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.
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