C04 基础标准与通用方法 标准查询与下载

GOST R 53079.2-2008 临床实验室技术.检验科试验质量保证.第2部分:临床诊断实验室质量提高用指南.典型模型

Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model

GOST R 53133.1-2008 临床实验室技术.检验科试验的质量控制.第1部分:临床诊断实验室内分析物测量值结果的允许误差限值

Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories

GOST R 53133.2-2008 医学实验室技术.检验科试验的质量控制.第2部分:检验科试验使用控制材料的计量学方法的实验室内质量控制规范

Medical laboratory technologies. Quality control of clinical laboratory tests. Part 2. Rules for intra-laboratory quality control of quantitative methods of clinical laboratory tests using control materials

GOST R 52623.1-2008 简易医疗服务功能检查的技术

Technologies of simple medical services for functional check-up

ANSI/HL7 EHRCHFP, R 1-2008 HL7 EHR儿童健康功能轮廓.版本1

HL7 EHR Child Health Functional Profile, Release 1

GOST R 53133.3-2008 临床实验室技术.检验科试验的质量控制.检验科调查的质量控制用材料描述

Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations

ANSI/MEDBIQ LO.10.1-2008 卫生保健知识对象元数据

Healthcare Learning Object Metadata extends the IEEE Learning Object Metadata standard for describing educational resources. Healthcare specific extensions include metadata relevant to learning objects, assets, and events, including credit information, target audience, content expiry date, date and location information for live events, modality, commercial support information, disclosures, clinical history, magnification, orientation, radiograph type, and specimen type, among others. It also supports referencing medical terminologies.

Healthcare Learning Object Metadata

ASTM E2525-08 评定纳米粒子材料费对老鼠粒细胞巨噬细胞集落形成影响的标准试验方法

Stem cells of hematopoietic origin are pluripotential and may be particularly sensitive to the effects of stimulation by nanoparticulate materials. The effect of particles on macrophage responses has an extensive history and can be assessed by Practice F 1903. The test method described here will assess the effect on stem cells which can be progenitor cells to the macrophage line.1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution on granulocyte-macrophage colony-forming units. 1.2 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted. 1.3 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration in medical applications. 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 Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies

GOST R 53133.4-2008 医学实验室技术.检验科试验的质量控制.第4部分:医疗机构活动中实验室准备效率的临床严密检查的执行规则

Medical laboratory technologies. Quality control of clinical laboratory tests. Part 4. Rules for conducting of clinical audit of efficiency of laboratory provision of medical institution activity

BS PAS 131:2007 纳米技术的医疗、健康和个人护理设备用术语

Terminology for medical, health and personal care applications of nanotechnology

BS PAS 132:2007 生物纳米接口用术语

Terminology for the bio-nano interface

BS EN ISO 10993-12:2007 医疗器械的生物学评估.样品制备和参考材料

ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses: test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of and requirements for reference materials; preparation of extracts. ISO 10993-12:2007 is not applicable to materials or devices containing live cells.

Biological evaluation of medical devices - Sample preparation and reference materials

PAS 131-2007 纳米技术应用在医疗、健康和个人护理的术语

This Publicly Available Specification (PAS) lists terms and definitions used in or associated with naming or describing applications of nanotechnologies and nanomaterials for medicinal products, medical devices, cosmetics, sunscreens and other personal care products. This PAS is intended for use by technologists, regulators, non-governmental organizations (NGOs), consumer organizations, members of the public and others with an interest in the medical, health and personal care applications of nanotechnology.

Terminology for medical, health and personal care applications of nanotechnology

DIN-Fachbericht 157:2007 临床相关酵母用符合DIN58940标准的氟康唑最低抑制浓度(MIC)和抑菌圈直径(IZD)评估标准的基本原理和对照菌株用氟康唑的控制极限规范

Rationale for assessment criteria for minimum inhibitory concentration (MIC) and inhibition zone diameter (IZD) of fluconazole according to DIN 58940 for clinically relevant yeasts, and specification of fluconazole control limits for control strains

KS I ISO 14644-1:2007 洁净室和相关控制环境.第1部分:空气洁净度分级

이 규격은 클린룸 및 관련된 제어환경에서의 공기 청정도 등급 분류를 다룬다. 이 규격에 따

Cleanrooms and associated controlled environments－Part 1：Classification of air cleanliness

KS I ISO 14644-2:2007 洁净室和相关控制环境.第2部分:与KS M ISO 14644-1连续相配位的检测和监控规范

이 규격은 클린룸 또는 청정 구역이 KS M ISO 14644-1에서 정한 공기 중 입자의

Cleanrooms and associated controlled environments－Part 2：Specifications for testing and monitoring to prove continued compliance with KS M ISO 14644－1

KS I ISO 14644-4:2007 洁净室和相关控制环境.第4部分:设计、建造和启用

이 규격은 클린룸의 설계와 공사에 대한 요구 조건을 규정하지만 이 요구 조건을 맞추기 위한

Cleanrooms and associated controlled environments－Part 4：Design, construction and start-up

SN/T 1861-2007 出入境口岸突发公共卫生事件应急处理规程总则

General rules for the rapid response to the public health emergency occurred at entry-exit ports

DIN EN ISO 11140-1 Berichtigung 1:2007 卫生保健产品的灭菌.化学指示剂.第1部分:一般要求.技术勘误DIN EN ISO 11140-1-2006

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005, Corrigenda to DIN EN ISO 11140-1:2006-04

DIN 58940-6:2007 医用微生物学.病原体对抗菌剂的敏感性测试.第6部分:用琼脂稀释法测定最小抑制浓度

This standard specifies a test method for the determination of the moisture content of sanitary papers.

Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 6: Determination of the minimum inhibitory concentration (MIC) with the agar dilution method; Text in German and English