DIN西德医疗器械标准目录

编号 DIN 58255-1-2005 DIN 58255-2-1983 DIN 58255-2-2005 DIN 58256-1976 DIN 58257-1983 DIN 58259-1976 DIN 58260-1979 DIN 58262-1973 DIN 58263-1973 DIN 58264-1974 DIN 58265-1974 DIN 58266-1974

中文名称

DIN——德国标准化学会目录 DIN——德国标准化学会目录 —— 英文名称

医疗器械.Gross 型敷料钳.第 1 部分: 直敷料钳 医疗器械；Gross 式弯粒状敷料钳 医疗器械.Gross 型敷料钳.第 2 部分: 弯敷料钳 医疗器械；Toennis 型持针器 医疗器械；Crile 型持针器 医疗器械；Masson 型持针器 医疗器械.Deschamps 型结扎针 医疗器械；Jennig 式伤口牵开器 医疗器械；Heister 式伤口牵开器 医疗器械；Finochietto 式肋骨牵开器 医疗器械；Finochietto 型持针器 医疗器械；Crile-Wood 型持针器 (Medical instruments; needle holder, type T 攏 nis) (Medical instruments; needle holder type Crile) (Medical instruments; needle holder type Masson) (Medical instruments; ligature needle type Deschamps) (Medical instruments; mouth gag Jennings) (Medical instruments; mouth gag Heister`s) (Medical instruments; rib spreaders Finochietto`s) (Medical instruments; needle holder Finochietto`s) (Medical instruments; needle holder Crile-Wood`s) (Medical instruments; dressing forceps type Gross, curved)

DIN 58266-2-1979

(Medical instruments; needle 医疗器械； 镶硬合金的 Crie-Wood 型持 holder Crile-Wood`s with carbide 针器 inserts) 医疗器械；Mathieu 型有内锁止牙的持 (Medical instruments; needle 针器 holder Mathieu`s with inside catch) 医疗器械；膝弯式镊子 医疗器械；枪状镊子 医疗器械；细镊子 医疗器械；固定镊子 医疗器械；虹隔镊 医疗器械；睑板囊肿镊子 医疗器械；Adson 式镊子 (Medical instruments; dressing forceps, angular) (Medical instruments; dressing forceps, bayonet) (Medical instruments; microscopic forceps, fine pattern) (Medical instruments; fixation forceps) (Medical instruments; iris forceps) (Medical instruments; chalazion forceps) (Medical instruments; forceps type Adson)

DIN 58267-1974 DIN 58270-1983 DIN 58271-1983 DIN 58272-1983 DIN 58273-1983 DIN 58274-1983 DIN 58275-1983 DIN 58276-1983

DIN 58277-1983 DIN 58278-1983 DIN 58279-1984 DIN 58280-1-1980 DIN 58281-1-1980 DIN 58282-1980 DIN 58283-1971 DIN 58284-1971 DIN 58285-1983 DIN 58286-1983 DIN 58287-1983 DIN 58288-1983

医疗器械；Wachenfeld 式伤口夹镊子 医疗器械；睫毛镊子 急救剪 医疗器械；不镶硬质合金的虹膜剪 医疗器械； 不镶硬质合金的斜视眼用剪 医疗器械；Stevens 式切肢剪刀 口腔科器械；龈剪 口腔科器械；牙冠剪 医疗器械；Volkman 式伤口拉钩 医疗器械；Kocher 式伤口拉钩 医疗器械；Koerte 式伤口拉钩 医疗器械；Langenbeck 式伤口拉钩

(Medical instruments; suture clip applying forceps, type Wachenfeld) (Medical instruments; cilia forceps) (First aid scissors) (Medical instruments; iris scissors wi

thout carbide inserts) (Medical instruments; strabismus scissors without carbide inserts) (Medical instruments; tenotomy scissors, type Stevens) (Dental instruments; dental scissors) (Dental instruments; dental scissors, crown) (Medical instruments; retractor type Volkmann) (Medical instruments; retractor type Kocher) (Medical instruments; retractor type K 攔 te) (Medical instruments; retractor type Langenbeck)

DIN 58289-1-1983

(Medical instruments; abdominal 医疗器械；Mikulicz 式拱形腹壁和肝 and liver retractor Mikulicz, blade 拉钩 curred) 医疗器械；Bergmann 式伤口拉钩 (Medical instruments; retractor Bergmann`s)

