C30 医疗器械综合 标准查询与下载

YY/T 0287-2017 医疗器械 质量管理体系 用于法规的要求

本标准为需要证实自身有能力提供持续满足顾客要求和适用的法规要求的医疗器械和相关服务的组织规定了质量管理体系要求。这类组织能涉及医疗器械生命周期的一个或多个阶段，包括医疗器械的设计和开发、生产、贮存和流通、安装或服务，以及相关活动(例如技术支持)的设计和开发或提供。本标准也能用于向这类组织提供产品(包括与质量管理体系相关的服务)的供方或外部方。 除非明确规定，本标准的要求适用于各种规模和类型的组织。本标准中应用于医疗器械的要求同样适用于组织提供的相关服务。 对于本标准所要求的适用于组织但不是由组织实施的过程，在质量管理体系中组织通过监视、维护和控制这些过程对其负有责任。 如果适用的法规要求允许对设计和开发控制进行删减，则能作为在质量管理体系中将其删减的理由。若这些法规要求能提供其他方法，这些方法要在质量管理体系中予以说明。组织有责任确保在符合本标准的声明中明确对设计和开发控制的任何删减。 本标准第6、7或8章中的任何要求，如果因组织开展的活动或质量管理体系所涉及的医疗器械的特点而不适用时，组织不需要在其质量管理体系中包含这样的要求。对于经确定不适用的任何条款，组织按照4.2.2的要求记录其理由。

Medical devices.Quality management systems.Requirements for regulatory purposes

IEC TR 80001-2-9:2017 医疗器械IT网络的风险管理应用. 第2-9部分: 应用指南. 使用安全保障案例证明对IEC TR 80001-2-2安全能力信心的指南

This part of 80001 establishes a SECURITY CASE framework and provides guidance to health care delivery organizations (HDO) and MEDICAL DEVICE MANUFACTURERS (MDM) for identifying, developing, interpreting, updating and maintaining SECURITY CASES for networked MEDICAL DEVICES. Use of this part of 80001 is intended to be one of the possible means to bridge the gap between MDMs and HDOs in providing adequate information to support the HDOS RISK MANAGEMENT of IT-NETWORKS. This document leverages the requirements set out in ISO/IEC 15026-2 for the development of ASSURANCE cases2). It is not intended that this SECURITY CASE framework will replace a RISK MANAGEMENT strategy, rather, the intention is to complement RISK MANAGEMENT and in turn provide a greater level of ASSURANCE for a MEDICAL DEVICE by: mapping specific RISK MANAGEMENT steps to each of the IEC TR 80001-2-2 SECURITY CAPABILITIES, identifying associated threats and vulnerabilities and presenting them in the format of a SECURITY CASE with the inclusion of a re-useable SECURITY PATTERN; providing guidance for the selection of appropriate SECURITY CONTROLS to establish SECURITY CAPABILITIES and presenting them as part of the SECURITY CASE pattern (IEC TR 80001-2-8 provides examples of such SECURITY CONTROLS); providing EVIDENCE to support the implementation of a SECURITY CONTROL, hence providing CONFIDENCE in the establishment of each of the SECURITY CAPABILITIES. The purpose of developing the SECURITY CASE is to demonstrate CONFIDENCE in the establishment of IEC TR 80001-2-2 SECURITY CAPABILITIES. The quality of artifacts gathered and documented during the development of the SECURITY CASE is agreed and documented as part of a RESPONSIBILITY AGREEMENT between the relevant stakeholders. This document provides guidance for one such methodology, through the use of a specific SECURITY PATTERN, to develop and interpret SECURITY CASES in a systematic manner.

Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

BS EN ISO 10993-6:2016 医疗器械的生物学评价 植入后局部效果测试

Biological evaluation of medical devices. Tests for local effects after implantation

DB31/T 1019-2016 儿童验光配镜技术服务规范

本标准规定了儿童验光配镜技术服务规范的术语和定义、验光配镜要求、验光配镜技术规则、验光配镜流程、定配眼镜标志、包装要求和售后服务规范。 本标准适用于从事儿童验光配镜的经营性企业。设有儿童验光配镜的医疗机构可参照本标准。 本标准仅适用于7～14岁儿童的验光配镜。

Technical service specification for children's optometry

DIN EN ISO 15225:2016 医疗设备.质量管理.医疗设备命名法数据结构(ISO 15225-2016).德文版本EN ISO 15225-2016

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016

EN ISO 15223-1:2016 用于医疗器械标签符号,标记和提供信息-第1部分:一般要求(ISO 15223-1:2016,修正版本2017-03)

Dieses Dokument legt Anforderungen an Symbole zur Verwendung in Kennzeichnungen von Medizinprodukten fest, die zur Übermittlung von Informationen für die sichere und wirkungsvolle Anwendung von Medizinprodukten angewendet werden. Sie führt auch eine Liste von Symbolen auf, die den Anforderungen dieses Dokuments entsprechen. Dieses Dokument gilt für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit in Verkehr gebracht werden und daher unterschiedliche behördliche Anforderungen erfüllen müssen. Diese Symbole dürfen auf dem Medizinprodukt selbst, auf seiner Verpackung oder in den zugehörigen Dokumenten verwendet werden. Die Anforderungen dieses Dokuments sind nicht dazu vorgesehen, für Symbole zu gelten, die in anderen Normen festgelegt sind.

Medical devices - Symbols to be used with medical device labels@ labelling and information to be supplied - Part 1: General requirements

ETSI EN 302 537-2016 超低功耗医疗数据服务(MEDS)系统,工作频率范围为401 MHz至402 MHz,405 MHz至406 MHz;协调标准涵盖2014/53/EU欧盟指令第3.2条的基本要求(V2.1.1)

Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1)

ISO 7153-1:2016 外科器械.材料.第1部分:金属

Surgical instruments - Materials - Part 1: Metals

EN 16872:2016 顺势疗法医师资格(mdqh)-顺势疗法医师资格要求

This European Standard specifies the minimum requirements for medical doctors with additional qualification in homeopathy and their services. This European Standard is not applicable to services provided by persons not being medical doctors, nor to the preparation of homeopathic medicines, nor to the methodology and practice of homeopathic provings.

Services of Medical Doctors with additional qualification in Homeopathy (MDQH) - Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy

DIN EN ISO 13485:2016 医疗器械.质量管理体系.调整要求(ISO 13485-2016).德文版本EN ISO 13485-2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016

EN ISO 9626:2016 用不锈钢针管医疗装置的要求和试验方法(ISO 9626:2016)制造

Die vorliegende Internationale Norm gilt für biegesteife Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Injektionskanülen und anderen Medizinprodukten, vorwiegend für die Anwendung am Menschen. Diese Internationale Norm enthält Anforderungen an und Prüfverfahren für Rohre, die in Form von Kanülen für den Einsatz als Komponenten in Medizinprodukten hergestellt werden. Eine zusätzliche Leistungsprüfung der Rohre kann erforderlich werden, wenn die Komponente in das gebrauchsfertige Produkt integriert wird. Diese Internationale Norm legt die Maße und mechanischen Eigenschaften von Kanülenrohren aus Stahl der metrischen Nenngrößen von 3,4 mm (10 Gauge) bis 0,18 mm (34 Gauge) fest. Sie gilt nicht für flexible Kanülenrohre aus nichtrostendem Stahl, da deren mechanische Eigenschaften von den in dieser Internationalen Norm für biegesteife Rohre festgelegten Eigenschaften abweichen. Hersteller und Käufer von flexiblen Kanülenrohren sind jedoch angehalten, die maßbezogenen Spezifikationen dieser Internationalen Norm anzuwenden.

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

YY/T 1465.5-2016 医疗器械免疫原性评价方法 第5部分：用M86抗体测定动物源性医疗器械中α-Gal抗原清除率

Methods for evaluating the immunogenicity of medical devices Part 5: Determination of α-Gal antigen clearance rate in animal-derived medical devices using M86 antibody

YY/T 1500-2016 医疗器械热原试验 单核细胞激活试验 人全血ELISA法

Medical device pyrogen test Monocyte activation test Human whole blood ELISA method

YY/T 1465.3-2016 医疗器械免疫原性评价方法 第3部分：空斑形成细胞测定 琼脂固相法

Methods for evaluating immunogenicity of medical devices Part 3: Plaque-forming cell assay agar solid phase method

IEC TR 80001-2-8:2016 医疗器械IT网络的风险管理应用. 应用指南. 第2-8部分: 应用指南. 确定IEC TR 80001-2-2中已确认安全能力标准指南

This part of IEC 80001, which is a Technical Report, provides guidance to Health Delivery Organizations (HDOs) and MEDICAL DEVICE manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001-2-2. Managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS requires the disclosure of security-related capabilities and RISKS. IEC TR 80001-2-2 presents a framework for this disclosure and the security dialog that surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORKS. IEC TR 80001-2-2 presents an informative set of common, descriptive security-related capabilities that are useful in terms of gaining an understanding of user needs. This report addresses each of the SECURITY CAPABILITIES and identifies SECURITY CONTROLS for consideration by HDOs and MDMs during RISK MANAGEMENT activities, supplier selection, device selection, device implementation, operation etc. It is not intended that the security standards referenced herein are exhaustive of all useful standards; rather, the purpose of this technical report is to identify SECURITY CONTROLS, which exist in these particular security standards (listed in the introduction of this technical report), that apply to each of the SECURITY CAPABILITIES. This report provides guidance to HDOs and MDMs for the selection and implementation of management, operational, administrative and technical SECURITY CONTROLS to protect the confidentiality, integrity, availability and accountability of data and systems during development, operation and disposal. All 19 SECURITY CAPABILITIES are not required in every case and the identified SECURITY CAPABILITIES included in this report should not be considered exhaustive in nature. The selection of SECURITY CAPABILITIES and SECURITY CONTROLS should be based on the RISK EVALUATION and the RISK tolerance with consideration for protection of patient SAFETY, life and health. INTENDED USE, operational environment, network structure and local factors should also determine which

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

BS EN ISO 15225:2016 医疗器械.质量管理.医疗器械命名资料结构

Medical devices. Quality management. Medical device nomenclature data structure

EN ISO 15225:2016 医疗器械质量管理-医疗设备命名的数据结构(ISO 15225:2016)

Diese Internationale Norm legt Regeln fest und enthält Richtlinien für eine Datenstruktur für die Nomenklatur von Medizinprodukten, um die Zusammenarbeit und den Austausch von behördlich relevanten Daten auf internationaler Ebene zwischen den betreffenden Stellen, wie Behörden, Hersteller, Lieferanten, Einrichtungen der Gesundheitsversorgung und Endanwendern zu erleichtern. Diese Internationale Norm enthält Anleitungen für einen Mindestdatensatz und dessen Struktur. Diese Anleitungen sind für Systemplaner vorgesehen, die Datenbanken unter Verwendung des hierin beschriebenen Nomenklatursystems aufbauen. Die in dieser Internationalen Norm enthaltenen Anforderungen gelten für die Entwicklung und Pflege einer internationalen Nomenklatur zur Identifikation von Medizinprodukten. Diese Internationale Norm enthält nicht die eigentliche Nomenklatur, die als getrennte Datei bereitgestellt wird.

Medical devices - Quality management - Medical device nomenclature data structure

DIN EN 60601-2-52:2016 医疗电气设备.第2-52部分:医用床的基本安全性和基本性能的详细要求(IEC 60601-2-52-2009+Cor.-2010+A1-2015).德文版本EN 60601-2-52-2010+AC-2011+A1-2015

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009 + Cor.:2010 + A1:2015); German version EN 60601-2-52:2010 + AC:2011 + A1:2015

BS ISO 11197:2016 医用电源部件

Medical supply units

BS ISO 16142-1:2016 医疗设备 公认的医疗器械安全和性能的基本原则 所有非 IVD 医疗器械的一般基本原则和附加具体基本原则以及选择指南

Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...