11.040 医疗设备 标准查询与下载

GSO IEC 62366:2014 医疗设备 将可用性工程应用于医疗设备

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

Medical devices - Application of usability engineering to medical devices

GSO IEC/TR 62348:2014 评估 IEC 60601-1:2005 修正案 1 的最大变化的影响 并将 IEC 60601-1:2005 的条款移至先前版本

This technical report provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by: – those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended; – manufacturers of medical electrical equipment or medical electrical systems; – health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems.

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

DB65/T 3663-2014 西北地区特殊自然环境模拟舱 操作管理规范

Specifications for the operation and management of simulation cabins in special natural environments in Northwest China

EN 62353:2014 医用电气设备.医用电气设备修理后的循环试验和试验

IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions: - clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A; - revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment; - the inclusion of expected minimum insulation resistance values in Table 2; and - a reordering of the sequence of testing in Annex B.

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

YY/T 0932-2014 医用照明光源 医用额戴式照明灯

本标准规定了医用额戴式照明灯的要求和试验方法。医用额戴式照明灯临床上戴在医生头上用于对患者进行诊断检查照明。

Medical luminaires.Medical head-mounted luminaires

JIS T 0601-1 AMD 1:2014 医用电气设备.第1部分:基本安全性和基础性能通用要求(修改件1)

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (Amendment 1)

CAN/CSA-C22.2 No.60601-1-2014 医用电气设备 第1部分：基本安全和基本性能的通用要求

Scope, object and related standards 1.1 * Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. 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. NOTE: See also 4.2. This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3). 1.2 Object The object of this standard is to specify general requirements and to serve as the basis for particular standards. 1.3 * Collateral standards In the IEC 60601 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to: - a subgroup of ME EQUIPMENT (e.g. radiological equipment); - a specific characteristic of all ME EQUIPMENT not fully addressed in this standard. Applicable collateral standards become normative at the date of their publication and shall apply together with this standard. NOTE 1 When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with the collateral standards. NOTE 2 When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation. NOTE 3 Members of IEC maintain a register of valid International Standards. Users of this standard should consult this register to determine which collateral standards have been published. If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard. 1.4 * Particular standards In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. NOTE: Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should consult these registers to determine which particular standards have been published. A requirement of a particular standard takes priority over this standard.

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

CAN/CSA-CEI/IEC 62304-2014 医疗设备软件 软件生命周期流程（采用 CEI/IEC 62304:2006 第一版 2006-05）

Scope 1.1 * Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES. 1.2 * Field of application This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE. This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE. This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software. 1.3 Relationship to other standards This MEDICAL DEVICE SOFTWARE life cycle standard is to be used together with other appropriate standards when developing a MEDICAL DEVICE. Annex C shows the relationship between this standard and other relevant standards. 1.4 Compliance Compliance with this standard is defined as implementing all of the PROCESSES, ACTIVITIES, and TASKS identified in this standard in accordance with the software safety class. NOTE The software safety classes assigned to each requirement are identified in the normative text following the requirement. Compliance is determined by inspection of all documentation required by this standard including the RISK MANAGEMENT FILE, and assessment of the PROCESSES, ACTIVITIES and TASKS required for the software safety class. See Annex D. NOTE 1 This assessment could be carried out by internal or external audit. NOTE 2 Although the specified PROCESSES, ACTIVITIES, and TASKS are performed, flexibility exists in the methods of implementing these PROCESSES and performing these ACTIVITIES and TASKS. NOTE 3 Where any requirements contain "as appropriate" and were not performed, documentation for the justification is necessary for this assessment. NOTE 4 The term "conformance" is used in ISO/IEC 12207 where the term "compliance" is used in this standard.

Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05)

CAN/CSA-IEC 62366-2014 医疗设备 可用性工程在医疗设备中的应用（采用 IEC 62366:2007 第一版 2007-10）

1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

Medical devices - Application of usability engineering to medical devices (Adopted IEC 62366:2007, first edition, 2007-10)

IEC 62366:2007+AMD1:2014 CSV 医疗设备 可用性工程在医疗设备中的应用 装置

Medical devices - Application of usability engineering to medical devices

CAN/CSA-CEI/IEC 62304:2014 医疗器械软件-软件生命周期过程（第一版）

Medical device software - Software life cycle processes (First Edition)

CAN/CSA-C22.2 NO.60601-1-10 AMD 1-2014 修正案 1 医用电气设备 第 1-10 部分：基本安全和基本性能通用要求 并列标准：生理闭环控制器开发要求（第一版）

Amendment 1 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers (First Edition)

IEC 60601-1-10:2007+AMD1:2013 CSV 医用电气设备 第1-10部分 一般要求 基本安全和基本性能-附带标准 生理闭环系统的发展要求 控制器

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

DB14/T 772-2013 医用氧舱设备操作规程

本标准适用于山西省境内加压介质为空气和氧气的临床用氧舱。

Medical Oxygen Chamber Equipment Operating Procedures

DB14/T 773-2013 医用氧舱设备安全管理规范

本标准适用于山西省境内加压介质为空气和氧气的临床用氧舱。

Safety Management Specifications for Medical Oxygen Chamber Equipment

DB41/T 847-2013 医用氧舱安装监督检验规程

Regulations for Supervision and Inspection of Installation of Medical Oxygen Chamber

IEC 60601-1-10:2007/AMD1:2013 医用电气设备.第1-10部分:基本安全性和基本性能的通用要求.补充标准:生理闭环控制器开发的要求.修改件1

Replace the existing first dashed item with: – "the general standard" designates IEC 60601-1 alone (IEC 60601-1-1:2005+A1:2012);Replace the existing second dashed item with:– "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1- 10:2007+A1:2013)

Medical electrical equipment.Part 1-10: General requirements for basic safety and essential performance.Collateral Standard: Requirements for the development of physiologic closed-loop controllers; Amendment 1

IEC 60601-1-6:2010+AMD1:2013 CSV 医用电气设备 第1-6部分 一般要求 基本安全和基本性能-附带标准 可用性

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 80601-2-30:2009+AMD1:2013 CSV 医用电气设备第2-30部分:自动无创血压计基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

IEC 80601-2-30:2009/AMD1:2013 修改件1.医用电气设备.第2-30部分:自动型无创血压计基本安全和基本性能的特殊要求

Amendment 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers