Among the oldest package integrity tests. • Referred to as “non-simulation” test. • Not item-by-item comparable with ASTM. • ASTM D Distribution Cycle 2. ASTM-D describes the standard practice for performance testing of shipping containers and systems. It provides a guide for the evaluation of shipping units. 10 May Details on one of the most widely used distribution simulation test methods, ASTM D – Standard Practice for Performance Testing of.
|Published (Last):||23 September 2017|
|PDF File Size:||19.9 Mb|
|ePub File Size:||8.34 Mb|
|Price:||Free* [*Free Regsitration Required]|
ASTM D is the standard that has been used extensively in the medical device industry, as it is an FDA recognized consensus standard. Historical Version s – asstm previous versions of standard.
Astm d4169-09 Item s – proposed revisions of this standard. The values given in parentheses are mathematical conversions astm d4169-09 SI units that are provided for information only and are not considered standard.
This may, however, prohibit astm d4169-09 the influence of the container closure on container performance. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
Schedule H — Environmental hazard Slight changes were made to the water temperature during spray sessions of ambient conditioning during Assurance Level I. This practice is not intended to ashm material specifications or existing preshipment test procedures. For astm d4169-09 as a performance test, this practice requires astm d4169-09 the shipping unit tested remain unopened until the sequence of tests are completed.
ASTM-D describes the standard practice for performance testing of shipping containers and systems. This practice is not intended to supplant material specifications or existing astm d4169-09 test procedures.
ASTM D – 09 Standard Practice for Performance Testing of Shipping Containers and Systems
What does this mean for medical device manufacturers? If used for other purposes, such as package development, it may be useful to open and inspect shipping units at astm d4169-09 times throughout the sequence. If known, container impact surfaces should be the same as occur in actual shipment. ASTM D is the test method performed by subjecting shipping units to a test plan consisting of a d4169-099 of hazard astm d4169-09 which would be encountered in various distribution environments.
For more information visit www. This is accomplished by subjecting them to a astm d4169-09 plan consisting of a astm d4169-09 astmm anticipated hazard elements encountered in various distribution cycles. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.
This may, however, prohibit evaluating the influence of the container closure on container performance.
The Distribution Cycle DC most commonly used for medical device packages is DC which is designed for the small parcel and overnight shipping mode. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations astm d4169-09 to use.
Annother Distribution Cycle that is sometimes used when air transport will not astm d4169-09 used in the distribution enviroment is DC3, and it shown below. Schedule G — Rail switching Astm d4169-09 impacts instead of three shall now be performed Assurance Level I shall be used for open-top rail car load tests.
Revisions to ASTM D4169 and Impact on Medical Device Package Testing
Eight additional references were added. It provides astm d4169-09 guide for sstm evaluation of shipping units in accordance with a uniform system, using established test methods at levels representative of those occurring in actual distribution.
Learn more about the different testing c4169-09 provided at each location. Link to Active This link will always route to the current Active version astm d4169-09 the standard. The tests should be performed sequentially astm d4169-09 the same containers in the order given.
For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed.
If used for other purposes, such as package development, it may be useful astm d4169-09 open and inspect shipping units at various times throughout the sequence. If the shipping orientation is not known, or if more than one orientation is possible, the first three impacts should be on that test specimen surface which is deemed to be most sensitive to astm d4169-09.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not astm d4169-09 as part of the standard. D Terminology of Packaging and Distribution Environments.