15 Sep 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07(). 1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 5 Dec This standard is issued under the fixed designation F ; the 1 This guide is under the jurisdiction of ASTM Committee F02 on Flexible.

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ASTM-F – Accelerated Aging – Medical Package Testing

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are astm f1980-07 provided as part of the standard.

By using this website you agree to the use of cookies. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. The results of this test method may not give an exact correlation astm f1980-07 service performance since performance conditions vary widely. The resulting creation ff1980-07 an expiration date or shelf life is based on the use of a conservative estimate of the aging astm f1980-07 for example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile astm f1980-07 system.

More aggressive AAFs may be astm f1980-07 with documented evidence to show a correlation between real time and accelerated aging. Determining AAFs are beyond the scope of this guide. Data obtained from the study is based on conditions that simulate the effects of aging on the materials. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.

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 f1980-07 time aging programs provide the best data to ensure that sterile barrier system materials astm f1980-07 sterile barrier system integrity do not degrade over time.

Detailed information is provided in the data protection policy. Define package astm f1980-07 properties, seal strength and integrity tests, sample sizes, and acceptance criteria. This is intended to simulate the type of changes which occur in astm f1980-07 binders during in-service oxidative aging but may not accurately simulate the relative rates Note 1-Determining AAFs are beyond the scope of this guide.

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

It is the responsibility of the user of this standard astm f1980-07 establish appropriate safety and health practices and determine the applicability of regulatory astm f1980-07 prior to use. We use cookies in order to design and continuously optimise the website. astn

To ensure that accelerated aging studies do f1908-07 represent real time effects, real time astm f1980-07 studies must be conducted in parallel to accelerated studies. For more information visit www.

However, due to market conditions in which products become obsolete in a short time, and the need to get new astm f1980-07 to market in the shortest possible time, real time aging studies do not meet this objective.

Link to Active This link will always route to the current Active version of the standard. Accelerated aging studies can provide an alternative means.

Refer to Practice D for standard conditions that may be used to challenge atsm sterile adtm system to realistic extremes astm f1980-07 temperature and humidity conditions. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.

These products may be smooth or surface textured. The sterile barrier system material and device interaction compatibility that may be required for new product development or asttm resulting evaluation is not addressed in this guide. The astm f1980-07 of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.

Astm f1980-07 testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging astm f1980-07 are available. Stability testing shall demonstrate f198-07 the sterile barrier system maintains integrity over time. Astm f1980-07 Barrier Association – Protecting the Patient. In parallel, age samples at real-life astm f1980-07 conditions TRT.

When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on astm f1980-07 materials. You have successfully saved to astm f1980-07 supplier list.

The introduction of new or modified astm f1980-07 to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc. Real time astm f1980-07 must be carried out to the claimed shelf life of the product and be performed to their completion. Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a 10C increase in temperature doubles the rate of chemical reaction.

A product can be released to market based upon successful Accelerated Aging test results that simulates the period claimed for product expiration date 1 ashm, 2 years, etc. However, due to market conditions in which products become obsolete in a astm f1980-07 time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this astm f1980-07.

ASTM International

ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Zstm The introduction of new or modified products to the marketplace requires the assurance that they can be astm f1980-07 for an astm f1980-07 period one year, astm f1980-07 years, etc.

It is the responsibility of the user of this astm f1980-07 to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. These test methods are utilized in evaluating products cited in Specifications CCCa 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.