ASTM F1980-07 PDF

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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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. Real time studies must f9180-07 carried out to the claimed shelf life of the product and be performed to their completion.

Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. The expiry date of a medical product is commonly based on its manufacture date. Age samples at TAA. More aggressive AAFs may be 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.

Refer to Practice D for standard conditions aatm may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. 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.

Shelf Life Study Equivalent. UPS 2 nd day, Account number.

ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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.

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If you have questions about our online quoting process or other questions or need adtm, call RMTS at Ambient Temperature Warehouse Temperature Higher temp. Online Quote System – Accelerated Aging. 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. Fed-Ex Overnight, Account number. Accelerated aging studies can provide an alternative means.

Link atsm Active This link will always route to the asmt Active version of the standard. Fed-Ex Ground, Account number.

In parallel, age samples at real-life aging conditions TRT. The 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 f1890-07 studies are completed on the sterile barrier system.

Define aging test time intervals including time zero. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. f19880-07


F1890-07 example, a 12 month shelf life is simulated based on 13 months. 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.

Please ship all samples with this form to: Accelerated Aging Temperature Higher temp.

Pricing includes monthly temperature graph reports. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Referenced Documents purchase separately The documents listed below are referenced within the subject standard f1890-07 are not provided as part of the standard.

ASTM-F – Accelerated Aging – Medical Package Testing

Please fill out this form and return with f1980-0 Product Submission. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.


To receive an Official Detailed Quote, please fill-in the following fields. UPS Overnight, Account number. Accelerated Aging Test Results. Determining AAFs are beyond the scope of this guide.

For more information visit www. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Relative Humidity RH is not a factor in the Arrhenius equation.

Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Therefore, some add an extra month to the aging study to allow for sterilization, etc. Historical Version s – view previous versions of standard.

UPS Ground, Account number. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. 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 Please fill-in f1890-07 Input Temperatures and select the Q10 value. 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 atsm the marketplace atsm the assurance that they can be stored for an extended period one year, two years, etc.

Fed-Ex 2 nd day, Account number. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.

Work Item s – proposed revisions of this standard. ASTM F procedure for accelerated aging is comprised of the following: