The most recent addition of IEC 60601-1-2 has been released. The IEC 60601-1-2:2020 (ed4.1) features some new tests as well as some modifications to some existing tests. EMC Technologies is currently accredited to undertake this testing. As one of the leading testing labs in Australia, we can offer guidance for EMC testing to assist new customers from entering the global medical device market. EMC Technologies Sydney branch is currently is the only NATA accredited testing lab for both the IEC 60601-1-2 (EMC) and the IEC 60601-1 (safety) standards. As the only Australian based test lab that can undertake  NATA accredited testing for medical devices, EMC technologies are poised to offer you the most comprehensive electrical l test service for your electromedical device.  

A summary of the most significant changes concerning the previous edition includes the following modifications:

  • specification of IMMUNITY TEST LEVELS are specified according to the environments of INTENDED USE, categorized according to locations that are harmonized with IEC 60601-1-11: the PROFESSIONAL  HEALTHCARE ENVIRONMENT  HEALTHCARE FACILITY environment, the HOME HEALTHCARE ENVIRONMENT and SPECIAL ENVIRONMENTS;
  • specification of tests and test levels to improve the safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS when PORTABLE RF communications equipment is used closer to the MEDICAL ELECTRICAL EQUIPMENT than was recommended based on the IMMUNITY TEST LEVELS that were specified in the third edition of this standard;
  • specification of IMMUNITY tests and IMMUNITY TEST LEVELS according to the PORTS of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM;
  • specification of IMMUNITY TEST LEVELS based on the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE, resulting in some IMMUNITY TEST LEVELS that are higher than in the previous edition; and
  • better harmonization with the RISK concepts of BASIC SAFETY and ESSENTIAL PERFORMANCE, including deletion of the defined term “life-supporting”; and the following additions:
  • guidance for the determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS;
  • guidance for adjustment of IMMUNITY TEST LEVELS when special considerations of mitigations or INTENDED USE are applicable;
  • guidance on RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE about ELECTROMAGNETIC DISTURBANCES; and
  • guidance on the identification of IMMUNITY pass/fail criteria.

Test Standard Updates

  • IEC 60601-1:2005 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance Amendment 1:2012Amendment 2:2020
  • IEC 61000-4-5:2014, Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test Amendment 1:2017
  • IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measuring techniques –Voltage dips, short interruptions and voltage variations immunity tests Amendment 1:2017
  •  New IEC 61000-4-39:2017, Electromagnetic compatibility (EMC) – Part 4-39: Testing and measurement techniques – Radiated fields in close proximity – Immunity test
  • CISPR 11:2015 Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement Amendment 1:2016Amendment 2:2019
  • CISPR 14-1:2016, Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission
  • CISPR 16-1-2:2014, Specification for radio disturbance and immunity measuring apparatus and methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Coupling devices for conducted disturbance measurements Amendment 1:2017
  • CISPR 32:2015, Electromagnetic compatibility of multimedia equipment – Emission requirements
  • ISO 7137:1995, Aircraft – Environmental conditions and test procedures for airborne Equipment has been removed
  • New  ISO 14971:2019, Medical devices – Application of risk management to medical devices

New Testing Requirements

  • New Conducted DISTURBANCES (conducted EMISSIONS) to CISPR 11 at both Minimum and maximum RATED voltage at any one frequency
  • Test Power input voltage Power frequency magnetic field IMMUNITY IEC 61000-4-8 any one voltage Either 50 Hz or 60 Hz. During the test, the frequency of the generated magnetic field and the power frequency of the ME EQUIPMENT or ME SYSTEM shall be the same.
  • Voltage dips IMMUNITY IEC 61000-4-11 Minimum and maximum RATED Voltage any one frequency Voltage short interruptions and voltage variations IMMUNITY
  • Proximity magnetic fields IEC 61000-4-39 any one voltage any one frequency the test may be performed at any one power input voltage within the ME EQUIPMENT or ME SYSTEM RATED voltage range. If the ME EQUIPMENT or ME SYSTEM is tested at one power input voltage, it is not necessary to re-test at additional voltages. The test may be performed at any one power frequency within the ME EQUIPMENT or ME SYSTEM RATED frequency range. If the ME EQUIPMENT or ME SYSTEM is tested at one power frequency, it is not necessary to re-test at additional frequencies.

Also check this great article: IEC 60601-1-2 4th Edition: What You Need to Know

Essential performance guidance

EMISSIONS:

If non-ME EQUIPMENT is used in an ME SYSTEM, the non-ME EQUIPMENT should fulfil the same EMISSIONS requirements as the ME SYSTEM, proven by the applicable product standards of the non-ME EQUIPMENT.

IMMUNITY:

Consider if failure or degradation of the non-ME EQUIPMENT could result in the loss of BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM. If failure or degradation of the non-ME EQUIPMENT could result in the loss of BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM, apply to the non-ME EQUIPMENT the same IMMUNITY TEST LEVELS specified for the ME SYSTEM, based on the environments of INTENDED USE.

If the failure or degradation of the non-ME EQUIPMENT does not result in the loss of BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM, compliance with the product standard of the non-ME EQUIPMENT is sufficient.

PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS

The updated standard offers three methods for EMISSION testing of PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS:

  • on a test site as a system;
  • on a test site on a subsystem basis;
  • in situ as a system at the premises of a RESPONSIBLE ORGANIZATION.

