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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,
𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru’s very own
𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:‼️
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources
The international standard for the application of medical device symbols on labels, ISO 15223-1, has been amended and the 4th Edition will replace ISO 15223-1:2016
This amendment is multifaceted and will introduce many new changes to the symbol requirements that medical device organizations around the world will be expected to follow.
The 4th Edition of ISO 15223-1 will include 25 additional symbols in total, newly defined terms and removal of existing terms as well as inclusion of terms from other standards, and expansion of the informative annex containing examples—just to name a few.
IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, & 60601-1-12). It was published on 20 August 2020 on the
It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape. With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that