Buy ASTM F (R) GUIDE FOR ACCELERATED AGING OF STERILE BARRIER SYSTEMS FOR MEDICAL DEVICES from SAI. Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07().
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Work Item s – proposed revisions of this standard. Evaluate the package performance after accelerated aging relative to the initial package requirements. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Pricing includes monthly temperature graph reports.
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.
For example, a 12 month shelf life is simulated based on 13 months. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
UPS Overnight, Account number. Determining AAFs are beyond the scope of this guide.
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. If a different Temperature and or Temperature Humidity condition is required than listed above or more then 30 cubic feet of boxes, contact RMTS ast Pricing at UPS Ground, Account number.
ASTM F procedure for accelerated aging is comprised of the following: Please fill-in your Input Temperatures and select the Q10 value. Extracted information from ASTM F testing may be f190 to support expiration date claims for medical device sterile barrier systems. Relative Humidity RH is not a factor in the Arrhenius equation.
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:.
ASTM-F – Accelerated Aging – Medical Package Testing
For more information visit www. Fed-Ex Ground, Account number. Online Quote System – Accelerated Aging. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective.
Link to Active This link will always route to the current Active version of the standard. Please ship all samples with this form to: Try out our Accelerated Aging Calculator!
ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices 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.
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. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. Define aging test time intervals including time zero. 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.
More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. To receive an Official Detailed Quote, please fill-in the following fields. If you have questions about our online quoting process or other questions or need assistance, call RMTS at V1980 parallel, age samples at real-life aging conditions TRT. T1980 expiry date of a medical product is commonly based on its manufacture date.
Shelf Life Study Equivalent.
Online Quote System – Accelerated Aging
The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Age samples at TAA. Please fill out this form and return with your Product Submission. Ambient Temperature Warehouse Temperature Asfm temp.
Refer to Practice D for standard axtm that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
Fed-Ex 2 nd day, Account number. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc.
Accelerated aging studies can provide an alternative means.