C39 医用电子仪器设备 标准查询与下载

YY 0781-2010 血压传感器

本标准适用于经导管或直接的血管穿剌来测量血压的压力传感器，包括电缆。尽管本标准的要求和测试是围绕着以血压测量为预期用途的设备来进行研制与设计的，但是血压以外的生理参数的测量也可以用这种传感器。即使这个标准专注于血压测量的传感器的安全和功效，也宜关注确保专用传感器和血压监护设备的兼容性。 本标准的范围是包含设计用来测量血压的经留置导管或直接穿剌的传感器、电缆的安全和性能的要求，同时也给用户自己决定传感器和血压监护设备之间的兼容性提供参考。 本标准的范围是不包括被设计用于测量其他生理参数的传感器，本标准不阐述针对传感器或监护设备的操作程序，因此，参阅适合的使用说明书对于正确安装，平衡和校准该系统是完全必要的。 注：针对本标准条款制定和要求声明的原理性解释，请参见附录A。

Blood pressure transducers

DIN EN 60601-1-2 Berichtigung 1:2010 医用电气设备.第1-2部分:基本安全和主要性能的一般要求.间接标准:电磁兼容性.要求和试验 (IEC 60601-1-2-2007, 修改采用); 德文版本 EN 60601-1-2-2007, 技术勘误 DIN EN 60601-1-2 (VDE 0750-1-2)-2007-12; 德文版本 CENELEC-Cor. -2010 to EN 60601-1-2-2007

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007, modified); German version EN 60601-1-2:2007, Corrig

NF S97-101/IN2:2010 非侵入式血压表.第1部分:一般要求

Non-invasive sphygmomanometers - Part 1 : general requirements.

NF S97-101:2010 非侵入式血压计.第1部分:一般要求

Non-invasive sphygmomanometers - Part 1 : general requirements.

IEC 60601-2-33:2010 医用电气设备.第2-33部分:医疗诊断用磁共振设备的基本安全和基本性能用特殊要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. 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. The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

NF S97-103:2010 非侵害性血压计.第3部分:电-机血压测量系统的补充要求

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

NF S97-102:2010 非侵害性血压计.第2部分:机械血压计的补充要求

Non-invasive sphygmonanometers - Part 2 : supplementary requirements for mechanical sphygmomanometers.

KS P ISO TR 18112:2009 临床实验室试验和在实验室条件下诊断试验系统.实验室条件下诊断用的专用医学设备.制造商提供信息的管理要求概要

이 기술 보고서는 전문가용 IVD 의료기기와 관련하여 제조업체가 제공하는 정보에 대한 규제

Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer

IEC 60601-2-1:2009 医用电气设备.第2-1部分:1至50MeV范围内医用电子加速器的基本安全性和基本性能用详细要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS@ hereafter referred to as ME EQUIPMENT@ in the range 1 MeV to 50 MeV@ used for treatment of PATIENTS. This particular standard@ with the inclusion of TYPE TESTS and SITE TESTS@ applies respectively to the manufacture and some installation aspects of ELECTRON ACCELERATORS ?C intended for RADIOTHERAPY in human medical practice@ including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS)@ ?C that@ under NORMAL CONDITIONS and in NORMAL USE@ deliver a RADIATION BEAM of XRADIATION and/or ELECTRON RADIATION having ? NOMINAL ENERGY in the range 1 MeV to 50 MeV@- ? maximum ABSORBED DOSE RATES between 0@001 Gy ?? s?C1 and 1 Gy ?? s?C1 at 1 m from the RADIATION SOURCE@ ? NORMAL TREATMENT DISTANCES (NTDs) between 0@5 m and 2 m from the RADIATION SOURCE@ and ?C intended to be ? for NORMAL USE@ operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application@ for particular specified clinical purposes@ e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY@ ? maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE@ ? subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE 1 In this particular standard@ all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises. NOTE 2 In this particular standard@ all references to ABSORBED DOSE refer to ABSORBED DOSE in water.

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

DIN EN ISO 9919:2009 医疗电气设备.医用脉冲血氧仪基本安全性和必要性能的详细要求(ISO 9919-2005).德文版本EN ISO 9919-2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005); German version EN ISO 9919:2009

IEC 60601-2-18:2009 医疗电气设备.第2-18部分:内窥镜设备基本安全性和必要性能的详细要求

Addition:This Particular Standard specifies requirements for the safety of ENDOSCOPIC EQUIPMENT and its INTERCONNECTION CONDITIONS with ENDOSCOPICALLY-USED ACCESSORIES.NOTE ?C As the General Standard does not give requirements for the safety of APPLIED PARTS of different MEDICAL ELECTRICAL EQUIPMENT when used together@ this standard gives requirements for specific INTERCONNECTION CONDITIONS Commonly encountered during the use of ENDOSCOPES.

