11.040.20 输血、输液和注射设备 标准查询与下载

KS P ISO 9187-2:2014 医用注射器具 第2部分：色点刻（OPC）安瓿

Injection equipment for medical use-Part 2:One-point-cut(OPC) ampoules

DIN EN ISO 8871-5:2014 非肠道和制药设备用弹性件.第5部分:功能要求和试验(ISO 8871-5-2005); 德文版本EN ISO 8871-5-2014

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005); German version EN ISO 8871-5:2014

DIN ISO 15375:2014 医用输液瓶. 多用途悬吊装置. 要求和试验方法 (ISO 15375-2010)

Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods (ISO 15375:2010)

BS EN ISO 8871-5:2014 非肠道和制药设备用弹性件. 功能要求和试验

Elastomeric parts for parenterals and for devices for pharmaceutical use. Functional requirements and testing

DIN EN ISO 8871-2:2014 非肠道及制药设备用弹性件.第2部分:识别和表征(ISO 8871-2:2003 + Amd.1:2005);德文版本EN ISO 8871-2-2004+A1-2014

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003 + Amd.1:2005); German version EN ISO 8871-2:2004 + A1:2014

NF S93-102-2/A1:2014 非肠道及制药设备用弹性件. 第2部分: 鉴别和表征. 修改件1

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization - Amendment 1

EN ISO 8871-5:2014 非肠道及制药设备用弹性件.第5部分:功能要求和试验

Dieser Teil von ISO 8871 legt Anforderungen und Prufverfahren hinsichtlich funktioneller Merkmale von Verschlussen aus Elastomeren fest, die fur Injektionsflaschen verwendet und mit einer Injektionskanule durchstochen werden. ANMERKUNG Funktionelle Prufungen unter Verwendung von Dornen sind in ISO 8536-2 und ISO 8536-6 festgelegt.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)

YY/T 0918-2014 药液过滤膜、药液过滤器细菌截留试验方法

本标准规定的试验方法适用于对标称孔径不超过0.22 μm的医疗器械用除菌级药液过滤膜或药液过滤器的细菌截留能力进行评价。

Test method for determining bacterial retention of membrane/ filter assembly utilized for infusion liquid filtration

YY/T 0929.1-2014 输液用除菌级过滤器 第1部分:药液过滤器完整性试验

YY/T 0929的本部分规定了输液器具用滤膜标称孔径不超过0.22 μm的药液过滤器完整性试验方法。

Sterilizing-grade filters for medical infusion equipments.Part 1: Integrity test for fluid filters

EN ISO 8871-2:2004/A1:2014 非肠道及制药设备用弹性件.第2部分:识别和表征 包含修改件A1,2014

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)

GA/T 1147-2014 车辆驾驶人员血液酒精含量检验实验室规范

本标准规定了车辆驾驶人员血液酒精含量检验实验室的岗位设置、运行保障、质量控制和管理的基本要求。本标准适用于道路交通执法活动中对人员血液中酒精含量进行检验的实验室。

Labortory specifications for examination of ethanol concentration in driver's blood

JIS T 0601-2-16:2014 医用电气设备.第2-16部分:血液透析设备、血液全过滤设备和血液过滤设备基本安全性和基本性能的详细要求

Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

DIN EN ISO 8638:2014 心血管植入物和体外系统. 血液透析器, 血液透析滤过器和血液滤过器的体外循环血路(ISO 8638-2010); 德文版本EN ISO 8638-2014

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014

DIN EN ISO 8637:2014 心血管植入物和体外系统.血液透析器、血液透析过滤器、血液过滤器和血液浓缩器.(ISO 8637-2010,包括修改件1-2013-04-01).德文版本EN ISO 8637-2014

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014

DB22/T 2031-2014 血液透析机质量控制规范

Specifications for Quality Control of Hemodialysis Machines

EN ISO 8638:2014 心血管植入物和体外系统.用于血液透析器,血液透析滤过器和血液滤过器的体外血液循环(ISO 8638:2010)

