•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 testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in . Designation: F – 98 (Reapproved ) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual.

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ASTM F1886/F1886M – 16

Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems. Insufficient sealing temperature either too much, too little, or unevenly applied pressure; too short a process time; or, excessive material thickness asym are some of the conditions that may cause seals to appear to be spotty or mottled.

Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend.

Impact also may cause the seals to partially rupture.

If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, at the address shown below. The four different types of medical device packages are: It is possible to have continuous seal integrity but fail to give complete transfer. Individual reprints single or multiple copies of this standard f18886 be obtained by contacting ASTM at the above address or at phonefaxor service astm.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? There also can be foreign contamination on the packaging materials that prevents a seal from being made. Visual inspection may or may not detect tears or pinholes.


ASTM F (Reapproved )_百度文库

Mark the location of the channels. A superscript epsilon e indicates an editorial change since the last revision or reapproval. The ability to visually detect channel defects in package seals is highly reliant on: Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package.

Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility.

In some instances, a channel or unsealed area may be observed only after the package is peeled open.

ASTM-F – Medical Package Testing

Seal creep may be a result of the sterilization process or stressed seals at temperature extremes. Further evaluation may be required if visual inspection is not adequate to determine acceptability. Causes for channels have been astn above in X1.

The results are presented in Tables Light box inspection or physical package integrity tests may be appropriate. These types of characteristics often are hard to judge by visual inspection alone and need to be further evaluated ast, alternate means such as dye penetration. Each requirement should be established with appropriate rationale and necessary supporting documentation.

This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained. Care should be taken to ensure a smooth continuous ast motion so as not to cause any extraneous attributes.


Inspection of the seal should be performed at atm distance of 30 to 45 cm 12 to 18 in. NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.

In some situations the seal awtm be of adequate strength to form a complete seal. This is because the coating may have a stronger affinity for the substrate on which it is coated rather than the one to which it is sealed. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing. Last previous edition approved in as F — Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems.

These 1f886 can result in a channel through the entire seal.


Seal rupture can occur due to internal or external forces placed on the seal due to sterilization conditions, weight of product, stressful handling of the package, and so forth. In other situations there may not be adequate strength, and a channel results.

They aastm will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and? Precision and Bias 3 8.