Is there a special grade for electronic components made to be used in medical devices such as life support systems? I have read in most data sheets that "this product is not to be used in life support systems". So is there a medical grade version for every devices like "medical grade" Atmega 328?
3
-
2\$\begingroup\$ Nope! Many, many electronic products do not have a medical version. \$\endgroup\$– OldfartCommented Apr 2, 2020 at 7:21
-
\$\begingroup\$ You might be interested in the Medical Devices Regulation. The actual requirements are more on the whole system than on individual components. \$\endgroup\$– MSaltersCommented Apr 2, 2020 at 15:27
-
\$\begingroup\$ Reading between the lines here, if you use a component in a medical device, and the manufacturer has explicitly told you not to use it in life support systems, and the component fails, and someone dies, you will completely and solely liable for the failure of that product. \$\endgroup\$– Elliot AldersonCommented Apr 2, 2020 at 19:48
Add a comment
|
2 Answers
\$\begingroup\$
\$\endgroup\$
5
The only 'grade' that is sometimes specific to medical components is encapsulation. Stuff that is going to be used "in people" has different encapsulation requirements than stuff that is going to be used "in a home"
Medical components have test, traceability and documentation requirements. Test, traceability and documentation typically require that the production and distribution channels meet test, traceability and documentation requirements.
For the Atmega 328, it may only be used with "an Atmel officer's specific written consent." If you want a medically qualified 328, you'll have to pay for the test, traceability and documentation. And the business insurance.
-
1\$\begingroup\$ So does it mean same micro controller used for diy projects are/can be used for ventilators? \$\endgroup\$– UserCommented Apr 2, 2020 at 8:40
-
1\$\begingroup\$ david - in the vast majority of cases, these devices are not "in people", it applies to all equipment for medical use. The rest is all valid :) @ASWINVENU - there will be a lot of cross over, it costs a lot to develop a new chip and toolchain. Volumes for medical equipment are low. A specific medical product might contain more reliability functions, e.g. ECC on RAMs. \$\endgroup\$– awjloganCommented Apr 2, 2020 at 9:11
-
4\$\begingroup\$ @ASWINVENU Furthermore a new chip will always be less reliable than a massively used one. So, yes, life assistance devices use generic components, albeit with the highest quality offered by the industry. I would say, the complete design and concept is more important than the components taken individually. \$\endgroup\$– FredledCommented Apr 2, 2020 at 10:15
-
4\$\begingroup\$ "Test, traceability and documentation typically require that the production and distribution channels meet test, traceability and documentation requirements." Sorry but this sentence is pretty useless for anyone who does not already know what test, traceability and documentation requirements are. And, to think about it, it is also probably useless to people who already know, too. Could you rewrite it to get rid of circular definition? Define it in a way that does not rely on knowing that stuff already? \$\endgroup\$– MołotCommented Apr 2, 2020 at 15:49
-
\$\begingroup\$ @awjlogan In the vast majority of cases, devices are not "in people". Which is why the specific encapsulation requirements for use "in people" are not what is required - only test, documentation, and traceability. \$\endgroup\$– davidCommented Apr 4, 2020 at 2:56
\$\begingroup\$
\$\endgroup\$
3
There is no defined grade for medical. There are only norms defining what a medical product must comply with.
Some manufacturer may have e a special product series of a part such as military, space or aviation grade, but you usually don't see those on the manufactures websites.
Most common parts have the text line you mentioned because of liablity.
-
2\$\begingroup\$ You may also see "automotive grade". The general rule is that you're looking for components that may be used in life-critical systems, i.e. where failure of the system could put lives at risk. Luckily, a lot of medial hardware lives in hospitals, which have a well-controlled environment so you typically have less temperature issues. \$\endgroup\$– MSaltersCommented Apr 2, 2020 at 15:23
-
2\$\begingroup\$ @MSalters: As a further complication, many kinds of devices may be used in either life-critical or non-critical situations. For example, if an automatic respirator is only used in the presence of someone who would be trained, equipped, and ready to use a manual respirator if the automatic one fails, it might merely need to ensure that it sounds an alarm if something goes wrong; one that might be used unattended, by contrast, would need to not fail. Meeting the former objective with acceptable reliability may be much cheaper than meeting the latter. \$\endgroup\$– supercatCommented Apr 2, 2020 at 15:41
-
\$\begingroup\$ @supercat: Entirely correct. In fact, just this week I put a device on our lab that is certified to do exactly that, send out an alarm if a connected automated respirator fails. The hardware may be certified, but the way I installed it certainly isn't. (The certified install does have an alarm, but more importantly it has an all-OK led light indication. The reason is that such indicators are fail-safe. E.g. in a power outage they don't stay on). \$\endgroup\$– MSaltersCommented Apr 2, 2020 at 16:03