C04 基础标准与通用方法 标准查询与下载

ASTM F2386-04 组织工程医疗产品的保存的标准指南

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)

ASTM E2326-04 查封药品分析员的教育和培训的标准实施规程

These are minimum standards applicable to those performing seized-drug analyses. These standards are intended to apply to any laboratory analyst who: 3.2.1 examines and analyzes seized drugs or related materials, or directs such examinations to be done, 3.2.2 independently has access to unsealed evidence in order to remove samples from evidence for examination and 3.2.3 As a consequence of such examinations, signs reports for court or investigative purposes.1.1 This standard describes prerequisite formal education, training, and continuing professional development for those performing seized-drug analysis. It also describes the kinds of professional documents (for example, texts, manuals, or journals) that should be present in laboratories where analysis of seized drugs is conducted.

Standard Practice for Education and Training of Seized-Drug Analysts

ASTM F2211-04 组织工程医疗产品的标准分类

This classification outlines aspects of TEMPs which includes their individual components. The categories outlined in this classification are intended to list, identify, and group the areas pertinent to Tissue Engineered Medical Products. This classification will be used by the Tissue Engineered Medical Products subcommittees for the organization of the development of standards for the field of tissue engineering, TEMPs, and protocols for their use. The development of products from the new tissue engineering technologies necessitates creation and implementation of new standards (1).5 Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. The degree of overall risk for any given TEMP is reflected by the number and types of tests required to demonstrate product safety and efficacy.1.1 This classification outlines the aspects of tissue engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.1.2 This classification does 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 This standard does not purport to address specific components coverd in other standards. Any safety areas associated with the medical product''s use will not be addressed in this standard. 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 Classification for Tissue Engineered Medical Products (TEMPs)

ASTM F1490-04a 搜寻和营救的相关标准术语

1.1 This terminology document is a compilation of definitions of terms, abbreviations, and acronyms used in the search and rescue field collected in order to provide consistency in communication when used in actual operations, training, and literature dealing with this field.

Standard Terminology Relating to Search and Rescue

ASTM F1490-04 搜寻和营救的相关标准术语

1.1 This terminology standard is a compilation of definitions of terms, abbreviations and acronyms used in the search and rescue field collected in order to provide consistency in communication when used in actual operations, training and literature dealing with this field.

Standard Terminology Relating to Search and Rescue

ANSI/HL7 V3 UMLITSDT, Ra-2004 健康等级7第3版标准:UML实现技术规范.数据类型.第1次发行

Health Level Seven Version 3 Standard: UML Implementation Technology Specification - Data Types, Release 1

ANSI/HL7 V3 XMLITSDT, R 1-2004 健康等级7第3版标准:XML实现技术规范.数据类型.第1次发行

In previous submission the suggested designation was HL7 V3: DTXMLITS. Please note that I am requesting a change to this designation. This document defines the V3 data types that will be used by all of HL7 V3 and onwards. It also defines the representation of HL7 V3 data types in XML, including the schema necessary to derive XML schemas for HL7 V3 Hierarchical Message Descriptions (HMD)

Health Level Seven Version 3 Standard: XML Implementation Technology Specification - Data Types, Release 1.

JIS K 3810-3:2003 支原体检测方法.第3部分:窝形PCR检验法

この規格は，培養細胞及び細胞培養に用いる試薬類並びに細胞培養によって生産された製品中のマイコプラズマを二段階PCR(polymerise chain reaction)法によって検出する方法について規定する。

