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IMPORTANT MEDICAL DISCOVERY - CURE FOR CANCER, AIDS etc
Industry of medical devices is across of a many course, knowledge capital is concentrated, concentrated model hi-tech industry, it is current world develops one of properties with most active dealings of the fastest, trade. Gross value of industrial output of our country medical devices from 20 centuries rapid growth maintains all the time since 90 time, average amplitude maintains the level in 12%-15% all the time. According to industry of medical devices " 915 " of the program predict, total production value of industry of our country medical devices will achieve 100 billion yuan 2010.
Industry of global medical devices is analysed
Since entering new century, global medical devices exports market dimensions to magnify continuously, although be below the circumstance that financial danger four sweeps past, 1-11 month also reached one hundred and seventy billion four hundred and eighty-seven million dollar 2009. As we have learned, 2007, size of market of global medical devices amounts to turnover of 300 billion dollar, commerce to be trading business volume of 340 billion dollar, import to be 170 billion dollar about about, average increase rate is the market 7% , market vacuum is giant.
Suffer economic crisis effect, demand of European Union import glided 2009 4 percent, its basically import origin country to wait for a country for the United States, Switzerland, China, Japan, among them China holds market share 8.35% , grow 2.1% compared to the same period. The others country glides somewhat.
Regard the whole world as market of the 2nd big entrance, american demand glided 5 percent, reached twenty-seven billion one hundred and eighty-five million dollar only 2009. As a result of this country the market disperses quite, fail to form one state alone great topological features, the country such as Mexico, Ireland, Germany, China, Japan is holding main market, take import market 60% . China is the United States trade of the 4th big entrance is companionate, own the market share of 9% , came from Chinese entrance to grow 5% 2009.
2009, japan imports demand to keep balance basically, glided 0.59% , the United States held main market, portion is as high as 36% . China is associate of the 3rd large trade, came from Chinese entrance to grow 7.26% , market share is amounted to 9% .
Data makes clear, europe, beautiful, day is the whole world markets of 3 big medical devices. Chinese market share is occupied 7% , year all increase rate is amounted to 18% , have powerful inside need the market and the export market that grow quickly, become the state that has growing latent capacity most. Already amounted to 22666 2009, exit forehead already amounted to 12.24 billion dollar. Chinese medicine health care tastes vice director of chamber of commerce of imports and exports ministry Cao steel expresses, in future, the correlation of industry of our country medical devices and international market is spent will taller and taller.
Statistic shows, january 2010, our country medical devices exports amount to amount to nine hundred and fifty-four million eight hundred and nine thousand dollar, grow 10.73% compared to the same period, achieve the history new tall.
Current situation of industry of our country medical devices
Industry of our country medical devices by small arrive big, develop quickly, already became category of a product to compare ability of all ready, innovation to increase ceaselessly now, the sunny industry with market very exuberant demand. Especially in recent years, industry of medical devices grows speed to be accelerated further, not only successive much annual produce maintains two digit to grow, and the quantity that the product exports and content of science and technology also promote ceaselessly.
Accelerate move as international industry, china will become the significant production base of global medical devices, the instrument equipment that counts an import formerly partly is coming true stage by stage homebred replace an entrance. In the meantime, home already had many province city to regard new economic point of growth as industry of medical devices, clutch breed. The expert points out, henceforth 10 to 15 years, industry of our country medical devices will enter high speed to develop level.
According to concerning a section newest data shows, 2009, bead trigonometry, long triangle and group of industry of bay of annulus Bohai Sea lead an industry development, the province city such as Guangdong, Jiangsu, Shanghai, Zhejiang, Fujian, Beijing, Shandong, Liaoning, Hubei and Tianjin before the row 10 exit, among them forehead of Guangdong province exit is amounted to 28.82, occupy than 23.54% , be among the best of candidates.
Meanwhile, also want to see equipment of medical treatment of domestic high end basically has been held by the product firmly of transnational corporation, industry of our country medical devices grows instability, medical devices is superintended start later, business of medical devices is small, much, come loose and the phenomenon of low-level competition still did not get essential sex transforms, the technical innovation capacity that increases property of our country medical devices quickly, yield that strengthens medical appliance research and development, learn, grind jointly, had become urgent matter. How to keep away from vicious price war, produce immanent advantage, promoting competition ability is the problem that a lot of production companies think.
Automation business business chance is infinite
Industry of medical devices grows quickly, brought numerous opportunity to other and relevant industry. And in these numerous good luck, automation business cuts bit of chance bigger. More and more medical treatment produce an enterprise to deliver the view to manufacturing automation and the manufacturing standardization that conform with international, realise automation and standardization are right for the enterprise, can become the secret Ji that its show itself.
Current, level of the automation of enterprise of our country medicine, informatization is uneven, only the process automation that few enterprise reachs certain level, great majority company still stops in the monomer automation phase of device control character. And abroad especially the level that the pharmacy business of the developed country already achieved integrated automation, medical enterprise must maintain very high process automation level, in order to ensure what medicines and chemical reagents produces is safe, reliable with consistent, the security of information, essence allows to spend related medicines and chemical reagents, integrality, but record, memory, date from, get.
Director of industry of medicine of automation of Luoke Wei Er Ms. Zhu Ying expresses, on automation level, life science industry (turn eductional systme medicine and biology project especially) be a model mix model industry, among them the what craft of pre-treatment paragraph in often including process control and batch processing, the aftertreatment often is the disperse control of Electromechanical unifinication and athletic control. On information level, life science industry is the domain that superintends strictly, each countries have extremely strict superintendency code to need follow.
Use automation system, jockey gets information; to safeguard labour to be able to search resource; to control an engineer to be able to pass structure of all of computer science department to decide from inside physical position structure from inside the structure of process systematic work status. Of information get in time will great shorten decision-making time, assure quality, raise yield, increase benefit, hold active, promote an enterprise competition ability.
