AAMI TIR12 pdf free download

AAMI TIR12 pdf free download.Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.
5.3 Device equivalence (product families) 5.3.1 General considerations According to the FDA Guidance (Section VII, second paragraph), “It is possible that similarities in design, materials, and other factors may allow for establishing product families (e.g., devices with a range of available sizes) for the purpose of minimizing processing validation efforts.” Similarly, 4.3 of ANSI/AAMI/ISO 17664:2017 [15] states, “If a manufacturer supplies a number of different medical devices that share common attributes, then validation studies may be performed as a product family.” Both documents direct the medical device manufacturer to demonstrate commonality (equivalent or lesser processing challenges) in device materials, design features, intended use, and clinical soil exposure. Additionally, the processing instructions that will be provided to the user shall be the same for each device within the specified product family. Special consideration should be given to the worst-case design challenges to processing for each product family. 5.3.2 Master products Tests and assessments conducted during validation should address the worst-case features or attributes of the products within the defined family. According to the FDA Guidance (Section VII, second paragraph), “it may be possible to establish that validation data for the most difficult to reprocess devices in a family (i.e., the worst-case device or ‘master device’) covers devices that present an equivalent or lesser processing challenge.” Product-related variables that potentially affect the ability to clean, disinfect, and/or sterilize the products, as applicable, should be considered. Master products shall be process specific. That is, while one device may qualify as the greatest challenge to cleaning for a “family” of products, a different device in that family may qualify as the greatest challenge to disinfection, and a different device may qualify as the worst-case for steam sterilization. Furthermore, a device identified as a worst-case challenge for steam sterilization might not constitute a worst-case challenge for another sterilization modality or for post-sterilization processing. Device manufacturers are required to support label claims of reusability by providing complete and comprehensive written instructions for the processing of their products. When requested, device manufacturers should provide users with a statement that the recommended processing procedures have been tested and validated, as well as, a summary and interpretation of test data or other information related to the validation of the manufacturer’s recommendations for cleaning agents and cleaning procedures, if requested. Clause 7 of ANSI/AAMI/ISO 17664:2017 [15] states that processing instructions shall be presented in at least electronic format and available in printed format upon request. Further it states that for medical devices not accompanied by processing instructions, “… other means of communicating the information shall be used, such as user manuals, symbols … or wall charts, supplied separately or by electronic means.” IFUs are the primary source of written information from the medical device manufacturer about the proper use of the medical device, including the processing of that device. The processing instructions are based on the results of validation testing (Section 5) conducted to determine the efficacy of the processing steps.AAMI TIR12 pdf download.