C31 一般与显微外科器械 标准查询与下载
共找到 1323 条与 一般与显微外科器械 相关的标准，共 89 页
本标准规定了一次性使用输血器具用尼龙血液过滤网(以下简称过滤网)的要求。过滤网可安装于输(采)血器滴斗中或附件上,用于滤除血液或血制品中的凝血块、杂质和异物等。
Nylon blood filter nets for transfusion equipments for single use
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2015-03-02
- 实施
- 2016-01-01
La présente partie de l'ISO 11608 spécifie les exigences et les méthodes d'essai des systèmes d'injection à aiguille (NIS) destinés à être utilisés avec des aiguilles et des conteneurs remplaçables ou non remplaçables. Les conteneurs couverts par la présente partie de l'ISO 11608 comprennent les systèmes à seringue et à cartouche à dose unique ou à doses multiples, qu'ils soient remplis par le fabricant ou par l'utilisateur final.
Needle-based injection systems for medical use - Requirements and test methods - Part 1 : needle-based injection systems
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2015-02-28
- 实施
- 2015-02-28
Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems
- ICS
- 11.040.25
- CCS
- C31
- 发布
- 2015-01-31
- 实施
- 2015-01-31
Dieser Teil von ISO 11608 legt Anforderungen an und Prufverfahren fur kanulenbasierte Injektionssysteme (en: needle-based injections systems, NISs) fest, die zur Verwendung mit Kanulen und erneuerbaren oder nichterneuerbaren Behaltern bestimmt sind. Die von dem vorliegenden Teil von ISO 11608 erfassten Behalter umfassen durch den Hersteller oder den Endanwender befullte spritzen- und karpulenbasierte Systeme fur eine Einzeldosis und Mehrfachdosen. Zusatzliche Anleitungen fur NISs, die mit elektronischen oder elektromechanischen Bauteilen ausgestattet sind, und NISs, die mit automatisierten Funktionen ausgestattet sind, werden in ISO 11608-4 bzw. ISO 11608-5 gegeben. Kanulenlose Injektoren und Anforderungen auf Verfahren oder Vorrichtungen im Zusammenhang mit dem Fullen von Behaltern durch den Endbenutzer bezogen, liegen nicht im Anwendungsbereich dieses Teils von ISO 11608.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
- ICS
- 11.040.25
- CCS
- C31
- 发布
- 2015-01
- 实施
Needles for injections for repeated use. Specifications
- ICS
- 11.040.55
- CCS
- C31
- 发布
- 2015
- 实施
- 2017-01-01
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-11-01
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-11-01
In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-06-01
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-11-01
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-11-01
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-11-01
$iI$in $iv$ii$it$ir$io diagnostic test systems. Qualitative nucleic acid-based $ii$in $iv$ii$it$ir$io examination procedures for detection and identification of microbial pathogens. General requirements, terms and definitions
- ICS
- 01.040.19;11.100.01
- CCS
- C31
- 发布
- 2014-12-31
- 实施
- 2014-12-31
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user. Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively. Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
- ICS
- 11.040.25
- CCS
- C31
- 发布
- 2014-12
- 实施
Diese Internationale Norm legt Anforderungen an Einfuhrkanulen, Einfuhrkatheter, Fuhrungshulsen, Fuhrungsdrahte und Dilatatoren fest, die steril geliefert werden und zur einmaligen Verwendung mit intravaskularen Kathetern nach ISO 10555-1 bestimmt sind. ANMERKUNG Eine Anleitung fur die Werkstoffauswahl und fur die Gestaltung von Zubehorinstrumenten ist in Anhang A gegeben.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
- ICS
- 11.040.25
- CCS
- C31
- 发布
- 2014-11
- 实施
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
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2014-10-01
- 实施
Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods (ISO 15375:2010)
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2014-10
- 实施
Medical instruments - Part 1: Surgical scissors, curved on flat without carbide inserts
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2014-09-01
- 实施
Elastomeric parts for parenterals and for devices for pharmaceutical use. Functional requirements and testing
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2014-08-31
- 实施
- 2014-08-31
本规程适用于医用注射泵和输液泵检测仪(以下简称检测仪)的首次检定、后续检定和使用中检查。
Medical Syringe Pump and Infusion Pump Analyzers
- ICS
- CCS
- C31
- 发布
- 2014-08-01
- 实施
- 2014-11-01
本标准给出了在模拟实际使用条件下,以聚氯乙烯(PVC)为原料制成的医疗器械与临床使用液体接触后,增塑剂DEHP溶出量测定的化学分析方法。
Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2014-06-17
- 实施
- 2015-07-01
