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1、国内特种打印与材料领导厂商-FANTECH1国内特种打印与材料领导厂商-FANTECHFANTECH在医疗合格证打印中标识的应用说明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个解释的参考符号，可以发现在产品标签上。REFSymbol for catalog, reorder or reference part number. 考零件号码。符号为目录，重新排序或参GPN REFSymbol for global
2、product number and reference part number.全球产品编号和标志参考零件号码。Symbol for batch code/lot number.批处理代码符号 / 批号。The symbol isaccompanied by the manufacturers batch code.这个符号是伴随着制造商的批处理代码。Symbol for serial number.符号的序列号。 The manufacturers serial number isfound after or below this symbol.制造商的序列号是发现在或低于这个符号。Sym
3、bol for manufacturer.象征制造商。 This symbol is accompanied by thename and address of the manufacturer.这个符号是伴随着制造商的名称和地址。Symbol for date of manufacture.by a date.这个符号是伴随着一个日期。生产日期的象征。 This symbol is accompaniedSymbol for use by. 使用的象征。This symbol is accompanied by a date to indicate that the device shoul
4、d not be used after the end of the year, month or day shown.这个符号是伴随着一个日期来指示装置不应使用结束后的年、月或日显示。2国内特种打印与材料领导厂商-FANTECH#国内特种打印与材料领导厂商-FANTECHSymbol for do not reuse/single use only. used for disposable one-time-use products.符号不重用/单只使用。This symbol is这个符号是用于一次性产品使用一次。#国内特种打印与材料领导厂商-FANTECH#国内特种打印与材料领导厂商-F
5、ANTECHSymbol for caution.谨慎的象征。 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.这是一个安全标志用于突出，有特定的警告或预防措施相关的设备，否则将无法发现标签上。The symbol can also be used to meanattention, see Instructions for Us
6、e.这个符号也可以用来表示 注意，看使用说的。为参考使用说明的象征。Symbol for consult Instructions for Use.Symbol for sterile. 符号为无菌。This symbol is used only for terminally sterilizedmedical devices. 这个符号仅用于晚期消毒的医疗器械。#国内特种打印与材料领导厂商-FANTECHSTERILEA符号使用无菌消毒处理Symbol for sterilized using aseptic processing techniques. 技术。3国内特种打印与材料领导厂商
7、-FANTECH#国内特种打印与材料领导厂商-FANTECHSymbol for sterilized using ethylene oxide.符号使用环氧乙烷灭菌。Symbol for sterilized using irradiation.Symbol for sterilized using steam or dry heat.符号使用辐照灭菌符号使用蒸汽或干热灭菌Symbol for sterile fluid path.对无菌液体路径象征。This symbol indicates thepresence of a sterile fluid path within the de
8、vice when other parts of thedevice, including the exterior, may not be supplied sterile.这个符号表明存在无菌液体路径在设备当其他部分的装置，包括外观,不得提供无菌。The part of the devicethat is sterile shall be identified in information supplied by the manufacturer.设备的部分，应当确认是无菌的制造商提供的信息。The method of sterilization shallbe indicated in
9、the empty box as appropriate. 子。.灭菌的方法应当显示在适当的空盒Symbol for do not resterilize.符号不把.重新消毒。Symbol for nonsterile.非无菌的象征。This symbol should be used only todistinguish between identical or similar devices sold in both sterile and nonsterile conditions.这个符号应该只用于区分相同或类似设备出售在这两个无菌和非无菌条件下。ECREPSymbol for aut
10、horized representative in the European Community.授权代表符号在欧洲共同体。This symbol is accompanied by the name and address of theauthorized representative in the European Community.这个符号是伴随着的名称和地址授权代表在欧洲共同体。Symbol for CE Mark. CE 标志。 This symbol certifies that a product has metEuropean Union consumer safety, h
11、ealth or environmental requirements.符号，一个产品认证会见欧盟消费者安全、健康和环保要求。这个Symbol for sufficient for.足够的象征。 The number of items for which thecontents of the pack is sufficient appears adjacent to the symbol.物品的数量包装的内容足够岀现毗邻的象征。Symbol for temperature limitation/temperature range.象征,温度限制 / 温度范围。Both upper and l
