植入式給藥裝置檢測

植入式給藥裝置檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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GB/T 16432-2016康復輔助器具 分類和術語

本標準規定了特殊制作或一般可得到的康復輔助器具的分類。本分類包括那些需要他人幫助操作的康復輔助器具。下列術語不在本標準之內：——康復輔助器具的安裝所用的術語；——由本標準分類中的單個康復輔助器具組合的解決辦法；——藥品；——專用于保健的康復輔助器具和設備；——非技術解決辦法，比如他人輔助、導盲犬、唇讀法；——植入器；——財政支持。

YY/T 0285.6-2020血管內導管 一次性使用無菌導管 第6部分:皮下植入式給藥裝置

YY/T 0285的本部分規定了以無菌狀態供應、一次性使用的皮下植入式給藥裝置的相關性能和安全要求。本部分適用于預期在血管內長期或持久使用、由皮下植入式輸液港和導管組成的皮下植入式給藥裝置。本部分未規定與植入式給藥裝置專用針(以下簡稱專用針)相關性能和安全要求。

YY/T 0332-2011植入式給藥裝置

本標準規定了體內植入式給藥裝置(以下簡稱:給藥裝置,見3.1)的要求、本標準未規定與給藥裝置配套供應的輔助器械的要求、

YY/T 0881-2013一次性使用植入式給藥裝置專用針

本標準規定了一次性使用植入式給藥裝置專用針(包括輸液針和注射針)的要求,以保證與植入式給藥裝置和輸注裝置相適應。本標準為專用針所用材料的性能及其質量規范提供了指南。本標準不涉及專用針防針刺安全要求。

YY/T 0907-2013醫用無針注射器－要求與試驗方法

本標準應用于在臨床和相關醫療環境下的患者個人使用的一次或多次使用的無針注射器的安全、性能和試驗要求。注射器的劑量腔通常是丟棄式的,在一次使用或有限次數使用后將其更換。有時它與注射機械裝置是分離的并且通常稱為“藥筒”、“安瓿”、“注射器”、“膠囊”或者“圓盤”。反之,劑量腔也可以是永久的內腔,其使用性能在失效期限內能夠保持有效。不適用于本標準的是關于藥物的給藥方式:--使無針注射裝置本身的一部分的穿刺進入或通過皮膚或黏膜(比如針頭、尖部、微針、植入式緩慢釋放藥物裝置);--產生氣溶膠、液滴、粉末或其他形式用于吸入、吹人、鼻腔或口腔沉積(比如噴霧、吸人器、微小裝置);--皮膚或黏膜表面的沉積液、粉末或其他物質被動地擴散或被人體攝入(比如透皮吸收貼片、液滴);--應用于聲能或電磁能(比如超聲或離子導入裝置);--應用于累加或測量進入或通過人工管路、導管、和/或其本身進入人體的針頭的藥物的輸液系統。

YY/T 0907-2023醫用無針注射器 要求及試驗方法

本文件規定了在臨床和相關醫療環境下使用的或個人使用的一次或多次使用的醫用無針注射器(以下簡稱“無針注射器”)的要求和試驗方法。本文件適用于在臨床和相關醫療環境下使用的或個人使用的一次或多次使用的無針注射器。本文件不適用于無針注射器的如下給藥方式：——使無針注射裝置本身的一部分的穿刺進入或穿透皮膚或黏膜(如針頭、尖部、微針、植入式緩慢釋放藥品裝置)；——產生氣溶膠、液滴、粉末或其他形式用于吸入、吹入、鼻腔或口腔沉積(如噴霧、吸入器、霧化器)；——皮膚或黏膜表面的沉積液、粉末或其他物質被動地擴散或被人體攝入(如透皮吸收貼片、液滴)；——應用于聲能或電磁能(如超聲或離子導入裝置)；——輸液系統，用置入人體的人工管道、導管和/或針頭進行藥品添加或測量。

YY 0989.6-2016手術植入物 有源植入醫療器械 第6部分:治療快速性心律失常的有源植入醫療器械(包括植入式除顫器)的專用要求

YY 0989的本部分規定了適用于植入式心臟除顫器和用于具有治療快速性心律失常功能的有源植入醫療器械。本部分規定的試驗是型式試驗，通過對設備樣品的測試來確認其符合性。本部分同樣適用于有源植入醫療器械的某些非植入式部分和附件(見注1)。植入式脈沖發生器或電極導線的特性應通過本部分中列述的適當方法或其他方法進行驗證，其他方法的準確度應能被證明是等于或優于規定的方法。如有爭議，應采用本部分規定的方法。第2部分涵蓋了用于治療心動過緩的有源植入醫療器械的各個方面。

YY/T 1119-2008醫用高分子制品術語

本標準規定了用醫用高分子材料制成、且直接或間接與人體接觸的醫用高分子制品術語。本標準不包括人工器官術語。

DB31/T 1052-2017臨床核醫學工作場所放射防護與檢測評價規范

本標準規定了臨床核醫學診斷與治療活動中有關工作場所的輻射控制水平、放射防護要求、放射防護檢測方法等。本標準適用于采用單光子發射計算機斷層成像儀(SPECT)、正電子發射斷層成像儀(PET)、γ相機等進行影像診斷，以及放射性核素治療等核醫學診療活動。本標準不適用于骨密度測量、低能7射線粒子源植入治療、放射性核素敷貼治療等診療活動，以及放射性核素和放射性藥物生產等工作過程。

NF S99-501-7-2008醫療器械的生物學評估.第7部分:環氧乙烷滅菌殘留量

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健康信息學. 個人保健裝置通信. 第00103部分: 綜述(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心血管移植物和體外系統.血管裝置藥物并用產品.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健康信息學. 藥物警戒中個人病例安全報告 (ICSR). 第1部分:不良事件報告框架 (ISO 27953-1-2011); 德文和英文版本EN ISO 27953-1-2011, 僅用于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健康信息學. 藥物警戒中個人病例安全報告 (ICSR). 第2部分:ICSR人類醫藥報告要求 (ISO 27953-2-2011); 德文和英文版本EN ISO 27953-2-2011, 僅用于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含活性人體細胞的醫療產品. 風險管理的應用和生產實踐要求(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健康信息學.一般用途信息元.綜述

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醫療器械的生物學評估.環氧乙烷滅菌殘留量

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.