Medical Device Testing: IEC 60601-1

Are Your Electromedical Products Compliant and Safe?

Compliance to directives or norms can be fulfilled by showing compliance to various applicable national and international standards. Most of electro medical device must show compliance to IEC/EN 60601-1 series of standards. These requirements are almost common across the globe; In USA the same standard is adapted as national standard with country specific deviations and referred as ANSI UL 60601-1. Testing of medical devices in accrediated facilities is very important in the certification process. TUV Rheinland India has the necessary expertise and accredited test facilities for medical device testing (or medical testing) and certification.

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:

  • Testing
  • 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

Products Covered

Our services cover electromedical products.

Additional Information

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

Test Specification
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

Test Specification
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.

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).