C04 基础标准与通用方法 标准查询与下载

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

DIN 58940-9:2007 医用微生物学.病原体对抗菌剂的敏感性试验.第9部分:抑菌圈直径和最低抑制浓度相关性的回归分析

Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 9: Regression line analysis for the correlation of inhibition zone diameter (IZD) and minimum inhibitory concentration (MIC); Text in German and English

DIN 58940-31:2007 医学微生物学.微生物病源细菌对杀菌剂敏感性的检测.第31部分:敏感性补充方法.德文和英文本

Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 31: Supplementing methods for susceptibility testing; Text in German and English

KS P 1600-2007 细胞基础治疗的安全性试验一般通用标准

이 규격은 환자와 사용자 모두에 대한 기본적인 안전을 보장하기 위하여 세포기반치료제 시험에

General guideline of safety test for the cell based therapeutic substances

NF S98-101-1:2007 保健产品的灭菌.乙撑氧.第1部分:医疗设备灭菌过程开发、确认和常规控制的要求

Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

NF S92-060:2007 医学实验室.质量和能力的特殊要求

Medical laboratories - Particular requirements for quality and competence.

NF S99-501-6:2007 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.

DIN EN ISO 15189:2007 医学实验室.质量和资格的特殊要求

1.1 This International Standard specifies requirements for quality and competence particular to medical laboratories. 1.2 This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007); English version of DIN EN ISO 15189:2007-08

ANSI/ASTM E2457:2007 保健信息学标准术语

This standard is intended to name and document the principal concepts, and their associated terms, that are utilized in the Healthcare Information Domain and all of its specialized subdomains. It is applicable to all areas of healthcare about which information is kept or utilized. It is intended to complement and utilize those concepts already identified by other national or international bodies. It will identify alternate accepted terms for the same concept or its elected term. Its terms inteneded to clarify and simplify usage in the dialog and documentation about concepts, processes and data used to schedule, conduct, and manage all phases of healthcare.

Standard Terminology for Healthcare Informatics

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

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

DIN-Fachbericht CEN/TR 15592:2007 医疗卫生服务.质量管理系统.性能改善用医疗卫生服务中EN ISO 9004-2000的使用指南

Health services - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance improvement

NF T90-461/A2:2007 水质.微生物学.培养基的质量控制

Water quality - Microbiology - Quality control of culture media.

ANSI/ASTM E1714:2007 通用保健识别符特性指南(14.01)

This guide covers a set of requirements outlining the properties required to create a universal healthcare identifier (UHID) system. Use of the UHID is expected to initially be focused on the population of the United States but there is no inherent limitation on how widely these identifiers may be applied. This guide sets forth the fundamental considerations for a UHID that can support at least four basic functions effectively: 1.2.1 Positive identification of patients when clinical care is rendered; Automated linkage of various computer-based records on the same patient for the creation of lifelong electronic health care files; Provision of a mechanism to support data security for the protection of privileged clinical information; and The use of technology for patient records handling to keep health care operating costs at a minimum. 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.

The Properties of a Universal Healthcare Identifier, Guide for (14.01)

ISO 15189:2007 医学实验室.质量和能力的特殊要求

1.1 This International Standard specifies requirements for quality and competence particular to medical laboratories. 1.2 This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

Medical laboratories - Particular requirements for quality and competence

ASTM E2562-07 用疾病控制中心(CDC)生物膜反应器量化随高剪切连续流动生长的铜绿假单胞菌生物膜的标准试验方法

Bacteria that exist in biofilm are phenotypically different from suspended cells of the same genotype. Research has shown that biofilm bacteria are more difficult to kill than suspended bacteria (5). Laboratory biofilms are engineered in growth reactors designed to produce a specific biofilm type. Altering system parameters will correspondingly result in a change in the biofilm. For example, research has shown that biofilm grown under high shear is more difficult to kill than biofilm grown under low shear (6). The purpose of this test method is to direct a user in the laboratory study of a Pseudomonas aeruginosa biofilm by clearly defining each system parameter. This test method will enable an investigator to grow, sample, and analyze a Pseudomonas aeruginosa biofilm grown under high shear. The biofilm generated in the CDC biofilm reactor is also suitable for efficacy testing. After the 48 h growth phase is complete, the user may add the treatment in situ or harvest the coupons and treat them individually.1.1 This test method specifies the operational parameters required to grow a repeatable Pseudomonas aeruginosa biofilm under high shear (1). The resulting biofilm is representative of generalized situations where biofilm exists under high shear rather than representative of one particular environment.1.2 This test method uses the Centers for Disease Control and Prevention (CDC) biofilm reactor. The CDC biofilm reactor is a continuously stirred flow reactor with high wall shear. Although it was originally designed to model a potable water system for the evaluation of Legionella pneumophila (2), the reactor is versatile and may also be used for growing and/or characterizing biofilm of varying species (3 and 4).1.3 This test method describes how to sample and analyze biofilm for viable cells. Biofilm population density is recorded as log colony forming units per surface area.1.4 Basic microbiology training is required to perform this test method. 1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.6 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 Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor

ASTM E1588-07e1 用扫描电子显微镜法/能量色散X射线光谱测定法的射击残留物分析用标准指南

1.1 This guide covers the analysis of gunshot residue (GSR) by scanning electron microscopy/energy-dispersive X-ray spectrometry (SEM/EDS) by manual and automated methods. The analysis may be performed manually, with the operator manipulating the microscope controls and the EDS system software, or in an automated fashion, where some amount of the analysis is controlled by pre-set software functions.1.2 Since software and hardware formats vary among commercial systems, guidelines will be offered in the most general terms possible. The software manual for each system should be consulted for proper terminology and operation. 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 Guide for Gunshot Residue Analysis by Scanning Electron Microscopy/Energy Dispersive X-ray Spectrometry

ANSI/HL7 V3 CGPED, R 1-2007 HL7版本3标准:临床遗传学.血统.第1次发布

The Pedigree Topic deals with family history information. A number of family history applications are in use by healthcare professionals and patients, each having its own proprietary data format, thus making it difficult to exchange information between programs. By using this HL7 standard, disparate family history applications will be able to exchange an individual's family history as well as send it to an EHR system. The Pedigree Topic's static model has an optional reference to an elaborate representation of genetic data through the utilization of the Genotype Topic's models.

HL7 Version 3 Standard: Clinical Genomics; Pedigree, Release 1

ASTM E1588-07 用扫描电子显微镜法/能量色散X射线光谱测定法的射击残留物分析用标准指南

1.1 This guide covers the analysis of gunshot residue (GSR) by scanning electron microscopy/energy-dispersive X-ray spectrometry (SEM/EDS) by manual and automated methods. The analysis may be performed "manually," with the operator manipulating the microscope controls and the EDS system software, or in an automated fashion, where some amount of the analysis is controlled by pre-set software functions requiring little or no operator intervention.1.2 Since software and hardware formats vary among commercial systems, guidelines will be offered in the most general terms possible. The software manual for each system should be consulted for proper terminology and operation.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 Guide for Gunshot Residue Analysis by Scanning Electron Microscopy/ Energy Dispersive X-ray Spectrometry

ASTM D7372-07 熟练试验程序结果的分析和说明用标准指南

1.1 This guide covers the analysis and interpretation of proficiency test (PT) program results. For participants in interlaboratory proficiency test (or crosscheck, check scheme, etc.) programs, this guide describes procedures for assessing participants' results relative to the PT program results and potentially improving the laboratory's testing performance based on the assessment findings and insights (see ). For the committees responsible for the test methods included in interlaboratory proficiency testing programs, this guide describes procedures for assessing the industry's ability to perform test methods, and for potentially identifying needs for test method improvement (see 6.2).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 Guide for Analysis and Interpretation of Proficiency Test Program Results

ASTM E2522-07(2013) 健康分类用质量指标的标准指南

1.1 This international standard is intended to document principal ideas which are necessary and sufficient to assign value to a classification. The standard will serve as a guide for governments, funding agencies, terminology developers, terminology integration organizations, and the purchasers and users of classification systems toward improved terminological development and recognition of value in a classification. It is applicable to all areas of health about which information is kept or utilized. Appropriately, classifications should be evaluated within the context of their stated scope and purpose. It is intended to complement and utilize those notions already identified by other national and international standards bodies. This standard explicitly refers only to classifications. This international standard will also provide classification developers and authors with the quality guidelines needed to construct useful, maintainable classifications. These tenets do not attempt to specify all of the richness which can be incorporated into a classification. However, this standard does specify the minimal requirements, which if not adhered to will assure that the classification will have limited generalizability and will be very difficult if not impossible to maintain. We have used the word “Shall” to indicate mandatory requirements and the word “Should” to indicate those requirements which we feel are desirable but may not be widely achievable in current implementations. Classifications, which do not currently meet these criteria, can be in compliance with this standard by putting in place mechanisms to move toward these goals. This standard will provide classification developers with a sturdy starting point for the development of useful classifications. This foundation serves as the basis from which classification developers will build robust concept systems.

Standard Guide for Quality Indicators for Health Classifications