Spyros,
Thank you. I'm looking for degradation with a difference sense than 10993, but in a reliability sense. A classic example is a resistor changes value over time, it degrades. When it reaches a certain value the circuit no longer functions correctly.
The model monitors the value over time to predict when the resistor reaches the critical value. Often this done using accelerating factors. Also, the resistor, because it is high reliability, may not reach the critical value during the test, no failures.
I have not found a standard that address the method, but some textbooks. This is a response to FDA, so citing a standard could add weight to the response.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 01-Nov-2020 07:25
From: Spyros Drivelos
Subject: Degradation Analysis
Hi Dan,
i do not know the nature of the device you are refering to, but why don't you take a look to the ISO 10993 series? 10993-9 and 13,14,15 give a lot of valuable information about degradation products.
Hope they help you.
if you need something more specific we can continue the conversation
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
Original Message:
Sent: 30-Oct-2020 10:20
From: Dan O'Leary
Subject: Degradation Analysis
I'm working on project to set the shelf life of a medical vice. Previous studies have shown no failures, so I've decided to use degradation analysis. We don't have a method to accelerate the life, so we will use real time information.
There is a good discussion of degradation analysis in the NIST/SEMATEC Statistical Engineering Handbook. It refers to a book by Tobias and Trindade and one from Nelson for the methods and analysis. I have both books, and they are valuable.
We would like to find a standard, such as ISO, IEC, or ASTM for the method. I have not been able to identify one. The device is not medical electrical equipment, but IEC has a lot of reliability standards.
Do you know of a standard for degradation analysis?
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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