用于治疗、预防疾病或调节生理功能的物质统称。包括化学药物、医疗器械和化妆品等,需通过严格的质量标准和安全评估,全球采用统一标识系统。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| BS DD ENV 12610:1998 术语 |
Medical informatics - Medical product identification
活性成分 |
1998-11-15 英国标准学会 |
| BS EN ISO 11239:2023 术语标准 |
健康信息学 医药产品的鉴定 用于唯一识别和交换有关药物剂型、呈现单位、给药途径和包装的监管信息的数据元素和结构 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
|
2023-06-16 英国标准学会 |
| BS EN ISO 11616:2017 规范 |
健康信息学 医药产品的鉴定 用于受监管药品信息的唯一识别和交换的数据元素和结构 Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
|
2020-02-27 英国标准学会 |
| BS EN ISO 17523:2016 规范标准 |
Health informatics. Requirements for electronic prescriptions
电子处方 |
2016-07-31 英国标准学会 |
| BS EN ISO 17523:2025 规范标准 |
Health informatics. Requirements for electronic prescriptions
电子处方 |
2025-08-31 英国标准学会 |
| DB13/T 2160-2014 规范 |
Drug logistics service specification for chain pharmacies
|
2015-02-11 河北省标准 |
| DB1304/T 473-2024 规范 |
Specification for sample management of drug inspection and testing institutions
检验美利体育登录入口官网机构 |
2024-11-10 河北省标准 |
| DB14/T 1955-2019 |
Basic Requirements for Establishment of Pharmaceutical Retail Enterprises
|
2019-12-20 山西省标准 |
| DB14/T 2056-2020 规范 |
Drug logistics loading and unloading service specification
物流 |
2020-06-10 山西省标准 |
| DB31/T 1486-2024 规范 |
Sales inspection regulations for online trading platforms in the pharmaceutical field
|
2024-06-18 上海市标准 |
| DB3209/T 1240-2023 规范 |
Guidelines for Pharmacovigilance in Medical Institutions
|
2023-07-03 江苏省标准 |
| DB3305/T 172-2020 规范 |
Drug retail "online order store delivery" service and management norms
|
2020-11-18 浙江省标准 |
| DB34/T 4069-2021 规范 |
Evaluation system of smart drug store
评价体系 |
2021-12-28 安徽省标准 |
| DB3418/T 038-2024 规范 |
Standards for drug use management services in nursing homes
|
2025-01-03 安徽省标准 |
| DB36/T 1956-2024 规范 |
Management regulations for elderly people bringing their own medicines to nursing homes
老年人 |
2024-05-23 江西省标准 |
| DB37/T 3698.10-2021 规范 |
Guidance for Creating Model Units for Safe Consumption Part 10: Pharmacies
|
2021-06-15 山东省地方标准 |
| DB37/T 4825.1-2025 规范 |
药品、医疗器械、化妆品企业日常监督检查管理规范 第1部分:总则 Routine supervision and inspection management regulations for pharmaceutical, medical device and cosmetic enterprises Part 1: General principles
|
2025-02-14 山东省地方标准 |
| DB37/T 4825.3-2025 规范/规程 |
药品、医疗器械、化妆品企业日常监督检查管理规范 第3部分:日常监督检查 Routine supervision and inspection management regulations for pharmaceutical, medical device and cosmetic enterprises Part 3: Routine supervision and inspection
|
2025-02-14 山东省地方标准 |
| DB37/T 4825.5-2025 规范 |
药品、医疗器械、化妆品企业日常监督检查管理规范 第5部分:数据管理 Routine Supervision and Inspection Management Specifications for Pharmaceutical, Medical Device and Cosmetic Enterprises Part 5: Data Management
|
2025-02-14 山东省地方标准 |
| DB3713/T 316-2024 规范 |
Norms for the Monitoring of Adverse Drug Reactions in Medical Institutions
医疗机构 药品不良反应 |
2024-08-07 山东省地方标准 |
| DB42/T 1510-2019 规范 |
Pharmaceutical Warehousing Practices
|
2019-04-08 湖北省地方标准 |
| DB5104/T 51.3-2021 规范标准 |
Safe and comfortable consumption environment construction specification part 3: medical equipment business store
|
2021-09-03 四川省标准 |
| DD ENV 12610-1998 术语 |
Medical informatics. Medical product identification
活性成分 |
1998-11-15 英国标准学会 |
| DIN 58950-3:2021 试验标准 |
Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
湿热灭菌 蒸汽灭菌器 |
2021-06-01 德国标准化学会 |
| DIN 58950-3:2021-06 试验标准 |
Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English / Note: DIN 58950-3 (2011-01) remains valid alongside this standard until 2022-06-01.
