C46 手术室设备 标准查询与下载

BS EN ISO 7376:2009-08 麻醉和呼吸设备.气管插管术用喉镜

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

DIN EN ISO 7396-1:2010 医用气体管道系统.第1部分:压缩医疗气体和真空用管道系统(ISO 7396-1-2007 + Amd 1-2010 + Amd 2-2010).德文版本EN ISO 7396-1-2007 + A1-2010 + A2-2010

This part or ISO 7396 specifies requirements for design, installationm fuction,performance, documentation, testing and commissioning of pipeline systems for compresessed medical gases, gades for driving surgical tools and vacuum in healthcare facilitles to ensure continuous delivery of the correct gas and the provision of vacuum from the pipline system.

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007 + Amd 1:2010 + Amd 2:2010); German version EN ISO 7396-1:2007 + A1:2010 + A2:2010

JJF 1260-2010 婴儿培养箱校准规范

本规范适用于使用空气温度控制方式工作的婴儿培养箱的计量性能校准。 本规范不适用于利用辐射热源对婴儿保暖的开放式培养箱、使用婴儿皮肤温度控制方式工作的婴儿培养箱和转送婴儿用的转送式婴儿培养箱。

Calibration Specification for Baby Incubator

ISO/TS 16976-2:2010 呼吸保护装置.人为因素.第2部分:人体计测

This part of ISO/TS 16976 is one part of a series of technical specifications that provide information on factors related to human anthropometry, physiology, ergonomics and performance for the preparation of standards for design, testing and use of respiratory protective devices. This part of ISO/TS 16976 contains information related to anthropometry. In particular, information is given for: . anthropometric measurement methods; . anthropometric data for head, face and neck dimensions; . anthropometric data for torso dimensions; . human test panels; . models of headforms.

Respiratory protective devices - Human factors - Part 2: Anthropometrics

ISO 15001:2010 麻醉和呼吸设备.与氧气的兼容性

This International Standard specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa. Additionally, this International Standard gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition. Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages. This International Standard does not apply to biocompatibility. This International Standard is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators

Anaesthetic and respiratory equipment - Compatibility with oxygen

DIN EN ISO 11737-2:2010 医疗器械灭菌.微生物学方法.第2部分:灭菌过程的定义、有效性和维护中进行的无菌试验(ISO 11737-2-2009); 德文版本 EN ISO 11737-2-2009

This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009

BS EN ISO 21969:2009 同医疗气体设备一起使用的高压挠性连接件

ers or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C for use with the following medical gases: ⎯ oxygen; ⎯ nitrous oxide; ⎯ air for breathing; ⎯ helium; ⎯ carbon dioxide; ⎯ xenon; ⎯ mixtures of the gases listed above; ⎯ air for driving surgical tools; ⎯ nitrogen for driving surgical tools; ⎯ oxygen-enriched air. 1.2 This International Standard applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1. 1.3 This International Standard applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1. 1.4 This International Standard does not apply to high-pressure flexible connections intended to be used to fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5359.

High-pressure flexible connections for use with medical gas systems

JIS T 8201:2010 缺氧指示器

This Standard specifies the oxygen deficiency indicator to be used for the determination and monitoring of oxygen concentration, or for alarm inside wells, vertical shafts, tunnels, pneumatic caissons, pits, manholes, septic tanks, closed conduits, cellars, underground rooms, tanks, boilers, reaction towers, hoppers, silos, warehouses, holds, etc. liable to generate oxygen deficiency.

Oxygen deficiency indicator

DIN 13467:2010 医疗器械.马吉尔式麻醉导管导引钳

This standard defines dimensions and marking of catheter introducing forceps type Magill, as used in surgery abd public health service.

Medical instruments - Catheter introducing forceps type Magill

DIN EN ISO 26782:2010 麻醉和呼吸设备.用于测量人定时用力呼气量的肺活量计(ISO 26782-2009 + 勘误表1-2009).德文版本EN ISO 26782-2009+AC-2009

This International Standard specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg. This International Standard applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed. Devices intended for continuously monitoring patients are outside the scope of this standard.

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009); German version EN ISO 26782:2009 + AC:2009

BS EN 1282-2:2005+A1:2009 气管造口管.儿科学用导管

This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given. This document is not applicable to specialized tracheostomy tubes.

Tracheostomy tubes - Paediatric tubes

JJF 1234-2010 呼吸机校准规范

本校准规范适用于治疗型呼吸机使用过程中、维修后机械通气参数的校准。设备技术验收、通气功能和安全性检查可参照本规范。 本校准规范不适用于无创呼吸机、高频喷射呼吸机和高频振荡呼吸机，也不适用于医院中使用的仅用作增加患者通气量的设备。

Calibration Specification for Lung Ventilators

DIN EN 13544-2:2010 呼吸治疗设备.第2部分:管和连接件.德文版本EN 13544-2-2002+A1-2009

This European standard specifies requirements for tubing to be used for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i. e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases.

Respiratory therapy equipment - Part 2: Tubing and connectors; German version EN 13544-2:2002+A1:2009

DIN EN ISO 7376:2010 麻醉和呼吸设备.气管插管用喉镜(ISO 7376-2000).德文版本EN ISO 7376-2009

This Standard gives general requirements for laryngoscopes used for intubation and specfies critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addresses the interchangeability of blades and handles.It is applicable only to instruments with an internal battery-operated power source for illuminating the larynx, since electrical safety requirements can be more stringent for instruments connected to mains or external power packs. This Standard is not applicable to surgical instruments known by the same generic name.

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009); German version EN ISO 7376:2009

ISO 7396-1:2007/Amd 1:2010 医用气体管道系统.第1部分:压缩的医用气体和真空用管道系统.修改件1:装配于操作者可调部件医疗补给装置和连接于通路弹性软管管道的真空用终端设备要求

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline throug

ANSI/AAMI ST79-2010 卫生保健设施中蒸汽灭菌和无菌保证综合指南

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

YY 0601-2009 医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求

除以下内容外，GB 9706.1-2007第1章适用。 修改（在1.1的末尾增加）： 本标准规定了预期连续运行，并应用于患者的呼吸气体监护仪（RGM）（由3.15定义）的基本安全和主要性能的专用要求。 本标准规定了下列要求： a）麻醉气体监测； b）二氧化碳监测； c）氧气监测。 本标准不适用于预期与可燃性麻醉剂一起使用的呼吸气体监护仪。 本标准的要求取代或修订GB 9706,1-2007的相关要求，并将优先于相应的通用要求。 环境方面见附录CC。

Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory gas monitors

KS P ISO 8185:2009 医用增湿器.增湿系统的通用要求

이 표준은 가습 장치의 안전성과 필수적인 성능에 대한 요구사항을 다루고 있다. 또한 가열

Humidifiers for medical use -- General requirements for humidification systems

KS P ISO 9360-1:2009 麻醉和呼吸设备.使人体呼吸气体增湿的热和潮气交换器(HMEs).第1部分:250ML最小呼吸气容积用的热与湿度交换器

이 표준은 호흡 시스템 필터와 연결된 것을 포함한 열/수분 교환기에 대한 요구사항을 규정하

Anaesthetic and respiratory equipment-Heat and moisture exchangers(HMEs) for humidifying respired gases in humans- Part 1:HMEs for use with minimum tidal volumes of 250 mL

KS P ISO 8836:2009 用于呼吸道的吸气引液导管

이 표준은 플라스틱으로 만들어지고 기도의 흡입에 사용되는 흡입 카테터에 대한 요구조건을 규

Suction catheters for use in the respiratory tract