ĪNSI/AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.įDA Technical Contact Patrick Development Organization ASTM
Standards for Safety Software in Programmable Components, Second Edition. ĪNSI/AAMI/ISO 11607-2:2006(R2010) Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly process. Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. Relevant FDA Guidance and/or Supportive Publications* ANSI/AAMI/ISO 11607-1:2006(R2010) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Public Law, CFR Citation(s) and Procode(s)* This standard is relevant for all medical devices where sterilization and packaging are components of the development and manufacture of the product. This guide identifies consensus standards, ASTM and others, used to characterize detergents in other applications, which can also be used to characterize detergents used to clean clinically-used medical devices. 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.ġ.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.ġ.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. 1.1 Detergents play a critical role in the cleaning of clinically-used medical devices, but there are few consensus methods for describing the key characteristics of these detergents. Scope/Abstract 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.ġ.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.ġ.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Further testing of the extract liquid is specified in other ASTM standards.
Part B: Supplementary Information Sheet (SIS) Standard Practice for Extraction of Materials Used in Medical Devices.