1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 15 Sep 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07(). 5 Dec This standard is issued under the fixed designation F ; the 1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible.
|Published (Last):||2 June 2016|
|PDF File Size:||12.17 Mb|
|ePub File Size:||10.12 Mb|
|Price:||Free* [*Free Regsitration Required]|
A calculator is provided below to easily explore difference test scenarios. Real time studies must be carried out to the claimed shelf life of the product and be performed astm f1980 07 their completion.
The sterile barrier system material and aztm interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. ASTM-F Standard Guide for Accelerated Aging of Astj Barrier Systems for Medical Devices The introduction of new or modified products astm f1980 07 the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc. Accelerated Aging is an artificial procedure for establishing the lifespan or shelf life of a product in astm f1980 07 expedited manner.
To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Stability testing shall demonstrate that the sterile astm f1980 07 system maintains integrity over time.
Sterile Barrier Association – Protecting the Patient.
Data obtained from the study is based on conditions that simulate the effects of aging on the materials. Accelerated aging studies can provide an alternative means. Evaluate the package performance after accelerated aging relative to the initial package requirements. Try out our Astm f1980 07 Aging Calculator! In parallel, age samples at real-life aging conditions TRT. Define aging test time intervals including time zero. The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
Determining AAFs are beyond the scope of this guide. Referenced Documents purchase separately The documents listed below are referenced within the astm f1980 07 standard but are not provided as part of the standard. Four variables are used in calculating the accelerated aging test duration.
A product can be released to market based upon successful Accelerated Aging test results that simulates the period claimed for product expiration date 1 year, 2 years, astm f1980 07.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
More aggressive AAFs may astm f1980 07 used with documented evidence to show a correlation between real time and accelerated aging. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
Accelerated Aging data is recognized by regulatory bodies as a conservative estimate of the shelf life, but is only accepted until those tests can be repeated on “real time” aged samples. Historical Version s – view previous versions of standard.
Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until astj from real time aging studies are available.
Link to Active This link will always route to the current Astm f1980 07 version of the standard. 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. Follow the link for more details on ASTM Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a 10C f1908 in temperature doubles the rate of chemical reaction.
ASTM F procedure for accelerated aging astm f1980 07 comprised of the following: The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of astm f1980 07 aging factor for example, Q 10 d1980 is astm f1980 07 until the results of real time aging satm are completed on the sterile barrier system.
The sterile astm f1980 07 system shall maintain sterility to astm f1980 07 point of use or until the expiry date. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
Detailed information is provided in the data protection policy. For more information visit www. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems.
Age samples at TAA.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:.