{"id":7546,"date":"2024-05-16T01:22:22","date_gmt":"2024-05-16T01:22:22","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7546"},"modified":"2024-05-16T02:07:50","modified_gmt":"2024-05-16T02:07:50","slug":"whats-the-relationship-of-updated-imdrf-n47-n52-to-iec-60601-1-4th-ed","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2024\/05\/16\/whats-the-relationship-of-updated-imdrf-n47-n52-to-iec-60601-1-4th-ed\/","title":{"rendered":"What\u2019s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

\ud83d\udca5\ud835\uddd5\ud835\udde5\ud835\uddd8\ud835\uddd4\ud835\uddde\ud835\udddc\ud835\udde1\ud835\uddda \ud835\udde1\ud835\uddd8\ud835\uddea\ud835\udde6\ud83d\udca5 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\udde1\ud835\udff0\ud835\udff3 & \ud835\udde1\ud835\udff1\ud835\udfee recently updated to \ud835\uddd8\ud835\uddf1\ud835\uddf6\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb \ud835\udfee \u2013 \ud835\uddea\ud835\uddf5\ud835\uddee\ud835\ude01\u2019\ud835\ude00 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb\ud835\ude00\ud835\uddf5\ud835\uddf6\ud835\uddfd \ud835\ude01\ud835\uddfc \ud835\udddc\ud835\uddd8\ud835\uddd6 \ud835\udff2\ud835\udfec\ud835\udff2\ud835\udfec\ud835\udfed-\ud835\udfed, \ud835\udff0\ud835\ude01\ud835\uddf5 \ud835\uddf2\ud835\uddf1\u2753<\/p>\n\n\n\n

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4th<\/sup> edition. \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\uddfd\ud835\ude02\ud835\uddef\ud835\uddf9\ud835\uddf6\ud835\ude00\ud835\uddf5\ud835\uddf2\ud835\uddf1 two Final documents on \ud835\udfee\ud835\udff2 \ud835\uddd4\ud835\uddfd\ud835\uddff\ud835\uddf6\ud835\uddf9 \ud835\udfee\ud835\udfec\ud835\udfee\ud835\udff0, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices<\/a>, and
N52 Principles of Labeling for Medical Devices and IVD Medical Devices<\/a><\/p>\n\n\n\n

The \ud835\uddfd\ud835\ude02\ud835\uddff\ud835\uddfd\ud835\uddfc\ud835\ude00\ud835\uddf2 \ud835\uddfc\ud835\uddf3 \ud835\udde1\ud835\udff0\ud835\udff3 \ud835\uddf4\ud835\ude02\ud835\uddf6\ud835\uddf1\ud835\uddee\ud835\uddfb\ud835\uddf0\ud835\uddf2<\/a> is to provide harmonized Essential Principles that should be fulfilled in the design & manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended.  The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients\/consumers, and to Regulatory Authorities.  Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.<\/p>\n\n\n\n

While \ud835\udde1\ud835\udff1\ud835\udfee<\/a> \ud835\uddf9\ud835\uddf2\ud835\ude03\ud835\uddf2\ud835\uddff\ud835\uddee\ud835\uddf4\ud835\uddf2\ud835\ude00 \ud835\uddfc\ud835\uddfb \ud835\udde1\ud835\udff0\ud835\udff3<\/a> \ud835\uddee\ud835\ude00 \ud835\uddf6\ud835\ude01\u2019\ud835\ude00 \ud835\uddfd\ud835\ude02\ud835\uddff\ud835\uddfd\ud835\uddfc\ud835\ude00\ud835\uddf2 states this guidance is to provide globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support N47.  Specifically, this document provides guidance on the content of the label, instructions for use, and information intended for the patient in order to support the safe and effective use of medical devices and IVD medical devices by their intended users.<\/p>\n\n\n\n

