A consolidation of several previous standards, ANSI/AAMI ST79:2017 offers a Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities. Show Small Tiles. 9:00 am – 3:00 pm Conformity Assessment Symposium: Declarations of Conformity (DOCs) and their Role in Medical Device Submissions. Objectives. Sitting at the nexus of consensus standards and medical device regulatory review, conformity assessment plays an often underappreciated role in product review. Registration is open through midnight EST, Wednesday, March 11, 2020. When. The AAMI Sterilization Standards Committee (U.S. TAG to ISO/TC 198, sterilization of health care products) and several of its affiliated working groups will hold meetings March 16-19, 2020, ONLINE ONLY. %%EOF %PDF-1.6 %���� Decontamination of hemodialyzers (ANSI/AAMI RD47:2020). 14 defined and specified in the International Electrotechnical Commission (IEC) 60601 series of standards. Decontamination of hemodialyzer blood tubing (ANSI/AAMI/ISO 8638). h�bbd``b`�$f ƛ@��H09�XK�3�h� �{���@��!����` �Y 3:30 pm – 4:15 pm  Standards for Servicing, Refurbishing, and Repair Corporate Membership; Institutional Membership; Individual Memberships ; Retiree Membership; Student Join Process; Login. �#I-I+���9�i�UӒ���up�X(�|�ۘ[�o�u�f�F٨��iIZ}"Ag%��s. 967 0 obj <> endobj However, the efficacy of any sterilization process, like saturated steam, depends on the success of four critical interdependent phases. This site uses Akismet to reduce spam. Dates: November 2-6, 2020 from 8:00 a.m. to 5:00 p.m. 2020 Program. Advance Registration is REQUIRED for participation in the meetings. Made for you. In consideration of the continued rapid outbreak, some Sterilization Standard Week sessions have been cancelled or postponed. Events Close. 'Declarations of Conformity' (DOCs) offer a means for manufacturers to demonstrate conformity with FDA-recognized standards without the need to include complete test reports and are a key element of FDA's proposed Accreditation Scheme for Conformity Assessment (ASCA) pilot program. Powered by ANSI. Home » Registration. From. Health care facilities differ in their design, equipment, and personnel expertise, competence, and training. This website uses cookies, as described in the ANSI Privacy Policy. The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements . Filters. Join Membership Today. Meeting agendas are publicly accessible, as AAMI standards committee and working group meetings are open to the public to observe. Directions to AAMI. Your email address will not be published. 986 0 obj <>stream Health technology lifecycle: Delivering better patient outcomes . By clicking on the "Accept All Cookies" button, or by continuing to use our website, you consent to all cookies. Maps. AAMI Standards. Steam sterilization has been available for many years, and, due to its widespread practice, many might assume the process to be intrinsically controlled and understood. 0 area of respective group’s site in AAMI Committee Central. The AAMI Sterilization Standards Committee (U.S. TAG to ISO/TC 198, sterilization of health care products) and several of its affiliated working groups will hold meetings March 16-19, 2020, ONLINE ONLY. To. 3:00 pm – 4:00 pm Concurrent breakout sessions, 10:15 am – 10:45 am Networking Coffee Break, 3:00 pm – 3:30 pm Networking Coffee Break, 5:30 – 7:30 pm—Networking Reception—Light food and spirits, 12:00 pm – 12:45 pm Networking Lunch (in Hemingway Salon), 2:45 pm – 3:30 pm Post-Market Surveillance March 2020 Sterilization Standards Week will take place ONLINE ONLY. Date: 3 - 4 November 2020. Schedule; Venue; Accommodations; AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation and associated meetings and symposia . Directions to AAMI. intended to allow potential purchasers to evaluate the content . Required fields are marked *. Learn how your comment data is processed. ANSI/AAMI ST79:2017 does not cover the use of containment devices for packaging items other than instrument sets or procedural trays, the reprocessing of devices labeled for single use only, aseptic presentation, and reusable laboratory items, food service items, and items assigned to a patient for the length of stay (e.g., bedpans, thermometers).