11.100.20 标准查询与下载

NF S99-501-7*NF EN ISO 10993-7:2008 医疗器械的生物学评估.第7部分:环氧乙烷灭菌残留量

Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals.

YY/T 0690-2008 临床实验室测试和体外医疗器械.口服抗凝药治疗自测体外监测系统的要求

本标准规定了维生素K拮抗剂治疗自身监测体外测量系统的具体要求，包括性能、质量保证和用户培训以及由预期用户在真实和模拟使用条件下进行性能验证和确认的程序。 本标准单独适用于由个人使用监测自身维生素K拮抗剂治疗并以INR报告结果的PT测量系统。本标准适用于口服抗凝药体外监测系统的制造商及其对该系统性能评估负责的其他组织(如监管 机构和合格评定机构)。 本标准不 — 适用于体外测量系统由医生或医务人员对维生素K拮抗剂治疗中抗凝药量的评估; — 提供影响系统性能所有可能因素的综合评价; — 解决口服抗凝药治疗医学方面的问题。

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

ISO 10993-7:2008 医疗器械的生物学评价 第7部分:环氧乙烷灭菌残留量

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

TIS 2395.3-2008 医疗器械生物学评价.第3部分:遗传毒性,致癌性和生殖毒性试验

Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity

EN ISO 11145:2008 光学和光子学.激光和激光设备.词汇和符号

This International Standard defines basic terms,symbols and units of measurement for the field of laser technology in order to unify the terminology and to arrive at clear definitions and reproducible tests of beam parameters and laser-oriented product properties.

Optics and photonics - Lasers and laser-related equipment - Vocabulary and symbols

NF S97-601-1:2008 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用

Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management.

NF S97-601-2:2008 医疗设备用动物组织及其衍生物.第2部分:资源控制、采集和处理

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

NF S97-601-3*NF EN ISO 22442-3:2008 医疗设备用动物组织及其衍生物.第3部分:病毒和传染性海绵状脑病(TSE)试剂的销毁和/或失效的确认

Medical devices utilizing animal tissues and their derivatives - Part 3 : validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents.

NF S99-512:2008 医疗器械的生物评定.第12部分:样品制备和比对物

Biological evaluation of medical devices - Part 12 : sample preparation and reference materials.

BS EN ISO 22442-2:2008 医疗设备用动物组织及其衍生物.来源控制,采集和处理

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 - Controls on sourcing, collection and handling

BS EN ISO 22442-3:2008 医疗设备用动物组织及其衍生物.病毒和传染性海绵状脑病(TSE)试剂的消灭和/或失效的确认

This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents. NOTE 1 Analysis and management of risk is described in ISO 22442-1. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy. Selective sourcing is extremely important (see ISO 22442-1 and ISO 22442-2). NOTE 2 ISO 11135, ISO 11137, ISO 11737-1, ISO 13408, ISO 14160, ISO 14937 and ISO 17665 may be relevant for bacteria, moulds and yeast (see Bibliography). 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 part of a quality management system conforming to ISO 13485. This part of ISO 22442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.

Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

BS EN ISO 22442-1:2008 医疗设备用动物组织及其衍生物.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 - Application of risk management

DIN EN ISO 10993-12:2008 医疗器械的生物评定.第12部分:样品制备和参考材料

This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically this part of ISO 10993 addresses: -- test sample selection; -- selection of representative portions from a device; -- test sample preparation; -- experimental controls; -- selection of and requirements for reference materials; preparation of extracts. This part of ISO 10993 is not applicable to materials or devices containing live cells.

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2007

EN ISO 10993-7:2008 医疗器械的生物评定.第7部分:环氧乙烷消毒残余物

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 howThis document is applied, are also included in the informative annexes.

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

BS EN ISO 10993-12:2007 医疗器械的生物学评估.样品制备和参考材料

ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses: test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of and requirements for reference materials; preparation of extracts. ISO 10993-12:2007 is not applicable to materials or devices containing live cells.

Biological evaluation of medical devices - Sample preparation and reference materials

ISO 22442-1:2007 医疗设备用动物组织及其衍生物.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 management

ISO 22442-2:2007 医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理

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

ISO 22442-3:2007 医疗设备用动物组织及其衍生物.第3部分:病毒和传染性海绵状脑病(TSE)试剂的销毁和/或失效的确认

This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents. NOTE 1 Analysis and management of risk is described in ISO 22442-1. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy. Selective sourcing is extremely important (see ISO 22442-1 and ISO 22442-2). NOTE 2 ISO 11135, ISO 11137, ISO 11737-1, ISO 13408, ISO 14160, ISO 14937 and ISO 17665 may be relevant for bacteria, moulds and yeast (see Bibliography). 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 part of a quality management system conforming to ISO 13485. This part of ISO 22442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

KS P ISO 10993-11:2007 医疗器械的生物学评估.第11部分:身体组织毒性试验

이 규격은 의료기기 재료가 해로운 전신 반응을 일으킬 수 있는 잠재성을 평가하는 데 수반되

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

KS P ISO 10993-6:2007 医疗器械的生物学评估.第6部分:植入后局部作用试验

이 규격은 이식 시료의 생체 조직에 대한 부분적인 영향을 육안 및 현미경 관찰을 통하여 평

Biological evaluation of medical devices－Part 6：Tests for local effects after implantation