植入式给药装置检测

GB/T 16432-2016康复辅助器具 分类和术语

本标准规定了特殊制作或一般可得到的康复辅助器具的分类。本分类包括那些需要他人帮助操作的康复辅助器具。下列术语不在本标准之内：——康复辅助器具的安装所用的术语；——由本标准分类中的单个康复辅助器具组合的解决办法；——药品；——专用于保健的康复辅助器具和设备；——非技术解决办法，比如他人辅助、导盲犬、唇读法；——植入器；——财政支持。

YY/T 0285.6-2020血管内导管 一次性使用无菌导管 第6部分:皮下植入式给药装置

YY/T 0285的本部分规定了以无菌状态供应、一次性使用的皮下植入式给药装置的相关性能和安全要求。本部分适用于预期在血管内长期或持久使用、由皮下植入式输液港和导管组成的皮下植入式给药装置。本部分未规定与植入式给药装置专用针(以下简称专用针)相关性能和安全要求。

YY/T 0332-2011植入式给药装置

本标准规定了体内植入式给药装置(以下简称:给药装置,见3.1)的要求、本标准未规定与给药装置配套供应的辅助器械的要求、

YY/T 0881-2013一次性使用植入式给药装置专用针

本标准规定了一次性使用植入式给药装置专用针(包括输液针和注射针)的要求,以保证与植入式给药装置和输注装置相适应。本标准为专用针所用材料的性能及其质量规范提供了指南。本标准不涉及专用针防针刺安全要求。

YY/T 0907-2013医用无针注射器－要求与试验方法

本标准应用于在临床和相关医疗环境下的患者个人使用的一次或多次使用的无针注射器的安全、性能和试验要求。注射器的剂量腔通常是丢弃式的,在一次使用或有限次数使用后将其更换。有时它与注射机械装置是分离的并且通常称为“药筒”、“安瓿”、“注射器”、“胶囊”或者“圆盘”。反之,剂量腔也可以是永久的内腔,其使用性能在失效期限内能够保持有效。不适用于本标准的是关于药物的给药方式:--使无针注射装置本身的一部分的穿刺进入或通过皮肤或黏膜(比如针头、尖部、微针、植入式缓慢释放药物装置);--产生气溶胶、液滴、粉末或其他形式用于吸入、吹人、鼻腔或口腔沉积(比如喷雾、吸人器、微小装置);--皮肤或黏膜表面的沉积液、粉末或其他物质被动地扩散或被人体摄入(比如透皮吸收贴片、液滴);--应用于声能或电磁能(比如超声或离子导入装置);--应用于累加或测量进入或通过人工管路、导管、和/或其本身进入人体的针头的药物的输液系统。

YY/T 0907-2023医用无针注射器 要求及试验方法

本文件规定了在临床和相关医疗环境下使用的或个人使用的一次或多次使用的医用无针注射器(以下简称“无针注射器”)的要求和试验方法。本文件适用于在临床和相关医疗环境下使用的或个人使用的一次或多次使用的无针注射器。本文件不适用于无针注射器的如下给药方式：——使无针注射装置本身的一部分的穿刺进入或穿透皮肤或黏膜(如针头、尖部、微针、植入式缓慢释放药品装置)；——产生气溶胶、液滴、粉末或其他形式用于吸入、吹入、鼻腔或口腔沉积(如喷雾、吸入器、雾化器)；——皮肤或黏膜表面的沉积液、粉末或其他物质被动地扩散或被人体摄入(如透皮吸收贴片、液滴)；——应用于声能或电磁能(如超声或离子导入装置)；——输液系统，用置入人体的人工管道、导管和/或针头进行药品添加或测量。

YY 0989.6-2016手术植入物 有源植入医疗器械 第6部分:治疗快速性心律失常的有源植入医疗器械(包括植入式除颤器)的专用要求

YY 0989的本部分规定了适用于植入式心脏除颤器和用于具有治疗快速性心律失常功能的有源植入医疗器械。本部分规定的试验是型式试验，通过对设备样品的测试来确认其符合性。本部分同样适用于有源植入医疗器械的某些非植入式部分和附件(见注1)。植入式脉冲发生器或电极导线的特性应通过本部分中列述的适当方法或其他方法进行验证，其他方法的准确度应能被证明是等于或优于规定的方法。如有争议，应采用本部分规定的方法。第2部分涵盖了用于治疗心动过缓的有源植入医疗器械的各个方面。

YY/T 1119-2008医用高分子制品术语

本标准规定了用医用高分子材料制成、且直接或间接与人体接触的医用高分子制品术语。本标准不包括人工器官术语。

DB31/T 1052-2017临床核医学工作场所放射防护与检测评价规范

本标准规定了临床核医学诊断与治疗活动中有关工作场所的辐射控制水平、放射防护要求、放射防护检测方法等。本标准适用于采用单光子发射计算机断层成像仪(SPECT)、正电子发射断层成像仪(PET)、γ相机等进行影像诊断，以及放射性核素治疗等核医学诊疗活动。本标准不适用于骨密度测量、低能7射线粒子源植入治疗、放射性核素敷贴治疗等诊疗活动，以及放射性核素和放射性药物生产等工作过程。

NF S99-501-7-2008医疗器械的生物学评估.第7部分:环氧乙烷灭菌残留量

La présente partie de l'ISO 10993 spécifie les limites admissibles des résidus d'oxyde d'éthylène (OIE) et de chlorhydrate d'éthylène (ECH) pour des dispositifs médicaux individuels stérilisés à l'oxyde d'éthylène, les modes opératoires pour le mesurage de l'oxyde d'éthylène et du chlorhydrate d'éthylène et les méthodes de mesure en vue de déterminer leur conformité et de procéder à leur libération. Une documentation supplémentaire, y compris des directives et un diagramme de flux sont également inclus dans les annexes informatives.Les dispositifs stérilisés à l'oxyde d'éthylène ne présentant pas de contact avec le patient (par exemple les dispositifs de diagnostic in vitro) ne sont pas couverts par la présente partie de l'ISO 10993.