DIN 58290-1972 DIN 58291-1988 DIN 58292-1972 DIN 58293-1972 DIN 58294-1972 DIN 58295-1983 DIN 58296-1973 DIN 58297-1983 DIN 58298-1-1983

医疗器械.Simon 式和 Martin 式创口拉 (Medical instruments; retractors 钩 type Simon and Martin) 医疗器械；气管用拉钩 医疗器械；Bose 式气管拉钩 医疗器械；Desmarres 式眼睑拉钩 医疗器械；Volkmann 式骨科用拉钩 医疗器械.Semb 式骨膜剥离器 医疗器械.Doyen 式肋骨骨膜剥离器 医疗器械材料.结构和检验.镊子 (Medical instruments; tracheal hook) (Medical instruments; tracheal hook Bose`s) (Medical instruments; lid retractor Desmarres`) (Medical instruments; retractor type Volkmann) (Medical instruments; raspatories Semb`s) (Medical instruments; periosteal raspatories type Doyen) (Materials, finish and testing of medical instruments; forceps)

(Materials, finish and testing of 医疗器械材料.结构和检验.医用凿子. DIN 58298-10-1983 medical instruments; chisels and 圆凿和快口刮匙 gouges, bone curettes) DIN 58298-11-1979 医疗器械材料.结构和检验.锤 DIN 58298-12-1994 材料.医疗器械的制造和检验.手锯 (Materials, finish and testing of medical instruments; mallets) (Materials, finish and testing of medical instruments; hand saws)

(Materials, finish and testing of 医疗器械的材料、 加工和测试.第 19 部 DIN 58298-19-2002 medical instruments - Part 19: 分:套管针 Trocars) DIN 58298-2-1981 DIN 58298-2005 DIN 58298-3-1979 医疗器械材料.结构和检验.剪刀 医疗器械.材料、精加工和试验 医疗器械材料.结构和检验.环式钳 (Materials, finish and testing of medical instruments; forceps) (Materials, finish and testing of medical instruments; scissors)

DIN 58298-4-1983

(Materials, finish and testing of 医疗器械材料.结构和检验.剪骨钳和 medical instruments; bone cutting 咬骨钳 forceps and rongeurs) 医疗器械材料.结构和检验.分支钳 医疗器械材料.结构和检验.鼻甲刀 (Materials, finish and testing of medical instruments; forceps) (Materials, finish and testing of medical instruments; conchotome)

DIN 58298-5-1979 DIN 58298-6-1983

DIN 58298-7-1983

(Materials, finish and testing of 医疗器械材料.结构和检验.解剖刀和 medical instruments; skalpels and 手术刀 knives) 医疗器械的材料.

结构和检验；伤口拉 (Materials, finish and testing of medical instruments; retractor) 钩 医疗器械材料.结构和检验.探针 (Materials, finish and testing of medical instruments; explores) (Serrations for surgical instruments; profile angles, groove distances) (Joints for surgical instruments) (Medical instruments; rib contractor) (Medical instruments; cotton carrier; straight) (Medical instruments; throat cotton applicators type Fein) (Medical instruments; retractors Cushing`s) (Medical instruments; abdominal spatulas, malleable) (Medical instruments; elevator Henke`s)

DIN 58298-8-1983 DIN 58298-9-1983

DIN 58299-1964 DIN 58300-1982 DIN 58312-1988 DIN 58313-1981 DIN 58314-1981 DIN 58315-1979 DIN 58316-1979 DIN 58317-1973

外科器械的槽口.截面角.分度 外科器械连接方法 医疗器械.肋骨压缩器 医疗器械.药棉直托架 医疗器械.Fein 式喉头药棉 医疗器械.Cushing 型牵开器 医疗器械.Haberer 可弯腹腔扁平拉钩 医疗器械.Henke 式起子

DIN 58318-1973 DIN 58319-1973

医疗器械.Langenbeck 式起子 医疗器械.Williger 式起子

(Medical instruments; elevators Langenbeck`s) (Medical instruments; elevators Williger)

