C01 技术管理 标准查询与下载

WS/T 500.53-2016 电子病历共享文档规范 第53部分:出院小结

WS/T 500的本部分规定了出院小结的文档模板以及对文档头和文档体的一系列约束。 本部分适用于电子病历中的出院小结的规范采集、传输、存储、共享交换以及信息系统的开发应用。

Specification for sharing document of electronic medical record.Part 53:Discharged brief

GOST R 56894-2016 证明对体外诊断医疗设备的安全和性能的基本原则的符合性的技术文件摘要

Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices

GOST R 56892-2016 用于监管当局认可的医疗设备审计组织的要求

Requirements for medical device auditing organizations for regulatory authority recognition

GOST R 55746-2015 医疗器械. 不良事件的分级编码结构. 第1部分. 事件类型代码

Medical devices. Hierarchical coding structure for adverse events. Part 1. Event-type codes

GOST R 52623.4-2015 非侵入性干预运用简单医疗服务技术

Technologies of simple medical services for invasive interventions

DB44/T 1426.3-2014 中医及中西医结合临床路径工作导则 第3部分：技术要求

本部分规定了中医及中西医结合临床路径技术要求的术语与定义、制订基本技术、技术要素确定方法学、实施技术、评价技术、信息化技术的具体要求。 本部分适用于在二级甲等以上的中医或中西医结合医院或综合性医院的中医科开展的中医及中西医结合临床路径工作，其他中医或中西医结合医疗机构有关中医及中西医结合临床路径的工作程序也可参考使用。

Working Guidelines on Clinical Pathways of Traditional Chinese Medicine and Integrated Traditional Chinese and Western Medicine Part 3: Technical Requirements

DB44/T 1426.2-2014 中医及中西医结合临床路径工作导则 第2部分：管理要求

本部分规定了中医及中西医结合临床路径管理要求的术语与定义、制修订工作导则、实施工作导则、评价工作导则、信息化工作导则的具体要求。 本部分适用于在二级甲等以上的中医或中西医结合医院或综合性医院的中医科开展的中医及中西医结合临床路径工作，其他中医或中西医结合医疗机构有关中医及中西医结合临床路径的工作程序也可参考使用。

Working Guidelines on Clinical Pathways of Traditional Chinese Medicine and Integrative Traditional Chinese and Western Medicine Part 2: Management Requirements

DB44/T 1425-2014 中医诊疗指南评价规范

本标准规定了中医诊疗指南评价的术语和定义、评价基本原则与程序、评价内容与要求、评价方法。 本标准适用于中医医疗、科研、教育中的中医诊疗指南评价工作。

Guidelines for Evaluation of TCM Diagnosis and Treatment

DB44/T 1423-2014 寻常型银屑病中西医结合诊疗指南

本标准规定了寻常型银屑病的疾病诊断、中医辨证分型、中医/中西医结合治则治法、调摄与预防。本病相当于中医的“白疕”。本标准适用于寻常型银屑病中医、中西医结合的诊断、治疗；不适用于关节型银屑病、红皮病型银屑病、脓疱型银屑病的诊断及治疗。

Guidelines for the diagnosis and treatment of psoriasis vulgaris with integrated traditional Chinese and western medicine

DB44/T 1421-2014 健康体检服务规范

本标准规定了健康体检服务的基本要求、服务要求、服务提供、服务保障、健康管理、服务监督与改进。 本标准适用于广东省各类体检服务机构的健康体检服务。

Health checkup service specification

SB/T 11036-2013 药品物流设施与设备技术要求

本标准规定了药品物流设施与设备的术语和定义、技术要求、检验规则等。本标准适用于药品批发企业和药品零售连锁企业的现代医药物流中心。

The requirements of pharmaceutical logistics facilities and equipment technologies

