C42 理疗与中医仪器设备 标准查询与下载

YY 0323-2008 红外治疗设备安全专用要求

除下列内容外，《通用要求》的该章适用。 本标准规定了以2.1.101所定义的红外治疗设备的安全专用要求。 本标准不适用于红外热辐射类治疗设备。

Particular requirements for the safety of infrared therapy equipment

YY 0324-2008 红外乳腺检查仪

本标准规定了红外乳腺检查仪的分类、要求、试验方法、检验规则、标识、使用说明书、包装、运输、贮存等。 本标准适用于以红外透照法检查乳腺纤维瘤、增生、乳头状瘤、乳腺炎症及肿块等疾病的仪器。

Infrared examining equipment for mammary gland

YY 0650-2008 妇科射频治疗仪

本标准规定了妇科射频治疗仪的定义、分类、要求、试验方法、检验规则、标志、包装、运输及贮存等。 本标准适用于3.1所定义的妇科射频治疗仪（以下简称治疗仪），该仪器用于妇科相关疾病的手术治疗。

Gynecological radio frequency therapy instrument

YY 0649-2008 高电位治疗设备

本标准规定了高电位治疗设备的术语和定义、要求、试验方法、检验规则和标志、包装、运输、贮存。 本标准适用于3.1规定的高电位治疗设备（以下简称设备）。

High electrical potential therapy equipment

NF C97-909:2008 超声波学.物理治疗系统.频率范围0.5MHz～5MHz的范围规范和测量方法

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz.

YY 0607-2007 医用电气设备 第2-10部分：神经和肌肉刺激器安全专用要求

Medical electrical equipment—Part 2: Particular requirements for the safety of nerve and muscle stimulators

NF C74-345:2007 医用电气设备.第2-13部分:麻醉系统安全和基本性能的专用要求

Medical electrical equipment - Part 2-13 : particular requirements for the safety and essential performance of anaesthetic systems.

YY/T 0165-2007 热垫式治疗仪

本标准规定了热垫式治疗仪的要求、试验方法、检验规则及标志、包装、运输、贮存。 本标准适用于以热垫为应用部分的热垫式治疗仪（以下简称治疗仪）。

Medical heating pad therapy equipment

YY/T 1095-2007 肌电生物反馈仪

本标准规定了肌电生物反馈仪的术语、要求、试验方法、检验规则和标志、包装、运输、贮存。 本标准适用于肌电生物反馈仪（以下简称“肌反仪”）。

Myoelectric biofeedback equipment

YY/T 0061-2007 特定电磁波治疗器

本标准适用于 3.2 中定义的特定电磁波治疗器(以下简称治疗器)。 本标准规定了特定电磁波治疗器的定义、要求、试验方法、检验规则和标志、包装、运输、贮存。

Specified electromagnetic wave therapy equipment

YY/T 1096-2007 温度生物反馈仪

本标准规定了温度生物反馈仪的分类、要求、试验方法、检验规则、标志、包装、运输、贮存。 本标准适用于温度生物反馈仪（以下简称“温反仪”）。

Temperature biofeedback equipment

BS EN ISO 11137-1:2006+A1:2013 医疗保健产品的消毒. 辐射. 医疗器械消毒方法的制定, 确认和常规控制要求

Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

DIN EN 14931:2006 病员用高压仓(PVHO).高压疗法用多位置高压室.性能、安全要求和试验

Pressure chambers for therapeutic use are required for the administration of hyperbaric oxygen therapy and for the treatment of decompression illness. These chambers are made to allow the safe administration of hyperoxic gas mixtures at pressure while avoiding the risks of fire within the chamber and of uncontrolled compression or decompression. This standard is applicable to the performance and safety requirements and their associated test methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes.

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing English version of DIN EN 14931:2006-08

KS B ISO 32:2005 医疗用气瓶的标记.标识的内容

이 규격은 의료용 사용만을 목적으로 한 가스 용기의 내용물 확인을 위한 색상 및 표시 체

Gas cylinders for medical use-Marking for identification of content

JIS T 0601-2-203:2005 医用电气设备.红外治疗设备安全专用要求

この規格は，2.1.101で定義する，物理療法で用いる医家向けの赤外線治療器の安全に関する要求事項について規定する。

Medical electrical equipment -- Particular requirements for the safety of infrared therapy equipment

JIS T 0601-2-202:2005 医用电气设备.紫外线治疗设备安全专用要求

この規格は，2.1.101で定義する，物理療法で用いる医家向けの紫外線治療器の安全に関すろ要求事項について規定する。

Medical electrical equipment -- Particular requirements for the safety of ultraviolet therapy equipment

JIS T 0601-2-206:2005 医用电气设备.干热裹法治疗设备安全专用要求

この規格は，2.1.101で定義する，物理療法で用いる医家向けの乾式ホットパック装置の安全に関する要求事項について規定する。

Medical electrical equipment -- Particular requirements for the safety of dry hot pack therapy equipment

ISO 17510-2:2003 睡眠窒息呼吸治疗.第2部分:面具和使用附件

This part of the European Standard specifies requirements for masks and accessories which are required to connect the patient connection port to a sleep apnoea breathing therapy device and the mask to a patient, and are used for the application of sleep apnoea breathing therapy e.g. nasal masks, gas exhaust ports, connecting element and headgear. This part of EN ISO 17510 does not cover oral appliances. NOTE 1 Sleep apnoea breathing therapy devices are covered by EN ISO 17510-1 (see Figure A.1 for typical elements of the two parts of EN ISO 17510). NOTE 2 Annex A contains rationale statements for this Part of EN ISO 17510.

Sleep apnoea breathing therapy - Part 2: Masks and application accessories

ISO 17510-1:2002 睡眠窒息呼吸治疗.第1部分:睡眠窒息呼吸治疗仪

The scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition. This European Standard specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions. Jet and very high frequency ventilation and oscillation are not considered in this part of the European Standard. This European standard does not apply to devices covered by the scope of the EN 794 series. Masks and application accessories are adressed in Part 2 of this Standard (in preparation). This European Standard does not cover external body ventilators as defined in EN ISO 4135.

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices

DIN-Fachbericht 119:2002 氧化氮吸入治疗设备通用指南

General guidance on the equipment used for inhaled nitric oxide therapy; German version CR 13903