Software of medical devices superintends: Mo Rangji is become superintend " short leg "
2008-10-08
. Software of medical devices has two main character: One, it is computer application software; 2, the use of it and medical devices is concerned. But need is clear is, not be all using the software that concern with medical devices is medical devices, national bureau ever issued civilization truly, rise only show collect a figure (data) , collect, file, the hospital runs the software that wait for action and does not involve data analysis, do not press government of medical devices, press government of medical devices with the software that handles medical devices at result analysis, control. That is to say, the software that controls function of medical devices only and analytic software just serve as management of medical devices.
Manage the current situation
. Superintend with medicines and chemical reagents rise quite, medical devices is superintended all the time very fragile, it is superintendency process is medium " short leg " , among them, software is superintended is insufficient more, center a watch to superintend a level now severe shortage, superintendency equipment does not follow low, superintendency professional to go up, register examine and approve non-standard etc.
One, the superintendent deficient that has software of medical devices to manage knowledge.
. Software of medical devices and common software are same, written tool divides 3 kinds big into machine language, assembly language, advanced language, popular advanced language has VB, VC, FoxPro, Delphi. These software are the computer of formal consist in that goes in order to command or in the other medium that put store, some is flat compiled machine language, it is completely by the 0 data with 1 composition, want to use or superintend it to move through computer only. And current superintendency team cannot be competent however software of medical devices superintends the task. Above all, what major of medical devices learns in superintendency team is very few, those who learn the computer is fewer, what know medical devices to know computer software again already is little then little, the task is superintended with medical devices on structure of occupation unworthily; Next, because suffer the effect of thought of heavy medicine light instrument, plus medical devices relevant knowledge reachs software kind knowledge is updated very fast, master harder, bring about superintendency team to go up and superintend the task in intellectual structure also unworthily.
2, the device that software of medical devices controls government is almost 0.
. Software of medical devices is to put lay aside to digitlize a program mediumly in the computer, cannot see, feel do not wear, can pass moving computer ability to undertake superintendency to its only, so its superintendency cannot rely on to superintend the knowledge of personnel and experience solely, still must method of high-tech of have the aid of, take a technology and the way that supervisory photograph ties. But at present superintendency equipment of software of medical devices is done not have basically, superintendency personnel can adopt the software that will register certificate and actual application to undertake superintendency according to this kind of primitive means relatively only, develop illegally to those, of pilfer edition, random hits patch, random to upgrade the software of replacement is at a loss what to do.
3, software of medical devices is non-standard when register.
. Software is registered have form of a few kinds of expression, it is alone serve as software with software name kind appliance is declared register card name; 2 it is to be in what name approval is with workstation, such-and-such system in registering card product composition and function column to register card; 3 it is equipment of built-in main body in, register card to go up to was not made clear. Among them, the 2nd, 3 kinds brought a lot of inconvenience to superintendency job, if register the version name that the product did not make clear in card, the production that did not make clear a product develops manufacturer. The 3rd kind registers a form to give superintend brought difficulty bigger, in register the presence that essential report does not give software on card, and the weapon that uses actually has software however, are these software belonged to register a product or did not register a product? Superintendency staff is judged very hard.
Case study
It is production more confused, supervisory difficulty is great.
. The requirement that production of software of medical devices needs is not tall, it want software of a few a computer, computer to develop personnel only is OK to want software of a few a computer, computers to develop personnel only. The production of this kind of type is OK at any time, organize everywhere, and software is with data form consist in computer or on the other medium that put store, in half-baked before you know it is software of medical devices very hard, bring about production of software of medical devices to be superintended hard. In be superintended actually, the person that we ever discovered some appliance production, management manufacturer is used to let appliance feels this kind of medical devices is very advanced, belong to high-tech product, raise sale price thereby, add sale window, do sth without authorization adds software. The generator of these software is manufacturer of a few small-sized software, if some bureau is in some hospital to check discovery, the anaesthetic machine that its use is to pass computer to run software to come pilot, classics development investigates discovery, the developer of this software is the management company that sells this anaesthetic machine unexpectedly, and additional invoice collects fees software alone, investigated a sale one case to did not register record of software of medical devices thereby.
2 it is current concealment the gender is strong, be aware of not easily.
..Of software of medical devices current often do not take alone form, that is to say won‘t which medical devices manages an enterprise to be able to sell software of medical devices alone, they often bind a sale together with medical devices, the content that software of medical devices exists also can be not reflected in provides data, if check personnel to consult merely data or examine the medical devices that moving to the spot, can discover the existence of software of medical devices far from. Only thorough medical devices uses the site, examining medical devices is how to be operated, move, undertake communicating with operation personnel, just be informed this medical devices to have likely without software, this software is to use what record and save a data to still be used at control machine, auxiliary those who diagnose, the software that uses clearly namely needs to still need not be registered what register.
3 it is to use supervisory technology the demand is high.
. The software of medical devices that registers certificate without the product originally is superintended very easily, but because register certificate to be written non-standardly, bring about cannot only by registering the not clear software is used this certainly software on certificate is without what register, to superintend brought difficulty. Additional, software is the data that the electron converts, in consist in computer, want this one to register the mark on card to understand software only, it can upgrade at will in the following use process replacement, hit a patch for the program at any time, because lack corresponding technology to control a medium, these changes are to cannot use naked eye to check know, lack corresponding superintendency equipment again at the same time, be aware of not easily to this kind of behavior so, superintend not easily.
Superintendency countermeasure
One, make software of medical devices superintend professional team, get used to the need that superintends new condition.
. To get used to the requirement that software of medical devices superintends, must strengthen software of medical devices to superintend professional team construction. On one hand, undertake grooming to superintending personnel, groomed content includes knowledge of medical devices, electron knowledge, English knowledge, computer knowledge, software relevant knowledge, improve superintendency personnel quality with this; On the other hand, complement to superintend a team new blood, increase major of a few medical devices and the staff that computer major graduates.
2, increase software of medical devices to superintend hardware equipment, supervise the technology introduce software to superintend.
. Increase software of medical devices to superintend hardware equipment, add for software of medical devices with electronic technology for example similar the electronic Yin Wen that seals an autograph, wanted to undertake altering to the software that already examined and approve only, the electron seals an autograph to be able to hint, and superintend equipment of superintendency hardware of personnel have the aid of can receive this information. Such word can be changed effectively to do sth without authorization, dozen patch, upgrade the behavior of software undertakes superintendency, put an end to do sth without authorization to upgrade from technical level this kind of behavior.
3, annotate on of careful of software of normative medical devices book, make superintend have according to but by.
..In register the detailed information such as limits of date of the manufacturer home that software of medical devices makes clear on card, name, version, action, the software that examines and approve along with all the others to those and medical devices especially, must be in register the report on card to go out to whether software registers information, make in supervisory management of medical devices, register card to be able to have very good basis effect.
4, the examination strength that enhances production of pair of medical devices, management unit, stop illegal action from fountainhead.
. Increase the examination strength of production of pair of medical devices, management unit, the key examines his the production, medical devices that manage is accessary have software, if add the word that contains software, want to make clear this accessary software to whether need to register, if need to whether had been registered what register,wait a moment; Additional, whether does manufacturing company undertake upgrading undertaking checking without examining and approve to software to medical devices, because software upgrades,can be distinguished with different version name, can see with this whether software upgrades; To running a company, check its whether proper motion or entrust other to produce software of medical devices, sell an user together with medical devices.
5, the examination strength that increases pair of medical devices to use an unit, undertake to having the instrument of software the key is superintended.
. Increase the supervisory examination strength of pair of use units, thorough medical devices uses the site, examine the use method of medical devices, communicate with the doctor that uses this weapon, the key examines the medical devices in using to whether use software to undertake operating, supervise the software that controls a method to be used to place with the technology in time to undertake be superintendencied effectively with administration, see its whether be registered, whether to put in do sth without authorization to upgrade, the behaviour that do sth without authorization changes.
6, production of perfect medical devices, manage, system of the education of use unit, early-warning.
. To medical devices production, management unit undertakes relevant law laws and regulations is publicized, let them know do sth without authorization to manufacturing software, do sth without authorization is changed or upgrade the act of software violates, should assume relevant law responsibility, supervise and urge its are self-conscious and abide by the law production, manage; Undertake administrative grooming to medical establishment, let them understand software of medical devices presses government of medical devices, need to register, the product that should examine it when purchasing the medical devices that contains software registers certificate, look to whether be passed register, supervise and urge its strengthen software management. (Wang Zhangming) origin: Chinese medicine signs up for
. Be in imperceptible in the wind of health care of medical devices all round discovery increasingly be current, there is in smooth village, the village of the village face each other that lies between a driveway only has 2, and the business seems to return very hot, the in an endless stream of old man old lady of free experience.
.I am god-given half days of idle comes to poach experience this modernization instrument, the infrared instrument that treats cervical vertebra disease experienced in preexistence village, sale price is controlled in 300 yuan, the cotton chasm that heats child put on the back to heat about 40 minutes, without any peculiar senses, be a hot Hu Jin, see that girl insert in the instrument on nose to hear of nearly 3000 yuan to others, cup of a health care still also is preferential price nearly 300 yuan.
. The village on the village has the place of health care of 2 medical devices, one is a bed, one is a chair, although manufacturer is different, but those who say is infrared ray heats completely, some letting that flip through all over, some letting that sit silently over, of the a change in form but not in content in Hu You common people. Hear of that bed more than 10000, that chair also is close friends hundreds of. Look at the old fogey that lies in mulberry of dark green of on that bed one face and old lady, what flavor does not know in the heart, it is to earn a living and eat this free lunch. Another shipshape ground sits full the old fogey old lady of one house is enjoying physiotherapy at the same time over, listening to a teacher to give brainwashing at the same time, still one part person is waiting for below one batch in patience.
. Present businessman but true essence of life, after people solved problem of dress warmly and ear one‘s fill, when paying attention to life quality more and more, special the mentality that held old people, worked hard largely child old people arrives the disease pesters a body nowadays, go looking down on to the hospital, to give children people managing dot money, listen there what treat freely run toward where, and what sell an instrument now is special essence of life, do not let you buy first, however its let not tire of irritatedly first you experience, keep making you enchanted to your hair drier during the experience, you are here experienced a word that final or else buys another period of treatment also feels embarrassed, in those days is the thing of success will come when conditions are ripe. I very feel puzzled can different instrument treat same disease? Take medicine to cannot treat 100 disease, what is more,the rather that Where is this instrument? But family girl said, you take medicine also guarantee against can help a person, what is more,the rather that this instrument lets you do precaution of good health care ahead of schedule, have be defeated aid remedial effect to see a doctor beautiful Qian Jiang became much. See that girl dash along saying clear and logical, pardonable so much person by flicker go to every day here run.
. Look what wind of this health care blows is quite fierce still, in front of streak is passed annul like, impetus flourishing is worn. But the fantastic that don‘t I believe to these instruments are publicized like them really? Should kite just is a purpose.
