It does not tell you if you pass or fail, it is what comes after accelerated aging that indicates a pass or fail. If it is product testing, you want to go through all of the tests that you would have done at time-zero or your baseline to ensure aging … This means that every time you visit this website you will need to enable or disable cookies again. E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods. Nelson Laboratories, LLC 6280 S. Redwood Rd. E2953 Specification for Evaluating Accelerated Aging Performance of Electrochromic Devices in Sealed Insulating Glass Units However, there are some basic testing concepts that apply to all product and package types: expiry testing; strength, integrity, and microbial barrier testing; and package distribution testing. Please enable Strictly Necessary Cookies first so that we can save your preferences! Planning is the number one issue with accelerated aging. The documents listed below are referenced within the subject standard but are not provided as part of the standard. ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices For many products it’s critical that they can retain their performance and integrity over time. It is important, however, to consider the materials of construction when determining the test specifications. Packaging Compliance Labs provides ASTM F1980 testing to evaluate the long-term effects on packaging in a compressed timeline. In a perfect world with unlimited time and resources, manufacturers would only conduct real time aging tests. Related Products Some may keep moving the temperature up to meet specific needs for the launch date. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 4.5 When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. 1.1 This test method covers the accelerated aging of electrochromic devices (ECD) integrated in insulating glass units. 4.3 The procedures in this test method include (a) rapid but realistic current-voltage cycling tests emphasizing the electrical properties, and (b) environmental test parameters that are typically used in weatherability tests by standards organizations and are realistic for the intended use of large-area EC IGUs. Accelerated Aging Testing. Accelerated aging is a theoretical calculation of how a sterile packaging system will degrade over time. If you have a device and that device sits on the shelf with a three-year expiration date, by the time the three years goes by, the product may be obsolete. A package should be aged at low relative humidity because as the temperature is elevated you must also mimic that same about of moisture content. In the real world you are not aging your samples at 55 to 60°C. The calculator below generates a table of values for calculations based upon ASTM F1980, Accelerated Aging of … Accelerated aging is optional, but real-time aging is required when establishing an expiration date. Accelerated aging is based on time and temperature. As you will most likely run into problems with the product performance and packaging system failure by choosing a test temperature that’s not going to realistically mimic the real world. For more information on real-time or accelerated aging testing, contact your Nelson Labs Account Manager or our Service Center via or 801-826-2088. We’re here to help. If you disable this cookie, we will not be able to save your preferences. ). Please click here to view part one. FDA and ISO 11607 permit medical device manufacturers to go to market using accelerated aging data. If it is product testing, you want to go through all of the tests that you would have done at time-zero or your baseline to ensure aging hasn’t caused adverse effects and compare those results back up. Accelerated Aging – oftentimes referred to as Accelerated Shelf-Life Testing – is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. If you have any questions, or would like a quote, please contact us to speak with one of our packaging engineers.