Which standard must be observed for the approval of an electrical medical device? This article will explain how to determine this for the most important countries (i.e., the EU, the US, and China). The article refers to the 60601 family of standards. Additional legal requirements may apply to approval, such as environmental directives like RoHS (EU) and EMC requirements like FCC approval (US).
The basis for electrical medical devices in these countries is the IEC 60601 family of standards. Using the EMC standard for medical electrical devices, IEC 60601-1-2, as an example, we will determine whether it is valid and which version it applies to.
Interestingly, different versions of the EMC standard are currently valid in all three countries (as of February 2019). We'll see which ones they are in a moment.
EU
In the EU, harmonized standards are published in the Official Journal of the EU. This offers a search function:
https://eur-lex.europa.eu/oj/direct-access.html?locale=de
You can search for the standard and find the currently valid version and also the statement whether this standard is sufficient for the presumption of conformity:
USA
In the US, the FDA (Food and Drug Administration) is the government agency responsible for medical devices. The FDA publishes its "recognized consensus standards" on the following website:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
If you search for 60601-1-2, for example, you will get the following result:
So the 4th edition is currently valid there too.
Tip: The FDA also regularly publishes guidance documents that are helpful in understanding the agency's requirements and submitting the necessary documents and evidence.
| Dipl.-Ing. Martin Bosch, shareholder, hardware developer E-mail: bosch@medtech-ingenieur.de Phone: +49 9131 691 241 |
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Do you need support with the development of your medical device? We're happy to help! MEDtech Ingenieur GmbH offers hardware development, software development, systems engineering, mechanical development, and consulting services from a single source. Contact us. |
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China
In China, the state-run CFDA (China Food and Drug Administration) is responsible for translating international standards into country-specific standards. You can find out the classification of standards using a search engine:
http://eng.sfda.gov.cn/WS03/CL0755/
If you search for “60601-1-2” on the CFDA website, you will get a reference to the standard YY 0505-2012, which corresponds to IEC 60601-1-2:2004.
Another way to search for standards in China is on the SAC (Standardization Administration of China) website:
http://www.sac.gov.cn/was5/web//outlinetemplet/gjbzcx.jsp
For example, you can display all medical standards by searching with the ICS number 11.040 (see also https://www.iso.org/ics/11.040/x/).
However, only official standards are listed there, known in China as GB standards. Since 60601-1-2, for example, is listed as an industry-specific standard (YY stands for medical technology), it cannot be found there.
Summary
In China, the 2nd edition of IEC 60601-1-2 is still valid, which contains significantly different test levels and requirements than the version of the standard applicable in the EU or the US. As you can see, it is important for all countries in which a device is to be approved to identify the relevant standards, as there can be considerable differences.
Unfortunately, there isn't a single website that documents the requirements. Each country has its own approval procedures, and even if international standards apply, there may still be differences if different versions of the standards are still valid. If we can assist you with your approval, please feel free to call us or send us an inquiry.
Best regards
Martin Bosch