The FDA has rolled out a new standard for medical device testing. This is the 4th edition of standards and it has posed a lot of questions for medical device testing. If you are new to this edition, or if you are unsure how it effects your devices, then there are a few things you need to know. Here are four key points regarding the IEC 60601-1-2 4th edition guidelines.
One of the biggest questions people have regarding this 4th edition is how it will effect currently tested and certified medical devices and medical device testing for upcoming devices. The key thing to remember is that previous editions will no longer be accepted as a guideline for medical testing requirements after August 1, 2016. Keeping this date in mind will help you create a suitable schedule for medical device testing and ensure that your staff is ready for the regulation changes and new guidelines.
Changes to ESD Regulations
One of the impacts made by this edition of the FDA medical device testing regulations is the impact on ESD regulations. What you need to know is that the levels of ESD testing will change and that ESD connectors will be tested differently as well. These changes effect the testing of the contact discharge point and the connectors for the various medical devices. You will need to make sure that any medical device testing that deals with ESD testing is up to par with the latest edition and regulations.
Something else that the 4th edition brings to the table is new testing. One of the new tests is a Close Field Proximity test. According to Eisner Safety this test will include 15 frequency tests in addition to other related testing. Surge tests have also been added to this edition and will be tested on 12-volt chargers or energy up to 12 volts.
Some testing has seen increased testing parameters as well. For example, magnetic immunity tests have been increased to 30 A/m for certification and regulation purposes. You will also need to check for and adjust to any increased parameters that deal directly with your medical device equipment and related testing.
These are just a few of the things you need to know about IEC 60601-1-2 4th edition. If you have any other questions, ask your medical device testing representatives or contact the FDA for a full list of regulation changes and guidelines.