Hello all,

Camille raises a good point about the why.

In the medical sector, we have just published a new edition of the general
standard for medical electrical equipment (IEC 60601-1:2005).  It has an
extensive Annex A, rationale and guidance, which contains the why for most
of the requirements.  All of the related collateral and particular
standards of that family are under revision (for harmonization with this
new edition) and the responsible subcommittees expect the working groups to
include the why for every significant requirement.

The why is expected to include an indication of what hazard or hazardous
situation is being addressed and, where appropriate, why the working group
chose the risk control measure (requirement) that they did.

All though expensive, you may find that this standard is a good place to
start.

Best regards,

Dave Osborn
PM-UM
Philips Medical Systems
PMS-158 3178
Tel: +1 978 659 3178
Fax: +1 978 685 5624
[email protected]


                                                                           
                                                                           
                                                                           
                                                                        To 
                                       "Robinson, Kevin P."                
                                       <[email protected]>                
     Camille Good                      [email protected]                   
     <goodca_veris@yahoo.                                               cc 
     com>                                                                  
                                                                   Subject 
     Sent by:                          Re: Product Safety Educational      
     [email protected]                 Programs                            
                                                            Classification 
     05/26/2006 03:09 PM                                                   
                                                                           
                                                                           
                                                                           
                                                                           
                                                                           
                                                                           




Kevin,

I can't add much to what other members of this group have already stated,
but I do understand your frustration as I was similarly frustrated when I
first started working in product safety engineering.

I did work for UL for a couple of years from 1998 to 2000, but I never got
a chance to take their HBSE course. However, I never heard anything but
praise of it from a number of senior engineers there, and I was told that
it will really help you understand where a lot of the requirements come
from. I am hoping to take the course myself if I can get over to the PSES
convention this year in October.

My experience with product safety engineers is that they are a very helpful
group. Anyone who has worked with product safety (or EMC) for a while has
usually met more than enough young engineers who fight any "unnecessary"
product features or testing tooth and nail, so when someone actually wants
to learn and get it right the first time, it's a happy day!  Lurking on
this group is an excellent place to start; I know I've learned a lot over
the last couple of years.

Also, if there is a particular area or product type that you will be
working in, see if you can find a mentor or friendly expert in that area.
And, as has been mentioned by others, you may be too new to sit on
standards-writing committees, but you can learn a lot if you can attend
some of the meetings as an observer. "Why" is as important as "what" when
it comes to reading & applying product safety requirements, but "why" is
typically never documented, except in the memories and private
correspondence of those who have been working in product safety for years
or even decades. Going to the standards meetings, or finding an expert
willing to answer questions, is the best way to find out "why".

Best of luck,
-Camille Good
Portland, Oregon

"Robinson, Kevin P." <[email protected]> wrote:
Can anyone provide me with information on Product Safety training
courses that may be available through colleges/universities or private
sector (Laboratories, manufacturers etc). I know that many laboratories
offer 1-2 day seminars, but I am interested to see if there are courses
that go into much greater depth and detail.

Thank you,

Kevin Robinson




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