C31 一般与显微外科器械 标准查询与下载

DB44/T 1728.1-2015 负压引流护创材料套装 第1部分：聚乙烯醇敷料

本部分规定了由聚乙烯醇敷料制备的负压引流护创材料套装的基本要求和试验方法。该引流套装适用于急性创伤，皮肤、软组织创面和/或缺损，溃疡、褥疮性创面，外科术后需要引流的伤口等。 负压引流护创材料套装由聚乙烯醇海绵、引流导管（引流管分为带冲洗细管和不带冲洗细管两种）或吸盘、直通连接头三通连接头、管夹及贴膜组成。

Negative Pressure Drainage Wound Protection Kit Part 1: Polyvinyl Alcohol Dressing

ISO 1135-5:2015 输液用医疗器械. 第5部分: 带压力输液装置的一次性输液器

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus

DIN EN ISO 23500:2015 血液透析和相关治疗方法用流体的制备和质量管理指南(ISO 23500-2014);德文版本EN ISO 23500-2015

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014); German version EN ISO 23500:2015

ISO 1135-4:2015 输液用医疗器械. 第4部分: 一次性使用重力输液式输液器

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed

ISO 11040-1:2015 带药注射器.第1部分:齿科局部麻醉药筒用玻璃筒

This part of ISO 11040 speci fies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1 ,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges

ISO 8362-1:2009/Amd 1:2015 注射容器及附件.第1部分:管制玻璃注射瓶;修改件1

Injection containers and accessories - Part 1: Injection vials made of glass tubing; Amendment 1

DIN EN ISO 3826-4:2015 人体血液及血液成分用塑料可折叠容器. 第4部分: 集成功能脱落血包系统 (ISO 3826-4-2015); 德文版本EN ISO 3826-4-2015

Plastics collapsible containers for human blood and blood components - Part 4: Apheresis blood bag systems with integrated features (ISO 3826-4:2015); German version EN ISO 3826-4:2015

DIN EN ISO 5840-1:2015 心血管植入物. 心脏瓣膜假体. 第1部分: 通用要求 (ISO 5840-1-2015); 德文版本EN ISO 5840-1-2015

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015); German version EN ISO 5840-1:2015

NF S93-123-8*NF EN ISO 8536-8:2015 医用输液器具.第8部分:有压力输液仪的一次性输液器具

Infusion equipment for medical use - Part 8 : infusion sets for single use with pressure infusion apparatus

DIN EN ISO 8536-9:2015 医用输液器具.第9部分:压力输液仪用于单次使用的输液管(ISO 8536-9-2015);德文版本EN ISO 8536-9-2015

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015); German version EN ISO 8536-9:2015

DIN EN ISO 8536-10:2015 医用输液器具.第10部分:压力输液仪用于单次使用输液管的附件(ISO 8536-10-2015);德文版本EN ISO 8536-10-2015

Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015); German version EN ISO 8536-10:2015

DIN EN ISO 8536-8:2015 医用输液器具.第8部分:压力输液仪用于单次使用的输液器具(ISO 8536-8-2015);德文版本EN ISO 8536-8-2015

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015); German version EN ISO 8536-8:2015

DIN EN ISO 8536-11:2015 医用输液器具.第11部分:压力输液仪用于单次使用的输液过滤器(ISO 8536-11-2015);德文版本EN ISO 8536-11-2015

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015); German version EN ISO 8536-11:2015

BS EN ISO 8362-2:2015 注射容器及配件 注射瓶盖

Injection containers and accessories. Closures for injection vials

JIS T 3226-2:2015 医用针式注射系统. 第2部分: 针. 要求和试验方法

Needle-based injection systems for medical use -- Part 2: Needles -- Requirements and test methods

JIS T 3226-1:2015 医用针式注射系统. 第1部分: 医用针式注射系统. 要求和试验方法

Needle-based injection systems for medical use -- Part 1: Needle-based injection systems -- Requirements and test methods

ISO 8600-1:2015 内窥镜.医用内窥镜和内疗器件.第1部分:通用要求

This part of ISO 8600 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements

ISO 8362-2:2015 注射容器和附件.第2部分:注射瓶用瓶塞

This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Injection containers and accessories - Part 2: Closures for injection vials

DIN EN ISO 16061:2015 与非活性外科植入物联合使用的仪表装置.一般要求(ISO 16061-2015).德文版本EN ISO 16061-2015

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015

BS EN ISO 3826-4:2015 人类血液和血液成分用塑料可折叠容器. 具有整合特点的机采血袋系统

Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integrated features