6.ISO 80601-2-56{ed1.0}en文件
Reference numberISO 80601-2-56:2009(E)INTERNATIONAL STANDARD ISO80601-2-56First edition2009-10-01Medical electrical equipment —Part 2-56:Particular requirements for basic safetyand essential performance of clinicalthermometers for body temperaturemeasurementAppareils électromédicaux —Partie 2-56: Exigences particulières relatives à la sécurité fondamentaleet aux perfomances essentielles des thermomètres médicaux pour mesurer la température de corpsISO 80601-2-56:2009(E) PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed butshall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2009All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester.ISO copyright officeCase postale 56 • CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyright@Web Published in SwitzerlandISO 80601-2-56:2009(E)Contents PageForeword (v)Introduction (vi)201.1 * Scope, object and related standards (1)201.1. 1 Scope (1)201.1. 2 Object (2)201.1. 3 Collateral standards (2)201.1. 4 Particular standards (2)references (3)201.2 Normativeand definitions (3)201.3 Terminologyrequirements (6)201.4 General201.4. 2 R ISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS (6)201.4. 2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT orME SYSTEMS (7)201.4. 3 E SSENTIAL PERFORMANCE (7)201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE (7)201.4. 101 Environmental conditions of use (7)201.5 General requirements for testing of ME EQUIPMENT (7)of201.6 ClassificationME EQUIPMENT and ME SYSTEMS (7)201.7 M E EQUIPMENT identification, marking and documents (7)201.7. 2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts (8)201.7. 2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and interchangeable parts, marking of the packaging (8)201.7. 2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (8)201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT orME EQUIPMENT parts (8)201.7. 4.3 Unit of measure (8)201.7. 4.3.101 Additional requirements for unit of measure (8)201.7. 9 A CCOMPANYING DOCUMENT (9)201.7. 9.1 Additional general requirements (9)201.7. 9.2 Additional requirements for instructions for use (9)201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment,used material (9)201.7. 9.2.101 Instructions for use (9)201.7. 9.101 Additional requirements for ACCOMPANYING DOCUMENT (10)201.8 Protection against electrical HAZARDS from ME EQUIPMENT (10)mechanicalagainst201.9 ProtectionHAZARDS of ME EQUIPMENT and ME SYSTEMS (10)201.10 Protection against unwanted and excessive radiation HAZARD s (10)201.11 Protection against excessive temperatures and other HAZARDS (10)and instruments and protection against hazardous outputs (10)controlsof201.12 Accuracy201.12. 1 Accuracy of controls and instruments (10)201.12. 1.101 Additional requirements for accuracy of controls and instruments (10)201.12. 2 U SABILITY (11)201.12. 2.101 * Additional requirements for USABILITY (11)201.13 H AZARDOUS SITUATIONS and fault conditions (11)201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) (11)ISO 80601-2-56:2009(E)201.15 Construction of ME EQUIPMENT ................................................................................................11 201.16 M E SYSTEMS ...............................................................................................................................11 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . (11)201.101 Laboratory performance requirements (11)201.101. 