11.100 实验室医学 标准查询与下载
共找到 753 条与 实验室医学 相关的标准，共 51 页
Biological evaluation of medical devices — Part 2：Animal welfare requirements
- ICS
- 11.100
- CCS
- 发布
- 2004-04-20
- 实施
Biological evaluation of medical devices – Part 1：Evaluation and testing
- ICS
- 11.100
- CCS
- 发布
- 2004-04-20
- 实施
本标准规定在生物试验时使用动物的最低要求。本标准适用于脊椎动物的实验，但不适用于较未分化动物的实验，或在分离的组织与器官上进行的实验。本标准亦提供针对以下目的之建议：包括在生物兼容性试验时减少使用动物数目，与当可能时避免使用动物。本标准同时希望(1) 建立指
Biological evaluation of medical devices — Part 2：Animal welfare requirements
- ICS
- 11.100
- CCS
- 发布
- 2004-04-20
- 实施
- 2004-04-20
本标准适用于评估医疗器材与接触特性之一般规定。本标准涵盖：(1) 依据CNS 14393-1〔医疗器材生物性评估-第一部分：评估与试验〕所定义之用途及使用时间长短，对与血液接触的医疗及牙科器材进行分类。(2) 基本原理用于评估医疗器材与血液接触作用。(3) 依据特定分类结构性选
Biological evaluation of medical devices – Part 4：Selection of tests for interactions with blood
- ICS
- 11.100
- CCS
- 发布
- 2004-04-20
- 实施
- 2004-04-20
本标准规定(1) 医疗器材生物性评估之通则；(2) 依据与身体接触之性质及时间长短的医疗器材分类；(3) 适当试验方法的选择。
Biological evaluation of medical devices – Part 1：Evaluation and testing
- ICS
- 11.100
- CCS
- 发布
- 2004-04-20
- 实施
- 2004-04-20
Provides general requirements for evaluating the interactions of medical devices with blood. It describes a classification of medical and dental devices that are intended for use in contact with blood, the fundamental principles governing the evaluation of the interaction of devices with blood, the rationale for structured selection of tests according to specific categories and the principles and scientific basis of these tests. It 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
- ICS
- 11.100
- CCS
- C37
- 发布
- 2004-04-08
- 实施
本标准规定了干化学尿液分析仪的要求、试验方法、标志、标签和说明书、包装、运输和贮存等内容。 本标准适用于利用光反射原理对尿试纸条进行分析的干化学尿液分析仪。
General technical requirements for urine analyzer
- ICS
- 11.100
- CCS
- C44
- 发布
- 2004-03-23
- 实施
- 2005-01-01
Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. It includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.
Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
- ICS
- 11.100
- CCS
- C37
- 发布
- 2004-03-05
- 实施
This International Standard specifies requirements for quality and competence particular to medical laboratories
Medical laboratories - Particular requirements for quality and competence
- ICS
- 11.100
- CCS
- 发布
- 2004
- 实施
The preservation of TEMPs can affect their subsequent characteristics (for example, structural, mechanical, biological, and metabolic properties). The aspects of preservation that can most adversely affect these characteristics include, but are not limited to, cooling, cooling rates, warming, warming rates, freezing, freezing rates, thawing, thawing rates, preservation medium, and pre- and post-processing. The intent of this guide is to outline procedures that can minimize the loss or degradation of the desired characteristics of the TEMPs.1.1 This guide covers the development of standards related to the preservation of cells, tissues, and tissue engineered medical products (TEMPs). Preservation techniques include freezing, vitrification, and hypothermic preservation. This guide discusses preservation, including issues of pre-preservation processing, the process of preservation, storage, transport, recovery, post-preservation processing, quality assurance, and process control.1.2 This guide contains general guidelines for the preservation of cells, tissues, and tissue engineered medical products (TEMPs) and will identify more specific parameters relevant to the preservation of TEMPs.1.3 This guide does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.1.4 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 requirements prior to use.
Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs)
- ICS
- 11.100
- CCS
- C04
- 发布
- 2004
- 实施
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 with extracts of a device, and/or 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
- ICS
- 11.100
- CCS
- 发布
- 2003-09-12
- 实施
- 2003-09-12
Specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. In addition, it includes pyrogenicity testing.
Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ICS
- 11.100
- CCS
- 发布
- 2003-09-12
- 实施
- 2003-09-12
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; and the selection of appropriate tests.
Biological evaluation of medical devices Part 1: Evaluation and testing
- ICS
- 11.100
- CCS
- 发布
- 2003-09-12
- 实施
- 2003-09-12
本部分规定了血细胞分析仪用稀释液的分类与命名、要求、试验方法、检验规则、标志、包装、运输和贮存。 本部分适用于电阻抗法血细胞分析仪用稀释液。
Regents for hematology analyzer use-Part 3:Diluent
- ICS
- 11.100
- CCS
- C44
- 发布
- 2003-06-20
- 实施
- 2004-01-01
本部分规定了血细胞分析仪应用试剂溶血剂的命名与分类、要求、试验方法、检验规则、标志、标签、使用说明书、包装、运输、贮存。 本部分适用于电阻抗法原理的血细胞分析仪用溶血剂。
Regents for hematology analyzer use-Part 2:Hemolysin
- ICS
- 11.100
- CCS
- C44
- 发布
- 2003-06-20
- 实施
- 2004-01-01
本部分规定了血细胞分析仪应用试剂清洗液的命名与分类、要求、试验方法、检验规则、标志、标签、使用说明书、包装，运输、贮存。 本部分适用于血细胞分析仪用清洗液。
Regents for hematology analyzer use-Part 1:Rinse
- ICS
- 11.100
- CCS
- C44
- 发布
- 2003-06-20
- 实施
- 2004-01-01
General requirements for the laboratories for gene detection and identification
- ICS
- 11.100
- CCS
- C05
- 发布
- 2003-03-17
- 实施
- 2003-09-01
Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
- ICS
- 11.100
- CCS
- 发布
- 2002-06-11
- 实施
Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
- ICS
- 11.100
- CCS
- 发布
- 2002-06-11
- 实施
Procedure of micro-complement fixation test for bovine Q fever
- ICS
- 11.100
- CCS
- C04
- 发布
- 2002-03-15
- 实施
- 2002-09-01
