Are Your Electromedical Products Compliant and Safe?
The IEC 60601-1 standard – which addresses many of the risks associated with electronic medical devices – has become a de facto requirement by most companies for electromedical products.
TÜV Rheinland offers medical testing for compliance with this standard. We can also issue the cTUVus mark, the T-Mark, and the Bauart mark after successful product testing against applicable standards. We can also provide test reports for your technical files for European and U.S. Food and Drug Administration (FDA) approval submissions.
Benefits at a Glance
With IEC 60601-1 compliance testing from TÜV Rheinland, you can be sure of:
- A global benchmark for electrical medical equipment
- Conformity to approved standards worldwide
- Position your products competitively worldwide with an independent third party test mark
- Reduced risk of company liability with documented safety standards
- Fast audit times and long-standing experience from a company with a global presence
- TÜV Rheinland’s exclusive, one-stop service
- Compliance with local government and legal requirements
Our IEC 60601-1 Compliance Testing Services
Delivered by knowledgeable and experienced experts, our services comprise:
- Determining compliance with the IEC 60601-1 standard and with the ISO 14971 norm for risk management and essential performance
- Labeling products
- Providing needed documents
Our services cover electromedical products.
The IEC 60601-1 standard defines electromedical products as “equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision, and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient.”
IEC 60601-1 has become the global benchmark for medical electrical equipment, and many companies view compliance with IEC 60601-1 as a de facto requirement for most markets for product registration; “CE,” “UL,” and “CSA” markings; contract tenders; defense against claims in event of problems; and so on. Clause 1.3 in the latest edition, IEC 60601-1:2005, requires compliance with all collateral standards to maintain compliance with the main standard IEC 60601-1.
Some of the risks associated with medical equipment include:
- Excessive currents result in an electrical shock to the user or patient (because of this potential hazard, safety agencies have set standards for the maximum amount of current that may leak from a non-defective product)
- Ventricle fibrillation, caused by leak currents of devices
- Burns, caused by high-frequency surgical equipment
- An increase of corporal temperature caused by an abnormal working of incubations
- An increase of respiratory via pressure caused by an abnormal working of ventilators
Some of the requirements of the standard include:
- Mechanical requirements – for example, is the equipment enclosure strong enough to endure the wear and tear of normal use?
- Markings – IEC 60601 defines a list of details that must be displayed on the product’s nameplate, including information on its electrical requirements, model number, manufacturer, and so on. In addition, IEC 60601 defines test protocols for the durability of markings to ensure that they are not erased or worn off through normal use.
- Earthing – defines how the device is attached to the earth or safety ground connection of an electrical power supply to provide safety in the event of an electrical fault.
- Electrical – the compliance standard requires that the medical system operate safely, not only under normal conditions, but also in the event of what the IEC calls a “single fault” condition. The IEC 60601 norm requires that, in the event of a single fault, no safety hazard (electrocution, fire, and so on) will occur.
Related Services from TÜV Rheinland
If you’re interested in TÜV Rheinland’s FDA 510(k) fuel cells services, you may also be interested in these services:
- CB scheme approvals
- GMP certification
- Medical product safety
- CE certification of medical devices
- International approvals
- EMC, EN ISO 13485 (and EN ISO 9001)
- Certification of QM systems for processing medical devices in risk categories up to and including C-critical
- GM mark
- IVDD directives
- Canada CMDCAS