11.100.20 标准查询与下载

KS P ISO 22442-3:2010 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)试剂的销毁或失效的确认

이 표준은 무생육성이거나 무생육성으로 만들어진 동물 조직 또는 동물 조직에서 파생된 제품을

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 10993-2:2010 医疗器械的生物学评估.第2部分:动物保护要求

이 표준은 실험을 의뢰, 설계, 시행하는 사람들, 혹은 의료기기 재료 또는 의료기기 자체의

Biological evaluation of medical devices-Part 2:Animal welfare requirements

ISO/TR 22442-4:2010 使用动物组织以及衍生产品的医疗设备.第4部分:传染性海绵状脑病(TSE)试剂的消灭和/或失效的原则以及那些过程的确认试验

This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs). The TSE-removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non-viable tissues of human origin; this Technical Report does not address this issue. Some current information on human tissues and TSEs is presented which may be applied by analogy to other animal tissues. This Technical Report does not intend to imply a need for validation of methods involving specific materials identified as having a “negligible risk” of contamination with TSE agents as listed in Annex C of ISO 22442-1:2007. This Technical Report is intended to clarify final draft international standards included in the ISO 22442 series, as well as in ISO 14160. This Technical Report builds upon the specific discussion in ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination. As the understanding of inactivation and elimination of TSE agents evolves, this document will be revised when possible.

Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

DIN EN ISO 10993-10:2010 医用设备的生物学评定.第10部分:刺激和迟发型超敏反应的试验(ISO 10993-10-2010).德文版本EN ISO 10993-10-2010

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010

DIN EN ISO 10993-13:2010 医疗装置的生物学评定.第13部分:聚合物医疗设备产生的降解物的识别和量化(ISO 10993-13-2010).德文版本EN ISO 10993-13-2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010

BS EN ISO 10993-10:2010 医疗设备的生物学评价.刺激和皮肤过敏化试验

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.

Biological evaluation of medical devices. Tests for irritation and skin sensitization

BS EN ISO 10993-13:2010 医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only nonresorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see Annex B). The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and ISO 10993-17. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.

Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices

EN ISO 10993-10:2010 医用设备的生物学评定.第10部分:刺激和迟发型超敏反应的试验

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 10993-10:2010 医疗器械的生物评定.第10部分:刺激与持续型过敏症试验

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

NF S99-501-5*NF EN ISO 10993-5:2010 医疗器械的生物学评价.第5部分:体外细胞毒性试验

Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.

NF S99-501-16:2010 医疗设备的生物学评价.第16部分:对降解产物和可沥滤物的毒理动力学研究方案

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

BS EN ISO 10993-1:2009 医疗器械的生物学评估.风险管理过程评估和测试

This part of ISO 10993 describes: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device. This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.

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

BS EN ISO 10993-9:2009 医疗器械的生物学评估.潜在降解产物的鉴别和定量框架

This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials. This part of ISO 10993 is not applicable to: a) 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; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly. NOTE 2 This part of ISO 10993 can be applied to the degradation of materials used in any kind of product that falls within the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations from those applying to medical devices, e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliver drugs or biologics.

Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products

ISO 10993-1:2009/Cor 11:2010 医疗器械的生物学评价.第1部分: 在风险管理过程中的评价和测试

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

EN ISO 10993-13:2010 医疗装置的生物学评定.第13部分:聚合物医疗设备产生的降解物的识别和量化

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

ISO 10993-1:2009/cor 1:2010 医疗器械的生物评定.第1部分:风险管理过程内的试验和评定.技术勘误表1

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

DIN EN ISO 10993-16:2010 医疗设备的生物学评定.第16部分:降解产物和可溶出物的毒代动力学研究设计(ISO 10993-16-2010).德文版本EN ISO 10993-16-2010

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed.

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010

ISO 10993-13:2010 医疗器械的生物学评价.第13部分:聚合物医疗器械降解产物的鉴定与定量

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only nonresorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

DIN EN ISO 10993-1:2010 医疗器械的生物学评价.第1部分:在风险管理系统内的评价与试验

The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the number and exposure of test animals by giving preference to chemical constituent testing and in vitro models, in situations where these methods yield equally relevant information to that obtained from in vivo models. It is not intended that this international standard will provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical devices. Where a particular application warrants it, experts in the product or in the area of application concerned can choose to establish specific tests and criteria, described in a product-specific vertical standard. This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device, taking into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009

BS EN ISO 10993-16:2010 医疗器械的生物学评定.降解产物和可滤取物的毒物动力学研究设计

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

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