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
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:
- Earth leakage current
- Enclosure leakage current
- Patient leakage current
- Patient auxiliary leakage current
Based on the type of connection to patient, patient access points are defined as the applied parts. These are classified as
- Type B applied part
- Type BF applied part
- Type CF applied part
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
- Voltage: ± 5000Vdc
- Voltage wave form: 20x2200µsec
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
- Measuring wavelength range of SED623: 438-2100 nm
- Measuring Wavelength range of SED240: 180-400 nm
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
- Represents new state of the art for safety requirements
- Compliance can be presumed to verify acceptable risk unless there’s objective evidence to the contrary
- General requirement for design process to include a RISK MANAGEMENT process in accordance with ISO 14971
- Safety has been broaden from BASIC SAFETY to include ESSENTIAL PERFORMANCE
- 3rd Edition <--> 2nd Edition Mapping Document
- IEC TR 62348
- IEC 60601-1: General Requirements for Safety, Part 1
- Collaterals Inserted into General Standard, 3rd Edition
- Safety Philosophy, Clause 4.1, 4.2, 4.7
- “…Requirements shall apply in NORMAL USE and reasonably foreseeable misuse”
- “A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be performed”
- Residual RISK must be acceptable
- “ME Equipment shall … be SINGLE FAULT SAFE” (free of unacceptable RISK under SINGLE FAULT CONDITION)
- Safety Philosophy, 4.3
- “Manufacturer identifies which functions … are Essential Performance”
- Determined by manufacturer’s policy for Risk acceptability
- “Collateral and Particular Standards [aligned with 3rd edition] are expected to identify specific Essential Performance,” Annex A, 3.27
- Safety Philosophy, Clause 12.2
- Address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY
- Equivalent Safety
- “Equivalent Safety” clause
- 2nd edition, Clause 3.4; 3rd edition, Clause 4.5
- Alternative means of addressing risks are acceptable provided that residual risk from applying the alternative means and the verifiable requirements in the standard are equivalent or the alternative means is better (less risk).