11.100.20 标准查询与下载

KS P ISO 10993-20-2019 医疗器械生物学评价第20部分：医疗器械免疫毒理学试验原理和方法

Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices

KS P ISO 17593-2019 临床实验室检测和体外医疗器械 口服抗凝治疗自测体外监测系统要求

Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

ISO 10993-1:2018 医疗器械的生物学评价. 第1部分: 在风险管理过程内的评价与试验

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

BS EN ISO 10993-11:2018 医疗器械的生物学评价.第11部分:全身毒性试验

Biological evaluation of medical devices. Tests for systemic toxicity

EN ISO 10993-11:2018 医疗器械的生物学评价 第11部分:全身毒性试验

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

DIN EN ISO 10993-4:2017 医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO 10993-4-2017);德文版本EN ISO 10993-4-2017

This document provides general requirements for evaluating the interactions of medical devices with blood. It describes: a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1; b) the fundamental principles governing the evaluation of the interaction of devices with blood; c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017

ISO 10993-11:2017 医疗器械的生物学评价.第11部分:身体组织毒性试验

This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

DIN EN ISO 10993-6:2017 医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO 10993-6-2016);德文版本EN ISO 10993-6-2016

This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. The test specimen is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical or functional loading. This part of ISO 10993 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by control materials used in medical devices of which the clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or resorption/degradation of the material. In particular for degradable/resorbable materials the degradation characteristics of the material and the resulting tissue response should be determined. This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity.

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

BS EN ISO 10993-4:2017 医疗器械的生物评估.与血液相互作用的试验选择

Biological evaluation of medical devices. Selection of tests for interactions with blood

ISO 10993-16:2017 医疗器械的生物学评估.第16部分:降解产物和可滤取物的毒物动力学研究设计

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-4:2017 医疗器械的生物评定.第4部分:与血液相互作用的试验的选择

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

BS PD ISO/TR 15499:2016 医疗器械的生物学评价.在一个风险管理程序内进行生物学评价的指南

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

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

GSO ISO 22442-1:2016 利用动物组织及其衍生物的医疗器械 第1部分：风险管理的应用

This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This part of ISO 22442 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the application of this part of ISO 22442 see Annex A.

Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk manag ement

GSO ISO 10993-4:2016 医疗器械生物学评价 第4部分：与血液相互作用试验的选择

This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

GSO ISO 10993-17:2016 医疗器械生物学评价 第17部分：可浸出物质允许限量的制定

This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.

Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances

GSO ISO 10993-18:2016 医疗器械生物学评价 第18部分：材料的化学表征

This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example: — As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971). — Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17). — Judging equivalence of a proposed material to a clinically established material. — Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former. — Screening of potential new materials for suitability in a medical device for a proposed clinical application. This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Biological evaluation of medical devices -- Part 18: Chemical characterization of materials

GSO ISO/TS 10993-20:2016 医疗器械生物学评价 第20部分：医疗器械免疫毒理学试验原理和方法

This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices. This part of ISO 10993 is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place. The current state of knowledge with regard to immunotoxicity is described in Annex A. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in Annex B. NOTE See also Bibliographic Reference [11].

Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices

GSO ISO 10993-15:2016 医疗器械生物学评价 第15部分：金属和合金降解产物的鉴定和定量

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress. NOTE Mechanically induced degradation, such as wear, may be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered. Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (< 10-6) contained in the specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of ISO 10993. This part of ISO 10993 does not address the biological activity of the degradation products; see instead the applicable clauses of ISO 10993-1 and ISO 10993-17.

Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys

GSO ISO 22442-2:2016 利用动物组织及其衍生物的医疗器械 第2部分：采购、收集和处理的控制

This part of ISO 22442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management. NOTE 2 Manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 3 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485. NOTE 4 A general principle for the application of ISO 22442 is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.

Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling