11.100.20 标准查询与下载

KS P ISO 10993-17:2006 医疗器械的生物学评估.第17部分:可浸出物质容许限值的确定

이 규격은 의료 기기에서 용출되는 물질에 대한 허용 한도를 결정하는 방법에 대하여 규 정한

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

ISO/TS 20993:2006 医用设备的生物评价.风险管理处理导则

This Technical Specification describes a process by which a manufacturer can identify the biological hazards associated with medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.

Biological evaluation of medical devices - Guidance on a risk-management process

ISO 10993-11:2006 医疗器械的生物学评价.第11部分:身体组织毒性试验

This part of ISO 10993 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

ISO/TS 10993-20:2006 医疗设备的生物评定.第20部分:医疗设备的免疫毒物学试验的原则和方法

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

ISO 10993-10:2002/Amd 1:2006 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 is Amendment 1 to ISO 10993-10-2002 (Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity)

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity; Amendment 1

EN ISO 10993-2:2006 医疗器械的生物评定.第2部分:动物保护要求 ISO 10993-2-2006

This part of ISO 10993 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.It 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 also makes recommendations and offers guidance intended to facilitate future reductions in the overall number of animals used,refinement of test methods to reduce or eliminate pain

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)

ISO 10993-4:2002/Amd 1:2006 医疗器械的生物评定.第4部分:与血液相互作用的选择试验

This standard is about Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood AMENDMENT 1

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

ISO 10993-2:2006 医疗器械的生物学评价.第2部分:动物保护要求

This part of ISO 10993 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. It 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 also 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. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. It 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/TS 10993-19:2006 医疗设备的生物评定.第19部分:材料的物理化学、形态学和地形学特点

This Technical Specification provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18. The ISO 10993 series of International Standards is not applicable when the material or device does not contact the body directly or indirectly (see ISO 10993-1:2003, 4.2).

Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

ASTM F2567-06(2010) 用固体材料在血清中进行经典途径补体激活试验的标准操作规程

Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. Solid medical device materials may activate complement directly by the alternative pathway, or indirectly because of antigen-bound antibodies (as with immuno-adsorption columns) by the classical pathway. This practice is useful as a simple, inexpensive, function-based screening method for determining complement activation by solid materials in vitro by the classical pathway. This practice is composed of two parts. In part A (Section 11), HS is exposed to a solid material. If complement activation occurs by the classical pathway, C4 will be depleted. Activation by the alternative pathway will not deplete C4. In part B (Section 12), C4 activity remaining in the serum after exposure to the test material is assayed by diluting the serum below the concentration needed to lyse antibody-coated sheep RBC on its own, then adding the diluted HS to C4(-)GPS (which is itself at a dilution where all complement components are in excess save the missing C4). Lacking C4, the C4(-)GPS does not lyse the antibody-coated sheep RBC unless C4 is present in the added HS. The proportion of lysis remaining in the material-exposed HS sample versus the 37°C control HS sample (which was not exposed to the test material) indicates the amount of C4 present in the HS, loss of which correlates with classical pathway activation. This function-based in vitro test method for classical pathway complement activation is suitable for adoption in specifications and standards for screening solid materials for use in the construction of medical devices intended to be implanted in the human body or placed in contact with human blood outside the body. It is designed to be used in conjunction with Practice F1984 for function-based whole complement activation screening, and Practice F2065 for function-based alternative pathway activation screening. Assessment of in vitro classical complement activation as described here provides one method for predicting potential complement activation by solid medical device materials intended for clinical application in humans when the material contacts the blood. Other test methods for complement activation are available, such as immunoassays for specific complement components (including C4) and their split products in human serum (see X1.3 and X1.4). If nonspecific binding of certain complement components, including C4, to the materials occurs in part A of this practice, a false positive for classical pathway activation will be observed in step B. Classical pathway complement activation by the test material may be confirmed by demonstrating an absence of C4 bound to the material following removal of the serum, and/or production of complement split-products such as C4d in the serum (as determined by immunoassay). Although immunoassay could be done in place of this screening procedure, determination of C4d production alone may not be functionally significant. This practice does not detect trivial amounts of classical activation unable to affect functional lysis of sensitized RBC.1.1 This practice provides a protocol for rapid, in vitro functional screening for classical pathway complement activating properties of solid materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro classical pathway complement activating properties of solid materials intended for use in contact with blood. For this practice......

Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials

NF S99-518:2005 医疗器材的生物评价.第18部分:材料的化学特性

Biological evaluation of medical devices - Part 18 : chemical characterization of materials.

DIN EN ISO 10993-18:2005 医疗装置的生物评价.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 A 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 (ISO 10993-18:2005); German version EN ISO 10993-18:2005

ISO 10993-18:2005 医疗器械的生物学评价.第18部分:材料的化学特性

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

JIS T 0993-1:2005 医疗器械的生物学评价.第1部分:评价与试验

この規格は，次の事項について規定する。

Biological evaluation of medical devices -- Part 1: Evaluation and testing

BS EN ISO 10993-12:2004 医疗器械的生物学评定.样品制备和参照物品

Biological evaluation of medical devices - Sample preparation and reference materials

AS ISO 10993.17:2004 医疗器械的生物学评价．浸出物允许极限的确定

Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Not applicable to devices that have no patient contact, e.g. in？vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO？10993-17:2002.

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

BS EN ISO 10993-1:2003 医疗器械的生物评定.评价和检验

ISO 10993-1:2003 describes the general principles governing the biological evaluation of medical devices; the categorization of devices based on the nature and duration of their contact with the body; the selection of appropriate tests. It 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.

Biological evaluation of medical devices - Evaluation and testing

ISO 10993-3:2003 医疗器械的生物评定.第3部分:遗传毒性、致癌性和生殖毒性的试验

This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: — genotoxicity, — carcinogenicity, and — reproductive and developmental toxicity. This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. NOTE Guidance on selection of tests is provided in ISO 10993-1.

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

EN ISO 10993-1:2003 医疗装置的生物学评估.第1部分:评估和测试

This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests. 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. NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).

Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-1:2003

ISO 10993-1:2003 医疗器械的生物学评价.第1部分:评价与试验

This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests. 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. NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).

Biological evaluation of medical devices - Part 1: Evaluation and testing