蒸汽灭菌器 |
2021-06 德国标准化学会 |
| DIN CEN ISO/TS 19293:2018*DIN SPEC 13239:2018 规范标准 |
Requirements for medical information technology drug dispensing records
|
2018 德国标准化学会 |
| DIN EN ISO 11238 E:2017-07 术语标准 |
健康信息学 医疗产品的识别 物品药物上规定信息的唯一标识和交换用数据元和结构(草案) Health Informatics Data elements and structures for identification and exchange of specified information on medical products (draft)
物质 |
2017-07 德国标准化学会 |
| DIN EN ISO 11239 E:2010-10 术语 |
健康信息学 医疗产品的识别 管理和包装的用药途径 单位描述和药品剂型的规定信息唯一识别和交换用数据元素和结构(草案) Health Informatics Data elements and structures for unique identification and exchange of medical product identification, management and packaging, route unit descriptions and prescribed information for pharmaceutical dosage forms (draft)
给药途径 |
2010-10 德国标准化学会 |
| DIN EN ISO 11240:2013-03 规范 |
健康信息学 药品识别 用于唯一识别和测量单位交换的数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of units of measurement (ISO 11240:2012); German version EN ISO 11240:2012
参考物质 导出量 属性 映射 术语表 测量程序 溯源性 翻译 药物 计量单位 计量学 量 |
2013-03 德国标准化学会 |
| DIN EN ISO 11615 E:2010-10 术语 |
健康信息学 药品识别 用于受监管药品信息的唯一识别和交换的数据元素和结构(草案) Health Informatics Drug Identification Data elements and structures for the unique identification and exchange of regulated drug information (Draft)
|
2010-10 德国标准化学会 |
| DIN EN ISO 11615 E:2016-09 规范标准 |
健康信息学 药品识别 用于受监管药品信息的唯一识别和交换的数据元素和结构(草案) Health Informatics Drug Identification Data elements and structures for the unique identification and exchange of regulated drug information (Draft)
临床试验 |
2016-09 德国标准化学会 |
| DIN EN ISO 11616 E:2010-10 术语 |
健康信息学 医疗产品的识别 规定的药用物品信息的唯一标识和交换用数据元和结构(草案) Health Informatics Medical Product Identification Data elements and structures for unique identification and exchange of medicinal article information (Draft)
物质 |
2010-10 德国标准化学会 |
| DIN EN ISO 21976 E:2020-07 规范标准 |
Tamper verification functionality for packaged pharmaceutical product packaging (draft)
|
2020-07 德国标准化学会 |
| DIN V ENV 12610:1997 术语 |
Medical informatics - Medicinal product identification; English version ENV 12610:1997
活性成分 |
1997-07 德国标准化学会 |
| DIN-Fachbericht CEN/TR 15753:2008 指南标准 |
包装.医疗产品用包装散页印刷品.视觉缺陷人员用盲文和其它版式 Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people; German version CEN/TR 15753:2008
使用说明书 |
2008-08 德国标准化学会 |
| DVGW W Information Nr 54:1998-06 指南标准 |
On the correlation between drugs, hormone substances and cosmetics in water bodies
|
1998-06 德国煤气与水工业协会 |
| GB/T 26840-2011 规范 |
Electronic commerce.Core metadata for medicine
|
2011-07-29 国家市场监督管理总局 |
| GB/T 30335-2023 规范 |
Pharmaceutical logistics service specifications
信息系统 |
2023-09-07 国家市场监督管理总局 |
| GOST R 56700-2015 指南标准 |
Medicines for medical applications. Safety Pharmacology studies for human pharmaceuticals
|
2015 俄罗斯标准局 |
| GOST R 56701-2015 规范 |
医用药物. 为实施药物用人体临床试验和上市许可的非临床安全研究指南 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
临床试验 |
2015 俄罗斯标准局 |
| IRAM 37023:2013 规范 |
药品 供应商的选择、批准和评级标准 制药行业的储存、分销和运输 Medicines. Selection, approval and qualification criteria for suppliers. Storage, distribution and transport for the pharmaceutical industry.
储存 |
2013-04-16 阿根廷标准化研究所 |
| IRAM 37024-3:1998 规范 |
药品 冻干注射产品无菌加工中的良好生产规范 制剂区域美利体育官网首页网址的设计与维护准则 Medicaments. Good manufacturing practices. Aseptic processing of parenteral liofilized products. Directives relatives to the design and equipment maintenance of the manufacturing area.
|
1998-11-20 阿根廷标准化研究所 |
| IRAM 37031:2015 规范 |
Medicines. Traceability management system in the pharmaceutical chain.
|
2015-08-05 阿根廷标准化研究所 |
| IRAM 9800-5:2017 规范 |
Good pharmacy practice. Part 5 - Distribution and logistics.
物流 |
2017-08-22 阿根廷标准化研究所 |
| IRAM 9801:2022 术语 |
Good pharmacy practice. Vocabulary
生物制剂 |
2022-11-04 阿根廷标准化研究所 |
| ISO 11238:2012 术语标准 |
健康信息学.医疗产品的识别.物品药物上规定信息的唯一标识和交换用数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
物质 |
2012-11 国际标准化组织 |
| ISO 11238:2018 试验 |
健康信息学.医疗产品的识别.物品药物上规定信息的唯一标识和交换用数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
物质 |
2018-07-01 国际标准化组织 |
| ISO 11239:2012 术语标准 |
健康信息学.医药产品识别.药品剂型,陈述单元,给药途径和包装的唯一识别和交换规定信息用数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
药物剂型 |
2012-11 国际标准化组织 |
| ISO 11240:2012 规范标准 |
健康信息学.医药产品识别.计量单位识别和交换用数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement
可追溯性 计量单位 |
2012-11 国际标准化组织 |
| ISO 11615:2012 术语标准 |
健康信息学.医药产品识别.规定医药产品信息的唯一识别和交换用数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
识别 |
2012-11 国际标准化组织 |
| ISO 11615:2017/Amd 1:2022 规范 |
健康信息学.医药产品的识别.受管制医药产品信息的唯一识别和交换用数据元素和结构.修改件1 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1
标识符 |
2022-08-25 国际标准化组织 |
| ISO 11616:2012 规范标准 |
健康信息学.医疗产品的识别.规定的药用物品信息的唯一标识和交换用数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
|
2012-11 国际标准化组织 |
| ISO/TR 18728:2025 |
健康信息学 作为药品识别(IDMP)的一部分 全球药品及原料和批次注册 Health informatics — Global medicinal product and ingredient and batch registration as part of identification of medicinal products (IDMP)
成分 |
2025-12-12 国际标准化组织 |
| ISO/TS 19256:2016 规范 |
Health informatics - Requirements for medicinal product dictionary systems for health care
给药系统 |
2016-06 国际标准化组织 |
| ISO/TS 19293:2018 术语 |
Health informatics - Requirements for a record of a dispense of a medicinal product
|
2018-04-01 国际标准化组织 |
| ISO/TS 20451:2017 规范/规程 |
健康信息学. 医药产品的识别. 受管制医药产品信息的唯一识别和交换用ISO 11616数据元素和结构的实施指南 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
|
2017-10-19 国际标准化组织 |
| LST CEN ISO/TS 20443:2018 指南标准 |
卫生信息学 医药产品识别 ISO 11615 数据元素和结构在受监管医药产品信息唯一识别与交换中的实施指南(ISO/TS 20443:2017) Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)
|
2018-07-31 立陶宛标准局 |
| LST EN ISO 11615:2018 规范 |
卫生信息学 药品的识别 受监管药品信息的唯一识别与交换的数据元素和结构(ISO 11615:2017) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
|
2018-02-28 立陶宛标准局 |
| LST EN ISO 11616:2018 规范 |
医疗卫生信息 药物识别 用于唯一识别和监管药品信息交换的数据元素和结构(ISO 11616:2017) Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
|
2018-02-28 立陶宛标准局 |
| LST EN ISO 17523:2025 |
Health informatics - Requirements for electronic prescriptions (ISO 17523:2025)
电子处方 |
2025-09-30 立陶宛标准局 |
| NF EN ISO 11239:2023 |
健康信息学 药品识别 用于唯一标识和交换药品剂型、给药途径和包装等管制信息的数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
|
2023-06-01 法国标准化协会 |
