ASTM F1980-07 PDF

It offers multiple aging protocols to determine the effects of time on the sterile integrity of the packaging as well as the physical properties of the latter. While this guide does evaluate the sterile barrier system shelf life, it does not address the barrier system material and device interaction compatibility. The aging of products or materials refers to the variation of their properties over time. The properties of interest are those related to safety and efficacy. An aging study is a procedure that seeks the determination of the behavior of a device under normal-usage conditions over a relatively long time by exposing the material for a short period of time to an external stress, which is more severe or more frequently applied than normal environmental stresses. According to the latter, aging processes increase as a function of the ambient temperature.

Author:Aragore Kelmaran
Language:English (Spanish)
Published (Last):21 November 2005
PDF File Size:5.97 Mb
ePub File Size:17.55 Mb
Price:Free* [*Free Regsitration Required]

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.

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. See Termninology F for a definition of "environmental challenging. 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. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email.

You may delete a document from your Alert Profile at any time. This standard is also available to be included in Standards Subscriptions. Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards. Subscription pricing is determined by: the specific standard s or collections of standards, the number of locations accessing the standards, and the number of employees that need access.

As the voice of the U. Available for Subscriptions. Add to Alert PDF. Please first log in with a verified email before subscribing to alerts. Please first verify your email before subscribing to alerts. Already Subscribed to this document. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. PDF Price. Not a Member? This standard is not included in any packages.

We have no amendments or corrections for this standard. Request Proposal Price. Proceed to Checkout Continue Shopping. Useful Links.



We use cookies in order to design and continuously optimise the website. By using this website you agree to the use of cookies. Detailed information is provided in the data protection policy. Accelerated Aging is an artificial procedure for establishing the lifespan or shelf life of a product in an expedited manner. Data obtained from the study is based on conditions that simulate the effects of aging on the materials. A product can be released to market based upon successful Accelerated Aging test results that simulates the period claimed for product expiration date 1 year, 2 years, etc. Accelerated Aging data is recognized by regulatory bodies as a conservative estimate of the shelf life, but is only accepted until those tests can be repeated on "real time" aged samples.


ASTM F1980-07 Accelerated Aging Test

Designation: F — Standard Guide for. A number in parentheses indicates the year of last reapproval. A superscript epsilon e indicates an editorial change since the last revision or reapproval.

Related Articles