Steve Sauer previously wrote:
>Hi Steve,
>I believe according to UL, a class 3 medical device is a life support or
>life sustaining piece of equipment. Two examples would be a pacemaker and
>an incubator. As such the requirements of J-STD-001 or IPC-A-610 would
I don't have UL1601 in front of me, but that UL document was largely a
reprint of IEC601-1 (Medical Electrical Equipment, Part 1: General
Requirements for Safety), which in order to confuse us all, the IEC has now
renumbered IEC60601-1. In IEC60601-1, there are no class 3 devices. Here is
a thumbnail description of the classification scheme in IEC60601-1 (see
clause 5):
1) type of protection against electric shock
class I - uses basic insulation plus safety ground wire
class II - uses double or reinforced insulation without safety ground
wire
2) degree of protection against electric shock
type B - basic
type BF - basic with isolated (floating) patient circuitry
type CF - more stringent with isolated (floating) patient circuitry,
usually for direct cardiac application
3) degree of protection against harmful ingress of water
ordinary
drip-proof
splash-proof
watertight
4) method of sterilization
5) degree of safety in the presence of flammable anaesthetic gases
not suitable
category AP - for use with flammable anaesthetic mixture with air
category APG - for use with flammable anaesthetic mixture with oxygen
or nitrous oxide
6) mode of operation
continuous
short-time
intermittent
continuous with short-time loading
continuous with intermittent loading
Depending on the intended end use, PCB's would either be class 2 or 3.
The FDA does categorize medical devices as class I, II or III.
Unfortunately, the definitions of the three classes is slightly different
for each end use device classification. For more information on this, visit
http://www.fda.gov/cdrh/devadvice/313.html
So when someone says "class 3 medical" in reference to a board, they could
mean either a board for use in an FDA class III device or an IPC class 3
board for use in an unspecified medical device.
The FDA's current main document on medical device manufacturing is the Good
Manufacturing Practices/Quality Systems Regulation, see
http://www.fda.gov/cdrh/dsma/cgmphome.html#contents. This is similar in
intent to ISO9000. Depending on the end use device, it could mean no change
to your current operating procedures or a total revamping of them. For what
it's worth, I know of small board fabricators and assembly houses that do
medical business.
Seth Goodman
Goodman Associates
7687 Leta Way
Verona, WI 53593-8631
Tel (608)833-9933
Fax (608)833-9966
> -----Original Message-----
> From: TechNet [mailto:[log in to unmask]]On Behalf Of Steve Underwood
> Sent: August 03, 1999 6:01 AM
> To: [log in to unmask]
> Subject: [TN] class 3 medical
>
>
> Hello Technetters,
>
> One of our Sales persons has a customer inquiring if we can build a
> "class 3 medical" type board. Is this just a class 3 type board used in
> medical equipment, or is there a special category of boards out there
> classified as "medical?"
>
> Steve Underwood
> Engineering Manager
> Circuit Center, Inc., 4738 Gateway Circle, Kettering, Ohio 45440
> (937) 435-2131 phone (937) 435-7698 fax
> [log in to unmask]
>
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