11.100.10 标准查询与下载

NF S92-010-4:2010 体外诊断医疗器械.制造商提供的信息(标签).第4部分:自测体外诊断试剂

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.

NF S92-010-5:2010 体外诊断医疗器械.制造商提供的信息(标签).第5部分:自测体外诊断仪器

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.

BS EN ISO 18113-1:2009 体外诊断医疗器械.制造商提供的信息(标签).术语、定义和一般要求

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements

KS P ISO TR 18112:2009 临床实验室试验和在实验室条件下诊断试验系统.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

이 기술 보고서는 전문가용 IVD 의료기기와 관련하여 제조업체가 제공하는 정보에 대한 규제

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

ISO 18113-1:2009 体外诊断医疗器械.制造商提供的信息(标签).第1部分:术语、定义和一般要求

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

ISO 18113-5:2009 体外诊断医疗器械.制造商提供的信息(标签).第5部分:自测用体外诊断仪器

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

ISO 18113-4:2009 体外诊断医疗器械.制造商提供的信息(标签).第4部分:自测用体外诊断剂

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

ISO 18113-2:2009 体外诊断医疗器械.制造商提供的信息(标签).第2部分:专业用途的体外诊断试剂

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

ISO 18113-3:2009 体外诊断医疗器械.制造商提供的信息(标签).第3部分:专业用体外诊断仪器

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use

DIN EN ISO 15194:2009 医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(ISO 15194:2009),DIN EN ISO 15194:2009-10的英文版本

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); English version of DIN EN ISO 15194:2009-10

DIN EN ISO 15193:2009 体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO 15193:2009),DIN EN ISO 15193:2009-10的英文版本

This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, "international measurement standard" designates a material standard. The term "international standard" is used by WHO for reference materials.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); English version of DIN EN ISO 15193:2009-10

BS EN ISO 15193:2009 体外诊断医疗器械.生物源样品的数量测量.基准测量规程的内容和表示要求

This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, “international measurement standard” designates a material standard. The term “international standard” is used by WHO for reference materials.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

BS EN ISO 15194:2009 体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation

ISO 15193:2009 体外诊断医疗器械.生物有机体试样的数量测量.内容要求和基准测量过程介绍

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

ISO 15194:2009 体外诊断医疗设备.生物原始试样数量测量.认证参考材料和证明文件的内容要求

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation

ASTM F2721-09(2014) 临界尺寸节段性骨缺损的临床前体内评估的标准指南

4.1 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. 4.2 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. 4.3 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. 4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58. 4.5 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. 4.6 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 performa......

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

ASTM F2721-09 节段性骨缺损临界粒度的活体潜伏期评定的标准指南

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

SNI ISO 15197:2009 体外诊断试验系统. 糖尿病管理用血糖自测监测系统的要求

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

SNI ISO 15198:2009 临床实验室医学 体外诊断医疗器械 对制造商向用户提供质量控制程序的验证

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

ANSI/ATCC ASN-0001-2009 体外测定法测定炭疽霉素活动的标准化工作

This ASN-0001 document provides a standardization of reagents and procedures for handling and assaying the in vitro activities of individual toxin components (PA, LF, EF) and the activities of the bipartite toxins (LT, ET).

Standardization of in Vitro Assays to Determine Anthrax Toxin Activities