Hello from San Diego:
Jon Griver comments on the format of a generic standard.
A generic standard would not look like any standard we are currently
familiar with. Rather than think of a single standard, consider a
set of standards, each of which addresses a specific hazard. This
would not require particular standards for particular products.
Good examples of generic standards already in existence are intrinsic
safety standards, and DHEW x-radiation standards. Intrinsic standards
address circuits (regardless of product type) in hazardous atmospheres.
DHEW x-radiation standards address x-radiation for products with crt's.
If we consider electric shock, then the standard would be organized
something like:
1. Conditions for electric shock.
This would define the voltage and current under various situations
which would constitute an electric shock. For example,
a) Dry conditions.
b) Wet conditions.
c) Patient area.
d) Patient connections -- non-invasive.
e) Patient connections -- invasive.
Etc.
2. Protective mechanisms.
This would define the various schemes for providing protection
against electric shock for both normal conditions and abnormal
conditions.
a) Limited voltage (ELV, SELV).
b) Limited current.
c) Basic insulation requirements (air, solid, creepage).
d) Supplementary and reinforced insulation requirements.
e) Grounding requirements.
f) Accessibility.
g) Enclosure strength.
Etc.
3. Test methods and criteria.
This would define how to test the various protective schemes in
order to ascertain their adequacy.
a) Test method, i.e., how to do the test.
b) Test criteria, i.e., pass-fail numbers.
Standards for other hazards would follow the same format.
You would choose the applicable standards based on the various energy
sources in your product.
ECMA TC-12 is currently developing such a standard. Chairman is Jim
Kearns of Apple (Cork, Ireland). Secretary is Gino Lauri of ECMA
(Geneva). I believe they would make their drafts available for your
private review and comment (informal comment at this time as the work
is still in development). If you want their e-mail addresses, please
contact me privately.
Best regards,
Rich
+===========================================================+
|Richard Nute |Quality Department |
|Hewlett-Packard Company |Product Regulations Group |
|San Diego Division (SDD) |Tel : 619 655 3329 |
|16399 West Bernardo Drive |FAX : 619 655 4979 |
|San Diego, California 92127 |e-mail: [email protected] |
+===========================================================+
ps: If you want to know more about ECMA:
http://www.ecma.ch
