11.100 实验室医学 标准查询与下载

SN/T 1084-2002 副结核病皮内变态反应操作规程

Procedure of intradermal test for paratuberculosis

SN/T 1085-2002 副结核病补体结合试验操作规程

Procedure of complement fixation test for paratuberculosis

EN 13640:2002 在生物体外诊断剂的稳定性测试

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the - determination of IVD reagent shelf-life including transport stability; -determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability); - monitoring of stability of IVD reagents already placed on the market; - verification of stability after IVD reagent modifications that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.

Stability Testing of in Vitro Diagnostic Reagents

WS/T 209-2001 克山病疗效判定标准

本标准规定了克山病的疗效判定。 本标准适用于成人及小儿克山病。

Criteria for evaluating therapeutic effect of keshan disease

WS/T 212-2001 血清中氟化物的测定 离子选择电极法

本标准规定了用离子选择电极法测定血清中无机氟化物的浓度。 本标准适用于各种人群及动物血清中无机氟化物浓度的测定。

Determination for fluoride in serum.Ion selective electrode method

WS/T 211-2001 地方性砷中毒诊断标准 （2015年11月1日起废止）

本标准规定了地方性砷中毒临床诊断及分度标准。 本标准适用于地方性砷中毒流行病学调查、防治及监测工作中临床诊断。不适用于急性或亚急性砷中毒。

Standard of diagnosis for endemic arsenism

WS/T 210-2001 克山病病理诊断标准

本标准规定了克山病的病理诊断标准与诊断原则。 本标准适用于克山病个案的病理诊断及与其他心脏病的鉴别。

Standard of pathologic diagnosis of Keshan disease

WS/T 208-2001 氟斑牙临床诊断标准（已废止）

本标准规定了氟斑牙临床诊断分类指征。 本标准适用于人类恒齿，乳齿氟斑牙的临床分类诊断，预防效果判定，环境标准制定，氟化物中毒的其他研究工作等等。

Clinical diagnostic standard for dental fluorosis

ASTM E1246-88(1995) 临床实验室计算机系统可靠性报告的标准实施规程

Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems

ASTM F2147-01 豚鼠标准实践:接触性过敏原的分裂辅助和封闭补片测试

1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References.1.3 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 Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

NP EN ISO 10993-9:2001 医学设备的生物性评价．第9部分：降解产品的识别系统（ISO 10993-9-1999）

Esta Parte da ISO 10993 indica os princípios gerais para a avalia??o sistemática da biodegrada??o, potencial e observada, dos dispositivos médicos e para a concep??o e desempenho dos estudos de biodegrada??o. Esta Parte da ISO 10993 n?o é aplicável a: a) produtos de engenharia de tecidos viáveis; b) metodologias para a produ??o de produtos de degrada??o por processos mec?nicos. Metodologias para a produ??o deste tipo de produtos de degrada??o, est?o descritas em normas específicas de produtos, quando disponíveis; c) componentes lexíviáveis que n?o sejam produtos de degrada??o. Quando as normas de produtos fornecem metodologias (específicos de produto), para a identifica??o e quantifica??o de produtos de degrada??o, devem ser consideradas como alternativas.

Biological evaluation of medical devices Part 9:Framework for identification and quantification of potential degradation products(ISO 10993-9-1999)

ASTM E1811-96(2001) 大鼠和小鼠致癌性研究的标准试验方法

Standard Test Method for Oncogenicity Study in Rats and Mice

CAN/CSA-ISO 10993-5-01:2001 医疗器械生物学评价 第5部分：体外细胞毒性试验

This National Standard of Canada is equivalent to International Standard ISO 10993-5:1999. 1 Scope 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 either directly or through diffusion a) with extracts of a device, and/or b) 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

ASTM E1639-01 临床实验室信息管理系统功能要求标准指南

1.1 This guide covers the capabilities needed for a Clinical Laboratory Information Management System (CLIMS). It was written so that both the vendors or developers of CLIMS and laboratory managers would have a common understanding of the requirements and logical structure of a laboratory data system. This guide will also help answer many of the questions faced by designers of CLIMS and provide more uniformity in the way that requirements are expressed from one laboratory to another. It is therefore applicable to users who are involved with acquiring or operating a CLIMS.

Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems

ASTM E1246-01 临床实验室计算机系统可靠性报告的标准规程

1.1 This practice describes a system for collecting data, maintaining records, and reporting on the reliability of operating clinical laboratory computer systems. The reliability measure will be achieved by documenting the number, severity, cause, impact, and duration of the failures that a system experiences. This practice can be implemented with paper forms or computer records. The type of computer systems under consideration are those designed to assist the overall workflow of the laboratory, and generally include some or all of the functions of patient biographical data, test ordering, draw list printing, specimen check-in, workstation work list printing, test result entry, result verification, patient report printing, data archiving, quality control, and management report printing. This practice is applicable to all types of clinical laboratories, including major medical centers, teaching hospitals, community hospitals, referral clinics, emergency centers, health care maintenance organizations, specialty institutions, commercial laboratories, and private practices. The significance of portions of the reliability measure may be different in the different settings, but the measurement procedure is the same. This practice is not intended for computers inside instruments or for those systems designed to support a single workstation, although portions of this practice may be applicable.1.2 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 Practice for Reporting Reliability of Clinical Laboratory Computer Systems