Sea leaving the United States puts in Pu Zhongjie ‘s charge to appear to be in the office rarely, I ever called its company telephone exchange 3 days continuously with the friend‘s name, answer is same: The manager is not in a company today. I think the reason does not have 2: Really very busy, do not have company; these days by chance or outside busy move does poineering work board thing. Enlist the limited company of Beijing Le Pu medical devices that establish to Pu Zhongjie and him, outside report is very little, mystery is their pronoun. To understand this individual and Le Pu better, the person that I found another to accept media to interview rarely in recent years -- American Hua Ping invests group president Sun Jiang. Raise VC one by one only as what introduce till happy general medical treatment is current, hua Ping provides right to speak most undoubtedly. To my problem, sun Jiang‘s answer exceptionally candid: "I most those who value is Le Pu they this group. "I most those who value is Le Pu they this group.. Pu Zhongjie, 45 years old, material learns a doctor, take learned man of beautiful return to one‘s country. Introduced a talent to work to Florida international university as American government 1992, be hired to be a researcher, pursue the research of the bracket inside human body conduit and design for a long time. Sun Jiang people excited place depends on, happy general medical treatment is home in the person of the same trade the first obtains national medicines and chemical reagents to supervise bracket of management board coronary artery to register the business of approval, also be the first company of domestic that acquires patent of medicaments coating bracket. The logic that gives out with general VC is different, the medical treatment that Sun Jiang is in Le Pu intervenes product (the pharmaceuticals equipment that basically supplies support operation place to need) the market puts the 2nd in what evaluate. The dimensions of market of this and this fractionize is concerned. Market of current domestic medicaments bracket, ranking first is Shanghai small achieve. 2008, its sales revenue 490 million, own the share of native land market of 25% . That is to say, the total dimensions of native land market does not pass 2 billion. Happy general medical treatment achieved sales revenue 2008 445 million yuan, implementation net profit 200 million yuan, belong to the second inside course of study. Although market scale is not at present large, but this is a fractionize market that has growth sex extremely, annual increase rate is achieved 15% . "Enterprise of domestic medical devices has the following feature basically, father is the technology sends the sea to return mostly, in Euramerican had had study abroad and working experience, go back to the motherland after doing poineering work, duplicate product mode of the west come over, drive a new market. " a personage inside course of study tells me, "Spoken parts in an opera, this industry joins western market and company very easily car. This industry joins western market and company very easily car.. This also is the advantage place of posture of industry of medical treatment equipment to biology medicine industry. Compare with photograph of medicines and chemical reagents, medical the instrument produces a year of time to be able to take testimony, and medicines and chemical reagents examines and approve need 3~5 year. Company of equipment of a medical treatment from do not have have, arrive as a child big, time does not pass the left and right sides 5 years, as periodic as the investment that invests fund roughly be identical. And to pharmacy business, this cycle wants above 10 years at least. To " seize every minute " for VC too too endless. On charge of research and development, the devoted cost of biology medicine enterprise also should compare tower above of industry of medical devices a lot of, "Go up at every turn 100 million " , the personage inside a:appellant course of study says. And up to to July 2007, research and development of happy general iatrical throws accumulative total to be 15 million yuan of RMB. This ability is Hua Ping value key of happy general iatrical to nod. Nevertheless, market of intervening product of Chinese whole medical treatment is at present main still by forestall of transnational corporation place. "This domestic line of business has go regular, while transnational corporation is selling a hospital medical devices, the assistance that can not poor to hospital brushstroke is expended, this is equal to formed an aeriform competitive doorsill. Like Le Pu this kind establishs the company with not long time, which may have abundant financing to do these businesses. " the personage inside afore-mentioned course of study says.
. "To 2020, industry of our country medical devices or the scale that will attain 1 trillion yuan of RMBs. " Wang Hong of director of center of development of Chinese biology technology is wide express on exposition of medical devices of the 64th China International.
"Come nearly 5 years especially in recent years, industry of domestic medical devices obtained relatively rapid development, but domestic production company is much smaller messy situation still has no essential sex to change. " expert attending the meeting is evaluated so.
As we have learned, 2002 ～ 2004, the country uses national debt capital to throw item of 35 medical devices, gross amounts to 300 million yuan; 2006 ～ 2008, plan of the project of national science and technology that prop up, " 863 " the plan throws scientific research funds to make an appointment with 270 million yuan in domain of medical devices. " medical economy signs up for " the reporter understands in interview, the personage inside most course of study thinks, the country still should continue to increase the investment strength of industries of pair of medical devices, the industry that builds a standard, health with international difference to narrow grows an environment.
Native land and strong brand is rare be short of
Data shows, up to by 2008, the whole nation has medical devices actually to produce a business 13141; Among them, instrument of a kind of cure has 3368, instrument of 2 kinds of cure has 7533, instrument of 3 kinds of cure has 2240. Besides medical devices of a few high end, home can produce needs great majority medical devices basically.
However, "Equipment of Chinese brand medical treatment and company are too little. " Chen Yazhu of director of institute of instrument of medicine of biology of university of traffic of academician of Chinese Academy of Engineering, Shanghai plaints so.
Current, big company of each country medical devices market of gaze at China, base of a sale, production, research and development is built in Chinese mainland, realized global mainland to change, strategy of native land globalization. The brand such as riverside of GE, Xi Menzi, flying benefit has held our country to digitlize medical treatment equipment the market dimensions of 80% above.
Chen Yazhu with medical analytic instrument is exemple listed a few numbers: In prep above of only station price 100 thousand yuan domain, 99% what import biochemical analyzer to take capacity of aircraft of domestic general assembly; 100% what import immune analyzer to take capacity of aircraft of domestic general assembly; 100% what import haemal analyzer to take capacity of aircraft of domestic general assembly; And even if in this kinds of product under 100 thousand yuan article compasses, entrance product still has the 8 installed capacity that become above.
