13544 report91123.docx

1、13544 report91123JiangSu Yuyue Medical Equipment & Supply CO., LTD.压缩空气式雾化器产品评估报告Evaluation Report for Air Compressive Nebulizer依据EN 13544-1：2007 呼吸治疗设备-喷雾系统及其元器件Based Standard EN 13544：2007 Nebulizing systems and their components 评估部门 ： 技术部门机构Evaluated by: Research and Design Department地址. Location

2、 .评估项目 江苏鱼跃医疗设备股份有限公司生产的医疗用压缩空气式雾化器产品Item description .: Air Compressive Nebulizer manufactured by JiangSu Yuyue Medical Equipment & Supply CO., LTD.型号区分 ：403A, 403B, 403CIdentification：403A, 403B, 403C评估依据：欧盟标准: EN 13544-1:2007- 呼吸治疗设备-喷雾系统及其组件Evaluation Specification : EN 13544-1:2007评估结论：上述型号的喷雾器

3、产品符欧盟标准: EN 13544-1:2007内容条款之要求Evaluation result :The nebulizers mentioned are compliance with EN 13544-1:2007 Evaluated by: reviewed by: _ _Evaluation reportEn 13544-1:2007Part 1: Nebulizing systems and their components喷雾系统及其组件possible case verdicts （可能情况之的评估判定）the clause does not apply the evaluat

4、ing object .N (条款不适用评估产品)the OBJECT does comply with the requirements .P （评估产品符合要求）the OBJECT does not comply with the requirements F （评估产品不符合要求）General remark:（一般说明）Models, 403A, 403B and 403C are similar except as enclosure , PCB layout ,circuit input rating, and power adapter.Their interrelated c

5、onstruction data comes from the original test reports respectively ,which have been tested and determined to be in accordance with the requirements of test specification EN 60601-1:1990 ,and are applied to this report上述产品的相关的结构数据来自原测试报告。这些报告符合医疗标准EN 60601-1:1990 , EN 60601-1-2:2001的要求，并被本报告所引用 En 13

6、544-1:2007Clause条款Requirements要求Result结果Verdict评价5ClassificationClass IIBP6Identification ,marking and documents6.1Marking on the outside of equipment or equipment partsPe ) The name or trademark and address of the manufacturer. For devices imported into the European Union the following applies: the

7、 name or address of person responsible or au authorized representative of the manufacturer or the importer established within European Community shall be provide with the device or with the accompanying documentsPaa) all flow-direction sensitive components, breathing attachments or parts (e.g. mask

8、or mouth piece one-way valv) shall be either clearly and durably marked with an arrow showing direction of gas flow if operator detachable ,or shall be permanently attached (see not of 6.8.2 dd)Nbb) if gas-specific, the inlet and outlet shall be identified by clear and durable markingNcc) marking of

9、 devices, labels and packagingdevices, labels and /or packaging shall contain the following:-device identification and content informationP-if appropriate ,the symbol STERILE in accordance with EN 980 together with the method or sterilization N-if appropriate, the batch code, preceded by the symbol

10、LOT in accordance with EN 980,or serial numberP-the expiry date ,if the device is sensitive to storage or shelf life in accordance with EN980P-if appropriate, an indication that the device is for single useP-any special storage and/ or handing conditionsP-Any warning and/or precaution to take e.g. c

11、ompatibility with the use of oxygen and oxygen mixtures ,and compatibility between oxygen and administered drugN-For active medical advices the year of manufacture except for those covered by 6.1 cc) 5th dashNote : this indication can be the batch or serial numberP-If appropriate, the recommended me

12、thod of cleaning ,disinfection and sterilizationP-device packaging and /or labeling shall differentiate between non-sterile placed on the same or similar products both sterile and non- sterile placed on the market by the manufactureN- if appropriate, packages containing parts made of conductive mate

13、rial shall be clearly marked with the word “ ANTISTATIC” or “ CONDUCTIVE”N- the liquid container of the nebulizer shall be marked at the maximum filling level. This shall be defined in the instruction for use （see6.8.2 aa） 9th dash)P6.3 Marking of controls and instruments:(控制器和仪器标志)aa) gas supply pr

14、essures shall be displayed in kPaN6.4 Symbols 符号P6.8.2Instruction of use （使用说明）aa) as far as applicable the following information shall be provide with the nebulizing system ,its parts or the package:（尽可能地提供有关喷雾系统，其零件或包装的下列信息） -the purpose and intended use of the nebulizing system and/ or parts 喷雾系统

