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.
With IEC 60601-1 compliance testing from TÜV Rheinland, you can be sure of:
Delivered by knowledgeable and experienced experts, our services comprise:
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:
Some of the requirements of the standard include:
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It is also important to see if any other applicable directive and standards are applicable. It is necessary to show compliance to all applicable standards and directives/norms before placing the product in the market.
In general most of the active electrical medical device needs to show compliance to IEC/EN 60601 series of standard. IEC/EN 60601-1 provides the General requirements for safety. Along with IEC / EN 60601-1 standard there are many collateral standards such as IEC/EN 60601-1-1: Safety requirements for medical electrical systems, IEC/EN 60601-1-2: Electromagnetic compatibility (EMC) - Requirements and tests, IEC/EN 60601-1-4: Programmable electrical medical systems, IEC/EN 60601-1-8: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems etc... Apart from the collateral standards there are particular part 2 standards based on the type of medical device and provides the specific requirement of medical device. For example IEC/EN 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, IEC/EN 60601-2-19: Particular requirements for the safety of baby incubators etc.
The major concern in medical device compared to other products is leakage current, where the limits are more stringent than other products requirements. Also performance requirements form part of safety in medical device. Following are the various types leakage currents need to be evaluated in medical device:
Based on the type of connection to patient, patient access points are defined as the applied parts. These are classified as
Parts of medical device which are intended to be connected to the patients during defibrillation procedure must qualify as defibrillation proof applied parts. Type BF / CF Applied parts which have protection against defibrillation needs to be evaluated additionally for defibrillation protection. This can be done with the help of the defibrillation simulator according to the IEC/ EN 60601-1, IEC/EN 60601-2-27, IEC/EN 60601-2-25, IEC/EN 60601-2-51, IEC/EN 60601-2-49 and AAMI standards such as EC 13, EC 11, EC12 etc..,. Basically a high voltage which is similar to defibrillation voltage ( up to 5KV) is applied across the leads which are intended to be connected to the patient and at the same the residual voltage on the enclosure other signal ports because of defibrillation is measured. The residual voltage should not be high enough so that the operator and other personnel near patient are safe in terms of electric shock.
TUV Rheinland India has in-house capability to test and evaluate medical device which are having defibrillation applied parts according to most of IEC/EN 60601 and AAMI standards
The defibrillation test equipment Defib-5 can be configured to provide the circuits as per IEC/ EN 60601-1, IEC/EN 60601-2-27, IEC/EN 60601-2-25, IEC/EN 60601-2-49 and AAMI standard EC 13 with the following specification
Light based therapeutic or diagnostic medical device such as infant radiant warmers and infant phototherapy equipment shall be evaluated for Ultra violet (UV) and Infrared (IR) irradiation according to respective standards IEC/EN 60601-2-21 and IEC/EN 60601-2-50. During this test it is evaluated that the infant patient is not getting exposed to the dangerous UV and IR radiations.
TUV Rheinland India has specified measuring equipment, which can measure UV/IR irradiation in the range of 180nm to 2100nm
The test equipment ILT 1700 is a light measuring device with the different type of detectors. The detectors SED 623 is an IR detector and SED 240 is UV detector in the following wavelength range
If the product is targeted for global market where different countries required different approvals then it is recommended to have CB report and certificate which helps to get various country approvals. IS 13450-1 is equivalent Indian standard for IEC 60601-1.
Similarly electrical In Vitro Diagnostic Device needs to be tested according to IEC/EN 61010-1 along with particular standard IEC/EN 61010-1-101. Electro Magnetic Compatibility (EMC) needs to show compliance mainly according to IEC/EN 61326.
TÜV Rheinland’s services for ECG machines
TÜV Rheinland (India) Pvt. Ltd. offers manufacturers /Design houses to test their single or multichannel ECG as per IEC/EN/AAMI standards. TÜV Rheinland India has complete in-house test facilities for diagnostic, ambulatory or monitoring ECG system as per IEC 60601-1, IEC 60601-2-25, IEC 60601-2-47 and IEC 60601-2-27 and AAMI/ANSI EC11, EC13 standards.
Our CBTL and NABL accredited laboratories have capabilities to perform below tests for ECG machines for their international market access:
Recovery time, overload tolerance, channel crosstalk, distortion, tests with sinusoidal and impulse signals, high frequency response, low frequency response, linearity and dynamic range, record identification, patient identification sensitivity, frequency response, input impedance, pacemaker rejection, defibrillation protection for common and Differential-mode test, etc.,
Implementation of IEC/EN 60601-1 3rd edition