1 * General test requirements (11)201.101. 2 * Laboratory accuracy (12)201.101. 3 * Time response for a continuous clinical thermometer ........................................................13 201.102* Clinical accuracy validation.................................................................................................13 201.102. 1Method......................................................................................................................................13 201.102. 2* Human subject population requirements...........................................................................14 201.102. 3* Clinical bias calculation.......................................................................................................15 201.102. 4* Limits of agreement calculation..........................................................................................15 201.102. 5* Clinical repeatability calculation.........................................................................................16 201.103* Probes, probe cable extenders and probe covers............................................................16 201.103. 1General.....................................................................................................................................16 201.103. 2Labeling....................................................................................................................................17 202 Medical electrical equipment — Part 1-2: General requirements for basic safetyand essential performance — Collateral standard: Electromagneticcompatibility — Requirements and tests (17)202.6.2.1.10 Compliance criteria.................................................................................................................17 AnnexesAnnex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT andME SYSTEMS (19)Annex D (informative) Symbols on Marking (22)Annex AA (informative) Particular Guidance and rationale..........................................................................24 Annex BB (informative) R EFERENCE TEMPERATURE SOURCE .. (37)Annex CC (informative) Environmental aspects............................................................................................39 Annex DD (informative) Reference to the essential principles of safety and performance ofmedical devices in accordance with ISO/TR 16142 (40)Bibliography (42)Alphabetized index of defined terms used in this particular standard (45)ISO 80601-2-56:2009(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 80601-2-56 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in medical practice.ISO 80601 consists of the following parts, under the general title Medical electrical equipment:⎯Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators⎯Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation⎯Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors⎯Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement⎯Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical useIEC 80601-2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, IEC 80601-2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, IEC 80601-2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, IEC 80601-2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening and IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment are published by IEC.ISO 80601-2-56:2009(E)IntroductionIn this International Standard, the following print types are used.