This article is the second one of a series about IEC 60601. It contains insightful information about amendment 1 of IEC 60601-1-2, following a similar structure as the first article.

 

The latest amendment 1 of IEC 60601-1-2 for Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests (IEC 60601-1-2 Edition 4.1) was published on 2020-09-01 by the International Electrotechnical Commission (IEC). Edition 4.1 notably addresses issues raised by national committees and questions submitted to IEC/SC 62A with regard to previous version 4.0.

 

Since the 21st of December 2020, the United States Food & Drug Administration (FDA) has listed IEC 60601-1-2 4.1 Edition Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests as a recognized standard (FDA recognition number 19-36). IEC 60601-1-2 4.1 Edition will replace the current listed IEC 60601-1-2 4th Edition (FDA recognition number 19-8) by the 17th of December 2023. Until this date, FDA will accept declarations of conformity referring to IEC 60601-1-2 4th Edition, in support of the premarket submission.

 

To date, no announcement relative to an official transition period for the applicability of Edition 4.1 or to its harmonization under the Medical Device Directive (93/42/EEC) or Medical Device Regulation (EU 2017/745) has been issued in the official journal of the European Union.

 

In the absence of any official communication within the European Union on the matter, it is anticipated that manufacturers will be granted a transition period of 3 to 4 years after the date of publication before they will be expected to demonstrate compliance with the applicable new requirements introduced by the amended standard.

 

WHAT ARE THE MAIN DIFFERENCES BETWEEN CURRENT IEC 60601-1-2 EDITION 4.0 AND EDITION 4.1?

 

Clauses affected in IEC 60601-1-2 Edition 4.1 compared to 4.0 Edition are:

 

Clause 2 Normative references

Clause 3 Terms and definitions

Clause 4.3.3 Power input voltages and frequencies Table 1 – Power input voltages and frequencies during the tests

Clause 7.1.12 Permanently installed large ME equipment and large ME systems

Clause 7.3 Emissions requirements summary Table 2 – Emission limits per environment

Clause 8.1 Electromagnetic immunity requirements for ME equipment and ME systems – general

Clause 8.6 Permanently installed large ME equipment and large ME systems

Clause 8.9 Immunity test levels

Clause 8.11 Immunity to proximity magnetic fields in the frequency range 9kHz to 13,56 MHz

Figure 3 – Examples of locations within EM environments

Table 4 – Enclosure Port

Table 5 – Input a.c. power port (1 of 2 and 2 of 2)

Table 8 – SIP/SOP port

Table 9 – Test specifications for enclosure port immunity to RF wireless communications equipment

Table 10 – minimum test report contents (2 of 2)

Table 11 – Test specifications for enclosure port immunity to proximity magnetic fields

Table A.3 – Test specifications for enclosure port immunity to RF wireless communications equipment

Annex A.1 Safety and performance

Subclause 4.2 – Non-ME equipment used in an ME system

Subclause 4.3.3 – Power input voltages and frequencies

Subclause 5.2.2.1 a), Compliance with each emission and immunity standard

Subclause 7.1.12 – Permanently installed large ME equipment and Large ME systems

Subclause 8.6 – Permanently installed large ME equipment and large ME systems

Subclause 8.9 – Immunity test levels b) Environments

Subclause 8.9 – Immunity test levels c) Immunity test level determination

Subclause 8.10 – Immunity to proximity fields from RF wireless communications equipment

Subclause 8.11 – Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz

Annex F Guidance on the application of risk management with regard to electromagnetic disturbances in this collateral standard

Figure F.1 – Risk management flow in IEC 60601-1-2

Table G.1 Recommended minimum test plan contents (2 of 2)

 

Importantly, the normative references of the standard have also been updated in Edition 4.1. The changes to referenced standards are shown in bold text below:

 

IEC 60601-1:2005+AMD1:2012+AMD2:2020

IEC 60601-1-8:2006+AMD1:2012+AMD2:2020

IEC 60601-1-11:2015+AMD1:2020

IEC 60601-1-12:2014+AMD1:2020

IEC 61000-4-5:2014+AMD1:2017

IEC 61000-4-11:2004+AMD1:2017

IEC 61000-4-39:2017

CISPR 11:2015+AMD1:2016+AMD2:2019

CISPR 14-1:2016

CISPR 16-1-2:2014+AMD1:2017

CISPR 32:2015

ISO 14971:2019

 

WHAT DO THESE CHANGES MEAN IN PRACTICE?

