Products and Services / Standards & Publications / Standards Products, Developed by Subcommittee: F02.50 | Committee F02 | Contact Staff Manager. Refer to Practice D 4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. xڥY]��8|����%��#ɒ%p8d��N���$3�`�y�H�ͬ$:�4�����&�/i�Lt 26-VWwW����>S2�)fA����lAF�G���
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ASTM F1980 procedure for accelerated aging is comprised of the following: Select the Q10 value; Define the desired shelf life of the package (marketing and product needs, etc.). 1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems. I am sharing my Excel Accelerated Aging Calculators workbook. E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures) F17 Terminology Relating to Flexible Barrier Packaging.
Products and Services / Standards & Publications / Standards Products, Active (view current version of standard). Please let me know if you find any mistakes or have improvement suggestions. The aging of products or materials refers to the variation of their properties over time. %��������� ��,ɀ/N��¯'��Tgi삝��F�a���'��(����ֲdR�іuj�j�U!ڎef�`�x�g�-D�,�\���! 1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
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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. stream Unre- humidity are acceptable. Its title is Accelerated Aging of Sterile Medical Devices. Define test conditions, room temperature (TRT), and accelerated aging temperature (TAA). Current revision of the standard includes limited useful guidance on the application of humidity during accelerated aging. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. 2 0 obj Define aging test time intervals (including time zero). (Further discussion is available in ASTM F1980-02, “Standard Guide for Accelerated Aging of Sterile Medical Device Packages”). 1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607-1:2006 and the physical properties of their component packaging materials. (tx!�
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Accelerated Aging – ASTM F1980. See Terminology F 1327 for a definition of "environmental challenging.". %PDF-1.3
Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard. ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Status : Current ... standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. ASTM Standards. ������w���8��w�=�����6�>�0��� ���3"�Oޖ>ː!Y�-bY���:)am[I;��4���lD�:�1��r�� D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing. Users can follow guidance in the document to dry out the accelerated aging condition, or opt out of humidity controls all together.