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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Accelerated Aging Test Results. In parallel, age samples at real-life aging conditions TRT. 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 for Pricing at Therefore, some add an extra month to the aging study to allow for sterilization, 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. Please fill out this form and return with your Product Submission. Fed-Ex Overnight, Account number. Fed-Ex 2 nd day, Account number. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.

ASTM-F – Accelerated Aging – Medical Package Testing

Pricing includes monthly temperature graph reports. Please ship all samples with this form to: Determining AAFs are beyond the scope of this guide. Fed-Ex Ground, Account number. 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. ASTM F procedure for accelerated aging is comprised of the following: Age samples at TAA.

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Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the 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.

To ensure that accelerated aging studies do truly f19980 real time effects, real time aging studies must be conducted in parallel to accelerated studies. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Relative Humidity RH is not a factor in the Arrhenius equation. Shelf Life Study Equivalent. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.

Accelerated aging studies can provide an alternative means.

ASTM-F1980

Please fill-in your Input Temperatures and select the Q10 value. Try out our Accelerated Aging Calculator!

Define aging test time intervals including time zero. 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.

The expiry date of a medical product is commonly based on its manufacture date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Accelerated Aging Temperature Higher temp. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:.

Ambient Temperature Warehouse Temperature Higher temp. 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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Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.

Evaluate the package performance after accelerated aging relative to the initial package requirements. 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. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products astmm the marketplace requires the assurance asrm they can be stored for 0 extended period one year, two years, etc.

UPS Overnight, Account number. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Historical Version s – view previous versions of standard.

Evaluate package, or package performance, or both, after real time aging ast to the initial package requirements. Online Quote System – Accelerated Aging. Work Item s – proposed revisions of this standard. If you have questions about our online quoting process or other questions or need assistance, call RMTS at Link to Active This link will always route to the current Active version of the standard.