DIN 58320-1-1972

(Orthopedics; prostheses, braces, 矫形外科.矫形外科治疗和辅助用具. technical and therapeutic aids, 一览表.分类 survey table, classification) (Orthopedics; prostheses, braces, 矫形外科.矫形外科治疗和辅助用具. technical and therapeutic aids, 假腿的名称和零件 definitions and components for lower-limb-prosthese) 矫形外科.粘性衬垫 矫形外科.假骨架用管子.连接尺寸 (Orthopedics; cone tips) (Orthopedics; prosthesis, fitting dimensions)

DIN 58320-2-1972

DIN 58324-1973 DIN 58332-1973 DIN 58355-1-1990 DIN 58355-1-2005 DIN 58355-2-1990 DIN 58355-2-2005 DIN 58355-3-1990

膜式过滤器.扁平过滤器液体比流量. (Membrane filter; specific liquid 检验 flow rate for flat filter; testing) 膜式过滤器.第 1 部分:扁平过滤器液 体比流量的检验 膜式过滤器.起泡点.检验 膜式过滤器.第 2 部分:起泡点的检验 (Membrane filter; bacteria 膜式过滤器.扁平过滤器的细菌过滤能 challenge test for flat filter; 力.要求和检验 requirements and testing) 膜式过滤器.第 3 部分:扁平过滤器的 细菌过滤能力试验.要求和试验 膜式过滤器.第 3 部分:扁平过滤器的 细菌过滤能力试验.要求和试验 膜式过滤器.微粒漏出检验 膜式过滤器.第 4 部分:微粒物质漏出 检验 膜式过滤器.可抽出成分的检验 (Membrane filters - Test for extractable components) (Membrane filters; testing for particular matters) (Membrane filter; bubble point; testing)

DIN 58355-3-2005 DIN 58355-3-2005 DIN 58355-4-1991 DIN 58355-4-2005 DIN 58355-6-1998

DIN 58356-1-1991

(Membrane filter elements; 膜式过滤器件.过滤出细菌的能力.要 bacteria challenge test; 求和检验 requirements and testing) 膜式过滤器件.

第 1 部分:细菌滤出的 要求和检验

DIN 58356-1-2005

(Membrane filter elements - Part 膜式过滤器件.第 10 部分:非挥发性可 10: Determination of non volatile DIN 58356-10-1997 萃取的成份测定.过滤流体的极限浓度 extractable components - Filtrate concentration limit) DIN 58356-11-1997 膜式过滤器件.第 11 部分:用浸渍法测 (Membrane filter elements - Part 定非挥发性可萃取的成份 11: Determination of non volatile

extractable components by soaking procedure) (Filter elements - Membrane filter 过滤器件.膜过滤器件.第 12 部分:有 elements - Part 12: Integrity test DIN 58356-12-2000 水的疏水性膜过滤器件的完整试验 of hydrophobic membrane filters with water) DIN 58356-2-2000 DIN 58356-3-1993 DIN 58356-3-2005 膜过滤器件.第 2 部分:压力保持器的 (Membrane filter elements - Part 2: 试验 Pressure holder tests) 膜式过滤器件.液体比流速试验 膜式过滤器件.第 3 部分:液体比流率 的检验 (Membrane filter elements; 膜式过滤器件.流动蒸汽中灭菌.检验 sterilizing in pouring steam; testing) 膜式过滤器件.第 7 部分:浇注蒸汽的 消毒检验 膜式过滤器件.用蒸汽灭菌.检验 膜式过滤器件.第 8 部分:蒸汽消毒检 验 膜式过滤器件.第 9 部分:内毒素试验 膜式过滤器件.第 9 部分:内毒素试验 (Transfusion; transfusion 输血.输血器械和附件.名称.要求.检 equipment; nomenclature, 验 requirements, testing) (Infusion; infusion equipment; 输血.输液.输液设备；重力输液设备；gravity-fed infusion equipment; 名称.要求.检验 nomenclature, requirements, testing) (Infusion; infusion equipment and accessories; infusion equipment 输液.输液器和附件.压力输注装置的 for use with pressure infusion 输液器.名称.要求.检验 apparatus; nomenclature, requirements, testing) (Infusion; infusion equipment and 输液.输液器和附件.压力输注装置的 accessories; fluid lines for use 导管 with pressure infusion apparatus) (Infusion; infusion equipment and 输液.输液器和附件.压力输注装置的 accessories; accessories for fluid 导管的附件 lines for use with pressure infusion apparatus) 输液.输液器和附件.压力输注装置的 (Infusion; infusion equipment and 输液过滤器 accessories; infusion filter for (Membrane filter elements - Part 9: Testing for endotoxins) (Membrane filter elements - Part 8: Sterilizing with steam; testing) (Membrane filter elements; specific liquid flow rate; testing)

