•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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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. Insufficient sealing temperature either too much, too little, or unevenly applied pressure; too short a process time; or, excessive material thickness variation are some of the conditions astk may cause seals to appear to be spotty or mottled.
ASTM F (Reapproved )_百度文库
In such cases, an additional physical seal integrity test may be required to con? The ability to visually detect channel defects in package seals awtm highly reliant on: 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.
Seal creep may be a result of the sterilization process or stressed seals at temperature extremes. NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the astmm seal perimeter. A statistical analysis of the data by means of a contingency table show signi?
Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems.
ASTM F1886/F1886M – 16
Light box inspection c1886 physical package integrity tests may be appropriate. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package.
The values given in parentheses are for information only.
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. Record the number and location of channels identified on each package.
Any time requirement associated with visual inspection should allow for complete seal inspection without taking too much time to intensely focus on any given area.
This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? In some situations the seal may be of adequate strength to form a complete seal.
The negative control consists of the same type packages produced with no channels.
Current edition approved June 1, Your comments will receive asfm consideration at a meeting of the responsible technical committee, which you may attend. 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.
They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing. Visual inspection may or may not detect tears or pinholes. 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.
These types of characteristics often are hard to judge by visual inspection alone and need to be further evaluated by alternate means such as dye penetration.
ASTM-F – Medical Package Testing
Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters. This adtm become evident through an evaluation for pinholes or cracks along the seal. There also can be foreign contamination on the packaging materials that prevents a seal from being made. Summary of Test Method 4. Impact also may cause the seals to partially rupture.
For more information visit www. Generally, this occurs with? A number in parentheses indicates the year of last reapproval.
Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in.