 

Due to technological progress and resulting technical changes, the standards to ensure a safe and effective medical device need to develop too (state of the art). To comply with IEC 60601-1-2 4.1 edition, the latest editions of applicable process, particular, collateral, and component standards need to be considered by the medical device applicant.

 

Medical device manufacturers are advised to take advantage of the transition period to perform a gap analysis of their technical documentation (TD) against Edition 4.1 and update their documentation accordingly. Once potential gaps have been cleared, a new test report according to IEC 60601-1-2:2014+AMD1:2020 Edition 4.1 can be requested from an external ISO/IEC 17025 accredited testing laboratory. If the current IEC 60601-1-2 test report uses CB-Scheme as test scheme, it should be kept in mind that according to IEC Operational Document OD-2037 clause 3.1, a new Certification Body (CB) test certificate shall be issued with a new CB test certificate number. Thanks to the fact that now the TD will have been revised to comply with technical state of the art, a smooth certification process will be assured.

 

Let´s focus on the introduction to IEC 60601-1-2 clause 8.11 – immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz.

 

Subclause 8.11 explains why this requirement has been added. Due to a wide variety of sources with radiated fields in professional healthcare facility environments and home healthcare environments, concerns about risks have been raised. Many medical electrical equipments contain electronic components and circuitry which might be sensitive to radiated magnetic fields (source: Cf. IEC 60601-1-2 Edition 4.1 Subclause 8.11). Figure A.3 – Steps for evaluation of immunity to proximity magnetic fields provides a great overview if testing in accordance with Table 11 of IEC 60601-1-2 4.1 Edition is applicable. IEC 61000-4-39 electromagnetic compatibility – part 4-39: Testing and measurement techniques – radiated fields in close proximity – immunity test, describe the test and measurement condition.

 

Another noteworthy update of IEC 60601-1-2 Edition 4.1 affects clause 4.3.3 power input voltage and frequencies. Table 1 of clause 4.3.3 specifies the power input voltages and frequencies during testing. For instance, conducted disturbances (conducted emissions) according to CISPR11:2015+AMD1:2016+AMD2:2019 specifies the power input voltage for minimum and maximum rated voltage, if the difference between the maximum and the minimum rated input voltage is greater than 25% of the highest rated input voltage. Meaning, if your medical electrical equipment has a wide range input voltage supply of 100Vac – 240Vac, the difference of maximum and minimum rated input voltage is 140Vac, which is greater than 25% of highest rated input voltage (240Vac*25% = 60Vac), therefore the test needs to be conducted at minimum and maximum rated input voltage.

 

Previous IEC 60601-1-2 Edition 4.0 specified this test according to CISPR11 at any one voltage.

 

How can Medidee support your company?

 

Medidee has a dedicated team of electrical safety specialists who assist you in identifying all areas requiring updates to meet the new requirements introduced by IEC 60601-1-2 Edition 4.1, through a detailed review of the technical documentation of your medical electrical device or system, as well as provide support in the implementation of applicable new IEC 60601-1-2 Edition 4.1 requirements and sub-standards like CISPR 11 or IEC 61000-4-39. For instance, Medidee reviews and updates the technical documentation according to the updated standards to comply with IEC 60601-1-2 Edition 4.1. Furthermore, Medidee updates the test plan which is required as input for external test labs.

 

In addition, Medidee supports you in communicating with external accredited testing laboratories and notified bodies, to ensure a smooth certification process of your medical electrical equipment or system.

 

Contact Medidee today to discuss your needs and how Medidee supports you in addressing them: www.medidee.com/contacts

 

This article was written by Stefan Staltmayr.