Some may keep moving the temperature up to meet specific needs for the launch date. The Accelerated Aging … 1.7.1 Exception—Inch-pound units are used 7.6.2. Nelson Laboratories, LLC 6280 S. Redwood Rd. After accelerated aging comes package strength testing and integrity testing to make sure there isn’t a sterility breach in the package. When a customer says, “I need to run a five-year expiration date before next month,” there is no physical way to do this. Accelerated aging is a conditioning step. 4.2 This test method is intended to provide a means for evaluating the relative serviceability of EC Glazings as described in Section 1. For more information on real-time or accelerated aging testing, contact your Nelson Labs Account Manager or our Service Center via ServiceCenter@NelsonLabs.com or 801-826-2088. We’re here to help. 1.2 The test method is applicable for any electrochromic device incorporated into sealed insulating glass units (IGUs) fabricated for vision glass (superstrate and substrate) areas for use in buildings, such as sliding doors, windows, skylights, and exterior wall systems. E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods. We are ready to discuss your project to recommend the best course of action. This means that every time you visit this website you will need to enable or disable cookies again. We will continue to monitor the situation and update our event schedule accordingly. 2. ASTM F1980 is the standard most people refer to for medical device accelerated aging. ISO / ANSI / AAMI 11607; ASTM F1980; ICH Q1A-Q1F; Accelerated Aging Test … 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. For example, if you are using a test temperature of 55° with a 60% relative humidity and look at the moisture content, you will be over 100% moisture rate. Putting the samples over 60°C is a red flag thought that will come up in regulatory review. However, this type of testing is not practical for manufacturers that need to quickly get their product on the market – they do not have the time to put a package system on the shelf for two or more years and await the results. Packaging Compliance Labs provides ASTM F1980 testing … Thank you for watching Part two of DDL’s PackReview series on ASTM-F1980 Accelerated Aging. If you have any questions, or would like a quote, please contact us to speak with one of our packaging engineers. The test is intended to simulate and, in some cases, to also accelerate actual in-service use of the electrochromic windows. These types of testing are the topics of our next blog post. FDA requires testing to demonstrate that the packaged product will maintain its integrity and sterility when stored over time, and this testing is required to establish an expiry date. 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. Packaging Compliance Labs provides ASTM F1980 testing to evaluate the long-term effects on packaging in a compressed timeline. The caveat is that real-time aging testing must be run in parallel, to confirm accelerated aging findings. Visit Copyright Clearance Center, Historical Version(s) - view previous versions of standard, Work Item(s) - proposed revisions of this standard, More E06.22 Standards The Accelerate Aging test simulates real-time aging using elevated temperatures to artificially speed up the aging process. After accelerated aging comes package strength testing and integrity testing to make sure there isn’t a sterility breach in the package. Tests that meet these regulatory requirements are accelerated aging testing, real-time aging testing, or a combination of both. Keeping this cookie enabled helps us to improve our website. It does not tell you if you pass or fail, it is what comes after accelerated aging that indicates a pass or fail. Real-time aging … 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. Our Aging Calculator is a great tool to estimate how many days your study will require. C168 Terminology Relating to Thermal Insulation, E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods, E631 Terminology of Building Constructions, E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method, E2953 Specification for Evaluating Accelerated Aging Performance of Electrochromic Devices in Sealed Insulating Glass Units, G113 Terminology Relating to Natural and Artificial Weathering Tests of Nonmetallic Materials, G173 Tables for Reference Solar Spectral Irradiances: Direct Normal and Hemispherical on 37 Tilted Surface, ICS Number Code 81.040.20 (Glass in building), ASTM E2141-14, Standard Test Method for Accelerated Aging of Electrochromic Devices in Sealed Insulating Glass Units, ASTM International, West Conshohocken, PA, 2014, www.astm.org. Link to Active (This link will always route to the current Active version 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. 1.3 The electrochromic (EC) glazings used in this test method are exposed under use conditions to solar radiation and are deployed to control the amount of radiation by absorption and reflection and thus, limit the solar heat gain and amount of solar radiation that is transmitted into the building. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. The typical temperatures used to test by most medical engineers are 50C, 55C, and 60C. Standard References. Because of this, accelerated aging was developed as it meets the testing requirements by FDA. 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 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.

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