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Designation: F – 98 (Reapproved ) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual. View Account▹ · Home; ASTM F/FM Add to Cart. Printed Edition + PDF;; Immediate download; $; Add to Cart. ASTM F - ISTA Procedures 1A, 2A, 3A. Table 1: Standards of Importance for Validation. ISO Requirements For Materials, Sterile Barrier Systems .
A superscript epsilon e indicates an editorial change since the last revision or reapproval. Scope 1. The values given in parentheses are for information only. 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.
Referenced Documents 2.
Terminology 3. Summary of Test Method 4.
Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing.
Apparatus 6. Procedure 7. NOTE 1—Magni? Current edition approved June 1, Published June Originally approved in Last previous edition approved in as F — NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.
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. Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi? Mark the location of the channels.
A statistical analysis of the data by means of a contingency table show signi? The results are presented in Tables NOTE 5—If con? Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous attributes. Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur.
In some instances, a channel or unsealed area may be observed only after the package is peeled open. It is possible to have continuous seal integrity but fail to give complete transfer.
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.
In such cases, an additional physical seal integrity test may be required to con?
ASTM F1886 Packaging Standard Update
Precision and Bias 3 8. The negative control consists of the same type packages produced with no channels. The four different types of medical device packages are: 8. Scope 1.
It also identies the mode of specimen failure. The values given in parentheses are for information only. 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. Referenced Documents 2. Terminology 3. Current edition approved May 1, Published June Originally approved in Last previous edition approved in as F 88 The plot starts from zero force after slack has been removed from the test strip.
The initial ramp-up from zero to the force level required to peel the seal is not indicative of seal strength, and data from that part of the curve should not be included in the calculation of average strength, nor should the return to zero following complete failure of the specimen.
The amount of data actually discarded on each end of the measured seal-prole curve must be the same for all tests within any set of comparisons of average seal strength see 6. Signicance and Use 4.
The ability to visually detect channel defects in package seals is highly reliant on:
Seal strength is not only relevant to opening force and package integrity, but to measuring the packaging processes ability to produce consistent seals. Seal strength at some minimum level is a necessary package requirement, and at times it is desirable to limit the strength of the seal to facilitate opening. A cohesive failure of the bond, delamination, or failure elsewhere in the test strip indicates that the substrate, not the seal interface, would be the limiting factor in the strength of a package.
In those cases seal strength may be reported as no less than the strength measured. Because the effect of each of these on test results is varied, consistent use of one technique Technique A, Technique B, or Technique C throughout a test series is recommended. Examples of xtures and techniques are illustrated in Fig.
The more exible tail is folded over the seal and is held in the opposing grip while the test is being conducted. Interferences 5. These interferences are discussed in the annex. Apparatus 6. The rate of separation of the jaws shall be uniform and capable of adjustment from approximately to mm 8 to 12 in. The gripping system shall be capable of minimizing specimen slippage and applying an even stress distribution to the specimen.
Preferably, the machine shall have the capability also to plot the curve of force versus grip travel. Tolerance shall be Sampling 7. Practice D provides guidance for test specimen selection. Indiscriminate elimination of defects can bias results.
Aging and Conditioning 8. Procedure 9.
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Edges shall be clean-cut and perpendicular to the direction of seal. Specimen legs may be shorter than shown, depending on the grip dimensions of the testing machine. The most rigid component of the specimen should be clamped in the top grip. The sealed area of the specimen shall be approximately equidistant between the grips.
Recommended distance between grips initial unconstrained specimen length is: Copyright by ASTM Int'l all rights reserved for licensee's use only.
B Refer to Fig. Align the specimen in the grips so the seal line is perpendicular to the direction of pull, allowing sufficient slack so the seal is not stressed prior to initiation of the test.
The test report should indicate the details of any technique used to control tail orientation. In those cases, the testing machine should be programmed to generate the plot.A suggested classication of modes is see Fig.
This is followed by the actual visual inspection method itself, in clearly numbered steps meet roulette. Published June Referenced Documents 2.
The rate of separation of the jaws shall be uniform and capable of adjustment from approximately to mm 8 to 12 in.