C04 基础标准与通用方法 标准查询与下载

BIP 3040-2005 SMART检查DDA存取检查软件

SMART audit DDA access audit software

BIP 3038-2005 CEDREC 卫生和安全专业

Covers business related health & safety legislation. Acts of Parliament and statutory instruments for England, Wales and Scotland are summarized and also EC regulations, directives and proposals. As well as the plain English summaries (also included in the standard version) CEDREC health & safety professional includes the consolidated full text of the English, Welsh and Scottish legislation and HSE Approved Codes of Practice (ACOPs).

CEDREC health & safety professional CD-ROM

BS EN 12381:2005 健康信息学.健康护理特殊问题的时间标准

This document specifies a set of representational primitives and semantic relations required for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time, and the exchange of time-related information that is expressed explicitly. This document is applicable to: 1) developers of medical information systems in which the need is felt to have explicit time-related concepts for internal organization (e.g. temporal data bases, temporal reasoning systems); 2) information modellers or knowledge engineers building models for the systems mentioned in (1); 3) experts involved in the development of semantic standards on precise subdomains in health care where time-related information need to be covered, (e.g. in the study of Pathochronology, i.e. the discipline dealing with the time course of specific diseases); 4) developers of interchange formats for messages in which time-related information is embedded. This document is not intended to be used directly for: 1) representing what is true in time; 2) reasoning about time; 3) representation of metrological time (which is covered in other standards).

Health informatics - Time standards for healthcare specific problems

ASTM E1954-05 进行欺骗的精神生理探测(测谎器)的研究标准规程

1.1 This practice covers essential and recommended elements in the design, conduct, and reporting of research on psychophysiological detection of deception (polygraph). Analog and field research are addressed separately. 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 Conduct of Research in Psychophysiological Detection of Deception (Polygraph)

ASTM F2097-05 医疗产品原包装的设计和评定的标准指南

1.1 This guide provides directions for the design and evaluation of primary packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.1.2 This guide provides a compendium of test methods. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.1.4 This guide does not assess the product to be packaged; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

Standard Guide for Design and Evaluation of Primary Packaging for Medical Products

ANSI/NSF 49(i9)-2005 II级(层流)生物安全室

Review of standard correcting significant figures between english and metric conversions.

Class II (laminar flow) biosafety cabinetry

ASTM F2475-05 医疗器件包装材料的生物可兼容性评价的标准指南

The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.1.1 This guide provides information to determine the appropriate testing for biocompatibility of packaging materials used to contain a medical device.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 to determine the applicability of regulatory limitations prior to use.

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

BS EN ISO 10993-12:2004 医疗器械的生物学评定.样品制备和参照物品

Biological evaluation of medical devices - Sample preparation and reference materials

YY/T 0501-2004 尿液分析质控物

本标准规定了屎液分析质控物的分类、要求.试验方法，标志、标签和说明书.包装.运输和贮存等内容。 本标准适用于尿液分析质控物 。质控物主要是用于干化学尿液分析试条和干化学尿液分析仪质量状态的控制。

Urinalysis control

DIN 58375:2004 等离子储存.定义、要求和试验

This standard specified requirements and tests under storageconditions by more than -30?for bloodplasma.

Plasma storage - Definitions, requirements, testing

ISO 14644-5:2004 洁净室和相关控制环境.第5部分:操作

This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

Cleanrooms and associated controlled environments - Part 5: Operations

DIN 13080 Bb.4:2004 将医院按功能分成区域和部门.普通医院的总体规划

Division of hospitals into functional areas and functional sections - Masterplanning for general hospitals

JIS K 3703-1:2004 正凝固酶葡萄球菌(金黄色葡萄球菌和其他试样)计数的水平方法.第1部分:使用Baird-Parker琼脂培养基的技术

この規格は，ペアード・パーカー寒天培地 (以下，寒天培地という。)を用いて35 ℃又は37℃で好気的に培養して得られるコロニー数を測定する方法について規定する。

Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) -- Part 1: Technique using Baird-Parker agar medium

JIS K 3703-2:2004 正凝固酶葡萄球菌(金黄色葡萄球菌和其他试样)计数的水平方法.第2部分:使用兔血浆血纤蛋白质琼脂培养基的技术

この規格は，ウサギ血しようフィブリノーゲン寒天培地(以下，寒天培地という。)を用いて35℃又は37℃で好気的に培養して得られるコロニー数を測定する方法について規定する。

Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) -- Part 2: Technique using rabbit plasma fibrinogen agar medium

BIP 3002-2004 进阶指南.健康和安全管理

Step through guide - Health and safety management

JIS S 0013 ERRATUM 1:2004 勘误表

ERRATUM

JIS S 0031:2004 老年人和残疾人用指南.视觉标牌及显示器.与年龄有关的相对亮度规范及其在光线评估中的使用

この規格は，若年者から高齢者までの年齢の観測対象者(以下，対象者という。)が光源及び物体を見るときの，光の視覚的効率及びそれに基づく視認性を，対象者の年齢を考慮した年代別相対輝度を用いて評価する方法について規定する。

Guidelines for the elderly and people with disabilities -- Visual signs and displays -- Specification of age-related relative luminance and its use in assessment of light

BS EN 556-2:2004 医疗器械灭菌.特指"无菌"的医疗设备的要求.无菌处理的医疗设备的要求

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices

ASTM F2312-04 组织工程医疗产品的相关标准术语

1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs.1.2 The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products.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 Terminology Relating to Tissue Engineered Medical Products

ASTM E2413-04 医院准备状态和应对措施的标准指南

1.1 This guide covers concepts, principles, and practices of an all-hazards comprehensive emergency management program for the planning, mitigation, response, recovery, and coordination of hospitals in response to a major incident.1.2 This guide addresses the essential elements of the scope, planning, structure, application, and coordination of federal, state, local, voluntary, and nongovernmental resources necessary to the emergency operations plan for a hospital.1.3 This guide establishes a common terminology for hospital emergency management and business continuity programs necessary to fulfill the basic service requirements of a hospital.1.4 This guide provides hospital leaders with concepts of an emergency management plan, but an individual plan must be developed in synchrony with the community emergency operations plan and the National Incident Management System.1.5 This guide does not address all of the necessary planning and response of hospitals to an incident that involves the near-total destruction of community services and systems.1.6 For the purposes of this guide, the definition of hospital will be the current definition provided by the American Hospital Association for an acute care facility.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 requirements prior to use.

Standard Guide for Hospital Preparedness and Response