C38 普通诊察器械 标准查询与下载

KS P ISO 15194:2010 实验室条件下医用诊断装置.生物原始试样中数量值的测量.标准物质的描述

이 표준은 KS P ISO 17511에 따라서 상위의 측정학적 체제를 고려하기 위하여 인증

In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Requirements for certified reference materials and the content of supporting documentation

BS EN 80601-2-30:2010 医疗电气设备.自动非入侵式血压测量计的基本安全和主要性能的特定要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for intermittent indirect measurement of the BLOOD PRESSURE without arterial puncture. This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION. This standard covers electrically-powered intermittent, indirect measurement of the BLOOD PRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimating BLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect measurement of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1. 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 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1.

Medical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

DIN EN 80601-2-35:2010 医疗电气设备.第2-35部分:利用毯、衬垫和床垫的加温设备和医用加温设备的基本安全性和必要性能要求(IEC 80601-2-35-2009).德文版本EN 80601-2-35-2009

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009); German version EN 80601-

DIN EN 80601-2-59:2010 医疗电气设备.第2-59部分:人类发热检查用检查温度记录仪的基本安全和基本性能用详细要求(IEC 80601-2-59-2008 + 勘误表 2009).德文版本EN 80601-2-59-2009

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2008 + corrigendum 2009); German version EN 80601-2-59:2009

JJG 692-2010 无创自动测量血压计检定规程

本规程适用于示波法、听诊法原理的无创自动测量血压计[以下简称血压计,包括无创血压监护仪、多参数监护仪(无创血压部分)、动态血压监护仪及电子血压计]的型式评价、首次检定、后续检定和使用中检验。

Verification Regulation of Non-invasive Automated Sphygmomanometers

BS EN 80601-2-59:2009 医疗电气设备.人体发烧温度筛选用筛选热录像仪基本安全性和基本性能的详细要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions, hereafter referred to as ME EQUIPMENT. This International Standard sets laboratory characterization test limits for the SCREENING THERMOGRAPH. 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.

Medical electrical equipment - Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

DIN EN 1060-3:2010 非侵入式血压计.第3部分:机电血压测量系统补充要求; 德文版本 EN 1060-3-1997+A2-2009

The document specifies performance and overall accuracy requirements for electro-mechanical blood pressure measuring systems. EN 1060-4 is specifies as test method for the overall accuracy

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems; German version EN 1060-3:1997+A2:2009

DIN EN 1060-2:2010 非侵入式血压计.第2部分:机械血计补充要求; 德文版本 EN 1060-2-1995+A1-2009

The document, in conjunction with EN 1060-1:1994 and EN 1060-1 A1:2009, specifies performance, efficiency and mechanical and electrical safety requirements, including test methods, for non-invasive mechanical sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure.

Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers; German version EN 1060-2:1995+A1:2009

NF S97-103/IN2*NF EN 1060-3/IN2:2010 非侵入式血压计.第3部分:电镀机械式血压计测量系统用增补要求

Non-invasive sphygmomanometers - Part 3 : supplementary requirements for electro-mechanical blood pressure measuring systems.

KS P 1309-2009 造瘘术设备检测方法

이 표준은 스토마 용품 중에서 스토마 장구, 판모양 피부 보호제(이하 피부 보호제라 한다.

Testing method for ostomy aids

DIN EN 12470-1:2009 医用温度计.第1部分:带限位装置的玻璃式液体金属温度计.德文版本 EN 12470-1:2000+A1:2009

This Part of EN 12470 specifies performance requirements and test methods for clinical liquid-in-glass thermometers with maximum device and applies only to thermometers filled with metallic liquid. NOTE 1 Note that in some European countries the use of mercury is prohibited in clinical thermometers. NOTE 2 Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. No reference is made to these in this European standard because there is no experience of clinical thermometers which use other substances. This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of this standard.

Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device(includes Amendment A1:2009); English version of DIN EN 12470-1:2009-11

EN 1060-3:1997+A2:2009 非侵入式血压计.第3部分:电动机械血压测量系统的补充要求

This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods. This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995. This Part of EN 1060 is to be used in conjunction with EN 1060-1.

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

DIN EN 12470-2:2009 临床体温计.相位变换式体温计(点矩阵),德文版本EN 12470-2:2000+A1:2009

This Part of EN 12470 specifies performance requirements and test methods for phase change-type (dot matrix) thermometers for measuring temperature in body cavities. N~TE A body cavity can be the mouth, rectum or armpit. This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for hypothermia) which owing to their measurement range, scale interval or maximum permissible error do not meet the requirements specified in this Standard.

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers(includes Amendment A1:2009); English version of DIN EN 12470-2:2009-11

DIN EN 12470-3:2009 体温计.第3部分:大刻度的小型电测温度计的性能(可预测和不可预测的),德文版本EN 12470-3:2000+A1:2009

This Part of EN 12470 specifies the performance requirements for compact clinical electrical thermometers with maximum device (non-predictive and predictive). This European Standard applies to devices that, when taking temperatures, are powered by an internal power supply and that provide a digital indication of temperature. This European Standard does not apply to clinical electrical thermometers for continuous measurement and thermometers intended to measure skin temperature.

Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device(includes Amendment A1:2009); English version of DIN EN 12470-3:2009-11

DIN EN 12470-4:2009 医用温度计.第4部分:连续测量下电气式温度计的性能,德文版本 EN 12470-1:2000+A1:2009

This part of EN 12470 specifies the metrological and technical requirements for electrical thermometers for continuous measurements. This European Standard applies to devices that are operated by an electrical power supply either by mains or internal power sources. The devices can be equipped to accommodate secondary indicators, printing devices, and other auxiliary devices The metrological requirements for such accessories are not covered by this European Standard. Thermometers intended to measure skin temperatures are not covered by this European Standard. This European Standard does not intend to exclude the use of any device based on other measuring principles that provides an equivalent performance in continuously measuring body temperature. NOTE Devices can have functions which are covered by different parts of EN 12470. In this case, it is the responsibility of the manufacturer to indicate by which part of EN 12470 the function is covered, e.g. electrical thermometer with maximum device and exchangeable temperature probes.

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement(includes Amendment A1:2009); English version of DIN EN 12470-4:2009-11

CKS 352-2009 无液和水银非自动血压计

Covers requirements for aneroid and mercury type non-automated sphygmomanometers to be used with occluding cuffs for the indirect measurement of arterial blood pressure. Requirements for occluding cuff, inflatable bladder, inflation device, connecting tu

Non-automated sphygmomanometers, aneroid and mercury

DIN EN ISO 15193:2009 体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO 15193:2009),DIN EN ISO 15193:2009-10的英文版本

This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, "international measurement standard" designates a material standard. The term "international standard" is used by WHO for reference materials.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); English version of DIN EN ISO 15193:2009-10

DIN EN ISO 15194:2009 医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(ISO 15194:2009),DIN EN ISO 15194:2009-10的英文版本

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); English version of DIN EN ISO 15194:2009-10

ISO 80601-2-56:2009 医疗电气设备.第2-56部分:人体体温测量用体温计的基本安全性和主要性能的详细要求

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

NF S97-150-4:2009 医用体温计.第4部分:连续测量用电体温计的性能

Clinical thermometers - Part 4 : Performance of electrical thermometers for continuous measurement.