Hello Bedwuine,
If there is not an available ASTM standard applicable to your product, then in most cases the development of testing methods would be a result of your design inputs, e.g. specifications for the product. There may be situations where you can use similar ASTM standards as a starting point and there may also be expectations for testing as well, such as competitor or similar devices on the market already having performance requirements. In my experience there were many times we had to develop our own internal test method for a product to ensure design outputs meets the design inputs. Also depending on the test method this should be validated to ensure the test method is correct and more importantly the test method is providing the correct results. The test method validation is sometimes not needed if the testing method is obvious, though should have rationale and justification around for how the company developed the internal test method.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-May-2022 22:16
From: Bedwuine Senatus
Subject: ASTM standards
I have a few questions here...What happened if you develop a product and you dont have an ASTM standards to comply with for testing.. Do you develop your own ASTM, if yes How? Or do you just come with an internal test method in the lab to test on product.
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Bedwuine Senatus
QA/RA Director
Springfield NJ
United States
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