DIN EN ISO 11073-00103-2017健康信息学. 个人保健装置通信. 第00103部分: 综述(ISO/IEEE 11073-00103-2015); 英文版本EN ISO 11073-00103-2017

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e. g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

DIN EN ISO 12417-1-2016心血管移植物和体外系统.血管装置药物并用产品.第1部分:一般要求(ISO 12417-1-2015);德文版本EN ISO 12417-1-2015

This standard specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action of the device. With regard to safety, this Standard outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This standard should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this standard also address VDDCPs that are not necessarily permanent implants.

DIN EN ISO 27953-1-2012健康信息学. 药物警戒中个人病例安全报告 (ICSR). 第1部分:不良事件报告框架 (ISO 27953-1-2011); 德文和英文版本EN ISO 27953-1-2011, 仅用于CD-ROM

Part 1 of this standard seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products. Part 1 is based upon the HL7 Reference Information Model and can be extended or constrained to accommodate a variety of reporting requirements based upon EN ISO 27953-2 and other regional and international requirements summarized in the storyboard section of this ballot. It should be noted that Part 1 will be harmonized over time with other HL7 public health and patient safety incident reporting standards to help ensure messaging constructs and vocabulary are harmonized across the PORR domain. Furthermore, Part 1 of this standard does not govern or dictate reporting requirements for any product. The use cases (storyboards) described in this standard are for demonstration purposes only and are provided to help demonstrate the standard's scalability and interoperability across multiple stakeholders and product types. Future releases of this standard may be developed to include conformance profiles and vocabulary for all or a limited subset of the use cases. Note that the data elements that were found to be consistent across all use cases are summarized as Generic Transmission Use Case Data Elements in this part. These data elements should be considered as a generic set of data elements that can be applied to any reporting scenario. Specific reporting requirements within organizations or regions may use all or only a subset of these data elements. Note this standard does not specify a vocabulary subset for these data elements in this release.

DIN EN ISO 27953-2-2012健康信息学. 药物警戒中个人病例安全报告 (ICSR). 第2部分:ICSR人类医药报告要求 (ISO 27953-2-2011); 德文和英文版本EN ISO 27953-2-2011, 仅用于CD-ROM

Part 2 of this standard is based upon EN ISO 27953-2 requirements for regulatory reporting for human pharmaceutical products. Part 2 seeks to create a framework for international regulatory reporting and information sharing by providing a common set of data elements and messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections and incidents that may occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination. The standard provides a structure where reports can be exchanged in a clear and unambiguous manner such that the nature of the case, the circumstances in which it arose, and particularly the identity of the medicinal product(s) in question, can be communicated with certainty. Requirements for this use case were initially based upon ICH and conformance includes parallel adoption of ISO vocabulary work items: Data Elements and Structures for the Exchange of Regulated Product Information for Drug Dictionaries (See prEN ISO 11615, 11616, 11238, 11239, and 11240) and Structures and Controlled Vocabularies for Laboratory Test Units for the Reporting of Laboratory Results (See EN ISO 11595).

DIN ISO 13022-2014含活性人体细胞的医疗产品. 风险管理的应用和生产实践要求(ISO 13022-2012)

This standard specifies a procedure to identify the hazards and hazardous situations and to manage the risk associated with viable cellular component (s) of products regulated as medicals products, biological, medical devices and active implantable medical devices or combination thereof. It covers viable human materials of autologous as well allogenic human origin. For the manufacturer of medical products containing viable cells of human origin, this standard specifies a procedure to identify the hazards and hazardous situations associated with such cells, to estimate and evaluate the resulting risks, to control this risk, and to monitor the effectiveness of the control. Furthermore the standard outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, and expected medical benefit as compared to available alternatives.

BS EN 14822-1-2005健康信息学.一般用途信息元.综述

This European Standard specifies General Purpose Information Components to be used in standards forinformation exchange and information models supporting various health specific business requirements. Thecomponents defined in this standard are the most commonly needed basic building blocks for suchstandardization but these components may require further specialisation and be complemented by otherobjects required for specific purposes not met by these generally useful components. Such standardizationusing these general purpose information components could be performed both on a European (CEN) level orbe done nationally or for specific user communities regionally as well as internationally.This European Standard provides an informative overview of this series of standards and includes rules forusing the components defined in the other parts and on conformance claims.

BS EN ISO 10993-7-2008医疗器械的生物学评估.环氧乙烷灭菌残留量

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin(ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, andmethods for determining compliance so that devices may be released. Additional background, includingguidance and a flowchart showing how this document is applied, are also included in the informative annexes.EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by thispart of ISO 10993.