๐ฅ๐๐ฅ๐๐๐๐๐ก๐ ๐ก๐๐ช๐ฆ๐ฅ ๐๐ ๐๐ฅ๐ ๐ก๐ฐ๐ณ & ๐ก๐ฑ๐ฎ recently updated to ๐๐ฑ๐ถ๐๐ถ๐ผ๐ป ๐ฎ โ ๐ช๐ต๐ฎ๐โ๐ ๐๐ต๐ฒ ๐ฟ๐ฒ๐น๐ฎ๐๐ถ๐ผ๐ป๐๐ต๐ถ๐ฝ ๐๐ผ ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ-๐ญ, ๐ฐ๐๐ต ๐ฒ๐ฑโ
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. ๐๐ ๐๐ฅ๐ ๐ฝ๐๐ฏ๐น๐ถ๐๐ต๐ฒ๐ฑ two Final documents on ๐ฎ๐ฒ ๐๐ฝ๐ฟ๐ถ๐น ๐ฎ๐ฌ๐ฎ๐ฐ, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and
N52 Principles of Labeling for Medical Devices and IVD Medical Devices
The ๐ฝ๐๐ฟ๐ฝ๐ผ๐๐ฒ ๐ผ๐ณ ๐ก๐ฐ๐ณ ๐ด๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ 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.
While ๐ก๐ฑ๐ฎ ๐น๐ฒ๐๐ฒ๐ฟ๐ฎ๐ด๐ฒ๐ ๐ผ๐ป ๐ก๐ฐ๐ณ ๐ฎ๐ ๐ถ๐โ๐ ๐ฝ๐๐ฟ๐ฝ๐ผ๐๐ฒ 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.
With the ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ-๐ญ, ๐ฐ๐๐ต ๐ฒ๐ฑ๐ถ๐๐ถ๐ผ๐ป ๐ฝ๐ฟ๐ผ๐ท๐ฒ๐ฐ๐ underway ๐ผ๐ป๐ฒ ๐ผ๐ณ ๐๐ต๐ฒ ๐๐ฒ๐๐ถ๐ด๐ป ๐ฆ๐ฝ๐ฒ๐ฐ๐ถ๐ณ๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ – ๐๐ผ๐ฎ๐น ๐ฒ of the ๐๐ฟ๐ฐ๐ต๐ถ๐๐ฒ๐ฐ๐๐๐ฟ๐ฒ ๐ฆ๐ฝ๐ฒ๐ฐ๐ถ๐ณ๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป:
โEstablish a policy relating requirements of the IEC 60601 series to the IMDRF essential principles and labelling principles.โ
๐๐ผ๐ฎ๐น ๐ฒ ๐ถ๐ ๐ฑ๐ถ๐ฟ๐ฒ๐ฐ๐๐น๐ ๐ฟ๐ฒ๐น๐ฎ๐๐ฒ๐ฑ ๐๐ผ ๐๐ต๐ฒ ๐๐ ๐๐ฅ๐ ๐ฑ๐ผ๐ฐ๐๐บ๐ฒ๐ป๐๐ ๐ก๐ฐ๐ณ ๐ฎ๐ป๐ฑ ๐ก๐ฑ๐ฎ ๐๐ต๐ถ๐ฐ๐ต ๐๐ฒ๐ฟ๐ฒ ๐ฟ๐ฒ๐ฐ๐ฒ๐ป๐๐น๐ ๐๐ฝ๐ฑ๐ฎ๐๐ฒ๐ฑ ๐๐ผ ๐๐ฑ๐ถ๐๐ถ๐ผ๐ป ๐ฎ.
