11.100.20 标准查询与下载

KS P ISO 20776-2:2009 临床实验室测试和体外诊断试验系统.传染者的易感性测试和抗菌剂易感性试验装置的性能评估.第2部分:抗菌剂易感性试验装置的性能评估

이 표준은 의학 검사실에서 항균제에 대한 세균의 감수성, 중간 내성 및 내성(SIR) 균주

Clinical laboratory testing and in vitro diagnostic test systems－Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices－Part 2：Evaluation of performance of antimicrobial susceptibility test d

KS P ISO 10993-20:2009 医疗设备的生物学评估.第20部分:医疗设备的免疫毒物学试验的原则和方法

이 표준에서는 의료기기의 잠재적인 면역독성에 중점을 두어 면역독성학에 대한 개요를 제시하고

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

KS P ISO TS 20993:2009 医用设备的生物评估.风险管理处理导则

이 기술 표준은 제조업체가 실시할 수 있는 의료기기의 생물학적 위험 요소들의 확인, 위험

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

KS P ISO 10993-18:2009 医疗器械的生物学评估.第18部分:材料的化学特性

이 표준에서는 재료의 식별과 그 화학적 성분의 식별과 정량화에 대한 구성체제에 대해 설명한

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

KS P ISO 20776-1:2009 临床实验室试验和在玻璃试管内诊断试验系统.传染介质易传染性试验和抗菌易传染性试验装置性能评估.第1部分:和传染疾病相关的抗有氧细菌快速增长的抗菌介质试管活性试验参照法

이 표준은 MIC 판단을 위한 하나의 인증된 시험방법인 액체배지 미량 희석법(broth m

Clinical laboratory testing and in vitro diagnostic test systems－Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices－Part 1：Reference method for testing the in vitro activity of antimicrob

KS P ISO 17593:2009 临床实验室测试和体外医疗装置.口服抗凝血剂治疗自测用体外监测系统的要求

이 표준은 비타민 K 길항제 요법의 자가시험을 위한 체외측정시스템 요구사항을 규정하고, 성

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

KS P ISO 10993-19:2009 医疗设备的生物学评估.第19部分:材料的物理化学、形态学和地形学特点

이 표준은 완성된 의료기기에 사용된 재료의 물리화학적, 형태학적 및 표면형태적(PMT) 속

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

NF S99-501-18:2009 医疗设备的生物学评价.第18部分:材料的化学特性

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

NF S99-501-6:2009 医疗装置的生物学评估.第6部分:植入后局部效应的试验

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

NF S99-501-4:2009 医疗设备的生物评估.第4部分:血统相互作用试验筛选

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

NF S99-501-3:2009 医疗设备的生物学评价.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.

ISO 10993-9:2009 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

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

EN ISO 10993-7:2008/AC:2009 医疗器械的生物评定.第7部分:环氧乙烷消毒残余物 包含修改件AC,2009

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

DIN EN ISO 14155-2:2009 用于人体的医疗器械临床研究.第2部分:临床研究方案(ISO 14155-2:2003),EN ISO 14155-2:2009的德文版本

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices.

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11

ISO 10993-7:2008/cor 1:2009 医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物.勘误表1

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1

DIN EN ISO 14155-1:2009 人体适用的医疗设备的临床调查.第1部分:一般要求(ISO 14155-1:2003)EN ISO 14155-1:2009的德文版本

This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to protect human subjects, ensure the scientific conduct of the clinical investigation, - assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This part of ISO 14155 a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); English version of DIN EN ISO 14155-1:2009-11

DIN EN ISO 10993-4:2009 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 10993-4:2002,含修改件1:2006),DIN EN ISO 10993-4:2009-10的英文版本

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 (ISO 10993-4:2002, including Amd 1:2006); English version of DIN EN ISO 10993-4:2009-10

DIN EN ISO 10993-5:2009 医疗设备的生物评估.第5部分:体外细胞毒性测试(ISO 10993-5:2009),英文标准DIN EN ISO 10993-5:2009-10

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 in contact with a device and/or extracts of a device either directly or through diffusion. 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 10993-5:2009); English version of DIN EN ISO 10993-5:2009-10

DIN EN ISO 10993-15:2009 医疗设备的生物评估.第15部分:金属与合金降解产物的识别与定性(ISO 10993-15:2000,DIN EN ISO 10993-15:2009-10的英文版本)

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 (

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); English version of DIN EN ISO 10993-15:2009-10

ISO 10993-1:2009 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