C46 手术室设备 标准查询与下载

KS P ISO 8835-4:2010 吸入式麻醉剂系统.第4部分:麻醉蒸汽传输设备

다음 이외에는 KS C IEC 60601-1:2002의 1.을 적용한다.추가:이

Inhalational anaesthesia systems－Part 4：Anaesthetic vapour delivery devices

KS P ISO 8835-5:2010 吸入式麻醉剂系统.第5部分:麻醉通风设备

다음 이외에는 KS C IEC 60601-1:2002, 1.을 적용한다.이 표준은

Inhalational anaesthesia systems－Part 5：Anaesthetic ventilators

KS P ISO 5358:2010 人用麻醉机

이 표준은 인체에 사용되는 마취기계와 관련된 구성품에 대한 기본적인 요구사항을 규정한다.

Anaesthetic machines for use with humans

YY 0786-2010 医用呼吸道湿化器 呼吸湿化系统的专用要求

除下述内容外，GB 9706.1-2007第1章适用。 修改（在1.1末尾增加）: 本标准规定了湿化系统（见3.6定义）的基本安全和基本性能的要求。也包括湿化系统中使用的特定的独立装置，如呼吸管路加热（呼吸管路加热丝）以及呼吸管路加热的控制装置（呼吸管路加热控制器）。呼吸管路其他方面的安全和性能要求参见YY 0461。 注：呼吸管路加热装置属于医用电气设备，应符合GB 9706.1中的规定。 *本标准也包括了有源HME(热湿交换器）的要求，即通过主动加热加湿来提高HME输送给患者气体的湿度水平的装置。本标准不适用于无源HMEs，即在吸气阶段将患者呼出的一部分湿气和热量 再返回到呼吸管路中而未增加湿气和热量的装置。YY/T 0735.1和YY/T 0735.2规定了无源HMEs的安全和性能要求，并对性能测试的方法进行了描述。 呼吸管路湿化器可以是气动的、电动的或是两者结合。然而，本标准是基于GB 9706.1基础上的一个专用标准，其考虑到了安全方面所有的通用要求，不仅仅是电气安全方面，还包括非电动但又适用于湿化器的许多要求。本标准指定GB9706.1中的某条款适用意味着只有在湿化系统相关的需求时才考虑该条款的适用。 本标准不适用于通常所说的“室内湿化器”的那些装置，或者用于加热、通气和空调系统的加湿，也不适用于已集成到婴儿培养箱中的湿化器。 本标准不适用于向患者输送药物的雾化装置。 依据本标准进行产品规划和设计时，应对产品在整个生命周期内对环境的影响给予考虑。关于环境方面的影响请参考附录GG。 注：环境影响方面附加的内容请依据YY 0316。

Respiratory tract humidifiers for medical use.Particular requirements for respiratory humidification systems

YY 0801.1-2010 医用气体管道系统终端 第1部分：用于压缩医用气体和真空的终端

1.1YY 0801的本部分适用于： a) 预期用在符合ISO 7396-1的医用气体管道系统中，并使用于以下医用气体的终端：1）氧气；2) 氧化亚氮；3) 医用空气；4) 二氧化碳；5) 氧气/氧化亚氮混合气体[50%/50% (体积比）]。 b) 预期用在符合ISO 7396-1的医用气体管道系统中，并使用于以下气体和用途的终端：1) 富氧空气；2) 驱动手术器械用的空气；3) 驱动手术器械用的氮气；4) 真空。 注1:驱动手术器械用的空气可以用不同的名字或符号，诸如器械空气，手术空气，空气驱动，空气-700和空气-800。 注2:本部分的要求能被用作其他气体终端的指导。当作一般使用时，这些其他的气体将被认为包括在本部分当中。 本部分特别注重确保气体专用性终端的组件，以防止这些组件在不同气体间以及用途间的互换。 1.2本部分规定了用于供应和处理驱动手术器械的氮气或空气的终端的要求。 1.3本部分规定了用于连接专用气体连接点的插入件的要求，该专用气体连接点是终端的一部分。 1.4本部分没有规定插入件或终端专用气体连接点的尺寸。 注：某些规定了插入件和专用气体连接点尺寸的地区或国家标准在参考文献中给出。 1.5本部分没有规定在YY/T 0799中定义的NIST接头的尺寸。 1.6本部分没有规定在CGA (压缩气体协会）V-5中定义的DISS接头的尺寸。 1.7本部分没有规定YY 0801.2所涉及用于麻醉气体净化系统（AGSS)的终端的要求。

