{"id":8039,"date":"2025-08-31T21:28:00","date_gmt":"2025-08-31T21:28:00","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=8039"},"modified":"2025-09-02T18:21:27","modified_gmt":"2025-09-02T18:21:27","slug":"what-ivd-manufacturers-need-to-know-about-iec-61326-2-62025","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2025\/08\/31\/what-ivd-manufacturers-need-to-know-about-iec-61326-2-62025\/","title":{"rendered":"What IVD Manufacturers Need To Know About IEC 61326-2-6:2025"},"content":{"rendered":"\n
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\n IVD EMC and IEC 61326-2-6:2025
\n FDA Recognition & the Tougher Road Ahead\n <\/h1>\n\n \n

\n FDA fully recognized IEC 61326-2-6:2025 and included it in ASCA on July 28, 2025<\/strong>.\n Here\u2019s what changes and how IVD manufacturers should respond.\n <\/p>\n\n \n

\n \"Lab\n <\/div>\n\n \n
\n \n \ud83d\udcc5 Schedule a Call\n <\/a>\n \n \ud83d\udd17 Connect on LinkedIn\n <\/a>\n <\/div>\n\n <\/div>\n<\/section>\n\n\n\n\n\n
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\n Bottom line:<\/strong> many will assume this removes the burden of IEC 60601-1-2 compliance.\n The reality is more nuanced. Parts of 60601-1-2 were incorporated into the updated 61326-2-6, and\n Essential Performance<\/strong> and risk management<\/strong> remain critical.\n The FDA 2022 EMC Guidance<\/strong> still applies.\n <\/p>\n\n \n

\n The technical reality \u2013 4 key takeaways\n <\/h2>\n\n \n
\n \"The\n <\/figure>\n\n \n

\n Global implications\n <\/h2>\n

\n IEC 61326-2-6:2025<\/strong> applies internationally, not just in the United States.\n Update your compliance strategy across markets, not only for FDA submissions.\n <\/p>\n\n \n

\n \"Global\n <\/figure>\n \n\n \n

\n What manufacturers should do now\n <\/h2>\n

\n If your EMC test plans, risk analysis, or labeling still reference IEC 60601-1-2 or IEC 61326-2-6:2020 for IVDs,\n it\u2019s time to recheck your EMC strategy<\/em><\/strong> \u2714\ufe0f\n <\/p>\n\n \n

\n \"Checklist\n <\/figure>\n\n