According to data of Chinese custom statistic, this year first half of the year, our country medical devices imports the forehead to reach 3.515 billion dollar, become the entrance that diagnoses the high-end medical devices such as equipment like line of device, X to appliance of embedded type orthopaedic, nuclear magnetic resonance growth is apparent. Nuclear magnetic resonance is become wait for an entrance to all exceed 100 million dollar like appearance of examination of fault of ray of device, X, entrance forehead is rising with two digit amplitude.
The corresponding period, our country medical devices exports the forehead to be 6.573 billion dollar, but in before exporting a rank 10 enterprise, foreign capital and joint ventures have 7. From whole export business form look, foreign capital and joint ventures are the main force that domestic medical devices exports. And enterprise of domestic medical devices still with " bandage of absorbent cotton gauze " , " the needle is provided, tracheal, spile " , " massage appliance " wait for product of division of low technology content, low exit is given priority to.
The bad-mouth that low end of home made product changes
"The large company that cross a state can take out abroad the one fraction of profit will throw research and development, and domestic company itself has only ‘ a bowl of water ‘ , research and development of a product wants to drop most bowl spray, how is this likely? " the reason that lags behind about development of estate of our country medical devices, chen Yazhu used a rhetorical question to answer back and forth.
"Net profit is too small, the enterprise throws research and development of equipment of large high end without sufficient financing. And do not have high-end equipment prop up, bring usury profit very hard. " the personage inside course of study expresses, product low end, coessential change bring about the main reason with low profit of company of medical devices badly.
Actually, net profit is small already was current the common fault of company of domestic medical devices, even if the company of a few medical devices that has appeared on the market is not exceptional also.
The data that according to appearing on the market annals showed the company 2009, net last year profit margin is medical treatment of in relief general 19% , ophthalmology love Er is 15% . And in in the fish dive medical treatment that platelet appears on the market, 9 install medical treatment and division Hua Hengcheng to also be achieved respectively only 19% , 12% with 15% ; Rate of integral net profit all is less than 20% .
The reporter exhibits meeting site to see in exposition of instrument of cure of the 64th international, some DR of homebred 200mA (ray of direct digitlization X is video system) hit " rise 398 thousand yuan " catchphrase. As we have learned, 10 thousand east, east soft, medium Kemeilun, fish dive, An Jian, La Yun, Heng Ruimei is couplet, Pu Lang, new China waited for the ten home company with differ size to all roll out DR, along with configuration different price goes to 10 thousand yuan about a hundred to differ in hundred thousands of yuan, and entrance DR price is 3 million ～ about 4 million yuan.
Regard high end as medical devices, DR lets a hundred flowers blossom quickly make the personage inside course of study open-eyed, but they still cherish cautious attitude to this: "Roll out a new product, cannot pass how long, have a lot of entrant very quickly, the price also is pulled very quickly subsequently. The price also is pulled very quickly subsequently..
1 trillion how to come true
Although industry of domestic medical devices exists to did not form the inferior position such as camp of forestall of market of dimensions benefit, foreign enterprise, new and high technology, but the addition that expands of market demand to support strength with the government ceaselessly, still can create favorable opportunity for industry of domestic medical devices.
Science and education of Ministry of Public Health manages director He Wei expresses, the government increased pair of biology medicine properties that include medical devices inside in recent years give aid to strength, will breed and as the strategy burgeoning industry develops, property of domestic medical devices is current should low end product scale of production is changed, intensive is changed, be in in the course that the technology takes to add market strategy on upright product, and choose to produce to high-end product learn to grind course of confluence of allied, the army and the people, may win by striking only after the enemy had struck.
Be based on the market dimensions that at present domestic medical devices controls 200 billion yuan, wang Hong is wide think, want to achieve the industrial ideal of 1 trillion to still need many sided hard.
Wang Hong is wide suggest industry of domestic medical devices puts evolution in precautionary health care mainly from this kind, diagnose detect kind, remedial operation kind, rehabilitation kind, medical information kind wait for a respect, in the meantime, should drive industry of medical devices to realize a technology to span type develops, this can divide a pace to go -- the first pace accumulates level for the technology, strive to 2015 total production value 500 billion yuan; The 2nd pace rises abruptly for the industry level, to 2020 the industry is achieved 1 trillion; The 3rd pace develops level to last.
"The biggest question is system. " the main reason that Chen Yazhu thinks industry of domestic medical treatment is lagging still depends on system. The government ought to solve the manner of the problem with the help nowadays, increase the support of own to medical devices innovation, enterprise and college research organization also should transform idea, distinguish respective duty, in order to come true double win. (reporter Li Yao)
. The definition that sterilization of medical devices packs should understand for:
. Use at medical devices kind of the product pack, can have sterilization to its, can undertake aseptic manipulation (like clean open) , can offer acceptability microbial cut off function, sterilization around can make protect and can be after sterilization inside proper time to the product (tagged period of efficacy) the packing system that maintains environment of systematic interior asepsis. Because this concept does not include the protection outside to pack a system normally (amortize is packed and the part such as assembly packaging) , so sterilization of medical devices packs what the system also can say to be " system of asepsis protective screen (SterilizationBarrier System, SBS) " (the standard appellation according to ISO11607-2006) . Sterilization of medical devices is packed belong to a burgeoning development domain, can say to burgeoning industry is belonged to inside limits all over the world, in and still be in ceaseless accumulation be being summed up, the development in home especially slow. With the sealed packing data that requires sterilization medical devices at be opposite, have function of microbial protective screen, can prevent microbial enter and offer asepsis to defend, make the product is packed finally in the aseptic when using.
