In both the US and the EU by the end of 2018 application of the 4th edition of IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests are mandatory.
The Medical Device Directive (MDD 93/42/EEC) and the Medical Device Regulation (MDR 2017/745) require “generally acknowledged state of the art” to be taken into account. In the context of EMC, this means the device shall not compromise the clinical condition or the safety of patients by showing compliance to EU harmonized standards. For the EU this has an impact on market access. Products that are placed on the market after 31/12/2018 must comply to EN 60601-1-2:2015 (IEC 60601-1-2:2014+Annex ZZ (Coverage of Essential Requirements of EU Directives)). With the implication that grandfathering is not allowed, and that retesting or additional test are likely required for finished designs.
The US appears to be a bit more industry-friendly, as grandfathering is allowed, meaning that products that have FDA market clearance can be continued to be placed on the market after 31/12/2018. However, after 31/12/2018, for declarations of conformity, in support to premarket submissions, FDA will only accept the 4th edition, with recognition number: 19-8 (or ANSI AAMI IEC 60601-1-2:2014, #19-12).
Key points of interest:
a) A formal test plan shall be provided to the test laboratory;
b) Environments outside the professional health care facility shall be addressed, including special environments, e.g. military and heavy industrial areas and harmonization with home healthcare environment, e.g. schools and vehicles (IEC 60601-1-11);
c) During immunity testing, the Basic Safety and Essential Performance shall be tested in the modes that are most likely to result in an unacceptable risk, requiring hazard analysis and defining pass/fail criteria prior testing;
d) Test levels for the immunity requirements have been increased;
e) New requirements for enclosure port immunity to RF wireless communications equipment have been added.
a) Test plan
ISO 13485:2016 now has a general requirement that every verification/validation report shall have a matching plan. With the earlier version of this collateral standard it was good practice to make such plans; with the 4th edition
it is now an explicit requirement. Annex G provides guidance and lots of details about the content of such a test plan. Deviations from the plan made during testing,
shall be documented in the test report.
Immunity test requirements shall be applied to the ports of the device according to the use environment(s) specified in the intended use.
Although healthcare professionals are present in the emergency medical services environment, the electromagnetic environment is similar to that of the home healthcare environment. Therefore, for the purposes of this collateral standard, the emissions and immunity requirements of the home healthcare environment apply to Medical Electrical (ME) equipment and ME systems intended for use in the emergency medical services environment. an example of such a location is an ambulance.
c) Risk management
The 4th edition prominently takes a risk-based approach. In the first sentence of the general requirement it is clearly indicated a risk management process shall be taken into account. This approach provides a better harmonization with the well-known risk concepts of Basic Safety and Essential Performance. In Annex F, table F.1 good guidance is provided on which electromagnetic (EM) phenomena should be added to the Design FMEA. This also implies that the cross-functional risk management team should include a true EM expert who is knowledgeable in the application of the medical device at hand.
d) Immunity Pass/fail criteria and Test levels
As said, the 4th edition requires manufacturers to define a test plan. In that plan all immunity pass/fail criteria shall be defined. In the pursuit of the pass/fail criteria, specific hardware, firmware and software functions and Essential Performance shall be analyzed. In addition, particular (IEC 60601-2-xx / IEC/ISO 80601-2-xx) standards or product standards and specification can also impose such criteria.
In the test plan, also the applicable test levels are set. Be aware some test levels have changed compared to the 3rd edition. For example, the Electrostatic Discharge (ESD) contact discharge test level has been significantly increased 6 kV to 15 kV. This new requirement can have a major impact on existing designs.
e) RF communications immunity
The 4th edition anticipates the new digital wireless technologies that have been introduced into the market. Healthcare providers specifically asked to define requirements for wireless communication equipment, enabling it to be used closer to medical equipment that was recommended with the 3rd edition or before that.
Examples of such RF wireless technologies used in healthcare are:
- Bluetooth or WIFI for controlling devices or transmission of data;
- RFID to track the location of devices;
- PDAs used during patient rounds.
The 4th edition now includes a comprehensive table of test specifications for enclosure port immunity to RF wireless communications equipment.
If you require support or resources do not hesitate to contact Qserve’s team of experts.