Accelerated Aging for Medical Products ASTM F1980 - 16 and ASTM D 4169 - 2016

 

ASTM F 1980 - 16 Chamber  

My company, QRA International has the honor of providing accelerated aging tests for medical devices in these 2 standards listed below :

- ASTM  F1980 - 16  (2016) and

- ASTM  D 4169

ASTM F 1980 - 16

This is a universal tests for accelerated aging whereby the F 1980 - 16 is attained by using temperature and humidity at accelerated levels (between 50 to 60 C) to age devices for durations of 9, or 18 months long depending on what is the planned expected end of life of the product.

The standard follows traditional Arrhenius equations whereby samples which have a shelf life of (for example) 3 years or 36 months, have to undergo aging tests in environmental chambers. My company manufactures such chambers (under the QRA brand) or  we provide testing services in our 2 Laboratories in Singapore. 

Currently we have 22 chambers in our Labs and are growing rapidly.

Please do contact me at mark@qra.com.sg or qrasale@qra.com.sg for a quotation and further consultation.

ASTM D 4169 - 13

This is another universal test for medical devices which has Schedules A to F whereby  each schedule refers to a different type of test procedure.

In the case above of the standard above, the schedules can be 

a) drop test

b) vibration

c) compressed packaging 

d) impact shock

Again, please do contact me if you are a medical device manufacturer and require quotation and / or consultation.

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