With the \ud835\udddc\ud835\uddd8\ud835\uddd6 \ud835\udff2\ud835\udfec\ud835\udff2\ud835\udfec\ud835\udfed-\ud835\udfed, \ud835\udff0\ud835\ude01\ud835\uddf5 \ud835\uddf2\ud835\uddf1\ud835\uddf6\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb \ud835\uddfd\ud835\uddff\ud835\uddfc\ud835\uddf7\ud835\uddf2\ud835\uddf0\ud835\ude01 underway \ud835\uddfc\ud835\uddfb\ud835\uddf2 \ud835\uddfc\ud835\uddf3 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\uddd7\ud835\uddf2\ud835\ude00\ud835\uddf6\ud835\uddf4\ud835\uddfb \ud835\udde6\ud835\uddfd\ud835\uddf2\ud835\uddf0\ud835\uddf6\ud835\uddf3\ud835\uddf6\ud835\uddf0\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb<\/a> \ud835\uddff\ud835\uddf2\ud835\uddfe\ud835\ude02\ud835\uddf6\ud835\uddff\ud835\uddf2\ud835\uddfa\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00 – \ud835\uddda\ud835\uddfc\ud835\uddee\ud835\uddf9 \ud835\udff2 of the \ud835\uddd4\ud835\uddff\ud835\uddf0\ud835\uddf5\ud835\uddf6\ud835\ude01\ud835\uddf2\ud835\uddf0\ud835\ude01\ud835\ude02\ud835\uddff\ud835\uddf2 \ud835\udde6\ud835\uddfd\ud835\uddf2\ud835\uddf0\ud835\uddf6\ud835\uddf3\ud835\uddf6\ud835\uddf0\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb<\/a>:<\/p>\n\n\n\n

\u201cEstablish a policy relating requirements of the IEC 60601 series to the IMDRF essential principles and labelling principles.\u201d
\ud835\uddda\ud835\uddfc\ud835\uddee\ud835\uddf9 \ud835\udff2 \ud835\uddf6\ud835\ude00 \ud835\uddf1\ud835\uddf6\ud835\uddff\ud835\uddf2\ud835\uddf0\ud835\ude01\ud835\uddf9\ud835\ude06 \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\ude01\ud835\uddf2\ud835\uddf1 \ud835\ude01\ud835\uddfc \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\uddf1\ud835\uddfc\ud835\uddf0\ud835\ude02\ud835\uddfa\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00 \ud835\udde1\ud835\udff0\ud835\udff3 \ud835\uddee\ud835\uddfb\ud835\uddf1 \ud835\udde1\ud835\udff1\ud835\udfee \ud835\ude04\ud835\uddf5\ud835\uddf6\ud835\uddf0\ud835\uddf5 \ud835\ude04\ud835\uddf2\ud835\uddff\ud835\uddf2 \ud835\uddff\ud835\uddf2\ud835\uddf0\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\uddf9\ud835\ude06 \ud835\ude02\ud835\uddfd\ud835\uddf1\ud835\uddee\ud835\ude01\ud835\uddf2\ud835\uddf1 \ud835\ude01\ud835\uddfc \ud835\uddd8\ud835\uddf1\ud835\uddf6\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb \ud835\udfee.<\/p>\n\n\n\n