ISO 13022:2012 含活性人体细胞的医疗产品.风险管理的应用和生产实践要求

This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof. It covers viable human materials of autologous as well as allogeneic human origin, obtained from living or deceased donors. For manufacturers of medical products containing viable cells of human origin, this International Standard specifies procedures to be used in processing and handling, as well as those to be used in identifying the hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International Standard outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk and expected medical benefit as compared to available alternatives. This International Standard provides requirements and guidance on risk management related to the hazards typical of medical products manufactured utilizing viable human materials, such as: a) contamination by bacteria, moulds, yeasts or parasites; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions; e) decomposition of the product and degradation products caused by inadequate handling; f) hazards related to the tumorigenic potential of the cell types used; g) complications resulting from unintended physiological and anatomical consequences (this includes unintended migration of cells, unwanted release of biologically active substances such as hormones and cytokines, and unintended interactions between cellular and non-cellular components of the product); h) failure of traceability; i) complications resulting from the material eliciting an unintended immunogenic reaction. For the evaluation of contamination with other unclassified pathogenic entities, similar principles might be applicable. Hazards related to genetic modification are outside the scope of this International Standard and are addressed elsewhere. NOTE 1 A definition of “genetically modified” can be found in ASTM F2312. NOTE 2 This International Standard does not specify a quality management system for the control of all stages of production of medical products as described above. If additional national or regional criteria beyond what is defined in this International Standard exist in the country where the medical product will be used, they are also applicable. NOTE 3 Regional requirements can be more stringent than requirements referenced in this International Standard, especially with regard to donor eligibility criteria. This International Standard is not applicable to: — non-viable materials of human origin; 1 — viable cells of non-human origin; — blood and its components used for transfusion, germ cells, organs and bone marrow used for transplantation, and other tissues that do not meet the definition of “medical product”; — in vitro diagnostic devices. NOTE 4 For guidance on the application of this International Standard, see Annex A.

Medical products containing viable human cells - Application of risk management and requirements for processing practices

BIP 3042-2007 BSI健康和安全快速检查

BSI Health & Safety Quick-Check

NF S97-555:2007 健康信息学 允许在不同系统之间交换信息期间对制药专业的不同标识符和/或其表示进行一致性检查的规则

Informatique de santé - Règles permettant un contrôle de cohérence entre différents identifiants des spécialités pharmaceutiques et/ou leurs présentations lors des échanges d'informations entre systèmes différents

ASTM E2117-06(2011) 医疗记录质量保证计划的鉴定和确立用标准指南

This guide lists the essential components of a quality assurance program/quality improvement program for medical transcription and is applicable in all work environments. It describes factors that should be considered when evaluating the individuals and processes responsible for producing patient care documentation and for establishing procedures to address and resolve problems that may arise in dictation and transcription. It clarifies who has the authority to make decisions regarding transcription style and editing and to resolve conflicts. This guide may be used to develop a quality assurance program for individual medical transcriptionists, medical transcription departments within healthcare institutions, medical transcription businesses, and authors of dictation. A quality assurance program verifies the consistency, correctness, and completeness of dictation and transcribed reports, including the systematic identification and resolution of inaccuracies and inconsistencies, according to organizational standards. Merely proofreading reports is not equivalent to a quality review process, which should involve comparison with the dictation at least part of the time and review for meaning of content all of the time. Quality is fundamental to the patient record, and clear, complete, accurate patient care documentation helps control the rising cost of health care and contributes to patient safety. The quality of the final report is the responsibility of both the author and the medical transcriptionist. It is the result of teamwork between the person dictating and the individual transcribing. It should be noted that while production standards are important, their value is diminished if quality is lacking. Likewise, transcribing dictation verbatim may not result in quality documentation or clear communication. It is the transcriptionist''s responsibility to recognize, identify, and report voice files that lack accuracy, completeness, consistency, and clarity for corrective action.1.1 This guide covers the establishment of a quality assurance program for dictation, medical transcription, and related processes. Quality assurance (QA) is necessary to ensure the accuracy of healthcare documentation. Quality documentation protects healthcare providers, facilitates reimbursement, and improves communication among healthcare providers, thus improving the overall quality of patient care. This guide establishes essential and desirable elements for quality healthcare documentation, but it is not purported to be an exhaustive list. 1.2 The QA personnel for medical transcription should have an understanding of the processes and variables or alternatives involved in the creation of medicolegal documents and an understanding of quality assurance issues as they pertain to medical transcription. Qualified personnel include certified medical transcriptionists (CMTs), quality assurance professionals, or individuals who hold other appropriately related credentials or degrees. 1.3 The medical transcriptionist (MT) and QA reviewer should establish a cooperative partnership so that the review outcomes are objective and educational to include corrective actions and remedies. Policies should be developed to minimize subjective review, which can lead to forceful implementation of one style at the expense of other reasonable choices. Objective review, including an appeals process, should follow organizational standards that have been agreed upon by the full team of QA personnel, MTs, and management staff.

Standard Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription

ANSI/HL7 V3 RCMR, R 1-2006 HL7第3版标准:医疗记录/信息管理.版本1

This is a second membership ballot of the proposed standard. This revision fixed typographic errors, included application role name changes to follow MnM guidelines, and included modifications to two messages, making one was generic and adding additional information to the other.

HL7 Version 3 Standard: Medical Records/Information Management, Release 1

ASTM E2117-06 医疗记录质量保证计划的鉴定和确立用标准指南

This guide lists the essential components of a quality assurance program/quality improvement program for medical transcription and is applicable in all work environments. It describes factors that should be considered when evaluating the individuals and processes responsible for producing patient care documentation and for establishing procedures to address and resolve problems that may arise in dictation and transcription. It clarifies who has the authority to make decisions regarding transcription style and editing and to resolve conflicts. This guide may be used to develop a quality assurance program for individual medical transcriptionists, medical transcription departments within healthcare institutions, medical transcription businesses, and authors of dictation. A quality assurance program verifies the consistency, correctness, and completeness of dictation and transcribed reports, including the systematic identification and resolution of inaccuracies and inconsistencies, according to organizational standards. Merely proofreading reports is not equivalent to a quality review process, which should involve comparison with the dictation at least part of the time and review for meaning of content all of the time. Quality is fundamental to the patient record, and clear, complete, accurate patient care documentation helps control the rising cost of health care and contributes to patient safety. The quality of the final report is the responsibility of both the author and the medical transcriptionist. It is the result of teamwork between the person dictating and the individual transcribing. It should be noted that while production standards are important, their value is diminished if quality is lacking. Likewise, transcribing dictation verbatim may not result in quality documentation or clear communication. It is the transcriptionistrsquo;responsibility to recognize, identify, and report voice files that lack accuracy, completeness, consistency, and clarity for corrective action.1.1 This guide covers the establishment of a quality assurance program for dictation, medical transcription, and related processes. Quality assurance (QA) is necessary to ensure the accuracy of healthcare documentation. Quality documentation protects healthcare providers, facilitates reimbursement, and improves communication among healthcare providers, thus improving the overall quality of patient care. This guide establishes essential and desirable elements for quality healthcare documentation, but it is not purported to be an exhaustive list.1.2 The QA personnel for medical transcription should have an understanding of the processes and variables or alternatives involved in the creation of medicolegal documents and an understanding of quality assurance issues as they pertain to medical transcription. Qualified personnel include certified medical transcriptionists (CMTs), quality assurance professionals, or individuals who hold other appropriately related credentials or degrees.1.3 The medical transcriptionist (MT) and QA reviewer should establish a cooperative partnership so that the review outcomes are objective and educational to include corrective actions and remedies. Policies should be developed to minimize subjective review, which can lead to forceful implementation of one style at the expense of other reasonable choices. Objective review, including an appeals process, should follow organizational standards that have been agreed upon by the full team of QA personnel, MTs, and management staff.

Standard Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription

DOD MIL-STD-188-197 A ADMIN NOTICE 2-2004 用于国家图像传输格式标准的可接受递推插值差值脉冲编码调制(ARIDPCM)

MIL-STD-188-197A remains inactive for new design (see NOTICE 1)

ADOPTIVE RECURSIVE INTERPOLATED DIFFERENTIAL PULSE CODE MODULATION (ARIDPCM) COMPRESSION ALGORITHM FOR THE NATIONAL IMAGERY TRANSMISSION FORMAT STANDARD

DOD MIL-STD-188-176 CHG NOTICE 1-1997 异步传送模式(ATM)标准化轮廓文件

STANDARDIZED PROFILE FOR ASYNCHRONOUS TRANSFER MODE (ATM)

STANDARDIZED PROFILE FOR ASYNCHRONOUS TRANSFER MODE (ATM)

YY/T 0247-1996 医药工业企业合理用能设计导则

本标准规定了医药工业企业在设计中贯彻实施节约和合理利用能源的原则。 本标准适用于医药工业企业新建、扩建和改建工程的设计。

Designed guides for rationality of energy usage in pharmaceutical industrial enterprise