12、ower limits are indicated adjacent to horizontal lines.上限和下限都表示相邻的水平线。4国内特种打印与材料领导厂商-FANTECHSymbol for lower limit of temperature. indicated adjacent to the lower horizontal line.符号的下限温度。This lower limit is这个下限是表示毗邻低水平线Symbol for upper limit of temperature.符号的上限温度。This upper limit isindicated adjace
13、nt to the upper horizontal line.这个上限是表示相邻至U上面的水平线。Symbol for biological risks.Symbol for keep away from sunlight.Symbol for protect from heat and radioactive sources.象征生物风险。象征远离阳光。为防止炎热和象征放射源。5国内特种打印与材料领导厂商-FANTECHSymbol for keep dry. 象征，保持干燥。Symbol for an item that contains or has a presence of nat
14、ural rubber latex.个项目符号包含或有一个存在的天然橡胶胶乳。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.这个符号时,使用的是天然橡胶胶乳是一种建筑材料在设备或包装，但不用于设备包含合成橡胶。It is intended to warnthose who may have allergic reacti
15、ons to natural rubber latex.它的目的是警告那些可能有过敏反应，天然橡胶胶乳。Symbol for device that device contains phthalates.符号的装置 ,装置包含邻苯二甲酸盐。 Specific phthalates contained in the device are identified beside orbelow the symbol by the following acronyms:特定邻苯二甲酸盐包含在设备旁边标邻苯二甲酸丁基基酯识或以下符号由以下缩写：BBP: Benzyl butyl phthalate?BBP
16、:? DBP: Di -n-butyl phthalate ?菲律宾：邻苯二甲酸二丁DEHP: Di(2 -ethylhexyl) phthalate ?DEHP:Di(2-乙基己基)邻苯二甲酸盐邻苯二甲酸二异癸邻苯二甲酸二 Diisononyl邻苯二甲酸二 Diisopentyl迪(methoxyethyl) 邻苯二甲酸盐? DIDP: Diisodecyl phthalate?DIDP:? DINP: Diisononyl phthalate?DINP:? DIPP: Diisopentyl phthalate?DIPP:DMEP: Di(methoxyethyl) phthalate?D
17、MEP:DNOP: Di -n-octyl phthalate?DNOP:邻苯二甲酸二辛酯DN PP: Di-n-pentyl phthalate ?DNPP:di n 戊基邻苯二甲酸盐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.邻苯二甲酸酯的潜在影响对怀孕妇女或儿童/护理没有被完整描述和可
18、能有关心生殖发育的影响。Symbol for fragile, handle with care.脆弱的象征，小心轻放。RxOnlyDo不Symbol for do not use if package is damaged.象征,不要使用如果包装损坏。not use if the product sterilization barrier or its packaging is compromised.要使用如果产品灭菌屏障或其包装被破坏。Symbol for prescription only.符号作为处方药只有。U.S. federal law restricts thisdevice
19、to sale by or on the order of a physician or properly licensedpractitioner.美国联邦法律限制此设备以出售或以正确的医生或执照的医生。Symbol for quantity per box.每箱数量的象征。 Any number can be representedin the box.任何数量都可以表示为这个盒子w.-Symbol for control. 符号控制。 This symbol is used to indicate a device thatCONTROLcontrols the intended per
20、formance of another device, e.g.这个符号来指示装置可控制在预期性能的另一个设备，例如。，a trueness or precision control material fora diagnostic test.,一个真实或精密控制材料做一个诊断测试。Symbol for negative control.Symbol for positive control.负控制符号。象征积极控制IVDSymbol for in vitro diagnostic medical device.符号为体外诊断医疗设备。7国内特种打印与材料领导厂商-FANTECH#国内特种打印
21、与材料领导厂商-FANTECHSymbol for a device that can be used for IVD performance evaluation only.征一种设备，可以用于试管绩效评估只有。Symbol for atmospheric pressure limitation.大气压力限制象征。Symbol for humidity limit.对湿度极限。象征Symbol for MR safe. 象征对奥安全。 This means the item poses no knownhazards in all magnetic resonance imaging (MR
22、I) environments.这意味着项目构成任何已知的危害在所有的磁共振成像(MRI)环境。Symbol for MR conditional.象征对奥条件。This means an item has beendemonstrated to pose no known hazards in a specified MRI environment withspecified conditions of use.这意味着一个项目已经被证实 ，姿势没有已知的危险在一个指定的核磁共振环境使用条件指定。Symbol for MR unsafe.不安全的象征 ,。This means an item is known to posehazards in all MRI environments.这意味着一个项目是众所周知的在所有环境构成危害 MRI。9