The Architecture Spec<\/a> states:<\/p>\n\n\n\n

\u201cIt is the \ud835\uddfd\ud835\uddfc\ud835\uddf9\ud835\uddf6\ud835\uddf0\ud835\ude06 \ud835\uddfc\ud835\uddf3 \ud835\udddc\ud835\uddd8\ud835\uddd6\/\ud835\udde7\ud835\uddd6 \ud835\udff2\ud835\udfee \ud835\ude01\ud835\uddfc \ud835\uddf6\ud835\uddfb\ud835\uddf0\ud835\uddf9\ud835\ude02\ud835\uddf1\ud835\uddf2 \ud835\uddee\ud835\uddfb \ud835\uddf6\ud835\uddfb\ud835\uddf3\ud835\uddfc\ud835\uddff\ud835\uddfa\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\ude03\ud835\uddf2 \ud835\uddee\ud835\uddfb\ud835\uddfb\ud835\uddf2\ud835\ude05 \ud835\uddfa\ud835\uddee\ud835\uddfd\ud835\uddfd\ud835\uddf6\ud835\uddfb\ud835\uddf4 the \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb\ud835\ude00\ud835\uddf5\ud835\uddf6\ud835\uddfd \ud835\ude01\ud835\uddfc \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\uddd8\ud835\udde6\ud835\udde6\ud835\uddd8\ud835\udde1\ud835\udde7\ud835\udddc\ud835\uddd4\ud835\udddf \ud835\udde3\ud835\udde5\ud835\udddc\ud835\udde1\ud835\uddd6\ud835\udddc\ud835\udde3\ud835\udddf\ud835\uddd8\ud835\udde6 \ud835\uddee\ud835\uddfb\ud835\uddf1 \ud835\udddf\ud835\uddd4\ud835\uddd5\ud835\uddd8\ud835\udddf\ud835\udddf\ud835\udddc\ud835\udde1\ud835\uddda \ud835\udde3\ud835\udde5\ud835\udddc\ud835\udde1\ud835\uddd6\ud835\udddc\ud835\udde3\ud835\udddf\ud835\uddd8\ud835\udde6 in \ud835\uddf2\ud835\uddee\ud835\uddf0\ud835\uddf5 \ud835\uddfc\ud835\uddf3 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\ude00\ud835\ude01\ud835\uddee\ud835\uddfb\ud835\uddf1\ud835\uddee\ud835\uddff\ud835\uddf1\ud835\ude00 \ud835\uddfc\ud835\uddf3 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\uddd8\ud835\uddd6 \ud835\udff2\ud835\udfec\ud835\udff2\ud835\udfec\ud835\udfed \ud835\udde6\ud835\uddd8\ud835\udde5\ud835\udddc\ud835\uddd8\ud835\udde6.\u201d
This is a goal of IEC\/TC 62.  For the IEC 60601-1, 4th<\/sup> edition project all Working Groups (WG\u2019s) are tasked to do this work in their WG\u2019s.  There are 12 WG\u2019s split up by hazards<\/a>. In the future all standards that are developed by IEC\/TC 62 should also follow this goal.
Another part of Goal 6 from the Architecture Spec<\/a> states:
\u201cThe \ud835\uddff\ud835\uddf2\ud835\uddfe\ud835\ude02\ud835\uddf6\ud835\uddff\ud835\uddf2\ud835\uddfa\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00 \ud835\uddf6\ud835\uddfb \ud835\uddfa\ud835\uddee\ud835\uddfb\ud835\ude06 \ud835\uddfc\ud835\uddf3 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\ude00\ud835\ude01\ud835\uddee\ud835\uddfb\ud835\uddf1\ud835\uddee\ud835\uddff\ud835\uddf1\ud835\ude00 \ud835\uddf6\ud835\uddfb \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\uddd8\ud835\uddd6 \ud835\udff2\ud835\udfec\ud835\udff2\ud835\udfec\ud835\udfed \ud835\udde6\ud835\uddd8\ud835\udde5\ud835\udddc\ud835\uddd8\ud835\udde6 are \ud835\uddf6\ud835\uddfb\ud835\ude01\ud835\uddf2\ud835\uddfb\ud835\uddf1\ud835\uddf2\ud835\uddf1 \ud835\ude01\ud835\uddfc \ud835\uddf3\ud835\ude02\ud835\uddf9\ud835\uddf3\ud835\uddf6\ud835\uddf9 \ud835\ude00\ud835\uddfc\ud835\uddfa\ud835\uddf2 \ud835\uddfc\ud835\uddf3 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\uddfd\ud835\uddff\ud835\uddf6\ud835\uddfb\ud835\uddf0\ud835\uddf6\ud835\uddfd\ud835\uddf9\ud835\uddf2\ud835\ude00 set out \ud835\uddf6\ud835\uddfb \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\uddf4\ud835\ude02\ud835\uddf6\ud835\uddf1\ud835\uddee\ud835\uddfb\ud835\uddf0\ud835\uddf2 \ud835\uddf1\ud835\uddfc\ud835\uddf0\ud835\ude02\ud835\uddfa\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00. To