Medical electrical equipment - Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment

DIN EN 60601-2-29:2009 医疗电气设备.第2-29部分:放射线疗法模拟器的一般安全和中药性能用特殊要求

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008); German version EN 60601-2-29:2008

ISO 81060-2:2009 非侵入性血压计.第2部分:自动测量式临床验证

Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

DIN VDE 0753-4:2009 透析治疗中医疗产品的安全使用指南

The present application principles describe the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles must be complied with to ensure safe, permissible and proper application. Dialysis treatment as a whole is a medical treatment and lies, therefore, in the attending physician's responsibility. However, the ORGANISATION administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. If applicable, the application principles can also be used for other extracorporeal blood treatment procedures. However, different requirements may be applicable to the use of equipment in paediatrics and home HAEMODIALYSIS. Today, the safety standard of SYSTEMS for extracorporeal renal replacement therapy is very high. This safety standard relieves the OPERATOR in many areas while also protecting the PATIENT. For example, it ensures monitoring of the temperature of the DIALYSING FLUID and prevents air infusion during the dialysis treatment through technical structures. This is expressed by the CE mark applied to the medical devices [9]. Despite the high safety level of the medical devices, the OPERATOR is responsible for the residual risk. The residual risk relates to medical-biological, physical-chemical and technical HAZARDS.

Guideline for the safe use of medical products in dialysis treatment - Text in German and English

BS EN 60601-2-29:2008+A11:2011 医疗电气设备.放射疗法模拟器基本安全性和必要性能的详细要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of radiotherapy simulators

IEC 60601-2-50:2009 医疗电气设备.第2-50部分:婴儿光线疗法设备的基本安全及重要性能用详细要求

Addition:This Particular Standard specifies requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT (as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the body of infants suffering from icterus in the first months of life.

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

IEC 60601-2-21:2009 医用电气设备.第2-21部分:婴儿辐射保暖箱的基本安全和基本性能用专用要求

This Particular Standard applies to INFANT RADIANT WARMERS as defined in 2.2.101.Requirements for INFANT RADIANT WARMERS intended for use outside a hospital baby care environment@ INFANT RADIANT WARMERS having a heated mattress@ and INFANT RADIANT WARMERS powered by an INTERNAL ELECTRICAL POWER SOURCE are not included in this Particular Standard.

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC 60601-2-20:2009 医用电气设备.第2-20部分:婴儿运输恒温箱的基本安全性和基本性能用专用要求

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment@ as defined in 201.3.211 of this standard@ also referred to as ME EQUIPMENT. 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 safety requirements for INFANT TRANSPORT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: ?C devices supplying heat via BLANKETS@ PADS or MATTRESSES in medical use; for information see IEC 80601-2-35 [1]1); ?C INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19 [2]; ?C INFANT RADIANT WARMERS; for information@ see IEC 60601-2-21 [3]; ?C INFANT PHOTOTHERAPY; for information@ see IEC 60601-2-50 [4]. 1) Figures between square brackets refer to the Bibliography.

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

IEC 60601-2-19:2009 医用电气设备.第2-19部分:基础安全性用特殊要求和婴儿恒温箱的基本性能

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS@ as defined in 201.3.209 of this standard@ also referred to as ME EQUIPMENT. 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 safety requirements for INFANT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: ?C devices supplying heat via BLANKETS@ PADS or MATTRESSES in medical use; for information see IEC 80601-2-35 [3]2); ?C INFANT RADIANT WARMERS; for information@ see IEC 60601-2-21 [2]; ?C INFANT TRANSPORT INCUBATORS@ for information@ see IEC 60601-2-20 [1]; ?C INFANT PHOTOTHERAPY EQUIPMENT@ for information see IEC 60601-2-50 [4]. 2) Figures in square brackets refer to the Bibliography.

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

ANSI/AAMI/IEC 80601-2-30/C1:2009 医疗电气设备.第2-30部分:自动非侵入式血压测量计的基本安全性和基本性能的详细要求

Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers