11.100.10 标准查询与下载

ASTM F2721-08 临床前体内评估临界尺寸节段性骨缺损的标准指南

This guide is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone. This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens. The user is encouraged to use appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein. It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58. Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE)), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs, respectively. Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.1.1 This guide covers general guidelines for the in vivo assessment of tissue engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this guide are segmental critical size defects which, by definition, will not fill with viable tissue without treatment. Thus, these models represent a stringent test of a material’s ability to induce or augment bone growth. 1.2 Guidelines include a description and rationale of various animal models including rat (murine), rabbit (leporine), dog (canine), goat (caprine), and sheep (ovine). Outcome measures based on radiographic, histologic, and mechanical analyses are described briefly and referenced. The user should refer to specific test methods for additional detail. 1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in the Referenced Documents (Section 2). 1.4 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications. 1.5 Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects

DIN EN ISO 20776-2:2007 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(ISO 20776-2:2007)

This part of ISO 20776 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. This part of ISO 20776 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing Performance of such devices. It defines how a Performance evaluation of an AST device is to be conducted. This part of ISO 20776 has been developed to guide manufacturers in the conduct of performance evaluation studies.

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 t

BS ISO 17593:2007 临床实验室测试和体外医疗设备.口服抗凝血剂治疗自测用体外监测系统的要求

This International Standard specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. This International Standard pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR). This International Standard is applicable to manufacturers of such systems and those other organizations (e.g., regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not -- pertain to in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers, -- provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or -- address the medical aspects of oral-anticoagulation therapy.

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

DIN EN ISO 20776-1:2007 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

This part of ISO 20776 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this part of ISO 20776, A modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

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 antim

BS EN ISO 20776-1:2006 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.抑制传染病菌在有氧环境 快速生长用抗菌剂玻璃试管活性试验的参考方法

ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization of bacteria as susceptible (S), intermediate (I), or resistant (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

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

CNS 15035-2006 体外诊断系统－糖尿病管理时自我检测用血糖监测系统之规定

本标准规范量测微血管血液样本之血糖浓度的体外血糖监测系统的规定，及使用者验证及确效性能的步骤。这些系统预定做为一般人士糖尿病管理时自我检测之用。本标准适用于此类系统的制造商及负责评估这些系统性能的其它组织(如法定权责机关与符合性评鉴机构)。本标准不适用于：

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

KS P ISO 15198:2006 临床实验室药物.体外诊断医疗设备.由制造商证实的用户质量控制程序

이 규격은 체외 진단 의료 기기의 제조자가 사용자에게 권장하는 정도 관리 절차의 타당성 확

Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer

DIN EN ISO 22870:2006 护理点试验(POCT).质量和能力要求

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006); English version of DIN EN ISO 22870:2006-06

ISO/TR 18112:2006 临床实验室试验和在实验室条件下诊断试验系统.在实验室条件下诊断用的专用医学设备.制造商提供信息的管理要求概要

This Technical Report summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included. Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. IVD medical devices for self-testing are excluded.

Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer

GOST R ISO 17511-2006 体外诊断医疗装置.生物样品的定量测量.已知校正器及控制材料值的计量跟踪性

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials

GOST R ISO 18153-2006 体外诊断用医疗器械.生物试样数量的测定.校准器和控制材料中的酶的催化浓度的指定值的计量可追溯性

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials

NF S92-036:2004 体外诊断医疗装置.收集来自于人体的试样(血液除外)用一次性容器

In vitro diagnostic medical devices - Single-use receptables for the collection of specimens, other than blood, from humans.

DIN EN 14254:2004 体外诊断医疗装置.收集来自于人体的试样(血液除外)用一次性容器

This standard specifies requirements and test methods for evacuated and non-evacuated single-use specimen receptacles intended by their manufacturers for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN 14820.#,,#

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans; German version EN 14254:2004

DIN EN 14136:2004 体外诊断检验程序性能评估的外部质量评估方案的使用

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004

BS ISO 15198:2004 临床实验室药物 体外诊断医疗设备 由制造商确认的用户质量控制程序

This International Standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. This International Standard applies to all in vitro diagnostic medical devices.

Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

BS EN 14254:2004 体外诊断医疗设备.取自于人体的不包括血液的样品用一次性容器

This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN 14820. NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test. This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

ISO 15198:2004 临床实验室药物.体外诊断医疗设备.由制造商证实的用户质量控制程序

This International Standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. This International Standard applies to all in vitro diagnostic medical devices.

Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

EN 14254:2004 体外诊断医疗装置.收集来自于人体的试样(血液除外)用一次性容器

This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles,intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN 14820.NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents,when being opened, this standard does not specify a test procedure for this because it has not

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

BS EN 14136:2004 体外诊断检验程序的性能评定中外部质量评定方案的使用

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: — scheme design and organisation; — identification of procedures (IVD MDs) used by the participant; — classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN 14136:2004 体外诊断检验程序性能评估的外部质量评估方案的使用

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:? scheme design and organisation;? identification of procedures (IVD MDs) used by the participant;? classification and evaluation of data.NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures