C31 一般与显微外科器械 标准查询与下载

YY 0286.3-2017 专用输液器 第3部分：一次性使用避光输液器

本标准规定了液路材料添加避光剂的一次性使用、重力输液式输液器的要求，为避光输液器所用材料的性能及其质量规范提供了指南。本标准适用于液路材料添加避光剂的一次性使用重力输液式输液器。

Special infusion set part 3: single-use light-proof infusion set

YY/T 0929.2-2018 输液用药液过滤器 第2部分：标称孔径1.2μm药液过滤器白色念珠菌截留试验方法

Medicinal fluid filters for infusion Part 2: Candida albicans retention test method for medicinal fluid filters with nominal pore size 1.2 μm

YY/T 0681.1-2018 无菌医疗器械包装试验方法 第1部分：加速老化试验指南

Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Tests

YY/T 1631.1-2018 输血器与血液成分相容性测定 第1部分：血液成分残留评定

Determination of compatibility between blood transfusion sets and blood components Part 1: Assessment of blood component residues

YY/T 1639-2018 一次性使用聚氨酯输注器具二苯甲烷二异氰酸酯（MDI）残留量测定方法

Method for determination of diphenylmethane diisocyanate (MDI) residues in disposable polyurethane infusion equipment

YY/T 0681.14-2018 无菌医疗器械包装试验方法 第14部分：透气包装材料湿性和干性微生物屏障试验

Test methods for sterile medical device packaging Part 14: Wet and dry microbial barrier tests on breathable packaging materials

YY/T 1617-2018 血袋用聚氯乙烯压延薄膜

PVC calendered film for blood bags

YY 0585.3-2018 压力输液设备用一次性使用液路及附件 第3部分：过滤器

Disposable fluid circuits and accessories for pressure infusion equipment Part 3: Filters

ISO 13926-1:2018 针头系列. 第1部分: 医用针头注射器用玻璃套筒

This document specifies the design, materials, performance and test methods, and gives recommendations for dimensions for glass cylinders used with pen-injectors for medical use. It applies to the primary containers used in direct contact with the drug.

Pen systems - Part 1: Glass cylinders for pen-injectors for medical use

DIN EN ISO 80369-6:2018 医疗保健设施中液体与气体用小型孔连接器. 第6部分: 椎管内应用连接器(ISO 80369-6-2016, 修正版本2016-11-15); 德文版本EN ISO 80369-6-2016

This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used in NEURAXIAL APPLICATIONS. This part of ISO 80369 does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. NOTE MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for SMALL BORE CONNECTORS, as specified in this part of ISO 80369, will be included. Furthermore it is recognised that standards will need to be developed for all MEDICAL DEVICES used for NEURAXIAL APPLICATIONS.

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016

YY/T 0573.2-2018 一次性使用无菌注射器 第2部分：动力驱动注射泵用注射器

Single use sterile syringes Part 2: Syringes for power driven syringe pumps

YY/T 1618-2018 一次性使用人体静脉血样采集针

Disposable human venous blood sample collection needle

DIN 13111:2018 医疗器械.绷带剪

The project defines dimensions and marking of Bandage scissors, as used in surgery and public health service.

Medical instruments - Bandage scissors

JIS T 3264:2018 一次性使用的肠道送食伸缩管

Extension tubes for enteral feeding for single use

BS EN ISO 7886-1:2018 一次性无菌皮下注射器.人工注射器

Sterile hypodermic syringes for single use. Syringes for manual use

YY/T 0587-2018 一次性使用无菌牙科注射针

Disposable sterile dental injection needle

DIN EN ISO 8536-14:2018 输液用医疗器械.第14部分:无流体接触的输血和输液设备止流夹和流体调节器(ISO 8536-14-2016);德文版本EN ISO 8536-14-2018

This part of ISO 8536 specifies requirements for devices used to control the flow of intravenous solutions and/or blood components through infusion and blood transfusion sets and blood bag assemblies without fluid contact. Such components may be an integral part of a medical device or a "stand-alone" component.

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016); German version EN ISO 8536-14:2018

YY/T 0326-2017 一次性使用离心式血浆分离器

本标准规定了用于制备血液制品的一次性使用离心式血浆分离器的要求，以保证与所配套的离心式自动血浆采集机相适应。本标准适用于将采集、贮存的血浆制备血液制品的离心式血浆分离器，不能用于临床输血。

Disposable centrifugal plasma separator

DIN EN ISO 10555-1:2018 血管内导管.一次性使用无菌血管内导管.第1部分:通用要求(ISO 10555-1-2013+Amd 1-2017);德文版本EN ISO 10555-1-2013+A1-2017

This part of DIN EN ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017); German version EN ISO 10555-1:2013 + A1:2017

YY/T 0285.5-2018 血管内导管　一次性使用无菌导管　第5部分：套针外周导管

Intravascular catheters—Sterile and single-use catheters—Part 5:Over-needle peripheral catheters