C38 普通诊察器械 标准查询与下载

NF S97-150-4/IN1:2009 医用体温计.第4部分:连续测量用电体温计性能

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

NF S97-150-3/IN1:2009 医用体温计.第3部分:最大装置小型电体温计(非预测型和预测型)的性能

Clinical thermometers - Part 3 : performance of compact electrical thermometers (non-predictive and predictive) with maximum device.

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.

BS EN ISO 15194:2009 体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求

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

BS EN ISO 15193:2009 体外诊断医疗器械.生物源样品的数量测量.基准测量规程的内容和表示要求

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 体外诊断医疗器械.生物有机体试样的数量测量.内容要求和基准测量过程介绍

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

DIN EN 60601-2-33 Berichtigung 1:2009 医疗电气设备.第2-33部分:医疗诊断用磁共振设备安全的特殊要求.技术勘误DIN EN 60601-2-33(VDE 0750-2-33)-2008-07

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002 + A1:2005 + A2:2007); German version EN 60601-2-33:2002 + A1:2005 + A2:2008, Corrigendum to DIN EN

ISO 15194:2009 体外诊断医疗设备.生物原始试样数量测量.认证参考材料和证明文件的内容要求

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

JIS T 3230:2008 充氧器

この規格は，滅菌済みで単回使用の，血液への酸素付加及び血液からの二酸化炭素除去を目的とする体外循環用人工心肺用血液ガス交換器(以下，人工肺という。)の要求事項について規定する。ただし，この規格は，次の機器には適用しない。

Oxygenators

ANSI/AAMI/ISO/IEC 81060-1:2007 非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法

This standard specifies requirements for mechanical sphygmomanometers and their accessories that, by means of inflatable cuffs, are used for the non-invasive measurement of blood pressure. This standard also specifies requirements for the safety, essential performance, effectiveness, and labelling for these instruments and their accessories, including test methods to determine the accuracy of their measurements.

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

JJG 270-2008 血压计和血压表检定规程

本规程适用于（台式和立式）水银血压计（以下简称血压计）和弹性式血压表（以下简称血压表）的首次检定、后续检定和使用中检验。

Verification Regulation of Sphygmomanometer

GOST R 52921-2008 医疗最大玻璃温度计.通用规范

Medical maximum glass thermometers. General specifitications

BS EN ISO 81060-1:2012 非侵入式血压计.非自动测量式血压计的要求和试验方法

Non-invasive sphygmomanometers. Requirements and test methods for non-automated measurement type

ISO 81060-1:2007 非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法

This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation. This part of ISO 81060 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement. The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow. EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods. Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in IEC 60601-2-30 [7]. Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34 [8]. EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures.

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

BS EN ISO 20776-2:2007 临床实验室测试和体外诊断试验系统.传染者的敏感性测试和抗菌剂敏感性试验装置的性能评定.抗菌剂敏感性试验装置的性能评定

ISO 20776-2:2007 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2:2007 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2:2007 has been developed to guide manufacturers in the conduct of performance evaluation studies.

Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test device

ANSI/AAMI/ISO 81060-1:2007 非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated meaasurement type

KS P 1002-2006 医用剪刀切剪力试验方法

이 규격은 의료용으로 사용하는 가위류의 끊김 시험 방법에 대하여 규정한다.

Cut and durability test methods for dressing scissors

KS P 1104-2006 呼吸用面罩泄漏率测试方法

이 규격은 호흡용 보호구에 사용하는 전면형 면체 및 반면형 면체의 누설률 시험 방법에대

Leakage rate testing method for facepieces of respirstors

DIN EN 1060-3:2006 非侵入式血压表.第3部分:机电血压测量系统补充要求(包括修改件A1-2005)

This Part of EN 1060 specifies performance, efficiency and safety requirements for electromechanical 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 60601-2-30:2000. 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; German version EN 1060-3:1997 + A1:2005

KS B ISO 8600-3:2006 光学和光学仪器.医用内窥镜和内窥镜附件.第3部分:光学内窥镜观察方向和观察区域的测定

이 규격에서는 내시경의 시야 및 시선 방향 측정에 대한 요건을 명시하고 권장하는 시험 방

Optics and optical instruments－Medical endoscopes and endoscopic accessories－Part 3：Determination of field of view and direction of view of endoscopes with optics