Malpractice Medical Coronary Artery Bypass Graft (CABG) Surgery 3
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7,
Sterilization of medical devices is packed a few mediumer effective design method
These design methods all come from practice, and had been proved be the cogent and effective a few thinking that can pack a design to bring value for sterilization of medical devices means and practice operation method, these methods had gotten acknowledgement and write into the one part that the standard serves as inside ISO11607 to offer industry reference of course!
7.1 worst circumstances (Worst Case)
Substantially for, "Worst circumstance " also apply scientific and reasonable sieve to choose a method namely, fall in what assure the premise with accurate result, undertake the practice of least frequency or experiment try. And its support theoretically, actually very simple also, say popularly, the likelihood assumes A is more than B namely, b is more than C again, can reach A is more than the conclusion of C.
"Worst circumstance " of all sorts of craft parameter limiting value when the category can include to doing test and verify of the craft that pack and sterilization craft test and verify choose, go to the sample that has endured these craft parameter having booked function test next, if such sample can pass these function tests, also can conclude reasonably so those normal sample that just pass reasonable parameter are more justifiable by through anticipated function test, decrease somewhat in experimental time aspect not only so, more it is in security the respect rises somewhat.
"Worst circumstance " another kind of form is reflected in next " the product is familial " in this content.
7.2 products are familial (Product Family)
Go up from essence for, "The product is familial " be " worst circumstance " form of a kind of expression, specific apply to practice, right ‘ the product is familial ‘ , for instance some company developed the product of some kind of medical devices of a series, they adopt the same way that pack again, so according to ‘ the product is familial ‘ this kind is academic, one can be found to have representative product most in this series, this kind of representative body such as size is the largest now, hardness highest, component most or structure the most complex, product is the most fragile waiting for a series of looking is the place that gives an issue the most easily, can reduce need to check the amount of the product so, reduce experimental frequency and workload, achieve the goal of reasonable and managing cost and time thereby.
See not hard, citing afore-mentioned ‘ the product is familial ‘ when the concept, should speak of when how selecting representative product, cited naturally also ‘ worst circumstance ‘ this concept, because select that representative product that come out, also be this at the same time ‘ worst circumstance ‘ delegate, this kind of thinking designs the meeting that pack when developing series product very valuable!
7.3 histories experience and data (Experience And Data)
No matter the respect thinks from which, sterilization of medical devices is packed it is a very omnibus course, and inside alive bound limits exceedingly novel, a lot of a lot academic understanding do not have final conclusion, the appellation of very much even professional title also has not been secured very well and unite.
Be based on these real problems, and the natural tradition that medical treatment industry pays attention to security and successive stability, of clearly is, referenced history experience and data are very necessary, also be very reliable, can be written at this o‘clock into relevant and academic literature or reference standard so, as sterilization the craft that pack sets one of timing standard!
7.4 detect the method affirms (Testing Method Validation)
Because sterilization of medical devices is packed,occurrence of this bit also is in fact all over the world inside limits for it is a newer science, very much to its thing is current inside course of study in still be being discussed, what ISO11607 of international dominant standard comes nearly ten years is frequent explained this is nodded adequately newlier, the experimental method that this brought about a lot of specific aim is not long-tested or absolutely and correct, and a lot of be in at present him business circles ‘ creation ‘ experimental method, although be returned at present,be not collected formally to be in standard and so on, but test result is actually same also however, the person that can pass experimental use comes from me or search lab of tripartite independence to confirm the effectiveness of experimental method, will get final self-identity.
And in fact the referenced experiment standard of place appendix is abhorrent at the back of version of every ISO 11607, and the amount is mixed content differs very big!
How should undertake experimental method admits really so? Actually main avenue still is passed and existing and similar standard experiment method contrasts, look both right same the experimental result that approves sample is consistent; If experimental result has difference, whether is this difference inside the limits that can be accepted etc.
Afore-mentioned process ought to come down with literal record, as the appendix of relevant report, this can call experiment of an equivalent sex to report probably, in order to replaces certain level to check a method to have a test!
Want of course the experimental method that him seek devises becomes an industry to test a level, so it is indispensable that the tripartite lab that entrusts authority will have a test and data of comparative test result analyses this test effectiveness, and how this looks is a costly the job of arduous take time, so, perhaps, only big company just is met so do!
Sterilization of medical devices is packed is an integrated task, look at present, need to consider to include material to learn at least, the knowledge of the domain course such as microbiology and mechanical automation, and pay attention to practice very much, the theoretical document that can offer reference is not much, and be in domestic and international all very novel, so some content do not have complete determinism, draw up come more is for cast a brick to attract jade-offer a few commonplace remarks by way of introduction so that others may come up with valuable opinions, discuss for industry and academic reference, perfect the theory of this domain gradually change, coach conversely then the development of industry!
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Civil / Randy
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