C04 基础标准与通用方法 标准查询与下载

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 E2457-07 保健信息学标准术语

1.1 This terminology 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 and international standards bodies. It will identify alternate accepted terms for the same concept and its elected term. Its terms are intended to clarify and simplify usage in the dialog and documentation about the concepts, processes and data that are used to schedule, conduct and manage all phases of healthcare. This common usage will improve the quality and management of all facets of healthcare by means of explicit information used in referring to each of these facets. These health informatics terms have been collected here specifically in order to facilitate the consistent use of common concepts in informatics standards development and use throughout healthcare. A separate process from this standard that is described in ISO 15188 will manage the approval of biomedical and healthcare terms.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 for Healthcare Informatics

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

JIS K 3836 AMD 1:2006 空气微生物取样器取样效率的检验方法（修改件1）

Testing methods for collection efficiency of airborne microbe samplers (Amendment 1)

JIS K 3810-3 AMD 1:2006 支原体检测方法.第3部分:窝形PCR检验法（修改件1）

Mycoplasma detection methods -- Part 3: Nested PCR assay (Amendment 1)

JIS K 3810-2 AMD 1:2006 支原体检测方法.第2部分:间接DNA染色检验法（修改件1）

Mycoplasma detection methods -- Part 2: Indirect DNA staining assay (Amendment 1)

JIS K 3810-1 AMD 1:2006 支原体检测方法.第1部分:微生物培养检验法（修改件1）

Mycoplasma detection methods -- Part 1: Microbiological cultivation assay (Amendment 1)

BS EN ISO 10993-2:2006 医疗器械的生物评定.动物保护要求

ISO 10993-2:2006 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. ISO 10993-2:2006 also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

Biological evaluation of medical devices - Animal welfare requirements

KS P 1509-2006 高龄者住宅设计的尺寸原则和基准

이 규격에서 다루는 주거 시설의 거주 대상은 고령자와 비고령자를 모두 포함한다.

Principle and recommendation for designingdimension of dwelling in consideration of the elderly

ISO 11137-1:2006 保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认、和常规控制的要求

1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of ISO 11137 covers radiation processes employing irradiators using, a) the radionuclide 60Co or 137Cs, b) a beam from an electron generator or c) a beam from an X-ray generator. 1.2 This part of ISO 11137 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.1 This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile. NOTE Attention is drawn to regional and national requirements for designating medical devices as "sterile." See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.2 This part of ISO 11137 does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party. 1.2.3 This part of ISO 11137 does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.1.2.4 This part of ISO 11137 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities. NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety requirements for occupational safety related to radiation. 1.2.5 This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed devices.

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-2:2006 保健产品的灭菌.辐射.第2部分:确定杀菌剂量

This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ISO 11137-3:2006 保健产品的灭菌.辐射.第3部分:剂量测定方面指南

This part of ISO 11137 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

ASTM E2502-06 医疗摹本工作站的标准指南

This guide provides recommended guidelines for the essential elements to be included in the design and implementation of an efficient, secure, risk-free work environment for medical transcription and health information documentation. 4.1.1 Improve and increase production. 4.1.2 Reduce healthcare costs by minimizing injury/illness. 4.1.3 Increase retention and professional longevity. 4.1.4 Ensure regulatory compliance with state and local government requirements as well as federal privacy and security regulations.1.1 This guide identifies ways to improve the medical transcription workstation, including, but not limited to, the work environment, which encompasses ergonomics and security issues, equipment, references, and tools.1.2 This guide will assist healthcare managers, vendors, medical transcription service owners, and individual medical transcriptionists to make informed decisions related to the design of an efficient medical transcription work environment compliant with federal regulatory agencies.1.3 This guide does not address the medical transcription process or training.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 Medical Transcription Workstations

ASTM E2457-06 保健信息学标准术语

1.1 This terminology 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 and international standards bodies. It will identify alternate accepted terms for the same concept and its elected term. Its terms are intended to clarify and simplify usage in the dialog and documentation about the concepts, processes and data that are used to schedule, conduct and manage all phases of healthcare. This common usage will improve the quality and management of all facets of healthcare by means of explicit information used in referring to each of these facets. These health informatics terms have been collected here specifically in order to facilitate the consistent use of common concepts in informatics standards development and use throughout healthcare. A separate process from this standard that is described in ISO 15188 will manage the approval of biomedical and healthcare terms.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 Terminology for Healthcare Informatics

ASTM E2210-06 指南要素模型版本2(GEM II)用标准规范.临床实施规程指南用文件模型

1.1 This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines. This specification is intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. It can be used to represent document content throughout the entire guideline life cycle. Information at both high and low levels of abstraction can be accommodated. This specification is based on the guideline elements model (GEM) created at the Yale Center for Medical Informatics and designed to serve as a comprehensive XML-based guideline document representation.1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C.1.3 Standard Guideline Schema This specification defines a standard Schema for clinical practice guidelines. The Schema is included in Annex A1.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 Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines

ASTM E2502-06(2011) 医疗转录工作站的标准指南

This guide provides recommended guidelines for the essential elements to be included in the design and implementation of an efficient, secure, risk-free work environment for medical transcription and health information documentation. Improve and increase production. Reduce healthcare costs by minimizing injury/illness. Increase retention and professional longevity. Ensure regulatory compliance with state and local government requirements as well as federal privacy and security regulations.1.1 This guide identifies ways to improve the medical transcription workstation, including, but not limited to, the work environment, which encompasses ergonomics and security issues, equipment, references, and tools. 1.2 This guide will assist healthcare managers, vendors, medical transcription service owners, and individual medical transcriptionists to make informed decisions related to the design of an efficient medical transcription work environment compliant with federal regulatory agencies. 1.3 This guide does not address the medical transcription process or training. 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 Guide for Medical Transcription Workstations

KS I ISO 14644-5:2005 洁净室和相关控制环境.第5部分:操作

이 규격은 청정실의 작업에 관한 기본적인 요구 조건을 설명한다. 이것은 청정실의 사용 및

Cleanrooms and associated controlled environments－Part 5：Operations

BS PD CEN/TR 15133:2005 术语.医疗装置类的综合术语和代码

This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation. For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:  to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturer’s quality system,  to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority,  for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED). For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term.

Nomenclature - Collective terms and codes for groups of medical devices

DIN-Fachbericht CEN/TR 15133:2005 术语.医疗装置类的综合术语和代码

Development of a list of collective terms based on the identified principles to be used, for example, as follows: - to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families, types of medical devices are covered within a manufacturers quality system, - to be used to identify the range of skills and general technological abilities for which a Notified body has been approved, and is so appointed by the relevant Competent Authority and - for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).

Nomenclature - Collective terms and codes for groups of medical devices; German version CEN/TR 15133:2005

NF S97-524:2005 健康信息学.医疗保健特定问题的时间标准

Health informatics - Time standards for healthcare specific problems.