Terminal units for medical gas pipeline systems.Part 1 :Terminal units for use with compressed medical gases and vacuum

YY/T 0735.2-2010 麻醉和呼吸设备 用于加湿人体呼吸气体的热湿交换器（HMEs）第2部分：用于气管切开术患者的250mL以上潮气量的HMEs

YY/T 0735的本部分基于YY/T 0735.1-2009，规定了没有机械连接口的热湿交换器，包括连为一体的呼吸系统过滤器的具体要求和测试方法。这些装置用于对250mL以上潮气量的气管切开术患者的呼吸气体进行湿化。

Anaesthetic and respiratory equipment.Heat and moisture exchangers (HMEs) for humidifying respired gases in humans.Part 2 :HMEs for use with tracheostomized patients having minimum tidal volumes of 250mL

YY 0801.2-2010 医用气体管道系统终端 第2部分：用于麻醉气体净化系统的终端

YY 0801的本部分规定了预期用在符合ISO 7396-2的麻醉气体净化处理系统中的终端的要求和尺寸。 本部分根据动力装置是在终端的上游还是下游规定了两种型式的终端。 本部分也规定了型式专用连接点的配对件(插入件)的要求和尺寸,该型式专用连接点是终端的一部分。 本部分没有规定ISO 7396-2定义的终端的标称工作压力的范围。 本部分没有规定适用YY 0801.1的用于压缩医用气体和真空的终端的要求。

Terminal units for medical gas pipeline systems.Part 2:Terminal units for anaesthetic gas scavenging systems

YY 0451-2010 一次性使用便携式输注泵 非电驱动

本标准规定了非电驱动一次性使用便携式输注泵（以下简称输注泵）基本要求和相应的试验方法。适用于可持续给液（固定的或可调节）和（或）自控给液的输注泵。 本标准不适用于： -IEC 60601-2-24所包括的电驱动或电控制的输液泵； -植入式装置； -肠给养泵； -经皮给液装置； -输液动力不是装置自身提供动力，而是通过患者主动干预来获得动力（如：只靠重力作为动力的装置）。

Portable infusion devices for single use.Non electrically driven

YY/T 0799-2010 医用气体低压软管组件

1.1本标准规定了用于下列医用气体的低压软管组件的要求： 氧气；氧化亚氮（笑气）；医用空气；氦气；二氧化碳；氙气；上述气体的专用混合气；富氧空气；驱动手术器械用空气；驱动手术器械用氮气；真空。 其目的主要是确保气体专用性，防止不同气体传输系统间的交叉连接。这些软管组件预期用于最大工作压力小于1400kPa的地方。 1.2本标准规定了对于医用气体的不可互换的螺紋（NIST)接头、直径限位的安全系统（DISS)接头和管接头限位系统（SIS)接头的配置，并规定了不可互换的螺紋（NIST)接头的尺寸。 1.3本标准未规定： 用于驱动手术器械用空气的供应和排放的同轴软管的要求； 电导率的要求。 1.4本标准未规定软管组件的预期用途。

Low-pressure hose assemblies for use with medical gases

YY/T 0801.1-2010 医用气体管道系统终端 第1部分：用于压缩医用气体和真空的终端

Terminals for medical gas pipeline systems Part 1: Terminals for compressed medical gases and vacuums