ASTM F2147-01(2016) 豚鼠的标准实施规程: 用于接触性过敏原的分片辅助和封闭斑贴试验

5.1 In selecting a material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction under relevant exposure conditions. Extractable chemicals produced by skin contact or during physiological exposures may cause allergic reactions. Therefore, this practice provides for evaluations of solid or semisolid dosage forms using material extracts or direct evaluation of the test article. The rationale for this animal model is based on the fact that the guinea pig has been shown to be an appropriate animal model for predicting human contact dermatitis. Its tractable nature, its availability from reputable suppliers, the historical database of information already acquired using this species, and the correlation of such results to data on known human allergens, all contribute to its widespread use for allergenicity studies (1-5).4 5.2 The need for sensitization procedures other than the maximization test (Practice F720) is based on: (1) the need for a route of exposure more similar to use conditions; (2) concern over the use of adjuvant because of its recruitment of cell types to the test site which are not typically involved in immunologic reactions, and because of the discomfort this causes in the animals; (3) absence of a proper FCA-irritant control group in the traditional maximization design; and (4) the frequency of false positives often encountered with the GPMT. Both of these tests are internationally accepted (1). 1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. 1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 limitations prior to use.

Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

ASTM E2146-01 用聚合酶链反应技术探测人体免疫缺乏病毒HIV-1的核酸类的标准指南

This guide is intended for use in any laboratory utilizing PCR to amplify DNA sequences or RT-PCR to amplify RNA sequences of HIV from cells, tissues, or body fluids such as whole blood, sera and plasma. The criteria used for the identification and evaluation of the amplification reactions should be administered by an individual trained in the use of molecular biological and microbiological techniques associated with PCR and HIV.1.1 This guide covers considerations, criteria, principles and recommendations that should be helpful when developing, utilizing, or assessing PCR protocols to amplify and detect DNA (by PCR) or RNA [by reverse transcriptase PCR (RT-PCR)] from HIV. This guide is not a specific protocol for the detection of HIV. It is intended to provide information that will assist the user in obtaining quality and reliable data. The guide is closely related to and should be used concurrently with the general PCR guideline E 1873.1.2 This guide has been developed for use in any molecular biology or biotechnology laboratory. This includes but is not limited to clinical and diagnostic laboratories involved with HIV detection.1.3 This guide does not cover details of the various methods such as gel electrophoresis, that can be utilized to identify PCR-amplified HIV nucleic acid sequences, nor does it cover details of instrument (thermocycler) calibration.1.4 This guide does not cover specific variations of the basic PCR or RT-PCR technology (e.g., quantitative PCR, multiplex PCR and in situ PCR).1.5 This guide does not address the additional considerations necessary for the performance and validation of a quantitative PCR test for HIV.Note 18212;Warning: Laboratory work involving certain clinical specimens and microorganisms can be hazardous to personnel.Note 28212;Precaution: Biosafety Level 2 facilities are recommended for potentially hazardous work (2), and many laboratories use Biosafety Level 3 facilities when working with HIV. Safety guidelines should be adhered to according to NCCLS M29-A and other recommendations (2).

Standard Guide for Detection of Nucleic Acid Sequences of the Human Immunodeficiency Virus HIV-1 by the Polymerase Chain Reaction Technique

ASTM E1045-00 Sahli血红蛋白吸管的标准规范

1.1 This specification covers reusable pipets calibrated "to contain" 20 cmm of whole blood and used for hemoglobin determinations.

Standard Specification for Pipet, Sahli Hemoglobin

NP EN ISO 10993-16:2000 医学设备的生物性评价．第16部分：可滤取物质以及降解物质的毒性分析（ISO 10993-16-1997）

Esta parte da ISO 10993 indica os princípios como devem ser concebidos e efectuados os estudos de toxicocinética relevantes para os dispositivos médicos. O Anexo A descreve as considera??es relativos à inclus?o dos estudos de toxicocinética na avalia??o biológica dos dispositivos médicos.

Biological evaluation of medical devices Part 16:Toxicokinetic study design for degradation products and leachables(ISO 10993-16-1998)

NP EN ISO 10993-2:2000 医学设备的生物性评价．第2部分：动物设备的相关要求（ISO 10993-2-1992）

Esta parte da ISO 10993 especifica os requisitos mínimos para a utiliza??o de animais em ensaios biológicos. Esta parte da ISO 10993 destina-se igualmente a: a) estabelecer directrizes que permitem aos cientistas respeitar a vida animal em geral; b) reduzir o número de experiências em animais e o número de animais submetidos a experiências, entre outras formas, através da optimiza??o das experiências que já s?o efectuadas; c) minimizar o sofrimento e manter a qualidade de vida dos animais utilizados nas experiências. Esta parte de ISO 10993 aplica-se às experimenta??es efectuadas em vertebrados. N?o se aplica a experimenta??es efectuadas em animais menos diferenciados; nem é aplicável aos trabalhos experimentais efectuados em tecidos isolados e em órg?os. Esta parte da ISO 10993 faz igualmente recomenda??es relativas ao apoio para a redu??o do número utilizado de animais para ensaios de biocompatibilidade, e quando possível, na aboli??o das experiências com animais, nesta área.

Biological evaluation of medical devices Part 2:Animal welfare requirements(ISO 10993-2-1992)