Raiding California: Medical Marijuana and Minors
State above all, this text should be written by official orgnaization, because the thing of occupation standard construction is the orgnaization or guild are responsible thing related the country after all, so relevant Information Circular nature is will be in charge of update and be being publicized by them. The author also appears now will write this to take sterilization of domestic medical treatment to pack slightly (note: MDSP of later development abbreviation) the article of random notes of history of occupation standard construction, because more or less also shared among them a few works at present,be, become so the fatigue of raise one‘s hand, introduce the content of this respect briefly incidentally, so that make oneself abound and provide continuity more more about the series article of MDSP. Below by me from prep as far as close, make some of brief introduction that concerns this respect for readers one by one.
2003 ISO (International StandardOrganization, international Organization for Standardization) released a name formally to be ISO11607.1: 2003, namely " Packagingfor Terminally Sterilized MedicalDevices " , but actually this version is only transfer version, the earliest ISO11607 version is at 6 years before, promulgate formally 1997 namely, but the place that among them a lot of is not perfect, begin to consider version to update since the day that its issue so, and the version 2003 also is early 2000 end already was written be in the United States at of the same age home is carried out, but till 3 years after just was ISO formally to admit 2003, also can figure giving this also is not a says so that finish the United States level from this.
But it is this ISO11607 - 2003, after its are promulgated formally 2005, by the GB/T19633 of translate into of relevant orgnaization adopting equation of our country - 2005, chinese standard interpreter is " of final sterilization medical devices pack " , carried out on May 1, 2005, the issuance of this standard produced bigger effect to my relevant enterprise. A lot of enterprises understood product of final sterilization medical devices to ask basically to what pack from inside this standard, from the product development company, production company, current business arrives use orgnaization (it is a hospital normally, a few more adscititious the individual is small-sized nurse clinic) the sterilization that takes product of medical devices seriously more and more with superintendency branch is packed, publicize hard implement this standard, improved the knowledge of domestic person of the same trade to MDSP importance greatly from this, advanced the development of industry of our country MDSP thereby.
And arrived between at that time 2006, ISO released ISO11607-1 again: 2006, " Packaging ForTerminally Sterilized Medical Device- Part 1: Requirements ForMaterials, sterile Barrier Systems, and PackagingSystems " with ISO11607-2: 2006, " Packaging For Terminally SterilizedMedical Device- Part 2: Validation Requirement For Forming, sealing, and AssemblyProcesses " , translating Chinese is respectively " of final sterilization medical devices package the first portion: System of material asepsis protective screen and requirement of the system that pack " and " of final sterilization medical devices package the 2nd portion: Figuration, sealed acknowledge a demand with what rig a process " .
What be necessary to make a specification here is, what translate a habit as a result of everybody is different, there is trifling difference with afore-mentioned content when the certain terminology in afore-mentioned standards are being translated before the author, be like typically ‘ SterileBarrierSystem ‘ general in my article interpreter is become ‘ asepsis cuts off system ‘ , and here is ‘ system of asepsis protective screen ‘ ; ‘ Validation ‘ be commonly in my article ‘ test and verify ‘ , and here is ‘ affirm ‘ . Of course to respect authority, the authority that I can respect national level in the article and the interpreter that changes oneself is used to.
ISO11607 - the current requirement that two standards of 2006 edition made clear MDSP further and specific requirement, it not only the requirement that provided the data that pack, and still set wider flood conceptual MDSP, shape beforehand for instance system of asepsis protective screen (PreformedSterile Barrier System) , system of asepsis protective screen (Sterile BarrierSystem) , the system that pack (PackagingSystem) , shape (Forming) , sealed (Sealing) and assemble (Assembly) the development in the process (Development) with affirm (Validation) the requirement that wait, no matter be right,produce enterprise, current business, use section consequently, right still unit of research and development or superintendency branch, have great and direct import and practice effect, our country also is undertaking GB adopting equation actively of this standard change the job, also be one of jobs that at present senior personage is taking an active part in inside the course of study like the author.
The word says, released GB/T19633 2005 when our country - 2005 IdtISO11607-2003 " of final sterilization medical devices pack " after the standard (note: ‘ Idt ‘ it is in this meaning ‘ adopting equation ‘ ) , limited company of attestation of Hua Guang of instrument of medical service of nation of the Beijing at the beginning of 2006 (note: Namely center of certificate of quality of former China medical devices, or weigh CMD) combine Du Bangzhong country company (Dupont) , company of the China when Bi Ma (Bemis) those who waited for unit collaboration to keep this level " introduction " , this " standard introduction " positive to publicizing this standard to rise effect. But because write time weak point, collection particular case is less, main around ISO11607: 2003 edition standard asks to write, have improvement need consequently.
And the most pressing reason that writes standard introduction afresh is current ISO released 2006 edition standard to replace 2003 edition standard again, the edition before be being compared, content of new edition standard is abounded greatly, standard requirement is more specific, on the colloquium that packs occupation standard construction about medical devices in of recent for this (in November 2007, beijing) , delegate attending the meeting thinks consistently to need to press ISO11607: 2006 edition standard is written again " standard introduction " , in an attempt to can get used to the change that ISO standard updates, achieve the goal of better conduct propaganda.
On another earlier 2007 when attend in the author relevant conference (in March 2007, annual meeting of branch of high polymer of guild of Chinese medical devices and sterilization pack technical seminar, hill of Fujian fierce exterminate) , also spoke of the replaces GB issue according to new edition standard, but everybody‘s idea is returned in those days is not very mature, still arguing our new nation level is good with EN868 series after all still continue set of ISO11607 of continue to use is good.
Him author recommends use ISO11607 series to the utmost, the left and right sides before be this to be in one year gave the controller of some government orgnaization that is in charge of this metric system to decide at that time technically still to write a very senior post to clarify my choice reason, and got positive response, from this I still arrange the content of this letter into the article, publish on relevant and professional magazine.
In the course that builds in MDSP state level, the requirement that sex of eliminate government administration dictates, some units, perhaps say the individual that is delegate unit, take an active part in from beginning to end, for instance Mr Liu Hao of company of Oliver of Mr Jiao Fei of company of Bemis of Mr Qian Jun of company of Dupont of Mr Wu Ping of institute of Mr. Li Yuanchun of CMD center, Shandong medical devices, United States, United States, United States, Tianjin Kangdelai company, and him author just has favour to get invited job one of wife person.
And the arrangement according to current tentative plan and real work schedule, should say this next year the standard is updated and the job that corresponding standard introduction replaces can be finished smoothly, this also changes the job with the standard of a version same, as it happens spends two years of time. Remain, let our wait and see what happens, awaiting this new country standard to come on stage!
Article \Randy
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