60601 1, 3rd Edition Linked In

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  • I would like to stress that this presentation is a very high level introductory meeting.
  • First let me comment that this meeting will not cover the product engineering aspects … the scope of this meeting is to convey
  • With the new edition … comes a number of safety changes. However the major areas of change is the required use of the product risk analysis.
  • NEW NAME The new edition now incorporates ‘essential performance’ as a safety requirement. NEW APPROACH In the 2 nd edition the risk analysis was mentioned but rarely used in compliance testing. In the 3 rd edition the Risk Analysis is used. NEW IMPLEMENTATION The European version will indicate a DOW for the second edition and a DOI for the third edition. This version will be a key ‘date’ indicator for the IEC countries, as well as the US and Canada.
  • With the theme encapsulated … I just would like to mention that the 3 rd edition is 396 pages cover to cover and the word ‘risk’ is mentioned 67 times which averages to once every 6 pages. 330 / 3 times … you can do the math on that one.
  • All features or functions that must perform properly to prevent HARM to the PATIENT, OPERATOR, or others are important, but not every feature or function of ME EQUIPMENT is ESSENTIAL PERFORMANCE. When a failure to perform would result in unacceptable RISK for the PATIENT, OPERATOR, or others, then those features or functions are, for the purposes of this standard, seen as ESSENTIAL PERFORMANCE.
  • Ok, the next portion of the presentation conveys implementation plan observations … which depict a “What do we do?’ or basic attack plan. Before we can implement any plan we really need to take a look at where we are at or our engineering processes with the requirements of the 3 rd edition. Over the past months I, along with a few other persons, have done some digging into the third edition: a brief recap: 1.) My initial research began on the third edition back in August 2005. In this dialog, I sourced Bob Burek of Intertek in numerous converstations. 2.) Conducted a formal meeting with Intertek in which we partnered with them to hash out 1. Specific Questions and most important 2. Intertek agreed that all new product would get a draft cut of the third edition report, with current 2 nd edition formal testing. I should also mention that Bob sets on the US technical committee for the 3 rd edition. 3.) Frank attended the AAMI Conference which highlight the arrival of the third edition and many general detail of the 3 rd edition. 4.) Last, if you have not notice I have been asking for the product DIS and additional documentation over the past months (and participating in the past in DFMEA’s) in order to make a concerted observation. In that, in regards to the requirements of the 3 rd edition we are in fair shape. SO WHAT DO WE DO?
  • Department Involvement
  • Current Product Risk Analysis should be updated to reflect the third edition changes and compliance.
  • The formal EN and Us version of the test report format has not been released.
  • 60601 1, 3rd Edition Linked In

    1. 1. 60601-1, 3 rd Edition Kick Off Presentation
    2. 2. Meeting Scope <ul><li>Highlight the Key aspects of the new edition of the General Safety Standard for Medical Devices. </li></ul><ul><li>Implementation Path </li></ul><ul><li>This Meeting Will Not Cover Testing Specifics. </li></ul>
    3. 3. Overview
    4. 4. 60601-1, 3 rd Edition <ul><li>NEW NAME </li></ul><ul><ul><li>General Requirements for Basic Safety and Essential Performance </li></ul></ul><ul><li>NEW APPROACH </li></ul><ul><ul><li>The Product Risk Analysis is a Key Measure of Compliance to the Safety Standard. </li></ul></ul><ul><li>NEW IMPLEMENTATION </li></ul><ul><ul><li>Expect World-Wide acceptance by 2009. </li></ul></ul>Basic Safety & Essential Performance Risk Analysis Implementation 2009
    5. 5. 60601-1, 3 rd Edition <ul><li>Encapsulated Theme of the 3 rd Edition </li></ul><ul><ul><li>The Product Risk Analysis is the Key Measure of Compliance to the Safety Standard. </li></ul></ul>
    6. 6. 60601-1, 3 rd Edition ‘New Name’
    7. 7. 60601-1, 3 rd Edition ‘New Name’
    8. 8. 60601-1, 3 rd Edition ‘New Approach’
    9. 9. 60601-1, 3 rd Edition ‘New Implementation’ <ul><li>Country Implementation </li></ul><ul><ul><li>The ‘Date of Withdrawal’ as published by the EU, European Union, will be the key “Date” for other countries. </li></ul></ul><ul><ul><li>No “Grandfathering”. </li></ul></ul>
    10. 10. 60601-1, 3 rd Edition ‘New Implementation’ First Look at Chattanooga Group CG 60601-1, 3 rd Edition
    11. 12. QUESTIONS COMMENTS
    12. 13. 60601-1, 3 rd Edition Recap
    13. 14. Next Steps <ul><li>What Do We Do? </li></ul><ul><ul><li>… that is cost effective! </li></ul></ul><ul><li>External Action Plan </li></ul><ul><li>Internal Action Plan </li></ul>
    14. 15. External Action Plan <ul><li>Complete Test Lab Audit of ISO 14971 </li></ul><ul><li>Ramp up work on the 3 rd edition with the Test Lab. </li></ul><ul><li>Start Draft Reports </li></ul>
    15. 16. Internal Action Plan
    16. 17. Combined Action Plans <ul><ul><li>Obtain Compliance to ISO 14971 </li></ul></ul><ul><ul><ul><li>Intertek will Audit our ISO 14971 System. </li></ul></ul></ul><ul><ul><li>Target Implementation Cost </li></ul></ul><ul><ul><li>Begin the transition to 60601-1, 3 rd </li></ul></ul><ul><ul><ul><li>Current Product </li></ul></ul></ul><ul><ul><ul><li>New Development </li></ul></ul></ul><ul><ul><ul><li>Registration Updates </li></ul></ul></ul><ul><ul><li>Complete transition before 2009 </li></ul></ul>
    17. 18. Forward Action <ul><li>Detail the 60601-1 requirements for the Product Risk Analysis. </li></ul><ul><ul><li>Must fit into the current product management and gate review process. </li></ul></ul><ul><li>Detail the Mechanical Requirements. </li></ul><ul><ul><li>May not be easy. </li></ul></ul><ul><li>Detail the remainder of the standard. </li></ul>
    18. 19. Check Point <ul><li>New Standard Is Here: </li></ul><ul><ul><li>Conduct the ISO 14971 Audit. </li></ul></ul><ul><ul><ul><li>Make Adjustments. </li></ul></ul></ul><ul><ul><li>Incorporate 3 rd Edition into all new designs. </li></ul></ul><ul><ul><ul><li>In Work </li></ul></ul></ul><ul><ul><li>Cover Risk Analysis and Mechanical Requirements Aspects of the 3 rd Edition. </li></ul></ul><ul><ul><ul><li>In Work – Mechanical </li></ul></ul></ul><ul><ul><li>Retesting Older Product </li></ul></ul><ul><ul><ul><li>Which Products? </li></ul></ul></ul><ul><ul><ul><li>Cost? </li></ul></ul></ul><ul><li>New Design </li></ul><ul><li>Mechanical </li></ul><ul><li>ISO 14971 Audit </li></ul>
    19. 20. Engineering Focus - Mgmt <ul><li>Keep Engineering Project Projections Updated. </li></ul><ul><li>Determine Which Products Stay and which Products Go. </li></ul><ul><li>FMEA and Internal (Documented) Testing… must be a living process. </li></ul><ul><li>Cost !#S#$&*… focus on product categories! </li></ul>
    20. 21. QUESTIONS COMMENTS

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