HC List of Rc'ed DStds Front pg

This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015.

Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015.  The changes included additions, updates and removals to the listing.  Part 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).  It includes some Canadian National Deviations in the standard.  To find out more detail about this standard please refer to a blog post  I wrote back in 2014 on the topic.  The IEC 60601-1:2012-Ed.3.1 was also added to this Listing.

Several other changes of significance to the list of Recognized Standards for Medical Devices include.  This is a partial list of changes so refer to the list for more details:

  1. The addition of the previous version of IEC 60601-1-11:2010-Ed. 1.0 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. For those that subscribe to the Eisner Safety Consultants Standards Reconnaissance Database you would know that the current version of IEC 60601-1-11 was updated in 2015.  This version of the standard is not on the Health Canada List of Recognized Standards for Medical Devices as of yet.
  2. The removal of ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.  This standard has a replacement which was placed on the list previously which is ISO 80601-2-61:2011-Ed.1.0, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.  In the Foreword of 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 been 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 So, the ISO 9919 standard has now been replaced by ISO 80601-2-61.  To 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 Standards Reconnaissance Database.  We provide you with the FDA & Health Canada information about each standard that is in the database.  This way you don’t have to search an extra databases as this information is all in one place for each standard.  
  3. The list added another older standard IEC 62366:2007 Medical devices – Application of usability engineering to medical devices.  The more recent version is IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices.  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).”  The 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 Standards Reconnaissance Database
  4. The Canadian and the International versions of IEC 60601-1, 2nd edition have been removed from the list including: CSA C22.2 NO. 601.1 M90 (R2006) Medical electrical equipment – Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990) and IEC 60601-1:1988-Ed.2.0 Medical electrical equipment – Part 1: General requirements for basic safety + IEC 60601-1/Amd.1:1991 + IEC 60601-1/Amd.2:1995 + IEC 60601-1/Cor.1:1995.

These are just some of the changes that are of importance.  The below listings shows the August 31, 2015 Additions, Updates, and Removals to the Health Canada List of Recognized Standards for Medical Devices.  When there are updates to Regulatory Lists of Standards we will update the Eisner Safety Consultants Standards Reconnaissance Database 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.  In the near future we will be adding in the European List of Harmonized Standards to this monitoring process.

Below are the 3 parts of the Health Canada list that have changed:

The Additions to the list of Recognized Standards include the following:

  • ISO 5840-3:2013 Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
  • ISO 14117:2012-Ed.1.0 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
  • IEC 60601-1:2012-Ed.3.1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  • CAN/CSA-C22.2 NO. 60601-1:14 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-11:2010-Ed. 1.0 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • IEC 60601-2-57:2011-Ed.1.0 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
  • IEC 62366:2007 Medical devices – Application of usability engineering to medical devices
  • ISO 13408-1:2008 Aseptic processing of health care products – Part 1: General requirements
  • ISO 13408-2:2003 Aseptic processing of health care products – Part 2: Filtration
  • ISO 13408-3:2006 Aseptic processing of health care products – Part 3: Lyophilization
  • ISO 13408-4:2005 Aseptic processing of health care products – Part 4: Clean-in-place technologies
  • ISO 13408-5:2006 Aseptic processing of health care products – Part 5: Sterilization in place
  • ISO 13408-6:2005 Aseptic processing of health care products – Part 6: Isolator systems
  • ISO 13408-7:2012 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products
  • ISO 14644-1:1999 Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness
  • ISO 14644-2:2000 Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
  • ISO 14644-3:2005 Cleanrooms and associated controlled environments – Part 3: Test methods
  • ISO 14644-4:2001 Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up
  • ISO 14644-5:2004 Cleanrooms and associated controlled environments – Part 5: Operations
  • ISO 14644-6:2007 Cleanrooms and associated controlled environments – Part 6: Vocabulary
  • ISO 14644-7:2004 Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments)
  • ISO 14644-8:2012 Cleanrooms and associated controlled environments – Part 8: Classification of air cleanliness by chemical concentration (ACC)
  • ISO 14644-9:2012 Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle concentration
  • ISO 14644-10:2013 Cleanrooms and associated controlled environments – Part 10: Classification of surface cleanliness by chemical concentration
  • ISO 14698-1:2003 Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
  • ISO 14698-2:2003 Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data
  • ASTM F2028-14 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

The Updates to the list of Recognized Standards include the following:

  • ISO 14708-2:2012 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
  • IEC 60601-2-24:2012-Ed.2.0 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    Note: Additional accuracy testing results for flow rates below 1 mL/h may be required depending on the pump’s intended use
  • IEC 60825-1:2014-Ed.3.0 Safety of laser products – Part 1: Equipment classification and requirements
  • CSA Z900.1-12 Cells tissues, and organs for transplantation: General requirements
  • ASTM F1160-14 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
  • ASTM F1377-13 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
  • ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
  • ASTM F2943-14 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

The Removals to the list of Recognized Standards include the following:

  • ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
  • ISO 21647:2004 Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors
    ISO 21647/Cor.1:2005
  • ANSI/AAMI DF80:2003 Medical electrical equipment – Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators)
  • ANSI/AAMI PC69:2000 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
  • ANSI/AAMI PC69:2007 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
    ANSI/AAMI PC69/ERTA:2008
  • CSA C22.2 NO. 601.1 M90 (R2006)
    Medical electrical equipment – Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990)
  • CSA C22.2 NO. 60601-1-2A-03 (R2006)
    Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests (Adopted Amendment 1:2004 to IEC 60601-1-2:2001)
  • IEC 60601-1:1988-Ed.2.0
    Medical electrical equipment – Part 1: General requirements for basic safety
    IEC 60601-1/Amd.1:1991
    IEC 60601-1/Amd.2:1995
    IEC 60601-1/Cor.1:1995
  • IEC 60601-1-2:2004-Ed.2.1
    Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard – Electromagnetic compatibility – Requirements and tests
  • IEC 60601-1-4:2000-Ed.1.1
    Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems
  • IEC 60601-1-6:2006-Ed.2.0
    Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
  • IEC 60601-2-10:1987-Ed.1.0
    Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
    IEC 60601-2-10/Cor.1:1987
    IEC 60601-2-10/Amd.1:2001
  • IEC 60601-2-25:1993-Ed.1.0
    Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs
    IEC 60601-2-25/Amd.1:1999
  • IEC 60601-2-26:2002-Ed.2.0
    Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs
  • IEC 60601-2-36:1997-Ed.1.0
    Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
  • IEC 60601-2-47:2001-Ed.1.0
    Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
  • IEC 60601-2-51:2003-Ed.1.0
    Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

If you need help withCAN/CSA C22.2 No. 60601-1:14 or IEC 60601-1, 3rd edition or edition 3.1 or you are interested in the Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at , or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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