Mycoplasma detection methods -- Part 3: Nested PCR assay

JIS K 3810-1:2003 支原体检测方法.第1部分:微生物培养检验法

この規格は，細胞培養及び細胞培養に用いられる試薬類並びに細胞培養によって生産された製品からマイコプラズマを分離培養して検出する方法について規定する。

Mycoplasma detection methods -- Part 1: Microbiological cultivation assay

JIS K 3810-2:2003 支原体检测方法.第2部分:间接DNA染色检验法

この規格は，マイコプラズマのDNAを蛍光染色することによって培養細胞中及び培養に必要な試薬類に含まれるマイコプラズマを問接的に検出する方法について規定する。

Mycoplasma detection methods -- Part 2: Indirect DNA staining assay

ANSI/AAMI ST 67-2003 保健产品的灭菌.验证和常规控制的要求.辐射灭菌

Establishes requirements and provides guidance for the selection of an appropriate Sterility Assurance Level (SAL) for terminally sterilized medical devices labeled "sterile." Also establishes acceptance criteria for maximum contamination rates for aseptically-filled products labeled "sterile."

Sterilization of Health Care Products - Requirements for products labeled "STERILE"

ANSI/AAMI ST67-2003 医疗装置的消毒.贴有"已消毒"标签的产品要求

This standard specifies requirements and provides guidance for selecting an appropriate SAI_ for a terminally sterilized medical device or a maximum contamination rate for an aseptically processed medical device that is labeled "STERILE." The requirements and guidance provided in this standard also apply to the selection of an appropriate SAL for a terminally sterilized medical device that is labeled "Sterile Fluid Path." This standard does not address medical devices that are not labeled =STERILE." For example, nonsterile medical devices that possess antimicrobial properties or contain preservatives for the control of microbial levels are not addressed. This standard also does not address products regulated as drugs or biologics by the FDA.

Sterilization of medical devices - Requirements for products labeled "STERILE"

DIN 58985:2003 实验室医学.决策标记准则

When evaluating the results of quantitative and qualitative tests in laboratory medicine cut-off-values are needed unless reference values are not available. This standard is applicable to the determination of these cut-off-values.

Laboratory medicine - Decision-marking criteria

BS ISO 15190:2003 医学实验室.安全要求

This International Standard specifies requirements for safe practices in the medical laboratory.

Medical laboratories - Requirements for safety

JIS Z 8071 ERRATUM 1:2003 JIS Z8071 勘误表 1

ERRATUM

BS EN ISO 15195:2003 实验室医学.基准测量实验室要求

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. ISO 15195:2003 is not applicable to routine medical laboratories. The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories". ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

Laboratory medicine - Requirements for reference measurement laboratories

JIS S 0014:2003 老年人和残疾人用指南.消费者用品的听觉信号.噪声条件下老年人用信号的声压级

この規格は，視覚障害者，加齢に伴う視力及び聴力の衰えが見られる高齢者をはじめとする消費生活製品の使用者にとって適切な大きさに聞き取れる報知音の音圧レペルの範囲を，妨害音の有無を考慮して設定するための指針(推奨事項)について規定する。

Guidelines for the elderly and people with disabilities -- Auditory signals on consumer products -- Sound pressure levels of signals for the elderly and in noisy conditions

JIS S 0032:2003 老年人和残疾人用指南.视觉标牌及显示器.日文单字符最小易读尺寸的评估

この規格は，若年者から高齢者までの任意の年齢の観測対象者(以下，対象者という。)が，様々な環境下で平仮名。片仮名，アラビア数字，及び漢字の日本語文字の1文字を読むことのできる最小の文字サィズの推定方法について規定する。

Guidelines for the elderly and people with disabilities -- Visual signs and displays -- Estimation of minimum legible size for a Japanese single character

ANSI/CAP SNOMED-1-2003 医疗保健术语结构

Healthcare Terminology Structure is proposed to become the ANSI standard for the delivery of healthcare terminology, which uses numeric identifiers, provides multiple descriptions for each concept, and supports semantic relationships between concepts, with description logic foundation and a structure for inclusion of multiple languages and dialects. This proposed standard contains substantive changes to the earlier proposed standard SNOMED CT Structure.

Healthcare Terminology Structure

DIN 13080 Bb.2:2003 按职能范围和职能分类划分的医院.专科学校和大学门诊部设置说明

Division of hospitals into functional areas and functional sections - Instructions for application for college and university clinics