| PD CEN ISO/TS 19293:2018 规范标准 |
Health Informatics. Requirements for a record of the dispense of a medicinal product
|
2018-06-07 英国标准学会 |
| PD CEN ISO/TS 20451:2018 指南标准 |
健康信息学 医药产品的鉴定 ISO 11616 数据元素和结构的实施指南 用于受监管药品信息的唯一识别和交换 Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
|
2018-05-24 英国标准学会 |
| PD ISO/TR 18728:2025 指南标准 |
健康信息学 作为药品识别(IDMP)组成部分的全球药品、成分和批次注册 Health informatics — Global medicinal product and ingredient and batch registration as part of identification of medicinal products (IDMP)
成分 |
2025-12-31 英国标准学会 |
| SS-EN ISO 11238:2018 术语 |
医疗信息技术 药品识别 物质的唯一标识和受监管信息交换的数据元素与结构(ISO 11238:2018) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)
物质 |
2018 瑞典标准研究所 |
| SS-EN ISO 11616:2012 规范标准 |
健康信息学 药品识别 用于唯一标识和交换受监管药品信息的数据元素和结构(ISO 11616:2012) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)
识别 |
2012 瑞典标准研究所 |
| SS-EN ISO 15378:2015 规范 |
药品初级包装材料 ISO 9001:2008 应用的特殊要求 参考良好生产规范 (GMP) (ISO 15378:2015) Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
|
2015 瑞典标准研究所 |
| SS-EN ISO 15378:2017 规范 |
药品的主要包装材料 对应用ISO 9001:2015的特殊要求 参考良好制造规范(GMP)(ISO 15378:2017) Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
|
2017-11-17 瑞典标准研究所 |
| SS-EN ISO 17523:2025 |
健康信息学 电子处方的要求(ISO 17523:2025 IDT) Health informatics — Requirements for electronic prescriptions (ISO 17523:2025, IDT)
电子处方 |
2025 瑞典标准研究所 |
| T/CHAS 10-4-5-2019 规范 |
Quality and safety management of Chinese hospital—— Part 4-5: Medical management—Medication safety management
处方 |
2019-07-06 中国团体标准 |
| T/GDPA 1-2020 规程 |
Technical Specification of 3D Printing Subdivided Tablets in Medical Institutions
医疗机构 |
2020-11-06 中国团体标准 |
| T/HENANPA 003-2022 规范 |
Specifications for the construction of inpatient electronic medical records
|
2022-08-05 中国团体标准 |
| UNE-EN ISO 11239:2013 术语标准 |
健康信息学 医药产品的识别 用于唯一识别和交换有关药物剂型、展示单位、给药途径和包装的受监管信息的数据元素和结构(ISO 1 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 1
药物剂型 |
2013-06-05 西班牙标准化协会 |
| UNE-EN ISO 11240:2013 术语标准 |
健康信息学 医药产品的识别 用于测量单位的唯一识别和交换的数据元素和结构(ISO 11240:2012) Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
可追溯性 计量单位 |
2013-06-05 西班牙标准化协会 |
| UNE-EN ISO 11615:2018 术语标准 |
健康信息学 药品识别 用于受监管药品信息的唯一识别和交换的数据元素和结构 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
标识 |
2018-12-26 西班牙标准化协会 |
| UNI EN ISO 17523:2025 |
Health informatics - Requirements for electronic prescriptions
电子处方 |
2025-09-18 意大利统一标准化组织 |
| WS 363.16-2011 术语标准 |
卫生信息数据元目录 第16部分:药品、美利体育官网首页网址与材料 Health data element dictionary. Part 16: Drug, equipment and material
|
2011-08-02 行业标准-卫生 |
| WS 364.16-2011 分类标准 |
卫生信息数据元值域代码. 第16部分:药品、美利体育官网首页网址与材料 Classification and coding for value domain of health data element. Part 16: Drug, equipment and material
|
2011-08-02 行业标准-卫生 |
| WS/T 363.16-2023 术语/符号/分类 |
Health Information Data Meta Catalog Part 16: Drugs and Medical Devices
疫苗 |
2023-10-07 行业标准-卫生 |
| WS/T 778-2021 规范 |
Drug procurement and use management classification codes and identification codes
|
2021-04-19 行业标准-卫生 |
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