The Architecture Spec states:
โIt is the ๐ฝ๐ผ๐น๐ถ๐ฐ๐ ๐ผ๐ณ ๐๐๐/๐ง๐ ๐ฒ๐ฎ ๐๐ผ ๐ถ๐ป๐ฐ๐น๐๐ฑ๐ฒ ๐ฎ๐ป ๐ถ๐ป๐ณ๐ผ๐ฟ๐บ๐ฎ๐๐ถ๐๐ฒ ๐ฎ๐ป๐ป๐ฒ๐
๐บ๐ฎ๐ฝ๐ฝ๐ถ๐ป๐ด the ๐ฟ๐ฒ๐น๐ฎ๐๐ถ๐ผ๐ป๐๐ต๐ถ๐ฝ ๐๐ผ ๐๐ต๐ฒ ๐๐ ๐๐ฅ๐ ๐๐ฆ๐ฆ๐๐ก๐ง๐๐๐ ๐ฃ๐ฅ๐๐ก๐๐๐ฃ๐๐๐ฆ ๐ฎ๐ป๐ฑ ๐๐๐๐๐๐๐๐ก๐ ๐ฃ๐ฅ๐๐ก๐๐๐ฃ๐๐๐ฆ in ๐ฒ๐ฎ๐ฐ๐ต ๐ผ๐ณ ๐๐ต๐ฒ ๐๐๐ฎ๐ป๐ฑ๐ฎ๐ฟ๐ฑ๐ ๐ผ๐ณ ๐๐ต๐ฒ ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ ๐ฆ๐๐ฅ๐๐๐ฆ.โ
This is a goal of IEC/TC 62. For the IEC 60601-1, 4th edition project all Working Groups (WGโs) are tasked to do this work in their WGโs. There are 12 WGโs split up by hazards. 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 states:
โThe ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ ๐ถ๐ป ๐บ๐ฎ๐ป๐ ๐ผ๐ณ ๐๐ต๐ฒ ๐๐๐ฎ๐ป๐ฑ๐ฎ๐ฟ๐ฑ๐ ๐ถ๐ป ๐๐ต๐ฒ ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ ๐ฆ๐๐ฅ๐๐๐ฆ are ๐ถ๐ป๐๐ฒ๐ป๐ฑ๐ฒ๐ฑ ๐๐ผ ๐ณ๐๐น๐ณ๐ถ๐น ๐๐ผ๐บ๐ฒ ๐ผ๐ณ ๐๐ต๐ฒ ๐ฝ๐ฟ๐ถ๐ป๐ฐ๐ถ๐ฝ๐น๐ฒ๐ set out ๐ถ๐ป ๐๐ต๐ฒ ๐๐ ๐๐ฅ๐ ๐ด๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ ๐ฑ๐ผ๐ฐ๐๐บ๐ฒ๐ป๐๐. 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 ๐ฐ๐น๐ฒ๐ฎ๐ฟ๐น๐ ๐ถ๐ป๐ฑ๐ถ๐ฐ๐ฎ๐๐ฒ ๐๐ต๐ถ๐ฐ๐ต ๐๐ ๐๐ฅ๐ ๐ฝ๐ฟ๐ถ๐ป๐ฐ๐ถ๐ฝ๐น๐ฒ๐ ๐ฎ๐ฟ๐ฒ ๐ฐ๐ผ๐๐ฒ๐ฟ๐ฒ๐ฑ ๐ฏ๐ ๐๐ต๐ถ๐ฐ๐ต ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ ๐ถ๐ป ๐ฎ ๐๐๐ฎ๐ป๐ฑ๐ฎ๐ฟ๐ฑ ๐ถ๐ป ๐๐ต๐ฒ ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ ๐ฆ๐๐ฅ๐๐๐ฆ.โ
This ๐๐ผ๐ฎ๐น ๐ฒ ๐๐๐ฝ๐ฝ๐ผ๐ฟ๐๐ ๐๐ต๐ฒ ๐๐ ๐๐ฅ๐โ๐ ๐ฐ๐ผ๐ป๐ฐ๐ฒ๐ฝ๐ ๐ผ๐ณ ๐ฒ๐น๐ถ๐บ๐ถ๐ป๐ฎ๐๐ถ๐ป๐ด ๐ฑ๐ถ๐ณ๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ๐ ๐ฏ๐ฒ๐๐๐ฒ๐ฒ๐ป ๐ท๐๐ฟ๐ถ๐๐ฑ๐ถ๐ฐ๐๐ถ๐ผ๐ป๐ which ๐ฑ๐ฒ๐ฐ๐ฟ๐ฒ๐ฎ๐๐ฒ๐ ๐๐ต๐ฒ ๐ฐ๐ผ๐๐ ๐ผ๐ณ ๐ด๐ฎ๐ถ๐ป๐ถ๐ป๐ด ๐ฟ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐ฐ๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ from the various AUTHORITIES HAVING JURISDICTION (AHJ) and allows ๐ฝ๐ฎ๐๐ถ๐ฒ๐ป๐๐ ๐ฒ๐ฎ๐ฟ๐น๐ถ๐ฒ๐ฟ ๐ฎ๐ฐ๐ฐ๐ฒ๐๐ ๐๐ผ ๐ป๐ฒ๐ ๐๐ฒ๐ฐ๐ต๐ป๐ผ๐น๐ผ๐ด๐ถ๐ฒ๐ ๐ฎ๐ป๐ฑ ๐๐ฟ๐ฒ๐ฎ๐๐บ๐ฒ๐ป๐๐. This is a positive impact on patients and also makes for an easier process for the manufacturers and for the AHJโs, as well.
When IEC TC 62/SC 62A/WG 39 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 edition project. One aspect WG 39 is dealing with is โInformation to be supplied by the manufacturerโ (i.e. Labeling). This is the IEC 60601-1, 4th 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. ๐ฆ๐๐ฎ๐ ๐๐๐ป๐ฒ๐ฑ ๐ณ๐ผ๐ฟ ๐บ๐ผ๐ฟ๐ฒ ๐๐ฝ๐ฑ๐ฎ๐๐ฒ๐โผ๏ธ
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