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Attention ISO 15223-1 4th Edition is Almost Here: How to …

WEBContact Leo Eisner: Leo@EisnerSafety.com +1 503-709-8328 www.eisnersafety.com Pg 2 of 18 Attention ISO 15223-1 4th Edition is Almost Here: How to Update Your Medical …

Actived: 4 days ago

URL: https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/09/ISO-15223-1-Webinar-FAQ-FINAL-v1.pdf

Health Canada Revised Significant Change Interpretation …

WEBOn January 20, 2011 Health Canada issued a notice in regard to the “Guidance for the Interpretation of Significant Change of a Medical Device”.. This newly …

Category: Medical Go Health

Med Dvcs E-Lableing: Health Canada TPD’s Interpretation

WEBOn November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with …

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FDA Issues Draft Guidance on MedDvcs Intended for Home Use

WEBOn 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended …

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IVDD Harmonized Standards List – Eisner Safety Consultants

WEBWhat’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed? May 16, 2024; IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

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Are you Ready for IEC 60601-1-2, 4th ed. (EMC)

WEBCanada – In Health Canada’s List of Recognized Standards it states that until December 31, 2018 it will accept Declarations of Conformity to either 3rd or 4th …

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IEC 60601 Medical Electrical Equipment Classifications: FAQ’s

WEBIEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog. Why do I need to classify my product for IEC 60601 …

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IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2

WEBThis blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard. This blog discusses the …

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GHTF has transitioned to IMDRF – Eisner Safety Consultants

WEBAs of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical …

Category: Medical Go Health

IEC 60601-1, 4th Edition Project – Where Do We Stand

WEBSome History. The “Architectural Specification for Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in …

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MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System …

WEBThis blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance …

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CAN/CSA C22.2 No. 60601-1:14 Added to Health Canada’s List of

WEBThis post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list …

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CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) …

WEBAs of March 1, 2014 Canada is now accepting edition 3.1 with National Deviations under CAN/CSA C22.2 No. 60601-1:14. I have been advised by CSA and a …

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FDA Finally Adds to Fall 2020 Recognized Consensus

WEBUpdated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in …

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Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC …

WEBToday (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE …

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IEC 60601-1:2012 Consolidated 3.1 Edition Just Published

WEBOn August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC 60601-1) combined …

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Welcome Mary Weick-Brady to Eisner Safety Consultants

WEBIf you need additional support for Wearable Medical Devices and Home Use Medical Devices email Leo Eisner at [email protected], or call Leo at +1- (503) …

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JIS T 0601-1:2012 Just Published (Japan’s National Version of IEC …

WEBOn June 1, 2012 Japan issued their national version of IEC 60601-1:2005 (or 3rd ed.). The transition period has started as of June 1, 2012 but I am still determining what products …

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CAN/CSA C22.2 No. 60601 Standard Changes

WEBCAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released. If you need additional support for IEC or CAN/CSA C22.2 No. 60601-1, 3rd …

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