facilitate the usage of the documents in the IEC 60601 SERIES for conformity assessment purposes by the AUTHORITIES HAVING JURISDICTION, it is important to \ud835\uddf0\ud835\uddf9\ud835\uddf2\ud835\uddee\ud835\uddff\ud835\uddf9\ud835\ude06 \ud835\uddf6\ud835\uddfb\ud835\uddf1\ud835\uddf6\ud835\uddf0\ud835\uddee\ud835\ude01\ud835\uddf2 \ud835\ude04\ud835\uddf5\ud835\uddf6\ud835\uddf0\ud835\uddf5 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\uddfd\ud835\uddff\ud835\uddf6\ud835\uddfb\ud835\uddf0\ud835\uddf6\ud835\uddfd\ud835\uddf9\ud835\uddf2\ud835\ude00 \ud835\uddee\ud835\uddff\ud835\uddf2 \ud835\uddf0\ud835\uddfc\ud835\ude03\ud835\uddf2\ud835\uddff\ud835\uddf2\ud835\uddf1 \ud835\uddef\ud835\ude06 \ud835\ude04\ud835\uddf5\ud835\uddf6\ud835\uddf0\ud835\uddf5 \ud835\uddff\ud835\uddf2\ud835\uddfe\ud835\ude02\ud835\uddf6\ud835\uddff\ud835\uddf2\ud835\uddfa\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00 \ud835\uddf6\ud835\uddfb \ud835\uddee \ud835\ude00\ud835\ude01\ud835\uddee\ud835\uddfb\ud835\uddf1\ud835\uddee\ud835\uddff\ud835\uddf1 \ud835\uddf6\ud835\uddfb \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\uddd8\ud835\uddd6 \ud835\udff2\ud835\udfec\ud835\udff2\ud835\udfec\ud835\udfed \ud835\udde6\ud835\uddd8\ud835\udde5\ud835\udddc\ud835\uddd8\ud835\udde6.\u201d
This \ud835\uddda\ud835\uddfc\ud835\uddee\ud835\uddf9 \ud835\udff2 \ud835\ude00\ud835\ude02\ud835\uddfd\ud835\uddfd\ud835\uddfc\ud835\uddff\ud835\ude01\ud835\ude00 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9\u2019\ud835\ude00 \ud835\uddf0\ud835\uddfc\ud835\uddfb\ud835\uddf0\ud835\uddf2\ud835\uddfd\ud835\ude01 \ud835\uddfc\ud835\uddf3 \ud835\uddf2\ud835\uddf9\ud835\uddf6\ud835\uddfa\ud835\uddf6\ud835\uddfb\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddfb\ud835\uddf4 \ud835\uddf1\ud835\uddf6\ud835\uddf3\ud835\uddf3\ud835\uddf2\ud835\uddff\ud835\uddf2\ud835\uddfb\ud835\uddf0\ud835\uddf2\ud835\ude00 \ud835\uddef\ud835\uddf2\ud835\ude01\ud835\ude04\ud835\uddf2\ud835\uddf2\ud835\uddfb \ud835\uddf7\ud835\ude02\ud835\uddff\ud835\uddf6\ud835\ude00\ud835\uddf1\ud835\uddf6\ud835\uddf0\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb\ud835\ude00 which \ud835\uddf1\ud835\uddf2\ud835\uddf0\ud835\uddff\ud835\uddf2\ud835\uddee\ud835\ude00\ud835\uddf2\ud835\ude00 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\uddf0\ud835\uddfc\ud835\ude00\ud835\ude01 \ud835\uddfc\ud835\uddf3 \ud835\uddf4\ud835\uddee\ud835\uddf6\ud835\uddfb\ud835\uddf6\ud835\uddfb\ud835\uddf4 \ud835\uddff\ud835\uddf2\ud835\uddf4\ud835\ude02\ud835\uddf9\ud835\uddee\ud835\ude01\ud835\uddfc\ud835\uddff\ud835\ude06 \ud835\uddf0\ud835\uddfc\ud835\uddfa\ud835\uddfd\ud835\uddf9\ud835\uddf6\ud835\uddee\ud835\uddfb\ud835\uddf0\ud835\uddf2 from the various AUTHORITIES HAVING JURISDICTION (AHJ) and allows \ud835\uddfd\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00 \ud835\uddf2\ud835\uddee\ud835\uddff\ud835\uddf9\ud835\uddf6\ud835\uddf2\ud835\uddff \ud835\uddee\ud835\uddf0\ud835\uddf0\ud835\uddf2\ud835\ude00\ud835\ude00 \ud835\ude01\ud835\uddfc \ud835\uddfb\ud835\uddf2\ud835\ude04 \ud835\ude01\ud835\uddf2\ud835\uddf0\ud835\uddf5\ud835\uddfb\ud835\uddfc\ud835\uddf9\ud835\uddfc\ud835\uddf4\ud835\uddf6\ud835\uddf2\ud835\ude00 \ud835\uddee\ud835\uddfb\ud835\uddf1 \ud835\ude01\ud835\uddff\ud835\uddf2\ud835\uddee\ud835\ude01\ud835\uddfa\ud835\uddf2\ud835\uddfb\ud835\ude01\ud835\ude00.  This is a positive impact on patients and also makes for an easier process for the manufacturers and for the AHJ\u2019s, as well.<\/p>\n\n\n\n

