Users can follow guidance in the document to dry out the accelerated aging condition, or opt out of humidity controls all together. (tx!� !5��1�ihP���J��#���lk�^��w��� �e����dt��l5b,EA����Y�� a���GNΘ̂��P�\�9ɮ:��Qb���Q��@s�. 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. �e,b����u8(��=���'zu��y�0�Γ$]P:O۾�&�ۦ%�U��ܳ�YS�d���b.x��7U8�Y�ȗd)u/_�RU�ƨ�?����Ӏ�eҏ�f#�.%�]��*T�#]S��_�,��,��Z�k^t�H�J���Ç��B�������d��#��q����Ezl��~�il#�7f8��� �=D�Z@���Y�MR��*��%)K�ZY7 2.1 ASTM Standards: D 3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission2 D 4169 Practice for Performance Testing of Shipping Con-tainers and Systems2 D 4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing2 E 337 Test Method for Measuring Humidity with a Psy-chrometer (The Measurement of Wet- and Dry-Bulb Tem … E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures) F17 Terminology Relating to Flexible Barrier Packaging. Use and factors to be considered . ��,ɀ/N��¯'��Tgi삝��F�a���'��(����ֲdR�іuj�j�U!ڎef�`�x�g�-D�,�\���! 1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. While the role of temperature is well documented and understood in this aging process, the impact of humidity is not. << /Length 1 0 R /Filter /FlateDecode >> Micom offers ASTM F1980 as part of its Medical devices testing services. Use the Q10, TRT, and TAA to calculate the test duration. Gerald Montgomery. 1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. Products and Services / Standards & Publications / Standards Products, Developed by Subcommittee: F02.50 | Committee F02 | Contact Staff Manager. ������w���8��w�=�����6�>�0��� ���3"�Oޖ>ː!Y�-bY���:)am[I;��4���lD�:�1��r�� F1327 Terminology Relating to Barrier Materials for Medical Packaging Products and Services / Standards & Publications / Standards Products, Active (view current version of standard). 1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems. ���Am�0E�'�k;��k$R� 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. 2 F1980 − 16 6.5 A humidity factor to calculate the accelerated aging time NOTE 4 —Tolerances of 62°C for the test temperature and 65 % for the (AAT) is not applicable for accelerated aging protocols. ��� 2��>�Bb�J��nd��R���g��%�bX�$����� ���ZM�����ֱ�u#׆�v,�,ꃭuCwR֔�jkt��, �w���I�]& K���R����9�;F����t}�f�x��E� xڥY]��8|����%��#ɒ%p8d��N���$3�`�y�H�ͬ$:�4�����&�/i�Lt 26-VWwW����>S2�)fA����lAF�G��� )���6��`���S�M�4����n(��.�= (Further discussion is available in ASTM F1980-02, “Standard Guide for Accelerated Aging of Sterile Medical Device Packages”). 2. 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 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.). 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. It is not formally validated but I am pretty sure it is accurate. ��*��z+t ��%�.��6�×+�E�� The aging of products or materials refers to the variation of their properties over time. The properties of interest are those related to safety and efficacy. ASTM Standards. 2 0 obj Define test conditions, room temperature (TRT), and accelerated aging temperature (TAA). 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. Its title is Accelerated Aging of Sterile Medical Devices. Accelerated Aging – ASTM F1980. Goal of this work item is to improve the guidance on how to use humidity during accelerated aging. 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. %��������� :��,Tc�eɣI~�mY��u�_�hbn]M:�[�)u�X(�^�Xs�J�N;E�vo �X��x��\^gd!e��^��C���[k;1�B��Y ��뛷�:\f�EM�vE��0B闖�?��8��7�������ij~��� /;�)'���dY�F����9t�v��.��vI��u.K�Y�{鄊 D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing, E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures), F17 Terminology Relating to Flexible Barrier Packaging, F1327 Terminology Relating to Barrier Materials for Medical Packaging, F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products, ICS Number Code 11.080.30 (Sterilized packages), UNSPSC Code 24120000(Packaging materials). 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. Users can follow guidance in the document to dry out the accelerated aging condition, or opt out of humidity controls all together. D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing. /�����B��,�$�K�}Ұ,ѝQr�r �9L{��;�{_�܀h$���v�Sf�T��WB���h��^-�>H�#��f�> 6�n�3K�[~�r���"\d��dt���؎�|޿������P�� Z���*���ƃ %PDF-1.3 Unre- humidity are acceptable. ASTM F1980 is the standard most people refer to for medical device accelerated aging. Goal of this work item is to improve the guidance on how to use humidity during accelerated aging. stream 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. �|��m)P#��J�j,�e��s�SFڶl�c��,��1Y�������>|(��Z���>�P� 9�ķ�؂&�o��\����H�T�D0�.�FV[��5��mt��~p� 5J�0�.c��a��t����T(U����n�� The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. See Terminology F 1327 for a definition of "environmental challenging.". Technical Contact: I am sharing my Excel Accelerated Aging Calculators workbook. Define aging test time intervals (including time zero). Please let me know if you find any mistakes or have improvement suggestions. 1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide. Current revision of the standard includes limited useful guidance on the application of humidity during accelerated aging. Current revision of the standard includes limited useful guidance on the application of humidity during accelerated aging.

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