C41 医用超声、激光、高频仪器设备 标准查询与下载
共找到 351 条与 医用超声、激光、高频仪器设备 相关的标准，共 24 页
Medical electrical equipment - Part 2-2 : particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
- ICS
- 11.040.30
- CCS
- C41
- 发布
- 2012-07-01
- 实施
- 2012-07-27
This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the HAEMODIALYSIS treatment prescription. However, the ORGANIZATION 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 scope may be applicable to the use of the equipment in paediatrics, home HAEMODIALYSIS, acute and SORBENT DIALYSIS SYSTEMS. The requirements of IEC 60601-2-16 ensure that equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite that high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical HAZARDS. The ORGANIZATION administering the treatment is responsible for managing the residual risk. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
Guideline for safe operation of medical equipment used for haemodialysis treatments
- ICS
- 11.040.20;11.040.25
- CCS
- C41
- 发布
- 2012-06
- 实施
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007); German version EN 60601-2-37:2008 + A11:2011
- ICS
- 11.040.55
- CCS
- C41
- 发布
- 2012-05
- 实施
- 2012-05-01
Replacement: This particular standard specifies the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT@ hereafter referred to as ME EQUIPMENT@ as defined in subclause 201.3.206. LOW POWER EQUIPMENT as defined in subclause 201.3.202 is exempted from certain requirements of this standard.
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2012-04-01
- 实施
- 2016-05-03
Replacement: This International Standard specifies requirements for the safety of MICROWAVE THERAPY EQUIPMENT used in medical practice@ as defined in 201.3.204. Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MICROWAVE THERAPY EQUIPMENT as defined in 201.3.204.
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
- ICS
- 11.040.50
- CCS
- C41
- 发布
- 2012-04-01
- 实施
- 2016-05-03
本标准规定了浅表组织超声治疗设备的术语和定义、要求、组成与基本参数、试验方法、检验规则。 本标准适用于3.1所定义的浅表组织超声治疗设备（以下简称“设备”）。 本标准不适用于YY 1090所涉及的超声理疗设备。 本标准不适用于YY 0592所涉及的高强度聚焦超声（HIFU）治疗系统。 本标准不适用于YY/T 0644所涉及的超声外科手术系统。
Ultrasonic therapy equipment for superficial tissue
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
Ophthalmic high frequency ultrasound scanner
- ICS
- 11.040.50
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
本标准规定了脉冲二氧化碳激光治疗机的基本参数和产品组成、技术要求、试验方法以及标志标签、包装等内容，本标准为脉冲二氧化碳激光治疗机制造商制定医疗器械注册产品标准提供技术规范。 本标准适用于只含有脉冲运行方式的脉冲二氧化碳激光治疗机和同时含有连续波运行方式、脉冲运行方式的二氧化碳激光治疗机中的脉冲运行部分（以下简称为治疗机）。本标准所指的“脉冲”，其脉冲持续时间（脉冲宽度）小于0.25s。治疗机通过波长为10.6μm的脉冲激光对人体组织的汽化、碳化、凝固和照射，达到治疗的目的。 同时含有连续被运行方式、脉冲运行方式的二氧化碳激光治疗机，其连续被运行部分应符合GB 11748，其脉冲运行部分应符合本标准。
Laser therapeutic equipment.Pulsed carbon dioxide laser treating instrument
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
本标准规定了连续波掺钕钇铝石榴石激光治疗机的定义、基本参数、要求、试验方法、抽样和标志、标签、包装等要求。 本标准适用于波长为1064nm的连续波掺钕钇铝石榴石激光治疗机（以下简称治疗机）。治疗机能对组织进行凝结、汽化、碳化和熔融。
Nd:YAG laser medical instrument with continuous wave(CW)
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
本标准规定了半导体激光光动力治疗机的术语和定义、产品组成、基本参数、技术要求、试验方法和检验规则等要求。 本标准适用于半导体激光光动力治疗机（以下简称治疗机），该治疗机采用特定波长的激光与光敏剂产生光化学作用，供临床单位进行光动力治疗。
Laser therapeutic equipment.Diode laser equipment for photodynamic therapy
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
本标准规定了掺钬钇铝石榴石激光治疗机的要求、试验方法、标志、包装、运输及贮存、使用说明书。 本标准适用于以掺Cr、Tm、Ho离子的钇铝石榴石（YAG）为工作介质，发射的激光波长在2.1μm附近的激光治疗机（以下简称治疗机）。 治疗机可用于人体组织的切割、汽化、凝固以及体内碎石等。
Laser therapeutic equipment.Ho:YAG laser equipment
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
Ultrasonic—Hydrophone—Part 1:Measurement and characterization of medical ultrasonic fields up to 40 MHz
- ICS
- 11.040.50
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
本标准规定了超声诊断和监护设备声输出参数测量不确定度的术语和定义、不确定度的主要来源、不确定度评定的程序和不确定度的评定、报告与表示。 本标准适用于超声诊断和监护设备（以下简称“设备”）声输出参数测量不确定度的评定。
Guide for evaluation of uncertainty in measurement of ultrasonic diagnostic and monitoring equipment acoustic output characteristics
- ICS
- 11.40.55;17.140.50
- CCS
- C41
- 发布
- 2011-12-31
- 实施
- 2013-06-01
이 표준은 201.3.217에 정의된 초음파 진단기기(ULTRASONIC DIAGNOSTI
Medical electrical equipment－Part 2-37：Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- ICS
- 11.040.55;17.140.50
- CCS
- C41
- 发布
- 2011-12-08
- 实施
- 2011-12-08
이 국제표준은 201.3.216에 정의된 초음파 물리치료기(ultrasound physio
Medical electrical equipment-Part 2-5:Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-08
- 实施
- 2011-12-08
이 표준은 의료용 극초단파 치료기(이하 “기기”라 한다.)의 안전에 관한 요구사항을 규정한
Medical electrical epuipment-Part 2:Particular requirements for the safety of microwave therapy equipment
- ICS
- 11.040.60
- CCS
- C41
- 发布
- 2011-12-08
- 实施
- 2011-12-08
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010 + Cor.: 2011); German version EN 62359:2011
- ICS
- 11.040.55
- CCS
- C41
- 发布
- 2011-11-01
- 实施
- 2011-11-01
Ultrasonics - Surgical systems - Specification and measurement of field parameters for High Intensity Therapeutic Ultrasound (HITU) transducers and systems
- ICS
- 11.040.30;17.140.50
- CCS
- C41
- 发布
- 2011-11
- 实施
Ultrasonics. Real-time pulse-echo scanners. Phantom with cylindrical, artificial cysts in tissue-mimicking material and method for evaluation and periodic testing of 3D-distributions of void-detectability ratio (VDR)
- ICS
- 11.040.55
- CCS
- C41
- 发布
- 2011-06-30
- 实施
- 2011-06-30