⎯Requirements and definitions: roman type.⎯Test specifications: italic type.⎯Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type.⎯T ERMS DEFINED IN C LAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.In referring to the structure of this International Standard, the term⎯“clause” means one of the 20 numbered divisions within the table of contents, inclusive of all subdivisions(e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);⎯“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7).References to clauses within this International Standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this International Standard are by number only.In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb:⎯“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;⎯“should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;⎯“may” is used to describe a permissible way to achieve compliance with a requirement or test.An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.This international standard deals with electrical CLINICAL THERMOMETERS, either already available or that will come available in the future.The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile or febrile is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the PATIENT is ill.ISO 80601-2-56:2009(E) There are different temperatures at each REFERENCE BODY SITE according to the balance between the production, transfer, and loss of heat.[38]C LINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state between the two thermometers.For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the characteristics of the PATIENT and the environment.[3] Therefore the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature.For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE(OPERATING MODE) with a sufficiently large group of human subjects.The intention of this International Standard is to specify the requirements and the test procedures for the VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.INTERNATIONAL STANDARD ISO 80601-2-56:2009(E)Medical electrical equipment —Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement201.1 * Scope, object and related standardsIEC 60601-1:2005, Clause 1 applies, except as follows:201.1.1 ScopeReplacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS.C LINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary equipment.M E EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard.EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard. EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard.EXAMPLE 3 P ATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of a REFERENCE BODY SITE in which they are in the scope of this standard.Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard.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.H AZARDS 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 IEC 60601-1:2005, 7.2.13 and 8.4.1.NOTE Additional information can be found in IEC 60601-1:2005, 4.2.ISO 80601-2-56:2009(E)201.1.2 ObjectReplacement:The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a CLINICAL THERMOMETER, as defined in 201.3.206, and its ACCESSORIES.NOTE A CCESSORIES are included because the combination of the CLINICAL THERMOMETER and the ACCESSORIES needs to be safe. A CCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER.standards201.1.3 CollateralAddition:This particular standard refers to those applicable collateral