Number of exposure temperatures: at least four, Type of oven: Type IIB (for temperature up to 70. The documents listed below are referenced within the subject standard but are not provided as part of the standard. Note: If you need help accessing information in different file formats, see Accelerated life testing is the process of testing a product by subjecting it to conditions (stress, strain, temperatures, voltage, vibration rate, pressure etc.) 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. The Accelerate Aging test simulates real-time aging using elevated temperatures to artificially speed up the aging process. Accelerated aging may be regarded as sufficient evidence for the claimed shelf life on the introduction of new products. Visit Copyright Clearance Center, Historical Version(s) - view previous versions of standard, Work Item(s) - proposed revisions of this standard, More F02.50 Standards Exposure to heat can cause many types of physical and chemical changes in plastics. Accelerated aging is optional, but real-time aging is required when establishing an expiration date. The elevated temperature condition typically used at Pacific Biolabs for the accelerated aging of medical device packages is 55°C. Micom offers ASTM D3045 as part of the polymer testing services. ASTM D3045 simulates hot conditions in which the materials are intended to be used to understand their durability and expected lifespan to avoid property losses. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, Public Law, CFR Citation(s) and Procode(s)*, Relevant FDA Guidance and/or Supportive Publications*, Instructions for Downloading Viewers and Players, Part B: Supplementary Information Sheet (SIS). Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.” 4.3 Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. For additional information about this type of test as well as for supplementary test methods, we invite you to read on Heat aging testing and ASTM F1980. In conjunction with a package validation test plan (within ISO 11607 guidelines), accelerated aging can generate quick results. ( Q 10 being set Arrhenius factor 2 ( standard requirement ) )Of course this is only a guide and should always be verified for each individual case . 4.2 ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. It is imperative to administer accelerated aging (ASTM F1980) tests to present experimental data in support of performance and shelf-life claims for these products until full-period or “real time” aged samples become available. *These are provided as examples and others may be applicable. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test … See Terminology F1327 for a definition of “environmental challenging.”. Extracted information from ASTM F1980 testing may be used to support expiration date claims for medical device sterile barrier systems. Instructions for Downloading Viewers and Players. ANSI/AAMI/ISO 11607-1:2006(R2010) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. The elevated temperature condition typically used at Pacific Biolabs for the accelerated aging of medical device packages is 55°C.