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. Scope of ASTM F ➢Provides information for developing accelerated aging protocols. ➢Information may be used to support shelf life and expiration date.
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Link to Active This link will always route to the current Active version of the standard. Evaluate the package performance after accelerated aging relative to the initial package requirements.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Online Quote System – Accelerated Aging. Pricing includes monthly temperature graph reports. Determining AAFs are beyond the scope of this guide. ASTM F procedure for accelerated aging is comprised of the following: D1980-07 fill-in your Input Temperatures and select the Q10 value.
Shelf Life Study Equivalent. For example, a 12 month shelf life is simulated based on 13 months.
Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Online Quote System – Accelerated Aging
Accelerated Aging Temperature Higher temp. 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. Relative Humidity RH is not a factor in the Arrhenius equation. Please fill out this form and return with your Product Submission.
Fed-Ex 2 nd day, Account number. Please ship all samples with d1980-07 form to: If you have questions about our online quoting process or other questions or need assistance, call RMTS at Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.
The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting f11980-07 is not addressed in this guide. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
ASTM-F – Accelerated Aging – Medical Package Testing
UPS 2 nd day, Account number. In parallel, age samples at real-life aging conditions TRT. Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc.
Therefore, some add an extra month to the aging study to allow for sterilization, etc. Accelerated aging f180-07 can provide an alternative means. Asmt expiry date of a medical product is commonly based on its manufacture date.
Fed-Ex Ground, Account number. 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. Extracted information from ASTM F v1980-07 may be used to support expiration date claims for medical device sterile barrier systems.
Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
UPS Ground, Account number. UPS Overnight, Account number.
If a different Temperature and or Temperature Humidity condition is required than listed above or more then 30 cubic feet of boxes, contact RMTS for Pricing at 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 data from real time aging studies are available. Work Item s – proposed revisions of this standard.
Aztm resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor for example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system.