standards that are listed in IEC 60601-1:2005, Clause 2, as well as Clause 2 of this particular standard.IEC 60601-1-3 does not apply.standards201.1.4 ParticularReplacement:In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.A requirement of a particular standard takes priority over IEC 60601-1.For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:“Replacement” means that the clause or subclause of the IEC 60601-1 or applicable collateral standard is replaced completely by the text of this particular standard.“Addition” means that the text of this particular standard is additional to the requirements of the IEC 60601-1 or applicable collateral standard.“Amendment” means that the clause or subclause of the IEC 60601-1 or applicable collateral standard is amended as indicated by the text of this particular standard.Subclauses or figures which are additional to those of the general standard are numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 6060-1-3, etc.The term “this standard” is used to make reference to the IEC 60601-1, any applicable collateral standards and this particular standard taken together.ISO 80601-2-56:2009(E) Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of the IEC 60601-1 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the IEC 60601-1 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.201.2 NormativereferencesNOTE Informative references are listed in the bibliography beginning on page 43.IEC 60601-1:2005, Clause 2 applies, except as follows:Replacement:IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and testsIEC 60601-1-6:2006, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral Standard: UsabilityIEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsAddition:ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General requirementsISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plansISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsAmendment 1:2008IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performanceIEC 60601-1-9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and essential performance — Collateral Standard: Requirements for environmentally conscious designIEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers201.3 Terminology and definitionsFor the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1-6:2006, IEC 60601-1-8:2006, and the following definitions apply.NOTE An alphabetized index of defined terms is found beginning on page 45.Additions:201.3.201* ADJUSTED MODEOPERATING MODE where the OUTPUT TEMPERATURE is calculated by adjusting the signal from the input SENSOR。
北京纽曼伟业科技有限公司企业手机产品标准(现行版)
北京纽曼伟业科技有限公司企业手机产品标准（现行版）文号：QC-C5868 VER：1.0说明：本标准适用于Newsmy伟业科技有限公司所有机型产品成品和配件产品的出货品质检验，另有关来料检验标准见《QC-C5867-Newsmy来料检验标准（现行版）-2008-03-28.rar》, 可靠性测试本大纲标准由Newsmy伟业科技有限公司质量部负责制定和解释。
本大纲自2008年4月7日起发布并执行。
制定人：魏中刚.林国岐日期：2008 年4 月3 日审核人：林国岐日期：2008 年4 月3 日主目录第一章结构件外观检查及成品测试规范标准第二章成品出货验收标准第三章纽曼USB线检验标准第四章纽曼耳机线检验标准第五章纽曼电池检验标准第六章旅行充电器规格书标准第七章手机各附配件可靠性测试标准本标准适用于北京纽曼伟业科技有限公司研制及生产的GSM手机的研发、试生产、IQC来料检验、QA增强性试验等各个阶段对配件的检验。
本标准主要参照国标要求、本行业中具有先进水平的公司的要求、纽曼手机配件现有的技术文件和检测能力，并根据公司的实际情况编写的。
本标准由北京纽曼伟业科技有限公司手机事业部提出，质量部归口。
特别说明：对于每款新机型，项目经理必须在技术文件中明确规定本款手机的高、中、低档定位，并以文件等形式通知质量人员，以便于按相应的档次来验收配件。
第一章手机结构件外观检查及成品测试规范标准次目录前言............................................................................. 错误!未定义书签。
1 范围 (5)2 引用标准 (5)3 定义 (5)3.1 不良缺陷定义 (5)3.2 手机测量面的定义 (6)IV测量面：只有在拆卸手机时才能看到的零件表面。
(6)3.3 缺陷代码对照表 (6)4 手机检验条件及环境 (7)5 整机装配检验 (7)6 喷漆件检验 (7)6.1 喷漆件外观检验 (7)6.2 附着力测试 (9)6.3 耐磨性测试 (10)6.4 耐醇性测试 (10)6.5 硬度测试 (10)6.6 耐化妆品测试 (10)6.7 耐手汗测试 (10)6.8 温度冲击试验 (10)6.9 膜厚测试 (11)6.10 底材颜色与油漆颜色要求 (11)6.11 特别说明： (11)7 塑料件检验 (11)8 镜片检验 (12)8.1 镜片外观检验 (12)8.2 耐磨性测试 (13)8.3 硬度测试 (13)8.4 抗冲击性测试 (13)8.5 抗霉菌测试 (13)9 按键检验 (13)9.1 按键外观检验 (13)9.2 弹力测试 (15)9.3 寿命测试 (15)9.4 耐磨性测试 (15)9.5 耐醇性测试 (16)10 塑料电镀件(外观件)检验 (16)10.1 外观检验 (16)10.2 镀层厚度 (16)10.3 附着力测试 (16)10.4 耐磨性测试 (17)10.5 耐醇性测试 (17)10.6 硬度测试 (17)10.7 耐手汗测试 (17)10.8 温度冲击测试 (17)10.9 盐雾测试 (17)11 塑料电镀件（内部件）检验 (17)11.1 外观检验 (17)11.2 镀层厚度测试 (18)11.3 电阻值测试 (18)11.4 附着力测试 (18)11.5 温度冲击测试 (18)11.6 平面度 (18)12 导电漆检验 (18)12.1 导电漆外观检验 (18)12.2 附着力测试 (19)12.3 电阻值测试 (19)12.4 膜厚测试 (19)12.5 温度冲击测试 (19)13 导电胶检验 (19)13.1 导电胶外观检验 (19)13.2 电阻值测试 (19)13.3 附着力测试 (19)13.4 胶的弹性测试 (20)13.5 温度冲击测试 (20)14 五金件检验 (20)14.1 五金件外观检验 (20)14.2 镀层厚度 (20)14.3 镀层硬度 (20)14.4 附着力测试 (20)14.5 盐雾试验 (21)14.6 可焊性试验 (21)14.7 镶件螺母的拉力及扭矩测试 (21)14.8 翻盖（翻盖轴）及翻盖接听按键的寿命测试 (21)15 橡胶件检验 (21)15.1 橡胶件外观检验 (21)15.2 硬度测试 (21)15.3 寿命测试 (21)16 印刷检验 (21)16.1 外壳上印刷的外观检验 (21)16.2 镜片及键盘上印刷的外观检验 (23)16.3 附着力测试 (25)16.4 耐醇性测试 (25)16.5 耐磨性测试 (25)17 显示屏(LCD)外观检验 (25)18 电池检验 (26)18.1 外观检验 (26)18.2 电池卡扣的寿命 (26)18.3 跌落试验 (26)18.4 电池标贴 (26)18.5 电池PCB板的检验（仅适用于电极触点为金手指的情况） (26)18.6 PHS手机的电池检验 (26)19 充电器（座充）检验 (26)19.1 外观检验 (27)19.2 充电器标贴 (27)19.3 人机界面 (27)19.4 金属插头及接触簧片镀层附着力的测试 (27)19.5 金属插头及接触簧片镀层耐腐蚀性的测试 (27)19.6 插头连接强度 (27)19.7 跌落试验 (27)20 耳机检验 (27)20.1 外观检验 (27)20.2 耳机插头与插座之间的插拔寿命 (27)20.3 耳机的插拔力 (27)20.4 抗急拉伸强度 (27)20.5 跌落试验 (27)20.6 导线疲劳弯曲强度 (28)20.7 盐雾试验 (28)21 天线检验 (28)21.1 外观检验 (28)21.2 安装强度 (28)21.3 跌落试验 (28)21.4 天线上五金件的耐腐蚀性测试 (28)21.5 天线上五金件的镀层附着力测试 (28)22吊绳穿孔的拉力试验 (28)23 前壳上按键孔位置的压力试验 (28)24 按键短路的压力试验 (28)25 各阶段所需的检验项目 (28)25.1 各阶段测试说明 (28)25.2 封样流程说明 (29)25.3 各阶段所需的检验项目 (29)各阶段所需的检验项目见表19。
中俄测温仪标准差异对比
中俄标准比对分析情况测温仪针对疫情防控急需的医用测温仪产品，共收集比对中国和俄罗斯相关标准4项，其中我国标准3项，俄罗斯标准1项。
我国现行标准主要包括GB9706.1-2007《医用电气设备第1部分:安全通用要求》、GB/T21417.1-2008《医用红外体温计第1部分：耳腔式》和GB/T21416-2008《医用电子体温计》。
在通用安全方面，我国现行国家标准GB9706.1-2007和俄罗斯国家标准GOST R IEC60601-1-2010均采用了国际标准IEC 60601-1，但两个国家采用的国际标准版本不一致。
中国已于2020年4月9日发布了新版安全通用标准GB9706.1-2020。
中俄标准比对详见表1。
在专用标准方面，我国制定了GB/T21417.1和GB/T21416。
而俄罗斯目前暂无该类设备的专用标准。
详见表2。
—37—表1医用测温仪国内外标准比对-安全通用标准国家标准号标准名称与国际标准的对应关系中国GB9706.1-2007医用电气设备第1部分：安全通用标准IEC60601-1:1995，IDT 俄罗斯GOST R IEC60601-1-2010医用电气设备第1部分：基本安全和基本性能的通用标准IEC60601-1:2005，IDT差异分析1、各国家标准与国际标准对应关系：——中国标准等同采用国际标准IEC60601-1:1995。
注：2020年4月9日，中国发布新版安全通用标准GB9706.1-2020，新标准修改采用国际标准IEC60601-1:2012，与国际标准相比较，没有重要技术指标的修改。
——俄罗斯标准等同采用国际标准IEC60601-1:2005。
2、国际标准各版本间比较：IEC60601-1:2012取消并代替了IEC60601-1:2005，而IEC60601-1:2005取消并代替IEC60601-1:1995。
——相对于IEC60601-1:1995，IEC60601-1:2005主要作了如下技术内容的修改：•增加了对基本性能识别的要求•增加了机械安全的相关要求•区分了对操作者的防护和患者防护不同的要求•增加了防火的要求——IEC60601-1:2012与IEC60601-1:2005之间无关键性技术指标的变化。
医用呼吸机国内标准与国外标准对比
对于预期传输通气量>300mL的呼吸机，每分 钟通气量30L/min；对于300 mL≥预期传输通气 量≥50 mL的呼吸机，每分钟通气量15L/min； 对于预期传输通气量≤50mL的呼吸机，每分钟 通气量5L/min。
对于预期传输通气量>300mL的呼吸机，每分钟通气量 30L/min；对于300 mL≥预期传输通气量≥50 mL的呼吸 机，每分钟通气量15L/min；对于预期传输通气量≤ 50mL的呼吸机，每分钟通气量5L/min。
系统承受的压 呼吸机系统应能承受至少1.5倍于额定输入压力的 力(气道压力) 压力而不破损和泄露。
在额定输入压力范围内，呼吸机应能正常运行 并满足本部分的要求；在1000 kPa的单一故障 状态下不应导致不可接受的风险。最大额定输 入压力超过600kPa的呼吸机，在两倍最大额定 输入压力的单一故障状态下，不应导致不可接 受的风险。
附表1-2 呼吸机标准对比
附表1-2
呼吸机标准对比
国内
国际/美国/欧盟
呼吸机 主要指标
YY0042-2007 高频喷射呼吸机
环境温度：5℃~40℃；
环境湿度：不大于80%；
工作环境要求
额定输入压力：大于350kPa； 电源：交流或交流、直流两用
交流：AC220V±22V 50Hz±1Hz
直流：应注明直流电压、电池规格
氧浓度
输出气体的最高氧浓度应该至少能够达到85%。
呼吸机应能向患者提供含氧的气体，其浓度从 环境浓度到至少90%氧浓度。 当气源的失效使输送的氧浓度的改变超过体积 氧气浓度范围：30-90% 分数3%时，则技术报警状态宜至少为中优先 级。
耗氧量 呼吸机连续使用24h，氧气瓶规格为12.25MPa/40L -
脉搏血氧仪设备临床评价技术审查指导原则
脉搏血氧仪设备临床评价技术审查指导原则本指导原则旨在为申请人准备脉搏血氧仪设备（以下简称“血氧仪”）临床评价提供具体建议，并规范血氧仪临床评价资料的技术审评要求。
本指导原则是对血氧仪临床评价的一般性要求，制造商应依据血氧仪的特性对临床评价资料的内容进行充实和细化。
制造商还应依据血氧仪的特性确定其中的具体内容是否适用，若不适用，需具体阐述其理由及相应的科学依据。
本指导原则是在现行法规和标准体系以及当前认知水平下、并参考了国外法规与指南、国际标准与技术报告制定的。
随着法规和标准的不断完善，以及认知水平和技术能力的不断提高，相关内容也将适时进行修订。
本指导原则是对制造商和审查人员的指导性文件，不包括审评审批所涉及的行政事项，亦不作为法规强制执行，应在遵循相关法规的前提下使用本指导原则。
一、适用范围本指导原则适用于脉搏血氧仪设备，包括脉搏血氧仪主机、血氧探头和探头延长电缆（如提供），其中探头延长电缆和血氧探头可组合成单一的部件。
本指导原则所述的血氧仪包含预期测量和监护脉搏血氧饱和度的各种设备或系统。
血氧仪可以单次测量或连续测量脉搏血氧饱和度，或是独立设备或集成在多参数模块的设备或系统中。
血氧仪可以使用透射、反射或散射方式，其中，透射、反射或散射方式指的是血氧探头几何结构，而不是指血氧仪的原理、光在血红蛋白上的作用机理。
本指导原则对于血氧仪的测量部位、预期使用环境等不做限制，例如，血氧仪的测量部位包含但不限于手指、耳、足、手、前额，背和鼻，血氧仪预期在医疗机构或在家庭中使用，等等。
二、基本要求制造商应提供血氧仪的下述信息：(一)综述信息1.临床机理、工作原理/作用机理、实现方法，例如，功能血氧饱和度或氧合血红蛋白、脉搏血氧饱和度的测量原理，等等；2.设计特点和功能，3.特殊的规格参数和性能指标，例如，连续测量的血氧仪是否包括过低的脉搏血氧饱和度？4.血氧仪采用单次测量还是连续测量方式？5.血氧仪是独立设备还是集成在多参数模块设备或系统中？6.所有的患者应用部分，例如，血氧探头，患者电缆，延长电缆，传感器，绑带,等等。
HAMILTON-T1 操作手册说明书
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THD2FE非接触前额温度计说明书
THD2FE Non-contact Forehead Thermometer⇔The device setting with buzzer is on, you can set buzzer on/off under Mute mode.beep sounds. You can also use the same process to turn off the Mute function.Use of the thermometerNote: If there is any temperature difference between the places where the device is stored and where you are going to measure, subject and the device should stay in the same room for at least 15 minutes before measurement.1. Always make sure the probe lens is clean without any damage and the forehead is clean. Warning: Choking from swallowing small parts and batteries by children or pets is possible, please keep small parts and batteries at places wherechildren and pets can’t reach.2. Power on:Press the “ON/MEM ” button (see figure 1).3. Measuring body temperature on the forehead:Indications for use: The Non-contact Clinical Thermometer, Model THD2FE is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.Ref No.：032020Press the “ON/MEM” button to power on the device. Forehead mode is the default mode. You can see the icon on the screenand hear two beep sounds (see figure 1). In this mode, you can hold the thermometer within 1.5 inch from the central forehead (Fig. 2) andpressthe "START" button to get the forehead measurement. The time consuming for measurement might be 1 second. After each foreheadmeasurement, wait icon stop flashing to be ready for next measurement.Figure 2 Points for attention:a. Forehead temperature is displayed in oral mode. This mode converts the forehead temperature to display its “oral-equivalent” value.b. Before the measurement, the subject should stay in a stable environment for 5 minutes and avoid exercise, bath for 30mins.c. Remember to keep the forehead area clean and away from sweat, cosmetics and scar while taking temperature.d. The “Clinical Bias” is -2.5 ~ -3.1°F (-1.4 ~ -1.7°C).e. The “Limits of Agreement” is 0.98.f. The "Repeatability" is 0.36°F (0.20°C)4. Measuring surface temperature:4.1 After power on, press and hold the “ON/MEM” button, and press the “START” button one time for “Infrared thermometer” mode to see icon on your LCDdisplay. In this mode, you can get the target surface temperature.4.2 When you press the “START” button, you will get the real time temperature immediately. If you press and hold the “START” button, the reading of measurement willbe continuously updated.4.3 Applications include temperature measurements for water, milk, cloth, skin or other objects.* Note: This mode shows the actual and unadjusted surface temperature which is different from the body temperature.5. Power off:5.1 Device will automatically shut off if left idle for more than 1 minute to extend battery life.ProblemWarranty:Warranty: 12 monthsManufacture Date: as the serial number (please open the battery cover, it is shown on the inside of the device.)Ex.SN:E512A000001, the first “E” is External, the second number “5” is the last number of manufacture year, the third and the fourth number “12” is the manufacture Note: The thermometer is calibrated at the time of manufacture. If you question calibration mode, the accuracy of temperature measurements or unexpected events at any time, please contact the dealers or nearest service address.Warning: No modification of this equipment is allowed.Please read the instructions for use BF type applied partMetris instrument east, IIcAdd: 25 Long Meadow PlaceSouth Setauket, NY USA 11720Figure 1 Figure 2 Figure 3IP220,120,23 FM c)±5 kHz deviation1 kHz sine。
QC080000的相关资料
前言世界范围内许多现行或待决的法规中，有许多要求消除产品中一系列的危害物质。
如欧盟RoHS指令将于2006年7月1日正式实施，它要求消除电子电气产品中含有的铅、汞、镉、六价铬、多溴联苯、多溴联苯醚等。
但是，要求对危害物质进行控制的法规层出不穷，客户对危害物质的要求也互有异同，各大公司一般都有自己的管理规范出台。
组织在危害物质管理方面面临巨大压力。
要想比较有效地解决这个问题，必须有世界范围内权威的标准或规范出台，让所有相关方有一个统一而明确的遵循准则，从而达到国际间产品贸易的技术壁垒最小化，有效地保护环境。
为应对上述的危害物质管理标准化的问题，IEC委托其下属的电子元器件质量评定委员会（IECQ）制订了专门的危害物质过程管理（HSPM）标准——“电子电器元件和产品危害物质过程管理体系要求（QC 080000）”，并为开展这一过程管理体系的认证制定了专门的程序规则——“危害物质过程管理要求（QC 001002-5）”，从而为危害物质管理和认证提供了较为权威的选择。
一、供应商、客户可能面临的困境●作为供应商，您有没有因面对不同客户的五花八门的危害物质要求和检查而晕头转向疲惫不堪？您知道自己的产品含有哪些物质而可能被顾客拒收吗？哪些材料中可能含有这些物质？您知道对哪些环节进行控制才能有效保证产品中不含受限物质吗？您知道如何进行管理才能持续保证产品中不含受限物质吗？您是否希望出现类似ISO9001等的国际标准用于指导对危害物质的管理？●作为客户，您有没有因为不知如何对供应商进行管理才能持续有效地确保公司采购的部品满足危害物质管理的要求而战战兢兢？是否会因仅有供应商一纸空白保证而心理发虚？有没有频繁地要求供应商进行产品检验而引发供应商怨声载道？有没有因频繁的对供应商进行“查厂”而感到力不从心？有没有即使频繁“查厂”仍无法保证采购的部品持续满足要求？我们应该如何做才能保证欧洲、日本等地的客户有没有希望出现类似ISO9001等可认证的标准来对供应商进行统一管理的渴望？解决您的困扰的最佳解决方案——国际权威的IECQ-HSPM管理体系和认证！二、迫在眉睫的各种法律法规要求和顾客要求●欧洲议会和理事会2003年1月27日第2002/95/EC号在电气电子设备中限制使用某些有害物质指令，2006年7月1日实施，禁止六种有害物质在电子电器设备中的使用。
CE认证标准清单
CE认证产品常用标准清单一.CE认证适用的一般标准：
二. 监护仪系列产品适用标准：
三. 生理参数检测仪适用标准：
注：生理参数检测含有的心电、血糖、无线传输功能并没有随产品做CE认证。
四. 血氧系列产品（含血氧探头）适用标准：
注：血氧探头没有IEC 60601-1-11: 2010标准。
五. 多普勒胎心仪适用标准：
六. 快速心电检测仪适用标准：
备注：第一部分属于常用标准，适用于公司做过CE认证的所有医疗产品，后面是根据产品的功能、特性附加的标准。
所以一般情况下，可用第一部分加上其他部分即可组成具体产品的适用标准。
EN 铁路应用——通信 信 和处理系统——铁路控制和防护系统软件
EN50128：2001
IV
同济大学、铁道科学研究院标准所
EN50128：2001
引言
本标准是相关标准系列中的一部分。其他标准有 EN50126 铁路应用——可靠性，可用性，可维护性和安全性 （RAMS）；EN50129 铁路应用——信号领域的安全相关电子系统。EN50126 适用于大范围的系统问题，而 EN50129 适用于整个铁路控制和防护系统中某单个系统的批准过程。本标准关注于需要使用的方法，以使软件能满足经全面 考虑后所分配到的安全完整性要求。
en1060标准与iec 80601-2-30关系
EN1060是一项用于医疗电气设备的标准，而IEC xxx-2-30是一项特定的医疗电气设备标准。
两者之间存在着密切的关系，本文将探讨它们之间的关系及其重要性。
2. EN1060标准EN1060是欧洲标准化委员会（CENELEC）发布的一项标准，适用于医疗电气设备的一般要求。
该标准规定了医疗电气设备在设计、制造和使用过程中所需要满足的安全、性能和可靠性要求，以确保在医疗环境中使用时的安全性和有效性。
3. IEC xxx-2-30标准IEC xxx-2-30是国际电工委员会（IEC）发布的一项标准，专门适用于心电图设备。
它规定了心电图设备在设计、制造和使用过程中所需要满足的特定要求，以确保其在检测和记录心电信号时的准确性和可靠性。
4. 两者之间的关系EN1060标准是一项通用的医疗电气设备标准，而IEC xxx-2-30标准是一项特定的医疗电气设备标准。
在设计和制造心电图设备时，必须确保符合EN1060的通用要求，同时还需符合IEC xxx-2-30的特定要求，以保证心电图设备在医疗环境中的安全性和有效性。
符合EN1060标准和IEC xxx-2-30标准对医疗电气设备制造商和使用者来说都非常重要。
在制造过程中，遵循这两项标准可以保证设备的安全性和性能，并减少因设计或制造缺陷而引起的意外事件。
在使用过程中，遵循这两项标准可以保证医疗电气设备在医疗环境中的安全和有效使用，保护患者和医护人员的生命和健康。
6. 结论EN1060标准和IEC xxx-2-30标准是医疗电气设备领域中非常重要的标准，它们之间存在着密切的关系。
遵循这两项标准可以确保医疗电气设备在设计、制造和使用过程中的安全、性能和可靠性，并为医疗环境中的患者和医护人员提供更好的保护和看护。
制造商和使用者都应该重视并严格遵循这两项标准，以促进医疗电气设备行业的进步和发展。
7. 制造商的责任符合EN1060标准和IEC xxx-2-30标准对于医疗设备制造商来说是非常重要的。