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ISO/TC 215

ISO/TC 215

국제표준

  • 국제표준화기구(ISO, International Organization for Standardization)에서 정하여 출판한 표준
  • ISO는 1947년도에 설립된 비정부조직(NGO,Non-Governmental Organization)으로 전 세계 160여 개국의 국가표준기관의 연합체로 상품 및 서비스의 국제간 교류를 원활하게 하고, 지식, 과학, 기술 및 경제활동분야의 협력발전이라는 관점에서 표준화 및 관련 활동을 증진시키기 위해 설립
국제표준 내용을 담은표로, 연번, 국제표준 번호, 국제표준명 항목으로 구분되어 있습니다.
연번 국제표준 번호 국제표준명
1 IEC 82304-1:2016 Health software — Part 1: General requirements for product safety
2 IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
3 IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples
4 IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
5 IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
6 IEC/TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations
7 IEC/TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
8 ISO/TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
9 ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
10 IEC/TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
11 IEC/TR 80001-2-9:2017 Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
12 ISO/TS 29585:2010 Health informatics — Deployment of a clinical data warehouse
13 ISO/TR 28380-1:2014 Health informatics — IHE global standards adoption — Part 1: Process
14 ISO/TR 28380-2:2014 Health informatics — IHE global standards adoption — Part 2: Integration and content profiles
15 ISO/TR 28380-3:2014 Health informatics — IHE global standards adoption — Part 3: Deployment
16 ISO/HL7 27953-1:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting
17 ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
18 ISO/HL7 27951:2009 Health informatics — Common terminology services, release 1
19 ISO/HL7 27932:2009 Data Exchange Standards — HL7 Clinical Document Architecture, Release 2
20 ISO/HL7 27931:2009 Data Exchange Standards — Health Level Seven Version 2.5 — An application protocol for electronic data exchange in healthcare environments
21 ISO/TR 27809:2007 Health informatics — Measures for ensuring patient safety of health software
22 ISO 27799:2016 Health informatics — Information security management in health using ISO/IEC 27002
23 ISO/TS 27790:2009 Health informatics — Document registry framework
24 ISO 27789:2013 Health informatics — Audit trails for electronic health records
25 ISO/TS 27527:2010 Health informatics — Provider identification
26 ISO 25720:2009 Health informatics — Genomic Sequence Variation Markup Language (GSVML)
27 ISO/TS 25238:2007 Health informatics — Classification of safety risks from health software
28 ISO 25237:2017 Health informatics — Pseudonymization
29 ISO/TS 23303:2020 Health informatics — Categorial structure for Chinese materia medica products manufacturing process
30 ISO 22857:2013 Health informatics — Guidelines on data protection to facilitate trans-border flows of personal health data
31 ISO/TS 22835:2018 Health informatics — Information model of combination of decoction pieces in Chinese medicines
32 ISO/TS 22789:2010 Health informatics — Conceptual framework for patient findings and problems in terminologies
33 ISO/TS 22773:2019 Health Informatics — Categorial structures for the representation of the decocting process in traditional Chinese medicine
34 ISO 22600-1:2014 Health informatics — Privilege management and access control — Part 1: Overview and policy management
35 ISO 22600-2:2014 Health informatics — Privilege management and access control — Part 2: Formal models
36 ISO 22600-3:2014 Health informatics — Privilege management and access control — Part 3: Implementations
37 ISO/TS 22558:2019 Health informatics — Classification of traditional Chinese medicine data sets
38 ISO/TS 22287:2019 Health informatics — Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)
39 ISO/TR 22221:2006 Health informatics - Good principles and practices for a clinical data warehouse
40 ISO/TS 22220:2011 Health informatics — Identification of subjects of health care
41 ISO 22077-1:2015 Health informatics — Medical waveform format — Part 1: Encoding rules
42 ISO/TS 22077-2:2015 Health informatics — Medical waveform format — Part 2: Electrocardiography
43 ISO/TS 22077-3:2015 Health informatics — Medical waveform format — Part 3: Long term electrocardiography
44 ISO/TS 22077-4:2019 Health informatics — Medical waveform format — Part 4: Stress test electrocardiography
45 ISO/HL7 21731:2014 Health informatics — HL7 version 3 — Reference information model — Release 4
46 ISO/TR 21730:2007 Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
47 ISO 21667:2010 Health informatics — Health indicators conceptual framework
48 ISO/TS 21564:2019 Health Informatics — Terminology resource map quality measures (MapQual)
49 ISO 21549-1:2013 Health informatics — Patient healthcard data — Part 1: General structure
50 ISO 21549-2:2014 Health informatics — Patient healthcard data — Part 2: Common objects
51 ISO 21549-3:2014 Health informatics — Patient healthcard data — Part 3: Limited clinical data
52 ISO 21549-4:2014 Health informatics — Patient healthcard data — Part 4: Extended clinical data
53 ISO 21549-5:2015 Health informatics — Patient healthcard data — Part 5: Identification data
54 ISO 21549-6:2008 Health informatics — Patient healthcard data — Part 6: Administrative data
55 ISO 21549-7:2016 Health informatics — Patient healthcard data — Part 7: Medication data
56 ISO 21549-8:2010 Health informatics — Patient healthcard data — Part 8: Links
57 ISO/TR 21548:2010 Health informatics — Security requirements for archiving of electronic health records — Guidelines
58 ISO/TS 21547:2010 Health informatics — Security requirements for archiving of electronic health records — Principles
59 ISO/TS 21526:2019 Health informatics — Metadata repository requirements (MetaRep)
60 ISO 21298:2017 Health informatics — Functional and structural roles
61 ISO 21091:2013 Health informatics — Directory services for healthcare providers, subjects of care and other entities
62 ISO 21090:2011 Health informatics — Harmonized data types for information interchange
63 ISO/TS 21089:2018 Health informatics — Trusted end-to-end information flows
64 ISO/TR 20831:2017 Health informatics — Medication management concepts and definitions
65 ISO/TR 20514:2005 Health informatics — Electronic health record — Definition, scope and context
66 ISO/TS 20451:2017 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
67 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
68 ISO/TS 20440:2016 Health informatics — Identification of medicinal products — Implementation guide for ISO 11239 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
69 ISO/TS 20428:2017 Health informatics — Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
70 ISO/TS 20405:2018 Health informatics — Framework of event data and reporting definitions for the safety of health software
71 ISO 20302:2014 Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers
72 ISO 20301:2014 Health informatics — Health cards — General characteristics
73 ISO/TR 20055:2018 Health informatics — Person-owned document repository for PHR applications and health information exchange
74 ISO/TS 19844:2018 Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances
75 ISO/TR 19669:2017 Health informatics — Re-usable component strategy for use case development
76 ISO/TS 19293:2018 Health informatics — Requirements for a record of a dispense of a medicinal product
77 ISO/TS 19256:2016 Health informatics — Requirements for medicinal product dictionary systems for health care
78 ISO/TR 19231:2014 Health informatics — Survey of mHealth projects in low and middle income countries (LMIC)
79 ISO/TS 18864:2017 Health informatics — Quality metrics for detailed clinical models
80 ISO 18812:2003 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
81 ISO/TS 18790-1:2015 Health informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine
82 ISO/TR 18638:2017 Health informatics — Guidance on health information privacy education in healthcare organizations
83 ISO/TS 18530:2014 Health Informatics — Automatic identification and data capture marking and labelling — Subject of care and individual provider identification
84 ISO 18308:2011 Health informatics — Requirements for an electronic health record architecture
85 ISO/TR 18307:2001 Health informatics — Interoperability and compatibility in messaging and communication standards — Key characteristics
86 ISO 18232:2006 Health Informatics — Messages and communication — Format of length limited globally unique string identifiers
87 ISO 18104:2014 Health informatics — Categorial structures for representation of nursing diagnoses and nursing actions in terminological systems
88 ISO/TS 18062:2016 Health informatics — Categorial structure for representation of herbal medicaments in terminological systems
89 ISO/TS 17975:2015 Health informatics — Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information
90 ISO/TS 17948:2014 Health informatics — Traditional Chinese medicine literature metadata
91 ISO/TS 17938:2014 Health informatics — Semantic network framework of traditional Chinese medicine language system
92 ISO/TR 17791:2013 Health informatics — Guidance on standards for enabling safety in health software
93 ISO 17523:2016 Health informatics — Requirements for electronic prescriptions
94 ISO/TR 17522:2015 Health informatics — Provisions for health applications on mobile/smart devices
95 ISO/TS 17439:2014 Health informatics — Development of terms and definitions for health informatics glossaries
96 ISO/TS 17251:2016 Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products
97 ISO/TR 17119:2005 Health informatics - Health informatics profiling framework
98 ISO 17117-1:2018 Health informatics — Terminological resources — Part 1: Characteristics
99 ISO 17115:2020 Health informatics — Representation of categorial structures of terminology (CatStructure)
100 ISO 17090-1:2013 Health informatics — Public key infrastructure — Part 1: Overview of digital certificate services
101 ISO 17090-2:2015 Health informatics — Public key infrastructure — Part 2: Certificate profile
102 ISO 17090-3:2008 Health informatics — Public key infrastructure — Part 3: Policy management of certification authority
103 ISO 17090-4:2020 Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents
104 ISO 17090-5:2017 Health informatics — Public key infrastructure — Part 5: Authentication using Healthcare PKI credentials
