ASTM F testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in . •Many Medical Device Manufactures are referencing ASTM F as the visual inspection method they use to verify the sterile barrier integrity of their packaging . ASTM F Visual Inspection is a process of methodically and purposefully examining a package for a specific range of defects and recording observations.

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Any part of the seal where channels appear across entire seal width must be identified and recorded. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other.

ASTM F1886/F1886M – 16

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You aastm delete a document from your Alert Profile at any time. Record the number and location of channels identified on each package.

They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative humidity.


ASTM-F – Medical Package Testing

Standards Subsctiption may be the perfect solution. Completeness and uniformity of the v1886 seal area of the package must be inspected. Add to Alert PDF.

This standard is also available to be included in Standards Subscriptions. Combining values from the two systems may result in non-conformance with the standard. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in.

ASTM F (Reapproved )_百度文库

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As the voice of the U. Visual seal defects will often be the initial indication of heat sealing process variation. You can download f18886 open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.

If the document is revised or amended, you will be notified by email. ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed. Visual seal characteristics and defects can bring forth evidence asrm sterile package integrity and production sealing problems.

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Please first log in with a verified email before subscribing to alerts. Please first verify your email before subscribing to alerts. Size of channel Degree of contrast from sealed and unsealed areas Amount and type of adhesive between the two package layers Reflecting light angle Types of materials used Use of magnification ASTM F procedure is comprised of the following: The ability to visually detect channel defects in package seals is highly reliant on: ASTM-F Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative humidity.

Already Subscribed to this document. 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.