11.100.20 标准查询与下载
共找到 320 条与 相关的标准，共 22 页
Biological Evaluation of Medical Devices Part 23: Stimulation Test
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2023-11-27
- 实施
- 2024-12-01
Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
- ICS
- 11.100.20
- CCS
- C 30
- 发布
- 2023-11-27
- 实施
- 2024-12-01
本文件规定了: ———风险管理过程中指导医疗器械生物学评价的基本原则; ———按器械与人体接触性质和时间的基本分类; ———所有来源的已有相关数据的评价; ———建立在风险分析基础之上的可用数据组中缺陷的识别; ———医疗器械生物学安全分析所需其他数据组的识别; ———医疗器械生物学安全的评估。 本文件适用于预期直接或间接接触下列情况的材料和医疗器械的评价: ———在预期使用过程中患者的身体; ———使用者的身体,如果该医疗器械是用于防护作用(如,外科手套、口罩等)。 本文件适用于各种类型医疗器械的生物学评价,包括有源、无源、植入和非植入性医疗器械。 本文件也给出了由下列情况所引起的生物学危险(源)的评估指南: ———作为全部生物学安全评估的一部分,由医疗器械随时间变化引起的风险; ———医疗器械或医疗器械组件的破损导致人体组织接触到新材料或创新材料。GB/T16886 其他部分包含生物学评估和相关试验的具体内容。医疗器械特定标准或产品标准中给出了机械性能测试。 本文件不适用于与细菌、真菌、酵母、病毒、传播性海绵状脑病(TSE)因子和其他病原体有关的危险(源)。
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2022-04-15
- 实施
- 2023-05-01 00:00:00.0
本文件规定了用于评估医疗器械所用生物材料植入后局部反应的试验方法。 本文件适用于下列材料: ———固形和非固形材料,如多孔材料、液体、胶状、膏状和颗粒材料, ———非吸收性材料,和 ———可降解和/或可吸收性固形或非固形材料。 本文件也适用于评价临床上预期用于局部损伤表面或损伤内表面的医疗器械产生的局部组织反应。 注1:将试验样品植入适宜种属的动物和部位以评价材料的生物学安全性,其目的为表征医疗器械/生物材料植入后组织反应的进程和演变,包括材料最终的组织整合或吸收/降解,尤其对可降解/可吸收性材料,确定材料的降解特性以及所产生的组织反应。 通过比较试验样品与已确立临床可接受性和生物相容性的医疗器械所用对照材料产生的组织反应,对局部反应进行评价。 本文件不适用于预期评价或测定试验样品在机械或功能负荷方面的性能的植入试验。 本文件不涉及全身毒性、致癌性、致畸性或致突变性。 注2:用来评价局部生物学反应的长期植入研究可能提供全身毒性、致癌性、致畸性或致突变性方面的一些信息。 通过植入进行的全身毒性研究可能满足本文件的要求。当进行联合研究来评价局部反应和全身反应时,两个文件的要求都要满足。
Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2022-04-15
- 实施
- 2023-05-01 00:00:00.0
本文件规定了评价医疗器械材料导致潜在不良全身反应时的要求,给出了试验步骤指南。 本文件适用于医疗器械或材料的全身毒性研究。
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2021-11-26
- 实施
- 2022-12-01 00:00:00.0
本文件规定了与医疗器械相关的设计和实施毒代动力学研究的原则。 附录A描述了医疗器械生物学评价中毒代动力学研究中考虑的问题。 本文件适用于医疗器械降解产物与可沥滤物的毒代动力学研究。
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2021-11-26
- 实施
- 2022-12-01 00:00:00.0
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2017-12-29
- 实施
- 2018-07-01 00:00:00.0
Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2017-12-29
- 实施
- 2018-07-01 00:00:00.0
Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2017-12-29
- 实施
- 2018-07-01 00:00:00.0
Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2017-12-29
- 实施
- 2018-07-01 00:00:00.0
Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
- ICS
- 11.100.20
- CCS
- 发布
- 2023-11-30
- 实施
- 2023-11-30
1 Scope This document specifies a framework for the identification , and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents , using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction ( medical device configuration ); — the characterization of the materials of construction via the identification and quantification of their chemical constituents ( material composition ); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use con...
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
- ICS
- 11.100.20
- CCS
- 发布
- 2023-07-31
- 实施
- 2023-07-31
What is BS EN ISO 10993-10 - Tests for skin sensitization about? This is the tenth in an international series of standards on how to conduct biological evaluations of medical devices. Relevant to the safety of medical materials and devices, BS EN ISO 10993-10:2023 covers the selection and conduct of tests for evaluating dermal sensitization responses. Who is BS EN ISO 10993-10 – Tests for skin sensitization for? Manufacturers and suppliers of medical devices Medical laboratories Regulatory authorities Notified bodies What does BS EN ISO 10993-10 - Tests for skin sensitization cover? BS EN ISO 10993-10 specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. BS EN ISO 10993-10 includes: Details of in vivo skin sensitization test procedures Key factors for the interpretation of the results
Biological evaluation of medical devices. Tests for skin sensitization
- ICS
- 11.100.20
- CCS
- 发布
- 2023-02-28
- 实施
- 2023-02-28
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
- ICS
- 11.100.20
- CCS
- 发布
- 2023-02-08
- 实施
- 2023-05-31
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2023-02-06
- 实施
- 2023-02
1 Scope This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals , and the replacement of animal tests by other scientifically valid means not requiring animal tests. This document applies to tests performed on living vertebrate animals , other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
Biological evaluation of medical devices - Animal welfare requirements
- ICS
- 11.100.20
- CCS
- 发布
- 2022-11-30
- 实施
- 2022-11-30
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
- ICS
- 11.100.20
- CCS
- 发布
- 2022-11-23
- 实施
- 2023-02-28
1 Scope This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products;
Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
- ICS
- 11.100.20
- CCS
- 发布
- 2022-05-31
- 实施
- 2022-05-31
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
- ICS
- 11.100.20
- CCS
- 发布
- 2022-05-11
- 实施
- 2022-05-11
What is ISO 20776-2 - Performance of antimicrobial susceptibility test device about? ISO 20776-2 is a standard that covers the performance of antimicrobial susceptibility test device, ensuring stable operability, safety and accuracy in the clinical laboratory and vitro diagnostic system applications. ISO 20776-2 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2 requirements for AST devices and procedures for assessing the performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2 has been developed to guide manufacturers in the conduct of performance evaluation studies. Who is ...
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial suscep...
- ICS
- 11.100.20
- CCS
- 发布
- 2022-01-31
- 实施
- 2022-01-31