105 ISO/TS 16843-1:2016 Health informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points
106 ISO/TS 16843-2:2015 Health informatics — Categorial structures for representation of acupuncture — Part 2: Needling
107 ISO/TS 16843-3:2017 Health informatics — Categorial structures for representation of acupuncture — Part 3: Moxibustion
108 ISO/TS 16843-4:2017 Health informatics — Categorial structures for representation of acupuncture — Part 4: Meridian and collateral channels
109 ISO/TS 16843-5:2019 Health Informatics — Categorial structures for representation of acupuncture — Part 5: Cupping
110 ISO/TS 16791:2020 Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
111 ISO/HL7 16527:2016 Health informatics — HL7 Personal Health Record System Functional Model, Release 1 (PHRS FM)
112 ISO 16278:2016 Health informatics — Categorial structure for terminological systems of human anatomy
113 ISO/TS 16277-1:2015 Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine
114 ISO/TR 16056-1:2004 Health informatics — Interoperability of telehealth systems and networks — Part 1: Introduction and definitions
115 ISO/TR 16056-2:2004 Health informatics — Interoperability of telehealth systems and networks — Part 2: Real-time systems
116 ISO/TR 14872:2019 Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms
117 ISO/TR 14639-1:2012 Health informatics — Capacity-based eHealth architecture roadmap — Part 1: Overview of national eHealth initiatives
118 ISO/TR 14639-2:2014 Health informatics — Capacity-based eHealth architecture roadmap — Part 2: Architectural components and maturity model
119 ISO/TS 14441:2013 Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment
120 ISO/TR 14292:2012 Health informatics — Personal health records — Definition, scope and context
121 ISO/TS 14265:2011 Health Informatics - Classification of purposes for processing personal health information
122 ISO 14199:2015 Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
123 ISO/TS 13972:2015 Health informatics — Detailed clinical models, characteristics and processes
124 ISO 13940:2015 Health informatics — System of concepts to support continuity of care
125 ISO 13606-1:2019 Health informatics — Electronic health record communication — Part 1: Reference model
126 ISO 13606-2:2019 Health informatics — Electronic health record communication — Part 2: Archetype interchange specification
127 ISO 13606-3:2019 Health informatics — Electronic health record communication — Part 3: Reference archetypes and term lists
128 ISO 13606-4:2019 Health informatics — Electronic health record communication — Part 4: Security
129 ISO 13606-5:2019 Health informatics — Electronic health record communication — Part 5: Interface specification
130 ISO/TS 13582:2015 Health informatics — Sharing of OID registry information
131 ISO/TS 13131:2014 Health informatics — Telehealth services — Quality planning guidelines
132 ISO/TR 13128:2012 Health Informatics — Clinical document registry federation
133 ISO 13120:2019 Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language (ClaML)
134 ISO 13119:2012 Health informatics — Clinical knowledge resources — Metadata
135 ISO/TR 13054:2012 Knowledge management of health information standards
136 ISO 12967-1:2020 Health informatics — Service architecture (HISA) — Part 1: Enterprise viewpoint
137 ISO 12967-2:2020 Health informatics — Service architecture (HISA) — Part 2: Information viewpoint
138 ISO 12967-3:2020 Health informatics — Service architecture (HISA) — Part 3: Computational viewpoint
139 ISO/TR 12773-1:2009 Business requirements for health summary records — Part 1: Requirements
140 ISO/TR 12773-2:2009 Business requirements for health summary records — Part 2: Environmental scan
141 ISO 12381:2019 Health informatics — Explicit time-related expressions for healthcare-specific problems
142 ISO/TR 12310:2015 Health informatics — Principles and guidelines for the measurement of conformance in the implementation of terminological systems
143 ISO/TR 12309:2009 Health informatics — Guidelines for terminology development organizations
144 ISO/TR 12300:2014 Health informatics — Principles of mapping between terminological systems
145 ISO 12052:2017 Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management
146 ISO/TR 11636:2009 Health Informatics — Dynamic on-demand virtual private network for health information infrastructure
147 ISO/TS 11633-1:2019 Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
148 ISO/TR 11633-2:2009 Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 2: Implementation of an information security management system (ISMS)
149 ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
150 ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
151 ISO/TR 11487:2008 Health informatics — Clinical stakeholder participation in the work of ISO TC 215
152 ISO 11240:2012 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement
153 ISO 11239:2012 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
154 ISO 11238:2018 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
155 ISO/IEEE 11073-00103:2015 Health informatics — Personal health device communication — Part 00103: Overview
156 ISO/IEEE 11073-10101:2020 Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature
157 ISO/IEEE 11073-10102:2014 Health informatics — Point-of-care medical device communication — Part 10102: Nomenclature — Annotated ECG
158 ISO/IEEE 11073-10103:2014 Health informatics — Point-of-care medical device communication — Part 10103: Nomenclature — Implantable device, cardiac
159 ISO/IEEE 11073-10201:2020 Health informatics — Device interoperability — Part 10201: Point-of-care medical device communication — Domain information model
160 ISO/IEEE 11073-10207:2019 Health informatics — Personal health device communication — Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
161 ISO/IEEE 11073-10404:2010 Health informatics — Personal health device communication — Part 10404: Device specialization — Pulse oximeter
162 ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
163 ISO/IEEE 11073-10407:2010 Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor
164 ISO/IEEE 11073-10408:2010 Health informatics — Personal health device communication — Part 10408: Device specialization — Thermometer
165 ISO/IEEE 11073-10415:2010 Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale
166 ISO/IEEE 11073-10417:2017 Health informatics — Personal health device communication — Part 10417: Device specialization — Glucose meter
167 ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
168 ISO/IEEE 11073-10418:2014/Cor 1:2016 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor — Technical Corrigendum 1
169 ISO/IEEE 11073-10419:2019 Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
170 ISO/IEEE 11073-10420:2012 Health informatics — Personal health device communication — Part 10420: Device specialization — Body composition analyzer
171 ISO/IEEE 11073-10421:2012 Health informatics — Personal health device communication — Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
172 ISO/IEEE 11073-10422:2017 Health informatics — Personal health device communication — Part 10422: Device specialization — Urine analyser
173 ISO/IEEE 11073-10424:2016 Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE)
174 ISO/IEEE 11073-10424:2016/Cor 1:2018 Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) — Technical Corrigendum 1
175 ISO/IEEE 11073-10425:2019 Health informatics — Personal health device communication — Part 10425: Device specialization — Continuous glucose monitor (CGM)
176 ISO/IEEE 11073-10427:2018 Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices
177 ISO/IEEE 11073-10441:2015 Health informatics — Personal health device communication — Part 10441: Device specialization — Cardiovascular fitness and activity monitor
178 ISO/IEEE 11073-10442:2015 Health informatics — Personal health device communication — Part 10442: Device specialization — Strength fitness equipment
179 ISO/IEEE 11073-10471:2010 Health informatics — Personal health device communication — Part 10471: Device specialization - Independant living activity hub
180 ISO/IEEE 11073-10472:2012 Health Informatics — Personal health device communication — Part 10472: Device specialization — Medication monitor
181 ISO/IEEE 11073-20101:2004 Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard
182 ISO/IEEE 11073-20601:2016 Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol
183 ISO/IEEE 11073-20601:2016/Cor 1:2016 Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol — Technical Corrigendum 1
184 ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
185 ISO/IEEE 11073-30200:2004 Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected
186 ISO/IEEE 11073-30200:2004/Amd 1:2015 Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected — Amendment 1
187 ISO/IEEE 11073-30300:2004 Health informatics — Point-of-care medical device communication — Part 30300: Transport profile — Infrared wireless
188 ISO/IEEE 11073-30400:2012 Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet
189 ISO 11073-90101:2008 Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test
190 ISO 11073-91064:2009 Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography
191 ISO/HL7 10781:2015 Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM)
192 ISO 10159:2011 Health informatics — Messages and communication — Web access reference manifest
193 ISO 1828:2012 Health informatics — Categorial structure for terminological systems of surgical procedures
194 ISO/TS 21831:2020 Health Information model of Chinese materia medica processing
195 ISO/IEEE 11073-20701:2020 Health informatics — Device interoperability — Part 20701: Point-of-care medical device communication — Service oriented medical device exchange architecture and protocol binding
196 ISO/TR 21835:2020 Health informatics — Personal health data generated on a daily basis
197 ISO 21860:2020 Health Informatics — Reference standards portfolio (RSP) — Clinical imaging
198 ISO/TR 22696:2020 Health informatics — Guidance on the identification and authentication of connectable Personal Healthcare Devices (PHDs)
199 ISO/TS 22756:2020 Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes
  • 관련 국제표준 개발현황은 '국제표준화기구(ISO)' 사이트 등에서 확인할 수 있습니다.
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