DIN 58356-7-1994

DIN 58356-7-2005 DIN 58356-8-1995 DIN 58356-8-2005 DIN 58356-9-1996 DIN 58356-9-2005 DIN 58360-1-1991

DIN 58362-1-1994

DIN 58362-2-1994

DIN 58362-3-1994

DIN 58362-4-1994

DIN 58362-5-1994

use with pressure infusion apparatus) DIN 58362-6-1994 DIN 58362-7-2002 输液.输液器和附件.带剂量管的输液 (Infusion; infusion equipment; 器 burette type infusion sets) 输液.输液器和附件.第 7 部分:止回阀 (In

fusion - Infusion equipment and accessories - Part 7: Check valves)

(Transfusion, infusion - Infusion 输血,输液.输液设备和附件.第 15 部 containers and accessories - Part DIN 58363-15-1996 分:塑料输液袋和输液瓶,安全技术要 15: Infusion bags and bottles made 求和检验 of plastic; requirements, testing) (Elastomeric parts for containers for parenterals and for devices for 制药装置和胃肠外容器用橡胶部件.第 pharmaceutical use - Part 2: Type 2 部分:型号检验.质量稳定性审核和橡 testing, testing of the quality 胶成份含量分析 consistency and analysis of rubber ingredients) (Transfusion, infusion 输血,输液.输血瓶和输液瓶用一次性 Disposable hanging devices for 吊挂装置.要求.检验 bottles for transfusion and infusion - Requirements, test) 贮血冷藏柜.定义、要求和试验 (Refrigerators for conserved blood - Definitions, requirements, testing) (Transfer sets for pharmaceutical preparations - Requirements, testing)

DIN 58367-2-1996

DIN 58369-1996

DIN 58371-2000

DIN 58373-2004 DIN 58373-2004

药物制备用转移装置.要求和检验 药物制备用转移装置.要求和检验

DIN 58374-1999

(Plastic caps with inserted 按照鼓风,填充,封闭的方法(BFS)制造 elastomeric liner for containers 的容器用带密封件的塑料盖 produced by the Blow Fill Seal (BFS) process) 等离子储存.定义、要求和试验 (Self-adhesive hanging devices for 输血瓶,输液瓶和注射瓶用自粘结悬挂 transfusion, infusion and injection bottles - Requirements, 装置.要求和检验 test) (Transfusion, infusion - Multiple 输液和输注.输注和输液用瓶的复式悬 hanging device for infusion and transfusion bottles 吊装置.要求和试验 Requirements, test) (Telescopes; optical 望远镜.观察望远镜和目标望远镜的光 characteristics for observation学参数 and sighting-telescopes) 望远镜.光学参数的测定 (Telescopes; determining the optical parameters)

DIN 58375-2004

DIN 58376-1998

DIN 58379-2000

DIN 58386-1-1971

DIN 58388-1966 DIN 58389-1-1999

望远镜.观察望远镜和望远镜描准器的 (Telescopes - Photometric

光度参数.第 1 部分:无效光测定

parameters for observation telescopes and telescopic sights Part 1: Determination of veiling glare)

DIN 58389-2-1996

(Telescopes - Photometric parameters for observation 望远镜.观察望远镜和望远镜描准器的 telescopes and telescopic sights 光度参数.第 2 部分:光谱传输测定 Part 2: Determination of spectral transmission) 精密机械光学仪器用的润滑油的使用 (Temperature ranges for lubricants 温度范围 for optical instruments) 精密机械光学仪器用的润滑油脂.应用 (Greases for optical instruments; 分类.润滑油脂组 classes) 精密机械光学仪器用的润滑油脂.最低 (Greases for optical instruments; 限度要求 minimum requirements) (Testing of lubricating greases for 精密机械光学仪器润滑

脂的检验.汽化 precision engineering and optical 损失 instruments; evaporation loss)

DIN 58395-1976 DIN 58396-1-1977 DIN 58396-2-1977

DIN 58397-1-1983

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