YY/T 0801.2-2010 医用气体管道系统终端　第2部分：用于麻醉气体净化系统的终端

Terminal units for medical gas pipeline systems—Part 2:Terminal units for anaesthetic gas scavenging systems

ISO 80369-1:2010 医疗保健设施中液体与气体用小型孔连接器.第1部分:一般要求

This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT. This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used. These healthcare fields of use include, but are not limited to, APPLICATIONS for: ? BREATHING SYSTEMS and driving gases, ? enteral and gastric, ? urethral and urinary, ? limb cuff inflation, ? neuraxial devices, and ? intravascular or hypodermic. SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with: ? the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; ? the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and ? the nipples of EN 13544-2:2002. This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer CONNECTORS that will be developed under future parts of this series of standards. It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after they have been assessed according to the PROCEDURE given in Clause 6. NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included. NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during the revision of the relevant part of this series of standards.

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

KS P ISO TS 16976-1:2010 呼吸保护装置.人性因素.第1部分:代谢速率和呼吸流动速率

이 기술서는 행동 요건, 시험 그리고 호흡기 보호 장비 사용에 대한 표준의 준비를 위해 인

Respiratory protective devices－Human factors－Part 1：Metabolic rates and respiratory flow rates

NF S95-156:2010 麻醉和呼吸器.医疗气体的非互换螺纹(NIST)低压接头.

Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases.

IEC 60601-2-46:2010 医用电气设备 第2-46部分:手术台基本安全性和必要性能的详细要求

This particular standard specifies safety requirements for OPERATING TABLES, whether or not having electrical parts, including TRANSPORTERS, used for the transportation of the table top to or from the base or pedestal of an OPERATING TABLE with detachable table top. NOTE See also 4.2 of the General Standard. This particular standard does not apply to – dental patient chairs; – examination chairs and couches; – patient-supporting systems of diagnostic and therapeutic devices; – OPERATING TABLE heating blankets; – patient transfer equipment; – delivery tables and beds; – medical beds; – field tables. NOTE If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the relevant requirements of each particular standard have to be considered.

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

IEC 60601-2-4:2010 医用电气设备.第2-4部分:心脏除颤器基本安全性和必要性能的详细要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter 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 does not apply to implantable defibrillators, remote control DEFIBRILLATORS, external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27 [2]2). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion. Defibrillation waveform technology is evolving rapidly. Published studies indicate that the effectiveness of waveforms varies. The choice of a particular waveform including waveshape, delivered energy, efficacy, and safety has been specifically excluded from the scope of this standard. However, due to the critical importance of the therapeutic waveform, comments have been added to the rationale which addresses considerations in waveform selection.

Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators

BS EN 15908:2010 麻醉剂和呼吸设备.医疗气体用非交替式螺栓-螺纹(NIST)低压力连接器

1.1 This European Standard specifies requirements for connectors intended for use with medical gases. 1.2 This European Standard specifies the dimensions and the allocation of non-interchangeable screwthreaded (NIST) connectors intended to be used at nominal operating pressures not greater than 1 400 kPa. NOTE As stated in EN ISO 5359, gas-specific quick-connectors conforming to EN ISO 9170-1 are considered as an alternative to NIST connectors. 1.3 The information to be supplied by the manufacturer is excluded from the scope of this European Standard because information about the use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted.

Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases

KS P 0387-2010 家庭疗养用手动床

이 표준은 장기 요양 중의 고령자와 장애인 등 거동이 불편한 사용자의 일상생활 편의나, 가

Manually operated adjustable bed for home care

DIN EN ISO 15001:2010 麻醉和呼吸设备.与氧气的兼容性(ISO 15001-2010).德文版本EN ISO 15001-2010

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010); German version EN ISO 15001:2010

BS EN ISO 15001:2010 麻醉和呼吸设备.氧气的可混用性

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