When IEC TC 62\/SC 62A\/WG 39<\/a> met in Arlington, VA on 1- 2 May 2024 this was brought up during the meeting, as this is an important issue that needs to be addressed during the IEC 60601-1, 4th<\/sup> edition project. One aspect WG 39 is dealing with is \u201cInformation to be supplied by the manufacturer\u201d (i.e. Labeling).  This is the IEC 60601-1, 4th<\/sup> edition WG that I am a co-convener of. There are lots of changes happening in the standards and regulatory world around labeling and we are working hard to keep informed on all these changes that will impact this project. \ud835\udde6\ud835\ude01\ud835\uddee\ud835\ude06 \ud835\ude01\ud835\ude02\ud835\uddfb\ud835\uddf2\ud835\uddf1 \ud835\uddf3\ud835\uddfc\ud835\uddff \ud835\uddfa\ud835\uddfc\ud835\uddff\ud835\uddf2 \ud835\ude02\ud835\uddfd\ud835\uddf1\ud835\uddee\ud835\ude01\ud835\uddf2\ud835\ude00\u203c\ufe0f <\/p>\n\n\n\n

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner<\/a> is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.<\/p>\n\n\n\n

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.<\/p>\n\n\n\n

Feel free to schedule a call with Leo<\/a> or contact Leo at Leo@EisnerSafety.com or through our contact form<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

What\u2019s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?<\/p>\n

\ud83d\udca5\ud835\uddd5\ud835\udde5\ud835\uddd8\ud835\uddd4\ud835\uddde\ud835\udddc\ud835\udde1\ud835\uddda \ud835\udde1\ud835\uddd8\ud835\uddea\ud835\udde6\ud83d\udca5 \ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\udde1\ud835\udff0\ud835\udff3 & \ud835\udde1\ud835\udff1\ud835\udfee recently updated to \ud835\uddd8\ud835\uddf1\ud835\uddf6\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb \ud835\udfee \u2013 \ud835\uddea\ud835\uddf5\ud835\uddee\ud835\ude01\u2019\ud835\ude00 \ud835\ude01\ud835\uddf5\ud835\uddf2 \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\uddfc\ud835\uddfb\ud835\ude00\ud835\uddf5\ud835\uddf6\ud835\uddfd \ud835\ude01\ud835\uddfc \ud835\udddc\ud835\uddd8\ud835\uddd6 \ud835\udff2\ud835\udfec\ud835\udff2\ud835\udfec\ud835\udfed-\ud835\udfed, \ud835\udff0\ud835\ude01\ud835\uddf5 \ud835\uddf2\ud835\uddf1\u2753<\/p>\n

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4th edition.<\/p>\n

\ud835\udddc\ud835\udde0\ud835\uddd7\ud835\udde5\ud835\uddd9 \ud835\uddfd\ud835\ude02\ud835\uddef\ud835\uddf9\ud835\uddf6\ud835\ude00\ud835\uddf5\ud835\uddf2\ud835\uddf1 two Final documents on \ud835\udfee\ud835\udff2 \ud835\uddd4\ud835\uddfd\ud835\uddff\ud835\uddf6\ud835\uddf9 \ud835\udfee\ud835\udfec\ud835\udfee\ud835\udff0, both to Version 2:
\nN47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and N52 Principles of Labeling for Medical Devices and IVD Medical Devices <\/p>\n","protected":false},"author":4,"featured_media":6249,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1402,1425,1517,1386,1325,1354,1510,1398,1403,1481,1526,1502,1520,1443,1503,1445,1365,1344,1389,1499,1393,1394,1501,1378,1528,1424,1518,1427,1459,1529,1396,1370,1461,1369,1429,1381,1431,1522,1521,1491,1435,1391,1368,1438,1457,1492,1524,1527,1525],"tags":[],"class_list":["post-7546","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-1402","category-15223-1","category-1517","category-60601-series","category-60601-1","category-60601-1-8","category-60601-1-4th-edition","category-1398","category-62366-1","category-aami","category-alarm-systems","category-architecture-specification","category-combination-device","category-combination-product","category-design-specification","category-device","category-eu","category-fda","category-guidance-documents","category-hazards","category-health-canada","category-iec","category-iec-60601-1","category-imdrf","category-information-provided-by-the-manufacturer","category-iso-15223-1","category-iso-20417","category-labeling","category-marking","category-may-2024","category-mdd","category-mdr","category-medical-device","category-medical-device-regulation","category-mhra","category-notified-bodies","category-regulation","category-regulatory-affairs","category-risk-management","category-saudia-arabia","category-standards","category-standards-development","category-state-of-the-art","category-uk","category-ukca","category-us","category-usability","category-usability-engineering-process","category-user-interfaces"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7546","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=7546"}],"version-history":[{"count":10,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7546\/revisions"}],"predecessor-version":[{"id":7557,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7546\/revisions\/7557"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6249"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7546"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7546"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7546"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}