Component reliability and longevity data for medical product

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1

Good morning sir/maam,

Myself Rajesh Jat, working on medical device insulin pump. For component selection, I have referred STM medical component selection application notes [en.brhealth 2.pdf] but some components are available on only one distributor website, so looking to know longevity data for following components:

STC3100 : Reliability and longevity data,

STM32L476RG : Reliability and longevity data,

STM BLUE NRG 2 M2SP : Reliability and longevity data,

STSPIN 250 : Reliability and longevity data,

M24M02-DR : Reliability and longevity data.

Please provide me some suggestion also, replacement of IC with other new arrival component. Thanks for your time and support

From Rajesh Jat,

2

@Rajeshjat welcome to the forum! Could you please explain what you expect for such data? “Reliability and longevity” is a little vague. Are you asking for shelf life, MSL, the status of the part (obsolescence info), RoHS information, etc…? Also, could you please provide the full manufacturer part numbers for all of the parts? Each part number provided leads to a few options in our systems, I want to make sure I’m looking at the right items. The third part number especially is missing key data for me to locate.

Thank you in advance, clarification will help us identify exactly what you need.

3

Good Morning Sir,
I am looking for working without hardware failure, testing report and status of obsolescence for 10 years and certification data. Part no of following component are:

  1. 497-STM32L476ZGT6CT-ND
  2. 497-BLUENRG-M2SPCT-ND

  3. STC3100IST

  4. M24M02-DRMN6TP

  5. 497-17035-1-ND

Thank for your reply.

4

Thank you for some clarification. For the “obsolescence status” request, we cannot provide info that far out for any component. Manufacturers do not have “planned obsolescence reports” but rather analyze whether the parts are going to be 1: up to date, 2: profitable, 3: see if there is a replacement technology amongst other factors year to year (some review their parts far more often). The manufacturers then inform the distributors when and if the parts become obsolete or start off being “Not Recommended for New Design” parts (this is usually the first sign that the parts are going obsolete soon). When a part’s status is finally given an EOL (end of life) date, then it usually quickly obtains an obsolete status. All of these parts have a current status of “Active”, which is usually a good sign that they will not become obsolete for quite some time, unfortunately, there is no good way to know for sure how long but I’ve seen Active parts stay active far beyond ten years.

We need to know what kind of test report you are looking for and what type of certification data you need. We can certainly provide a certificate of conformance for each part upon request, but there are a lot of types of certification. The same thing applies to test data, there is a lot of different kinds of tests done on parts if you mean to ask for the shelf life of each part we can certainly find out what that may be per part.

5

Good morning sir,
Thanks for above clarification of obsolescence status. For test report, I am looking for Mean time between failure, Under temperature stress component failure and without failure working hours report. For certification, we are going for medical product certification class 3 for ISO and IEC, related to this certification you have what document about each component, please provide us the following on this medium or by mail :

6

Anything more needed from my side. Please provide me data, it getting bit late.