醫(yī)療器械合格證打印中標(biāo)識的應(yīng)用說明

1、國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECH1國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECHFANTECH在醫(yī)療合格證打印中標(biāo)識的應(yīng)用說明The information provided below is an explanation of reference symbols that can be found onproduct labels.以下提供的信息是一個解釋的參考符號，可以發(fā)現(xiàn)在產(chǎn)品標(biāo)簽上。REFSymbol for catalog, reorder or reference part number. 考零件號碼。符號為目錄，重新排序或參GPN REFSymbol for global

2、product number and reference part number.全球產(chǎn)品編號和標(biāo)志參考零件號碼。Symbol for batch code/lot number.批處理代碼符號 / 批號。The symbol isaccompanied by the manufacturer's batch code.這個符號是伴隨著制造商的批處理代碼。Symbol for serial number.符號的序列號。 The manufacturer's serial number isfound after or below this symbol.制造商的序列號是發(fā)現(xiàn)在或

3、低于這個符號。Symbol for manufacturer.象征制造商。 This symbol is accompanied by thename and address of the manufacturer.這個符號是伴隨著制造商的名稱和地址。Symbol for date of manufacture.by a date.這個符號是伴隨著一個日期。生產(chǎn)日期的象征。 This symbol is accompaniedSymbol for use by. 使用的象征。This symbol is accompanied by a date to indicate that the de

4、vice should not be used after the end of the year, month or day shown.這個符號是伴隨著一個日期來指示裝置不應(yīng)使用結(jié)束后的年、月或日顯示。2國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECH#國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECHSymbol for do not reuse/single use only. used for disposable one-time-use products.符號不重用/單只使用。This symbol is這個符號是用于一次性產(chǎn)品使用一次。#國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECH#國內(nèi)特種打

5、印與材料領(lǐng)導(dǎo)廠商-FANTECHSymbol for caution.謹(jǐn)慎的象征。 This is a safety symbol used to highlight thatthere are specific warnings or precautions associated with the devices that arenot otherwise found on the label.這是一個安全標(biāo)志用于突出，有特定的警告或預(yù)防措施相關(guān)的設(shè)備，否則將無法發(fā)現(xiàn)標(biāo)簽上。The symbol can also be used to mean"attention, see Ins

6、tructions for Use."這個符號也可以用來表示 注意，看使用說的。為參考使用說明的象征。Symbol for consult Instructions for Use.Symbol for sterile. 符號為無菌。This symbol is used only for terminally sterilizedmedical devices. 這個符號僅用于晚期消毒的醫(yī)療器械。#國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECHSTERILEA符號使用無菌消毒處理Symbol for sterilized using aseptic processing techniq

7、ues. 技術(shù)。3國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECH#國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECHSymbol for sterilized using ethylene oxide.符號使用環(huán)氧乙烷滅菌。Symbol for sterilized using irradiation.Symbol for sterilized using steam or dry heat.符號使用輻照滅菌符號使用蒸汽或干熱滅菌Symbol for sterile fluid path.對無菌液體路徑象征。This symbol indicates thepresence of a sterile fl

8、uid path within the device when other parts of thedevice, including the exterior, may not be supplied sterile.這個符號表明存在無菌液體路徑在設(shè)備當(dāng)其他部分的裝置，包括外觀,不得提供無菌。The part of the devicethat is sterile shall be identified in information supplied by the manufacturer.設(shè)備的部分，應(yīng)當(dāng)確認(rèn)是無菌的制造商提供的信息。The method of sterilization

9、 shallbe indicated in the empty box as appropriate. 子。.滅菌的方法應(yīng)當(dāng)顯示在適當(dāng)?shù)目蘸蠸ymbol for do not resterilize.符號不把.重新消毒。Symbol for nonsterile.非無菌的象征。This symbol should be used only todistinguish between identical or similar devices sold in both sterile and nonsterile conditions.這個符號應(yīng)該只用于區(qū)分相同或類似設(shè)備出售在這兩個無菌和非無菌條

10、件下。ECREPSymbol for authorized representative in the European Community.授權(quán)代表符號在歐洲共同體。This symbol is accompanied by the name and address of theauthorized representative in the European Community.這個符號是伴隨著的名稱和地址授權(quán)代表在歐洲共同體。Symbol for CE Mark. CE 標(biāo)志。 This symbol certifies that a product has metEuropean Un

11、ion consumer safety, health or environmental requirements.符號，一個產(chǎn)品認(rèn)證會見歐盟消費者安全、健康和環(huán)保要求。這個Symbol for sufficient for.足夠的象征。 The number of items for which thecontents of the pack is sufficient appears adjacent to the symbol.物品的數(shù)量包裝的內(nèi)容足夠?qū)绗F(xiàn)毗鄰的象征。Symbol for temperature limitation/temperature range.象征,溫度限制 /

12、 溫度范圍。Both upper and lower limits are indicated adjacent to horizontal lines.上限和下限都表示相鄰的水平線。4國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECHSymbol for lower limit of temperature. indicated adjacent to the lower horizontal line.符號的下限溫度。This lower limit is這個下限是表示毗鄰低水平線Symbol for upper limit of temperature.符號的上限溫度。This upper li

13、mit isindicated adjacent to the upper horizontal line.這個上限是表示相鄰至U上面的水平線。Symbol for biological risks.Symbol for keep away from sunlight.Symbol for protect from heat and radioactive sources.象征生物風(fēng)險。象征遠(yuǎn)離陽光。為防止炎熱和象征放射源。5國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECHSymbol for keep dry. 象征，保持干燥。Symbol for an item that contains or

14、 has a presence of natural rubber latex.個項目符號包含或有一個存在的天然橡膠膠乳。This symbol is used when naturalrubber latex is a material of construction within the device or packaging, but isnot used for devices containing synthetic rubber.這個符號時,使用的是天然橡膠膠乳是一種建筑材料在設(shè)備或包裝，但不用于設(shè)備包含合成橡膠。It is intended to warnthose who ma

15、y have allergic reactions to natural rubber latex.它的目的是警告那些可能有過敏反應(yīng)，天然橡膠膠乳。Symbol for device that device contains phthalates.符號的裝置 ,裝置包含鄰苯二甲酸鹽。 Specific phthalates contained in the device are identified beside orbelow the symbol by the following acronyms:特定鄰苯二甲酸鹽包含在設(shè)備旁邊標(biāo)鄰苯二甲酸丁基基酯識或以下符號由以下縮寫：BBP: Benz

16、yl butyl phthalate?BBP:? DBP: Di -n-butyl phthalate ?菲律賓：鄰苯二甲酸二丁DEHP: Di(2 -ethylhexyl) phthalate ?DEHP:Di(2-乙基己基)鄰苯二甲酸鹽鄰苯二甲酸二異癸鄰苯二甲酸二 Diisononyl鄰苯二甲酸二 Diisopentyl迪(methoxyethyl) 鄰苯二甲酸鹽? DIDP: Diisodecyl phthalate?DIDP:? DINP: Diisononyl phthalate?DINP:? DIPP: Diisopentyl phthalate?DIPP:DMEP: Di(met

17、hoxyethyl) phthalate?DMEP:DNOP: Di -n-octyl phthalate?DNOP:鄰苯二甲酸二辛酯DN PP: Di-n-pentyl phthalate ?DNPP:di n 戊基鄰苯二甲酸鹽The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.鄰苯二甲酸酯的潛在

18、影響對懷孕婦女或兒童/護(hù)理沒有被完整描述和可能有關(guān)心生殖發(fā)育的影響。Symbol for fragile, handle with care.脆弱的象征，小心輕放。RxOnlyDo不Symbol for do not use if package is damaged.象征,不要使用如果包裝損壞。not use if the product sterilization barrier or its packaging is compromised.要使用如果產(chǎn)品滅菌屏障或其包裝被破壞。Symbol for prescription only.符號作為處方藥只有。U.S. federal law

19、 restricts thisdevice to sale by or on the order of a physician or properly licensedpractitioner.美國聯(lián)邦法律限制此設(shè)備以出售或以正確的醫(yī)生或執(zhí)照的醫(yī)生。Symbol for quantity per box.每箱數(shù)量的象征。 Any number can be representedin the box.任何數(shù)量都可以表示為這個盒子w.-Symbol for control. 符號控制。 This symbol is used to indicate a device thatCONTROLcon

20、trols the intended performance of another device, e.g.這個符號來指示裝置可控制在預(yù)期性能的另一個設(shè)備，例如。，a trueness or precision control material fora diagnostic test.,一個真實或精密控制材料做一個診斷測試。Symbol for negative control.Symbol for positive control.負(fù)控制符號。象征積極控制IVDSymbol for in vitro diagnostic medical device.符號為體外診斷醫(yī)療設(shè)備。7國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-FANTECH#國內(nèi)特種打印與材料領(lǐng)導(dǎo)廠商-