years of hands-on experience in testing and certifying to 60601 and 61010 standards. We will work hand-in-hand with you and your team to interpret and apply the requirements, offer custom solutions to your unique needs, provide support throughout your entire product development cycle, and ultimately help you meet your deadlines.
We offer the following services for both 60601 and 61010 series of standards:
- Pre-certification testing and evaluation for the purpose of design verification
- Testing and certification for North America
- Review of your Risk Management File
- Testing and certification for Worldwide Market Access via the IECEE/CB Scheme
- Provide testing and technical reports used to support manufacturer’s Declaration of Conformity (DoC) for CE Marking
- Customized on-site and off-site training seminars
- Field Evaluation to SPE 1000 and SPE 3000
The QPS Certification Mark and Approval Labels
Regulatory Authorities Having Jurisdiction (AHJs) across the USA and Canada recognize and accept the QPS Mark and approval Label as evidence of compliance with the required North American safety standards and codes. The QPS Mark/Label demonstrates to your customers, distributors and AHJs that your equipment has been tested and certified.