{"id":4472,"date":"2015-11-02T22:09:49","date_gmt":"2015-11-02T22:09:49","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4472"},"modified":"2015-11-02T22:09:49","modified_gmt":"2015-11-02T22:09:49","slug":"cancsa-c22-2-no-60601-114-added-to-health-canadas-list-of-recognized-standards","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/11\/02\/cancsa-c22-2-no-60601-114-added-to-health-canadas-list-of-recognized-standards\/","title":{"rendered":"CAN\/CSA C22.2 No. 60601-1:14 Added to Health Canada’s List of Recognized Standards"},"content":{"rendered":"

\"HC<\/a><\/p>\n

This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective\u00a031 Aug 2015.<\/p>\n

Health Canada updated their list of Recognized Standards\u00a0for Medical Devices<\/a><\/strong>\u00a0on August 31, 2015. \u00a0The changes included additions, updates and removals to the listing. \u00a0Part of the update was adding the Canadian National Version of IEC 60601-1, edition 3.1 (or 3rd edition + Amendment 1) which is the Canadian National Standard CAN\/CSA C22.2 No. 60601-1:14 (issued in 2014). \u00a0It includes some Canadian National Deviations in the standard. \u00a0To find out more detail about this standard please refer to a blog post<\/a><\/strong>\u00a0\u00a0I wrote back in 2014 on the topic. \u00a0The\u00a0IEC 60601-1:2012-Ed.3.1 was also added to this Listing.<\/p>\n

Several other changes of significance to the\u00a0list of Recognized Standards\u00a0for Medical Devices<\/a><\/strong>\u00a0include. \u00a0This is a partial list of changes so refer to the list for more details:<\/p>\n

    \n
  1. The addition of the previous version of IEC 60601-1-11:2010-Ed. 1.0\u00a0Medical electrical equipment \u2013 Part 1-11: General requirements for basic safety and essential performance \u2013 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.\u00a0<\/em>For those that\u00a0subscribe to the\u00a0Eisner Safety Consultants\u00a0Standards Reconnaissance Database<\/a><\/strong>\u00a0you would know\u00a0that the current version of IEC 60601-1-11 was updated in 2015. \u00a0This version of the standard is not on the Health Canada List of Recognized Standards for Medical Devices as of yet.<\/li>\n
  2. The removal of ISO 9919:2005\u00a0Medical electrical equipment \u2013 Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use<\/em>. \u00a0This standard has a replacement which\u00a0was placed on the list previously which is ISO 80601-2-61:2011-Ed.1.0,\u00a0Medical electrical equipment \u2013 Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment<\/em>. \u00a0In the Foreword\u00a0of the ISO 80601-2-61:2011 it says “This first edition of ISO 80601-2-61 cancels and replaces the second edition of ISO 9919:2005, which has\u00a0been revised to harmonize it with the third edition of IEC 60601-1:2005.” So, the ISO 9919 standard has now been replaced by ISO 80601-2-61. \u00a0To find out more details about this standard in regard to the FDA & Health Canada Recognized Standards Lists you may want consider subscribing to the Eisner Safety Consultants\u00a0Standards Reconnaissance Database<\/a><\/strong>. \u00a0We provide you with the FDA & Health Canada information about each standard that is in the database. \u00a0This way you don’t have to search an extra databases\u00a0as\u00a0this information is all in one place for each standard. \u00a0<\/span><\/li>\n
  3. The list added another older standard IEC 62366:2007\u00a0Medical devices \u2013 Application of usability engineering to medical devices.\u00a0<\/em> The more recent version is IEC 62366-1:2015\u00a0Medical devices – Part 1: Application of usability engineering to medical devices. \u00a0<\/em>The Foreword of the most recent standard indicates “This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014).” \u00a0The summary of changes noted here is part of the information we provide in each of the current versions of the standards for our paid subscribers for the Eisner Safety Consultants\u00a0Standards Reconnaissance Database<\/a><\/strong><\/li>\n
  4. The Canadian and the International versions of IEC 60601-1, 2nd edition have been removed from the list including:\u00a0CSA C22.2 NO. 601.1 M90 (R2006)\u00a0Medical electrical equipment \u2013 Part 1: General requirements for safety<\/em> (adopted amendment 2:1995 to IEC 601-1:1990) and\u00a0IEC 60601-1:1988-Ed.2.0\u00a0Medical electrical equipment \u2013 Part 1: General requirements for basic safety +\u00a0<\/em>IEC 60601-1\/Amd.1:1991 +\u00a0IEC 60601-1\/Amd.2:1995 +\u00a0IEC 60601-1\/Cor.1:1995.<\/li>\n<\/ol>\n

    These are just some of the changes that are of importance. \u00a0The below listings shows the August 31, 2015 Additions, Updates, and Removals to the Health Canada\u00a0List of Recognized Standards for Medical Devices. \u00a0When there are updates to Regulatory Lists of Standards we will update the\u00a0Eisner Safety Consultants\u00a0Standards Reconnaissance Database<\/a><\/strong> listing as soon as possible so you are kept up to date on the changes to the standards of that specific Regulator. Currently we are monintoring the list of standards for FDA & Health Canada. \u00a0In the near future we will be adding in the European List of Harmonized Standards to this monitoring process.<\/p>\n

    Below are the 3 parts of the Health Canada list that have changed:<\/p>\n

    The Additions to the list of Recognized Standards include the following:<\/p>\n