11.040.20 输血、输液和注射设备 标准查询与下载

ISO 8536-11:2015 医用输液器具.第11部分:与压力输液仪一起单一使用的输液过滤器

This part of ISO 8536 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment

ISO 8536-8:2015 医用输液器具.第8部分:有单一压力输液仪的输液器具

This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

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

ISO 8536-10:2015 医用输液器具.第10部分:与压力输液仪一起单一使用的流体线路附件

This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. This part of ISO 8536 includes the following: a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold; NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions. b) units with injection site or check valve; c) stoppers or adapters. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment

ISO 8536-9:2015 医用输液器具.第9部分:与压力输液仪一起单一使用的流体线路

This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: a) syringe pump lines (SPL); c) lines with integrated injection cannula (LIC). b) connecting lines (CL); In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment

EN 60601-2-24:2015 医用电气设备.第2部分:输液泵和控制器安全性的特殊要求

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

YY/T 0328-2015 一次性使用动静脉穿刺器

本标准规定了一次性使用动静脉穿刺器(以下简称穿刺器)的要求,以保证与所配套的血路和血液处理系统相适应。

A.V. fistula needle sets for single use

YY/T 1288-2015 一次性使用输血器具用尼龙血液过滤网

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

YY/T 1286.1-2015 血小板贮存袋性能 第1部分:膜材透气性能测定 压差法

YY/T 1286的本部分规定了在一定压力差下测定血小板贮存袋膜材气体透过量的方法。

Platelets storage container performances.Part 1:Determination of gas permeability of the film.Differential-pressure method

NF S93-020-1*NF EN ISO 11608-1:2015 医用针式注射系统.试验方法和要求.第1部分:针式注射系统

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

CAN/CSA-C22.2 NO.60601-2-24-2015 医用电气设备 第 2-24 部分：输液泵和控制器安全的特殊要求（第二版）

Medical Electrical Equipment - Part 2-24: Particular Requirements for the Safety of Infusion Pumps and Controllers (Second Edition)

GSO IEC 60601-2-16:2014 电气医疗器械 第2-16部分：人工肾、过滤和血液透析装置基本安全和基本性能的特殊要求

Addition: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. This International Standard does not take into consideration the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and CENTRAL DELIVERY SYSTEMS. It does however take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This International Standard specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These devices are intended for use either by medical staff or for use by the PATIENT or other trained personnel under the supervision of medical expertise. This International Standard includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering from kidney failure. The particular requirements in this International standard do not apply to: – EXTRACORPOREAL CIRCUITS; – DIALYSERS; – DIALYSIS FLUID CONCENTRATES; – water treatment equipment; – equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39). If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1. NOTE See also 4.2 of IEC 60601-1:2005.

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

GSO IEC 60601-2-41:2014 医用电气设备 第2-41部分：手术灯具和诊断灯具基本安全和基本性能的特殊要求

Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments; – luminaires of an emergency lighting, which are covered by IEC 60598-2-22. NOTE See also 4.2 of the general standard.

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

GSO IEC 60601-2-24:2014 电气医疗设备 第2-24部分：静脉溶液泵和控制器的基本安全和基本性能的特殊要求

Replacement: This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT. This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However this standard does not specify requirements or tests for other aspects of ADMINISTRATION SETS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223. These particular standard does not apply to the following: a) devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR); b) devices for extracorporeal circulation of blood; c) implantable devices; d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water); e) ME EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography); f) devices covered by ISO 28620.

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

KS P ISO 1135-4:2014 医用输血器具 第4部分：一次性输血器

Transfusion equipment for medical use — Part 4: Transfusion sets for single use

KS P ISO 8362-4:2014 注射容器及附件 第4部分：模制玻璃注射瓶

Injection containers and accessories — Part 4: Injection vials made of moulded glass

KS P ISO 9187-1:2014 医用注射设备 第1部分：注射针剂瓶

Injection equipment for medical use — Part 1: Ampoules for injectables

KS P ISO 8536-1:2014 医用输液器具 第1部分：输液玻璃瓶

Infusion equipment for medical use — Part 1: Infusion glass bottles

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

KS P ISO 8362-6:2014 注射容器及附件 第6部分：注射小瓶用铝和塑料复合物制帽盖

Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials

KS P ISO 8536-4:2014 医用输液器具 第4部分：一次性重力输液式输液器

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed