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. 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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Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.

Try out our Accelerated Aging Calculator! For more information visit www. Please fill-in your Input Temperatures and select the Q10 value. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but atsm not provided as part of the standard.

Please fill out this form and return with your Product Submission.

Online Quote System – Accelerated Aging

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 aging studies are completed on the sterile barrier system. Online Quote System – Accelerated Aging. Historical Version s – view previous versions of standard. The sterile barrier system shall maintain sterility to the point of use or g1980 the expiry date.

Age samples at TAA.

ASTM-F – Accelerated Aging – Medical Package Testing

To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Accelerated Aging Test Results. Work Item s – proposed revisions of this standard. 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.

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

Pricing includes monthly temperature graph reports. If a different Temperature and or Temperature Humidity condition is required than aatm above or more then 30 cubic feet of boxes, contact RMTS for Pricing at It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations satm to use. Shelf Life Study Equivalent.

Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Please ship all samples with this form to: Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Fed-Ex 2 nd day, Account number.

Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. In parallel, age samples at real-life aging conditions TRT.

Real time studies must be carried out to the claimed shelf zstm of the product and be performed to their completion. 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.

Determining AAFs are beyond the scope of this guide.

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Define package material properties, 70 strength and integrity tests, sample sizes, and acceptance criteria. 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. Therefore, some add an extra month to the aging study to allow for sterilization, etc.

ASTM-F1980

ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Axtm 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. If you have questions about our online astn process or other questions or need assistance, call RMTS at Relative Humidity RH is not a factor in the Arrhenius equation.

Accelerated aging studies can provide an alternative means.

ASTM F procedure for accelerated aging is comprised of the following: To receive an Official Detailed Quote, please fill-in the following fields. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. Evaluate the package performance after accelerated aging relative to the initial package requirements. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.

UPS Ground, Account number.