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A Simple Trick that Safety Test Labs Don’t Want You to Know!

posted Sep 9, 2014, 1:43 PM by Unknown user   [ updated Oct 30, 2014, 7:39 AM by Unknown user ]
Important Changes Made to IEC 60601-1 Test Report Form, Ver j

On July 4th 2014 a new version j of the IEC 60601-1 Test Report Form (TRF) was published  to replace version h.   Version j is like version h in that they both are used with amendment 1 of 3rd ed 60601-1, which requires less risk results compared to without the amendment. The difference is that it changes how to document the risk results in the TRF in hopes to be more straightforward and simpler.

The list of changes are the following:

  1. Only one risk management (RM) result table for Clause 4.2.2 to document references to all elements of ISO 14971:2007.  All other RM results tables have been removed.

  2. The clauses that need risk results are now documented within the “Result - Remarks” column of the TRF. Remarks must include references the specific line item of the hazard analysis/FMEA, containing the hazard and the related risk control information for the specific medical device under investigation.

The end result was to simplify the risk management documentation compared to the previous 60601-1 TRF versions.  For example version j has one RM table (for Cl. 4.2) compared to version H which requires up to 80 RM Result Tables.  Without RM result tables there is not a need to repeat information that added little value.  This process of referencing risk results will take less time time and make it simpler for the both the customer and test laboratory.

About OBCM

OBCM specializes in providing testing, consulting, and training services for IEC 60601-1, ed 3.1 and related standards for medical equipment, for our clients located worldwide.  

Each year, our 3 day training course is offered in the US on the east and west coasts; and in Europe.  The course continues to evolve to stay up to date with the latest standards, interpretations, regulatory guidance, and feedback from over 1000 past participants.