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().

Author: Akinorg Mezizragore
Country: Japan
Language: English (Spanish)
Genre: Spiritual
Published (Last): 15 July 2005
Pages: 395
PDF File Size: 12.49 Mb
ePub File Size: 10.95 Mb
ISBN: 670-7-29190-957-1
Downloads: 49506
Price: Free* [*Free Regsitration Required]
Uploader: Faurr

ASTM-F1980

UPS 2 nd day, Account number. The sterile barrier system shall maintain sterility to the point of use or until the expiry date.

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. In parallel, age samples at real-life aging conditions TRT. Age samples at TAA.

Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.

For more information visit www. ASTM F procedure for accelerated aging is comprised of the following: Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. 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 ast.

  CLAUDIO BERTONI NI YO PDF

ASTM-F – Accelerated Aging – Medical Package Testing

Accelerated Aging Test Results. Accelerated Aging Temperature Higher temp. UPS Overnight, Account number. Evaluate the package performance after accelerated aging relative to the initial package requirements.

Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Try out our Accelerated Aging Calculator! Pricing includes monthly f19800 graph reports. Please ship all samples with this form to: Ambient Temperature Warehouse Temperature Higher temp. Online Quote System – Accelerated Aging. Please fill-in your Input Temperatures and select the Q10 value. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to ast marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.

Define package material properties, seal strength and integrity tests, sample sizes, and acceptance wstm. Fed-Ex 2 nd day, Account number. 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.

More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.

Fed-Ex Ground, Account number. 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. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.

  ASTM D3775 PDF

If you have questions about our online quoting process or other questions or need assistance, call RMTS at Define aging test time intervals including time zero. Determining AAFs are beyond the scope of this guide. 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.

Accelerated aging studies can provide an alternative means.

Fed-Ex Overnight, Account number. UPS Ground, Account number. Relative Humidity RH is not a factor in the Arrhenius equation.

If a different Temperature and or Temperature Humidity condition asstm required than listed above or more then 30 cubic feet of boxes, contact RMTS for Pricing at To receive an Official Detailed Quote, please fill-in the following fields. Therefore, some add an extra month to the aging study to allow for sterilization, etc.

Historical Version s – view previous versions of standard. 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.

For example, a 12 month shelf life is simulated based on 13 months. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:.

The expiry date of a medical product is commonly based on its manufacture date.