15、及部件的用途及目的P-a list of necessary parts which are not an integral part of the nebulizing system(喷雾系统之非整体部分的必需的零件清单)P-a statement that the parts listed in6.82 aa) 2nd dash are required for correct function and that they have to be in compliance with this European Standard（声明上述零件符合本标准P-the minimum and ma

16、ximum recommended driving gas flows and the corresponding pressures for gas power nebulizerN-R)-the particle size distribution curve, measuredas described in Annex CC, figure CC.3, or measured with an alternative type-test method validated as described in 4.3,under the normal operation conditions fo

17、r maximum, and minimum ,if applicable, pressures and flow（须有）符合附录CC或类似测试的颗粒尺寸分布P-The aerosol output and aerosol output rate minimum maximum and recommended mid diving gas flows and fill volumes along with the corresponding pressures in the testing conditions defined in Annex CC.P-Whether the nebuliz

18、er is suitable for use in anaesthetic systems or lung ventilator breathing systemN-The maximum temperature, if above ambient, reached in the nebulizing chamber for the maximum recommended fill volume or the solution in normal use conditionsP-the maximum and minimum recommended fill volume as declare

19、d by the manufacturerP-details of recommended power or control devices and accessories for use with the nebulizerP-the maximum A-weighted sound pressure level as measured in clause 26N-a statement that performance information provided by the manufacturer in accordance with this European standard may

20、 not apply to drugs supplied in suspension or high viscosity form. In such cases ,information should be sought from the drug supplier（需）一个陈述或声明：符合本标准的性能也许不适用悬浮状或高浓粘度形式的药物。此情况下，应向药商需求信息P-the recommended driving gasesNbb) as far as applicable the following information shall be provided with powered an

21、d / or control device its parts or the packages thereof:-the recommended range of gas flows and the corresponding pressesN-the recommended gas(es) or gas mixture(s)N-details of recommended power or control devices and accessories for use with the power or control device; Pcc) the instruction for use

22、 shall contain information on methods of cleaning and /or sterilization prior to use and the number of cycles of cleanings and /or sterilizations the nebulizing system will withstand. These instruction shall contain procedures for reassembly (see 6.82 dd)Pdd) dismantling and reassemblythe manufactur

23、er shall recommend a functional test of operation to be carried out after reassembly and before useNee) information about monitoring ,alarm and protection modules; as far as applicable the instructions for use shall contain:-A description of the methods of verying alarm functions;N-Details of any pr

24、essure relief valves fitted;Nff) information about electromagnetic compatibilityPgg) information about disposal （有产品处理信息）the instruction for use shall include information about any precaution to be taken if it is a specific unusual risk associated with the disposal of a device若装置有特定不同的处置危害，说明书上应有处理措

25、施警告信息P6.83Technical description Technical description shall additionally include the following information:（附加技术规格描述信息如下）-Interdependence of control ,if applicable-The pressure and flow characteristics of any gas power outlet under worst case conditions stated by the manufactureN-The specified range

26、 of flows required from any gas source ,if applicable;N-If relevant, a statement of the composition and dryness specification for or gases to be supplied to the nebulizer;N-Details of non-return valves and pressure relief valves and their characteristics if fitted;N-Lifetime of reusable partsP7Power

27、 input （功率输入）130VAP8Basic safety categories （基本安全分类）II类设备 B型应用部分P10Environmental conditions （环境条件）环境温度：1040 相对湿度：30%75%大气压力：70KPa106KPa10.101If it is declared by the manufacturer that a nebulizer is intended to be directly connected to pipeline system complying with EN ISO 7396-1 or a pressure regul

28、ator complying EN ISO 10524-1, the nebulizer shll meet the requirements of this European Standard for a pneumatic power having a range of 280kPa(2,8bar) to 600kPa (6bar) and shall not cause a safety hazard under single fault conditions of the medical gas supply i.e.up to 1 MPa (10bar) inlet pressure

29、. The time-weighted average input flow required by the medical equipment shall not exceed 60 l/min at a pressure of 280 kPa (2.8bar) at the gas inlet portN14Requirements related to classification有关分类要求P15Limitation of voltage and /or energy电压和或能量限制P16Enclosure And Protective Covers外壳和防护性盖P17Separati

30、on 隔离P18Protective earthing , functional earthing and potential equalization 保护性接地，功能性接地以及电位补偿N19Continuous leakage currents and patient auxiliary currents连续漏电流和病人辅电流外壳漏电流： 正常 0.1mA，单一故障状态0.5mA患者漏电流： 正常 0.1mA，单一故障状态0.5mAP19.1e-The patient leakage current shall be measured with the nebulizer filled with saline solution containing 9 g/1 sodium chloride to the maximum recommended volume-the nebulizer is tested with a metal foil wrapp