Diese Internationale Norm legt Anforderungen an Hamodialysatoren, Hamodiafilter, Hamofilter und Hamokonzentratoren (nachstehend als "das Gerat" bezeichnet) sowie (integrale und nicht integrale) Schutzvorrichtungen fur Messwandler ("Transducer-Protector") fur die Anwendung bei Hamodialyse, Hamodiafiltration und Hamofiltration fest. Die vorliegende Internationale Norm ist nicht anwendbar auf: Hamodialysatoren, Hamodiafilter oder Hamofilter; Plasmafilter; Hamoperfusionsgerate; Gerate fur den vaskularen Zugang; Blutpumpen; Druckaufzeichnungsgerate fur extrakorporale Blutkreislaufe; Luftnachweisgerate; Systeme fur die Herstellung, Aufbewahrung oder Uberwachung der Dialyseflussigkeit; Systeme oder Ausrustungen fur die Durchfuhrung von Hamodialyse, Hamodiafiltration, Hamofiltration oder Hamokonzentration. ANMERKUNG Anforderungen an Hamodialysatoren, Hamodiafilter, Hamofilter und Hamokonzentratoren sind in ISO 8637 festgelegt.

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers@ haemodiafilters and haemofilters

EN ISO 8637:2014 血液透析器、血液过滤器和血液浓缩器

Diese Internationale Norm legt Anforderungen an Hamodialysatoren, Hamodiafilter, Hamofilter und Hamokonzentratoren, nachstehend zusammenfassend als "das Gerat" bezeichnet, fur die Anwendung beim Menschen fest. Die vorliegende Internationale Norm ist nicht anwendbar auf: extrakorporale Blutkreislaufe; Plasmafilter; Hamoperfusionsgerate; Gerate fur den vaskularen Zugang; Blutpumpen; Druckaufzeichnungsgerate fur extrakorporale Blutkreislaufe; Luftnachweisgerate; Systeme fur die Herstellung, Aufbewahrung oder Uberwachung der Dialyseflussigkeit; Systeme fur die Durchfuhrung von Hamodialyse, Hamodiafiltration, Hamofiltration oder Hamokonzentration; Verfahren und Ausrustung fur die Wiederaufbereitung. ANMERKUNG Anforderungen an den extrakorporalen Blutkreislauf fur Hamodialysatoren, Hamodiafilter und Hamofilter sind in ISO 8638 festgelegt.

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

ASTM F2077-14 椎间体融合设备的试验方法

5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method outlines materials and methods for the characterization and evaluation of the mechanical performance of different intervertebral body fusion device assemblies so that comparisons can be made between different designs. 5.2 This test method is designed to quantify the static and dynamic characteristics of different designs of intervertebral body fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of intervertebral body fusion device assemblies to specific force modalities. 5.3 The forces applied to the intervertebral body fusion assemblies may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different intervertebral body fusion device assemblies. 5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is desired, the investigator should consider testing in a saline environmental bath at 37°C (for example, 0.9-g NaCl per 100-mL water) at a rate of 1 Hz or less. A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37°C could also be used with adequate justification. 5.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 5.4. Devices that require physiologic solution for testing should be tested in the same type solution for comparison purposes. 5.6 The location within the simulated vertebral bodies and position of the intervertebral body fusion device assembly with respect to the loading axis will be dependent upon the design, the manufacturer’s recommendation, or the surgeon’s preferred method for implant placement. 5.7 It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing one of these parameters (for example, frequency, material, or environment), all others must be kept constant to facilitate interpretation of the results. 1.1 This test method covers the materials and methods for the static and dynamic......

Test Methods For Intervertebral Body Fusion Devices

KS C IEC 61289-2-2013 高频手术设备 第2部分：维护保养

High frequency surgical equipment－Part 2：Maintenance

KS C IEC 61289-2:2013 高频外科设备 第2部分：维护

High frequency surgical equipment－Part 2：Maintenance