A few when sterilization of medical devices packs a design main demands (2)

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2, the product is familial (Product Family) with worst circumstance (the definition of WorstCase) and apply

About this at 2 o‘clock, mention clearly in ISO11607-2006. The purpose this 2 o‘clock is consistent essentially, also apply scientific and reasonable sieve to choose a method namely, fall in what assure the premise with accurate result, undertake the experiment of least frequency tries. 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.

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, achieve reasonable and managing goal thereby.

See not hard, citing afore-mentioned ‘ the product is familial ‘ when the concept, should speak of when how selecting representative product, automatical also derivative ‘ worst circumstance ‘ this concept, because select that representative product that come out, also be this at the same time ‘ worst circumstance ‘ delegate.

Of course ‘ worst circumstance ‘ be confined to of not mere bureau is in the category ‘ the product is familial ‘ in select representative product so simple, of all sorts of craft parameter limiting value when it still 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, this also is ‘ the product is familial ‘ and ‘ worst circumstance ‘ these two kinds of the most important distinction that apply theoretically.

3, scientific design packs systematic performance experiment (Packaging System PerformanceTesting)

If each reader notices somewhat, with respect to meeting discovery the author is in last year about the corresponding period when the article that has written test of function of a concerned MDSP, this also is the domain that the author studies with respect to sortie at the beginning and carries out hard.

Pack a system to sterilization of medical devices (Medical Device Sterilization PackagingSystem) for, the characteristic that is based on its to ask to packing function (basically be to ask the system can cut off microbial and can stand the way of will adopted of all kinds sterilization with be designed good beforehand) , can be this system cent two parts again, the asepsis that belongs to category of inner packing system namely cuts off system (SterilizationBarrier System, SBS) pack a system with the protection that belongs to outer packing system (Protective Packaging System, PPS) . Opposite for, SBS is more crucial, because its invalidation means the absolutely be no longer in force of the whole system that pack namely; And if PPS did not achieve the end that expects a design to be not meant certainly however whole or whole batch the invalidation of the system that pack, the invalidation method that and discovery is mixed searchs this kind to pack is very simple and cost very low.

Look so actually so, the system of sterilization of medical devices that pack cuts off with those pairs the packing system with more sensitive sex, for instance special provision is packed and medicines and chemical reagents is packed same, can divide for inner packing system and outer packing system, dot and this common industrial product are packed different, also mix the home appliance that pays attention to amortize to pack very much kind, car component kind or of electric subclass product packing is to have very big different.

And according to the author‘s real individual view, assign the function test that is aimed at system of MDSP inner packing commonly it is 3 kinds big, pack integrality experiment namely (PackagingIntegrity Testing) , experiment of the protection that pack (Protective PackagingTesting) with experiment of clean open sex (Cleaning PeelTesting) ; And those who be aimed at system of MDSP outer packing, the likelihood needs to carry the test that pack only.

Because the article has undertaken treatise to this part content, more detailed content, can refer to clumsy article " the experiment of a few function of the system of sterilization of medical devices that pack " , this article is published at " information of Chinese medical devices " 2007 the 8th period on.

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