. English name: Sterilepouch
.The relevant code that sterilization of medical devices packs standard:
The code that packs about sterilization of medical devices standard, current, what worth while discussion is below these two: ISO11607 and EN868, of course these two belong to category of level of general rule sex, covered again inside them a lot of pack a system about sterilization of medical devices the relevant test standard of particular test method, basically be the standard such as ASTM and ISO!
ISO11607 shares 3 version so far, it is 1997 edition, 2003 edition are mixed respectively 2006 edition, also can seeing sterilization of medical devices packs this domain from here is new inside limits all over the world, according to the program, next version should be rolled out inside 5 years after 2006.
Newest 2006 edition, promulgate formally in April 2006, two parts are comprised, the first part basically is about packing material, asepsis to cut off the system is mixed of the system that pack, the craft that the 2nd part basically told about sterilization of concerned medical devices to pack affirms (Validation, similarly hereinafter) problem, pack asepsis so affirm with the craft that pack by design of the system that pack content of this two large principal part distinguishs came. More important is, in this version, absorb formally incorporated the EN868 standard system of European popularity, cancelled the system of general rule sex that EN868-1 conflicts this each other already, absorb optionally incorporated EN868-2 arrives - 10 these 9 are mixed about specific data of the product child standard, this also was proclaiming in fact the sterilization of medical devices with unified whole world packs a standard to was born 2006 eventually, already ISO11607-2006.
About EN868 this standard, standard of sex of this general rule also promulgates its original EN868-1 1997, ever since - 2 to - 10 are in as accessary standard ever since make up a few years slowly in time write development to rise, but as a whole the criterion that this fits sterilization to pack manufacturer to control material and production like more, is not the is used at coaching sterilization packs a system check mark that for medical devices manufacturer designs one allows, and this standard is done not have all the time fore-and-aft update, it is redo only some transverse child of the standard patulous!
What what I hope is, discuss concerned medical devices when us later when sterilization packs a standard, need to pay close attention to ISO11607 only this one standard! As to our country, 2005 coequal cited ISO11607-2003 as recommend sexual GB GB/T19633-2005, also doing the work that updates ISO11607-2006 translate into edition GB/T19633 all the time at present!
.Functional action: Scandium aning enclosure for storing grain tritium presses bottom of natrium of clear Bo having enough of Xi of Piao of Qian of of grave admires glare of flatter of of of of ÇŽ of any of several hot spice plants of Mu of У of of Jie of Dun of ü imprison farring away having enough is Suo of Quan of Mo of ⒛ of of Se of pump of the blade of a sword of Nai ⑸ Ç– male
.., can get used to corresponding sterilization process; .., protector fetterses, make appliance maintains in acceptability use condition falls; .., have a bacterium to cut off function, the asepsis sex of appliance and integrality can maintain before using; .., can asepsis open, in order to use weapon; .., identify correctly with use product.
. The principle pursues as follows:
......Quality technology asks:
1, include material to must cut off effectively microbial / bacterial ASTM F-1608 2, the sterilization means ISO11134\ISO11135\ISO11137 that must get used to acceptance 3, the asepsis position that maintains a product. Pack cannot have quite be polluted by air, fiber damaged, the exotic such as dirt, microbial invasive opportunity (ASTMD-. 2019).. Accordingly, pack need to ensure: ..- - include material not to have damaged; ..- - close complete, come off intensity (ASTM F88) appropriate, without permeate (ASTM
... F1929:1998) , without blow up (ASTM F-1150 / ASTM F-2054) , come off clean ... Clean (EN868-5) .
4, include material or pack follow-up Ying Yi at be being machined; . Material makes when the reduces grain desquamation that needs the oldest rate, for example fiber, chip, printing ink falls off, dirt. (ASTM D-2019) 5, after the open that pack, due and apparent trace shows ever had been opened; .After open of mouth of the open the envelop that pack, not due and aleatoric seal again add up to a gender. (precaution is packed open be added up to afresh again next by pollution)
6, should mark open position and direction; . Answer to unseal easily, and unseal the position should go to the lavatory the person that use hits open (EN980)
7, must can admit fasten a product (presswork Ma head should accord with laws and regulations of cure appliance law to ask, include material to have the stuff with transparent one side, can see in-house yield
. Article) EN980
The category differentiates:
In order to anticipate utility differentiates . - - the hospital is used (personalized requirement, make up operation combination to pack by oneself with; Repeatability makes .......... Use with appliance sterilization; Sterilization of big appliance whole) ; ..- - dentistry clinic is used (repeatability uses weapon again sterilization is packed use) ; ..- - manufacturer is used (sterilization of one-time asepsis use product packs use) ; ..- - other, be like lab. Differentiate with sterilization means ..- - sterilization of high temperature vapour High Temperature Steam; ..- - irradiation Radiation sterilization - Gamma, electron Beam; ..- - aeriform sterilization Gaseous - Ethylene Oxide of sterilization of annulus oxygen ethane ..- - Low Temperature Oxidative - of microtherm oxidation sterilization crosses Sterrad of oxidation hydrogen sterilization.
