11.100.20 标准查询与下载

EN ISO 10993-17:2002 医疗器械的生物评定.第17部分:可浸出物质容许限值的确定ISO 10993-17-2002

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances ISO 10993-17: 2002

AS ISO 10993.5:2002 给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Specifies requirements for test methods to assess the in vitro cytotoxicity for biological evaluation of medical devices.

Biological evaluation of medical devices - Tests for in vitro cytotoxicity

AS ISO 10993.1:2002 给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Describes the principles governing biological evaluation and testing of medical devices.

Biological evaluation of medical devices - Evaluation and testing

BS EN ISO 10993-14:2001 医疗器械的生物评定.陶瓷降解产品的识别与量化试验

This part of IS0 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 IS0 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 (e 10-6) contained in the specific metal or alloy is not addressed in this part of IS0 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of IS0 10993. This part of IS0 10993 does not address the biological activity of the degradation products; see instead the applicable clauses of IS0 10993-1 and IS0 10993-1 7.

Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics

ISO 10993-14:2001 医疗器械的生物学评价 第14部分：陶瓷降解产物的识别和量化

This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis of degradation products. Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified. Further, this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products. Although these materials are intended for biomedical applications, the biological activity of these degradation products is not addressed in this part of ISO 10993.

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

BS EN ISO 10993-8:2001 医疗器械的生物评定.生物试验用参考材料的选择和鉴定

This part of ISO 10993 specifies requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. It specifies the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference materials as experimental controls.

Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests

BS EN ISO 10993-15:2001 医疗器械的生物评定.金属及合金中降解产物的识别与量化

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) 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 - Identification and quantification of degradation products from metals and alloys

GOST R ISO 10993-14-2001 医疗器械.医疗器械的生物学评价.第14部分:陶瓷的降解产物的识别和量化

Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics

GOST R ISO 10993-15-2001 医疗器械.医疗器械的生物学评价.第15部分:金属和合金的降解产物的识别和量化

Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys

ISO 10993-15:2000 医疗器械的生物学评价 第15部分:金属与合金降解产物的识别与定性

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) 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

EN ISO 10993-15:2000 医疗器械的生物评定.第15部分:金属及合金中降解产物的识别与量化 ISO 10993-15-2000

Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys ISO 10993-15:2000

BS EN ISO 10993-5:1999 医疗器械的生物评定.实验室细胞毒性试验

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Biological evaluation of medical devices - Tests for in vitro cytotoxicity

EN ISO 10993-5:1999 医疗器械的生物评定.第5部分:在试管内的细胞毒性试验 ISO 10993-5-1999;代替EN 30993-5-1994

Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity ISO 10993-5:1999; Supersedes EN 30993-5:1994

ISO 10993-5:1999 医疗器械的生物学评价 第5部分:体外细胞毒性试验

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

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

ISO 10993-9:1999 医疗器械的生物学评价 第9部分:潜在降解产物的定性与定量总则

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. This part of ISO 10993 is not applicable to: a) viable-tissue engineered products; b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available; c) leachable components which are not degradation products. Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

BS EN ISO 10993-13:1999 医疗器械的生物学评定.聚合物医疗装置降解物的确认与量化

This part of ISO 10993 provides guidance on general requirements for the design of tests 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. For materials which 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 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. 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 and ISO 14538. 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 - Identification and quantification of degradation products from polymeric medical devices

NF S99-513:1999 医疗器材的生物评价.第13部分:聚合的医疗器材降解产品的识别与量化

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

GOST R ISO 10993.9-1999 医疗设备 医疗器械的生物学评价 第9部分 潜在降解产物的识别和量化框架/注：将被 GOST R ISO 10993-9（2009）取代

Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products / Note: To be replaced by GOST R ISO 10993-9 (2009).

GOST R ISO 10993.7-1999 医疗设备 医疗器械的生物学评价 第7部分环氧乙烷灭菌残留物

Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

CAN/CSA-ISO 10993.11-1998(C2002) 医疗器械生物学评价 第11部分：全身毒性试验

La présente Norme nationale du Canada est équivalente à la Norme internationale ISO 10993-11:1993. 1 Domaine d'application La présente partie de l'ISO 10993 fixe des méthodes d'évaluation du potentiel de toxicité systémique des dispositifs médicaux susceptibles de relarguer des constituants dans le corps. Elle comporte, en outre, des essais de pyrogénicité. Les méthodes d'essai citées dans la présente partie de l'ISO 10993 sont issues de Normes internationales, de normes nationales, de directives et de réglementations. La présente partie de l'ISO 10993 concerne le produit proprement dit et/ou les substances relargables. Il est prévu que les essais intéressant les extraits ou les substances relargables soient effectuées en choisissant des véhicules d'extraction appropriés permettant une extraction maximale de substances relargables, afin d'effectuer les essais biologiques.

Biological evaluation of medical devices - Part 11: Systemic toxicity testing