For some ME SYSTEMS, testing on a test site or on a subsystem basis is deemed to be very difficult. ME SYSTEMS (e.g. large X-ray equipment and particle therapy systems) requiring ceiling installation, or equipment that needs to be placed in different locations such as examination rooms, technical rooms and control rooms, cannot be installed in today’s test sites due to the size or installation requirements. Note that “large” in this context is defined in this collateral standard to mean ME EQUIPMENT or ME SYSTEMS that cannot fit within a 2 m x 2 m x 2,5 m volume in any orientation (see 3.12 and 3.13). Testing on a subsystem basis requires the simulation of the physical behaviour of the replaced system, which is also deemed to be technically very difficult and sometimes impossible without a representative configuration. Such a test would likely not fulfil the “worst case” or “modes that maximize EMISSIONS” approach of CISPR 11/IEC 60601-1-2 without several reconfigurations and extensive test time.

In situ testing – testing at the place of installation – as a system, at a RESPONSIBLE ORGANIZATION (i.e. a hospital or individual clinic) often requires a certification/approval before shipment to the facility. The ME SYSTEM might be in use and might not present the maximum configuration. Furthermore, it might not be possible to be tested in the modes that maximize EMISSIONS as required by this subclause because the available configuration for such testing is limited to what the customer/RESPONSIBLE ORGANIZATION has installed. Moreover, BASIC SAFETY and ESSENTIAL PERFORMANCE needs to be verified according to the

MANUFACTURER’s specification and requires specific operating modes and auxiliary equipment that might not be available or authorized in situ.

At the MANUFACTURER’s premises, the equipment used to provide input to, and monitoring of, the equipment under test (EUT) is likely to be fully available and testing in representative configurations is usually possible. Testing at the MANUFACTURER’s premises could fulfil the operational mode requirements of this subclause. Furthermore, at the MANUFACTURER’s premises, all necessary components, service support and knowledge of maintenance is in place, as well as protection requirements (e.g. to protect the environment and personnel). Comparing the limitations as described in this subclause against the advantages of testing at the MANUFACTURER’s premises, the latter could be considered equal to in situ testing. In such cases, good EMC practice regarding the measurement distance and positions should be achievable, and for EMISSION testing at the MANUFACTURER’s premises, a measurement distance of at least 3 m should be maintained. Additionally, a rationale to explain why testing the ME EQUIPMENT or ME SYSTEM on the MANUFACTURER’s premises is justified should be provided in the test plan and documented in the test report. The measurement locations, including distance to the EUT, should be documented in the test report

IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz

This requirement was added due to concerns about the RISKS associated with fields radiated by a wide variety of sources in both the professional healthcare facility environment and the HOME HEALTHCARE ENVIRONMENT. ME EQUIPMENT can contain electronic components and circuitry that are sensitive to radiated magnetic fields from these sources. The procedure for determining the applicability of the proximity magnetic fields IMMUNITY test and the testing required is shown in Figure A.3. In general, this subclause applies to all ME EQUIPMENT and ME SYSTEMS. However, due to the fact that the sources of magnetic fields considered for this subclause are proximity sources, appropriate exemptions from testing are specified. Even if this test is not performed, there are requirements for documentation of the choices/decisions made. It should be noted that MANUFACTURERS are permitted to bypass these exemptions and conduct the tests if they so choose.

Exemptions

The first of three exemptions (see 8.11 a)) is where the ME EQUIPMENT or ME SYSTEM does not contain (i.e. within the ENCLOSURE or as part of an attached ACCESSORY) magnetically sensitive components or circuitry. For the purposes of this subclause, magnetically sensitive components are those components that are either designed to sense magnetic fields or are likely to be influenced as a result of the fields specified in this subclause while in close proximity to the sources. Examples include but are not limited to coils, signal transformers, and hall-effect sensors. Magnetically sensitive circuitry includes but is not limited to those circuits where voltages induced into wiring or the interconnect structure might alter the intended function of the circuit. Examples of such circuits are:

  • an analogue signal processing circuit whose passband is within the frequency range specified in this subclause and where the area enclosed by any interconnecting pathways is such that the induced voltage can interfere with signals of interest.
  • digital circuits where the induced voltage in an inter-connect pathway approaches the logic threshold of the devices.
  • an external pacemaker system, where the leads attached to temporarily implanted heart wires form a loop whose area is sufficient to result in an induced voltage comparable to the ECG signals being sensed from the heart

Test specifications for ENCLOSURE PORT IMMUNITY to proximity magnetic fields Test frequency Modulation IMMUNITY TEST LEVEL (A/m)

ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry not meeting the separation distance criteria in b) or the RISK acceptability criteria in c) shall be tested for IMMUNITY to magnetic fields as specified in Table 11 using the test methods specified in IEC 61000-4-39. The magnetic field shall be applied only to those surfaces of the ENCLOSURE or attached ACCESSORIES that are accessible during INTENDED USE. The test windows to be used with IEC 61000-4-39 may be selected to illuminate only the area of the magnetically sensitive components or circuitry. The location of application of the magnetic field should be specified in the test plan and shall be documented in the test report.

Note that the IEC 60601-1-2:2020 (ed 4.1) contains a revised risk assessment procedure as well as a more detailed guide via flow charts.

If you have a medical product that requires medical product approvals for EMC or Electrical safety please get in touch we would like the opportunity to help you comply with the latest standards and get to market with the shortest possible lead time.

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