Differentiate with product structure . - - planar bag (use at ply small, standardize a product) . - - canal bag (use at a variety of a few product, but aleatoric intercept length) . - - stereo bag (use at ply tall, the product with irregular bulk) . - - coming directly towards bag (use at the area big, weight is great, volume is large and the product with additional low cost) . - - in envelope (use at asking to pack fatigue to originally and the product with additional low cost) . - - lid material (use at with suck model box heat forcedly to close, suck the product that model packages forcedly) . - - wrap up material (use at needing to disinfect wrap up, and the product that uses namely after disinfection) . - - roll material (the data that is used at him automation sterilization to pack production)
Add up to means in order to seal to differentiate
..- - heat is sealed model ..- - Leng Feng / self-given model
Differentiate with agglutinate principle ..- - coating of the collosol that do not have heat sticks heat to close oneself
- - coating of glue of solvent sex thermosol - heat seals agglutinate ..- - coating of water-solubility thermosol glue - heat seals agglutinate ..- - coating of solvent sex cold collosol - pressure agglutinate ..- - coating of water-solubility cold collosol - pressure agglutinate ..- - rip profile easily to expect without coating - heat seals agglutinate Differentiate with material permeability ..- - breathe freely (analyse) the gender packages data ..- - blame permeability packages data Medical model of paper of disinfection of sterilization of medical devices wraps bagging - groovy material category
Surface ability ..- gelatinize is dialytic paper
- stick dialytic paper oneself ..- strengthen dialytic paper ..- Tyvek - PET/ rips film easily Bottom material Drench velar paper, groovy structure is: Paper/PE .. Compound film, groovy structure is: PET/PE, PET/CPP, opp/PE .. Squeeze film in all, groovy structure is: Corona Layer, main Layer, heat Seal Layer .. Soft film suction model, groovy structure is: PA/PE, PP/PE, PP/PA/PE, PA/PP, EVA/Surlyn/EVA .. Suck model film forcedly, groovy structure is: PETG, APET, HIPS, PP. Coating of surface ability paper pressworks paper + bottom material is dialytic paper, a kind of trend that makes manufacturing paper paper bag. Sterilization of medical devices is packed - chemical indicator and presswork ink
1, sterilization becomes angry chemical indicator, this product is similar to presswork ink, treatment principle pressworks together Chinese ink, presswork its to be installed at the bag normally inside bag or exterior. Its principle is fall in specific sterilization requirement, indicator Yin Mo is become by initiative color beforehand the color of set. The function depends on indicating the sterilization condition that whether is sterilization product passed and accords with a regulation intuitionisticly. Sterilization becomes angry indicator divides chemistry to be mixed for ability in swimming oily, distinction is not containing heavy metal at ability in swimming.
2, presswork ink, normally cent is mixed for ability in swimming oily, be based on the quality requirement of medical treatment product, medical treatment is packed use bag of lake be surrounded by mountains knowledge normally, this ink should examine through ISO10993 biology compatibility, heavy metal content accords with IEC62321:2008, US EPA 3052:1996 requirements
The choice that sterilization of medical devices packs
The feature of appliance and requirement - horniness (whether acute angle) , soft qualitative; - regular, irregular sex; - ply. Sterilization requirement - ETO; - Steam - Sterrad - Gamma The product assigns sold route - before loading appliance, carry, still load ....Appliance hind is carried; - carriage kind and carriage distance; - the kind that cent sells, entire case, entire case is returned ....It is the smallest pack; - outer packing requirement. Ticket demand - presswork to Ma head requirement; - legal laws and regulations of place asks. Level of the unit that pack - manual ／ is automatic - the quality of the equipment that pack and precision. Cost - quality is oriented; - cost is oriented
Sterilization of medical devices is packed - groovy workmanship principle
Dialytic paper ..Net of shop of → of hydrolyze of → wood pulp, roller pressing, drying refines paper → receives a → cent to cut → to pack. (stick oneself with be not the main distinction that sticks paper oneself to be shape in papermaking in the process, bubble is invaded in the surface of paper industrial chemicals) Compound film (compound machine) ..→ deserves to choose makings bead to → blows film or flow delay 2 into velar stuff → or become preelection film more compound and into. Blow film in all agent or stream delay in all agent film (blow velar opportunity or flow delay machine) ..The photograph of 2 kinds of above sticks → → of dissolve makings bead is multilayer blow film or much laminar flow is delayed in all the agent shapes velar stuff → receives a → cent to cut → to pack. Drench film (drench velar machine) ..→ is on paper or its base material, through drenching plastic particle velar equipment high temperature dissolves, the modular head small Kong Zhonglin that passes adjustable ply next is on base material, cool next shape. Coating expects (spreader) .. → is on paper or other base material, pass reticulation roller, the means move that the hot collosol that will dissolve beforehand presses through pressure roller arrives on base material, next stoving is caky. Medical model of paper of disinfection of sterilization of medical devices wraps bagging - effectiveness affirms (1)
ISO 11607:2006. - of final asepsis medical devices pack;
ISO 11607-1: The system of protective screen of 2006 - material, asepsis, requirement with the system that pack; To packaging data, pack raise a requirement (replace EN 868Part 1)
ISO 11607-2: 2006- figuration, sealed acknowledge a demand with what rig a process; Hold equipment, production to the bag craft, with production moving process raises a requirement (IQ, OQ, PQ) , accord with a requirement in order to make sure every sterilization packages a product
(2)
ISO 11607 part 2 5.The process that pack admits really; .....- 5.1 general principles; .....- 5.2 installation appraisal (IQ -Installation Qualification) ; .....- 5.3 moving appraisal (OQ -Operational Qualification) ; .....- 5.4 function appraisal (PQ -Performance Qualification) ; .....- the formal approval that 5.5 processes affirm; .....- 5.6 processes control and surveillance; .....- 5.7 processes are changed and affirm afresh; Sterilization of medical devices packs – to create a condition basically
Medical treatment is packed, solid the category that belongs to medical devices, should press medical treatment implement make undertake administrative (FDA 2 kind) ; Accordingly, medical treatment packs production condition to should satisfy: . - ISO Class8, 10 thousand class of GMP 10 purify a workshop. 3 kinds of medical treatment are packed, need 10 thousand class to purify manufacturing environment; . - ISO13485 medical devices is special quality management system; . - FDACFR820 quality runs a requirement; . - ISO11607-2 figuration, sealed acknowledge a demand with what rig a process. Medical – of the bag of model of paper of disinfection of sterilization of medical devices that pack is basic accordance statement
System of quality of ISO13485 medical devices " accordance attestation " ; System of protective screen of ISO11607-1 material, asepsis and of the system that pack " accordance proves " ; ISO11607-2 figuration, sealed with what rig a process " effectiveness affirms a proof " ; EN868-2 ～ 10 wait for sterilization medical devices to pack material and system " the test and verify of relevant section proves " ; Of the biology assess of ISO10993 medical devices " security proves " ; 94/62/EC is packed and pack flotsam to dictate " accordance proves " ; Of pointer of chemistry of sterilization of product of ISO11140 medical treatment " accordance proves " ; FDA 510K registers a proof; ISO Class 8, 10 thousand class of GMP 10 purify a workshop " accordance proves " .
Medical establishment wraps bagging with sterilization - use note
(1) before loading
1, asepsis is packed before using, the sealing that needs to be packed finally to each undertakes checking, in order to ensure only asepsis article enters asepsis area inside. 2, enter all goods inside asepsis area, should open its according to asepsis program, distribute and move, in order to hold asepsis position. 3, choice of the bag that pack ..→ basis drafts the size of sterilization appliance, choose the sterilization bag of appropriate measure; ..→ plans to pack appliance to should be loaded easily, unfavorable skip closely, should maintain all around shake a space; ..After → plans to pack appliance to load, after paper of the end end sterilization bag and velar face are amalgamative, dimension should not less than 2 inches, in order to facilitate fatigue originallies heal.
4, warning! ..In process of sterilization of high temperature vapour, sterilization bag comes off intensity can drop somewhat, have in process of sterilization of additional together with take true course repeatedly. Accordingly, if load appliance to skip too closely, bag of can potential sterilization is cruel in sterilization process the risk that leave;
(2) appliance is loaded ..Before → appliance is loaded, answer to be in at the blank of sterilization bag surface, mark sticks the information such as time of the name that drafts sterilization appliance or code, lot number, sterilization, identify in order to facilitate with date from; ..→ loads the appliance with corresponding dry cleanness sterilization bag inside; ..When → plans to if compare acuteness,install medical devices, the placement that its acuteness carries the heading that direction should carry with open the envelop is contrary, the person that use in order to ensure comes off the security in the process.
(3) close sealed
Self-given model sterilization bag ...→ uncovers what the mouth carries to leave model paper, land of the level after delaying amount to of amount to line closes bag mouth; ...When → heal, seal glue should join closely with the paper face of bag and velar face firm, seal finger of the application when closing to relapse normally rub pressing. Heat is sealed model sterilization bag ...→ is sealed to heat model sterilization bag, the demand that should press ISO11607 undertakes sealing adding up to the test and verify of parameter, add up to parameter in order to decide first-rate is sealed. ...Card of → come true ensures the requirement that seals the result that combine to accord with EN868-5. ...→ this medical the condition that the sterilization bag that pack acknowledges according to IS011607 effectiveness, the proposal seals add up to parameter to be: ...→ is sealed add up to temperature 168-188, add up to pressure 0.45-0.65kpa, add up to time 0.8-1.5s. ...Explain: Temperature is higher, time should be jumped over short, pressure should be jumped over small; ....... Corresponding, temperature is lower, pressure should be jumped over big, time should grow more. ....... Above is sealed add up to temperature to be temperature of very hot knife. ....... Different equipment, its character is met somewhat difference, the proposal undertakes to the function of equipment effectiveness affirms, here base ....... Parameter closes to undertake effectiveness affirms to sealing on plinth, undertake regularly periodic affirm, seal the security that close in order to ensure. Warning! ...→ is self-given model when paper model bag is self-given, prohibit sealing add up to an area to produce drape or did not stick solid phenomenon, in order to prevent block bacterium be no longer in force! ...→ heat is sealed model when sterilization bag heat is sealed, prohibit sealing add up to drape or seal close come off force slants small phenomenon, in order to prevent block bacterium be no longer in force! Keep in storage:
. The appliance after → sterilization suggests to be used instantly, if although use,cannot stand, should press keep in storage at shady and cool, dry, ventilated, in the environment that does not have caustic gas.
. → is ensure first-rate sterilization effect, the appliance after proposal vapour sterilization, suggest to be used inside 6 months, the appliance after ETO sterilization, suggest to be used inside 24 months.
Warning! ..Sterilization bag should be checked before → appliance is loaded whether damaged, if have damaged, taboo! ..When → loads appliance, should take care treat sb without proper respect, prevent sterilization bag body or seal loiter combining a division broken, expose, if have crack, taboo!
........ National provision medicines and chemical reagents controls management board file.
..Do not need application about announcing the first batch " license of management business of medical devices "
........The 2nd kind of medical devices produces the announcement that tastes directory
................ The country feeds medical inspect city [2005]239 date
Medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government controls management board (medicines and chemical reagents controls management board) : Control management board according to national provision medicines and chemical reagents the 15th order " license of management business of medical devices runs way " in " do not need application " medical devices manages business license " directory of product of the 2nd kind of medical devices by national provision medicines and chemical reagents supervises management board to make " regulation, in ask for each province (area, city) on the foundation of opinion of supervisory management board of food medicines and chemical reagents, supervisory management board of medicines and chemical reagents of classics state provision is authorized, announce the first batch not to need application now " license of management business of medical devices " directory of product of the 2nd kind of medical devices (the following abbreviation " directory " , see accessory) . Announce this " directory " , add up to 7 kinds 13 products. " directory " after announcing, ask to had done relevant work according to concerned regulation please.
Accessory: The first batch does not need application " license of management business of medical devices " directory of product of the 2nd kind of medical devices
National provision medicines and chemical reagents controls management board 25 years on May 26
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