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Tagged-Item Grading: Testing Methodology Guideline
Category
Guidance Document
Organisation
GS1
Type
Standard
Version
1.2
Access
Open
Status
Active
Created
May 2024
This guideline is part of the Tagged-Item Performance Protocol (TIPP). The guideline defines the test procedures used for TIPP tagged-item grading. It defines the method and criteria to establish that a tagged item meets a specified grade performance level.
Tagged-Item Grading: Grade Definitions Guideline
Category
Guidance Document
Organisation
GS1
Type
Standard
Version
1.2
Access
Open
Status
Active
Created
May 2024
This guideline is part of the Tagged-Item Performance Protocol (TIPP). The guideline introduces the TIPP grades, explains the TIPP grade naming system, and defines the specifications for tagged-item sensitivity and backscatter for each grade.
Tagged-Item Grading: Test Configuration Guideline
Category
Guidance Document
Organisation
GS1
Type
Standard
Version
1.2
Access
Open
Status
Active
Created
May 2024
This guideline is part of the Tagged-Item Performance Protocol (TIPP). The guideline specifies the orientation and placement of tagged items when validating their grade.
Health informatics — Public key infrastructure — Part 1: Overview of digital certificate services
Category
Standard
Organisation
ISO
ID
ISO 17090-1:2021
Type
Standard
Version
3
Access
Fees apply to access
Status
Active
Created
March 2021
This standard defines the basic concepts underlying the use of digital certificates in health care and provides a scheme of interoperability requirements to establish a digital certificate-enabled secure communication of health information.
Health informatics — Public key infrastructure — Part 2: Certificate profile
Category
Standard
Organisation
ISO
ID
ISO 17090-2:2015
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
November 2015
This standard specifies the certificate profiles required to interchange health care information within a single organisation, between different organisations and across jurisdictional boundaries. It details the use made of digital certificates in the health industry and focuses, in particular, on specific healthcare issues relating to certificate profiles.
Health informatics — Public key infrastructure — Part 3: Policy management of certification authority
Category
Standard
Organisation
ISO
ID
ISO 17090-3:2021
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
March 2021
This standard gives guidelines for certificate management issues involved in deploying digital certificates in health care. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements.
Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents
Category
Standard
Organisation
ISO
ID
ISO 17090-4:2020
Type
Standard
Version
2
Access
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Status
Active
Created
October 2020
This standard supports interchangeability of digital signatures and the prevention of incorrect or illegal digital signatures by providing minimum requirements and formats for generating and verifying digital signatures and related certificates.
Health informatics — Public key infrastructure — Part 5: Authentication using Healthcare PKI credentials
Category
Standard
Organisation
ISO
ID
ISO 17090-5:2017
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
July 2017
This standard defines the procedural requirements for validating an entity credential based on healthcare public key infrastructure (PKI) defined in the ISO 17090 series used in healthcare information systems including accessing remote systems.
Health informatics — Terminological resources — Part 1: Characteristics
Category
Standard
Organisation
ISO
ID
ISO 17117-1:2018
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
April 2018
This standard defines universal and specialised characteristics of health terminological resources that make them fit for the purposes required of various applications.
Health informatics — Categorial structures for representation of nursing practice in terminological systems
Category
Standard
Organisation
ISO
ID
ISO 18104:2023
Type
Standard
Version
3
Access
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Status
Active
Created
December 2023
This standard specifies the characteristics of categorial structures representing nursing practice. The overall aim of this standard is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes.
Health Informatics — Messages and communication — Format of length limited globally unique string identifiers
Category
Standard
Organisation
ISO
ID
ISO 18232:2006
Type
Standard
Version
1
Access
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Status
Active
Created
April 2006
This standard specifies a common format for the exchange of commonly used globally unique identifiers (GUIs) expressed as alphanumeric strings.
Health informatics — Categorial structure for terminological systems of surgical procedures
Category
Standard
Organisation
ISO
ID
ISO 1828:2012
Type
Standard
Version
1
Access
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Status
Active
Created
September 2012
This standard specifies the minimal characteristics of a categorial structure for terminological systems of surgical procedures. It also specifies the minimal domain constraints to support interoperability, comparability and the exchange of meaningful information on surgical procedures.
Health informatics — Automatic identification and data capture marking and labelling — Subject of care and individual provider identification
Category
Standard
Organisation
ISO
ID
ISO 18530:2021
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
January 2021
This standard sets out the data elements and structure needed for accurate, sensitive and procedurally appropriate subjects of care (SoC) and individual provider identification.
Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
Category
Standard
Organisation
ISO
ID
ISO 18812:2003
Type
Standard
Version
1
Access
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Status
Active
Created
March 2003
This standard describes messages for the transfer of data between analytical instruments (AIs) and laboratory information systems (LISs) within a clinical laboratory.
Health informatics — Health cards — General characteristics
Category
Standard
Organisation
ISO
ID
ISO 20301:2014
Type
Standard
Version
2
Access
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Status
Active
Created
January 2014
This standard describes general characteristics of machine-readable cards used in the field of healthcare. It focuses on cards of ID-1 type that are issued for healthcare services that crosses the borders of two or more countries or areas.
Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers
Category
Standard
Organisation
ISO
ID
ISO 20302:2022
Type
Standard
Version
3
Access
Fees apply to access
Status
Active
Created
January 2022
This document specifies a numbering system and registration procedure for identifying healthcare application providers and health card holders for the purpose of information exchange through the use of healthcare cards.
Health informatics — Harmonized data types for information interchange
Category
Standard
Organisation
ISO
ID
ISO 21090:2011
Type
Standard
Access
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Status
Active
Created
February 2011
This standard provides a set of datatype definitions for representing and exchanging basic concepts that are commonly encountered in healthcare environments.
Health informatics — Directory services for healthcare providers, subjects of care and other entities
Category
Standard
Organisation
ISO
ID
ISO 21091:2013
Type
Standard
Version
1
Access
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Status
Active
Created
February 2013
This standard defines minimal specifications for healthcare directory services. It provides the common directory information and services needed to support the secure exchange of healthcare information over public networks.
Health informatics — Functional and structural roles
Category
Standard
Organisation
ISO
ID
ISO 21298:2017
Type
Standard
Version
1
Access
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Status
Active
Created
February 2017
This standard defines a model for expressing functional and structural roles for health professionals and consumers and populates the model with a basic set of roles for international use in health applications.
Genomics informatics — Omics Markup Language (OML)
Category
Standard
Organisation
ISO
ID
ISO 21393:2021
Type
Standard
Version
1
Access
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Status
Active
Created
July 2021
This document applies to the data exchange format that is designed to facilitate exchanging omics data around the world without forcing changes of any database schema. It specifies the characteristics of OML from 4 perspectives: informatics, molecular, application and biological species.
Health informatics — Patient healthcard data – Part 1: General structure
Category
Standard
Organisation
ISO
ID
ISO 21549-1:2013
Type
Standard
Version
2
Access
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Status
Active
Created
June 2013
This standard defines a general structure for the different types of data to be defined in other parts of ISO 21549 using UML notation.
Health informatics — Patient healthcard data – Part 2: Common objects
Category
Standard
Organisation
ISO
ID
ISO 21549-2:2014
Type
Standard
Version
2
Access
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Status
Active
Created
February 2014
This standard describes and defines the Common Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 3: Limited clinical data
Category
Standard
Organisation
ISO
ID
ISO 21549-3:2014
Type
Standard
Version
2
Access
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Status
Active
Created
February 2014
This standard describes and defines the Limited Clinical Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 4: Extended clinical data
Category
Standard
Organisation
ISO
ID
ISO 21549-4:2014
Type
Standard
Version
2
Access
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Status
Active
Created
February 2014
This standard describes and defines the Extended Clinical Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 5: Identification data
Category
Standard
Organisation
ISO
ID
ISO 21549-5:2023
Type
Standard
Version
3
Access
Fees apply to access
Status
Active
Created
October 2023
This standard describes and defines the basic structure of the identification data objects held on healthcare data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 6: Administrative data
Category
Standard
Organisation
ISO
ID
ISO 21549-6:2008
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
April 2008
This standard specifies the basic structure of the data contained within the administrative data data object.
Health informatics — Patient healthcard data – Part 7: Medication data
Category
Standard
Organisation
ISO
ID
ISO 21549-7:2024
Type
Standard
Version
3
Access
Fees apply to access
Status
Active
Created
February 2024
This standard specifies the basic structure of the data contained within the medication data object.
Health informatics — Patient healthcard data – Part 8: Links
Category
Standard
Organisation
ISO
ID
ISO 21549-8:2010
Type
Standard
Version
1
Access
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Status
Active
Created
June 2010
This standard defines a way to facilitate access to distributed patient records and/or administrative information using healthcards.
Health informatics — Health indicators conceptual framework
Category
Standard
Organisation
ISO
ID
ISO 21667:2010
Type
Standard
Version
1
Access
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Status
Active
Created
December 2010
This standard establishes a common health indicators conceptual framework, and aims to foster a common vocabulary and conceptual definitions for the framework. The framework defines the appropriate dimensions and sub-dimensions required to describe the health of the population and performance of a healthcare system.
Health Informatics — Reference standards portfolio (RSP) — Clinical imaging
Category
Standard
Organisation
ISO
ID
ISO 21860:2020
Type
Standard
Version
1
Access
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Status
Active
Created
November 2020
This standard establishes the reference standards portfolio (RSP) for the clinical imaging domain.
Health informatics — Medical waveform format — Part 1: Encoding rules
Category
Standard
Organisation
ISO
ID
ISO 22077-1:2022
Type
Standard
Version
2
Access
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Status
Active
Created
January 2022
This standard specifies how medical waveforms, such as electrocardiogram, electroencephalogram, spirometry waveform and so on, are described for interoperability among healthcare information systems.
Health informatics — Medical waveform format — Part 2: Electrocardiography
Category
Standard
Organisation
ISO
ID
ISO 22077-2:2023
Type
Standard
Version
1
Access
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Status
Active
Created
August 2023
This standard defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiography waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups.
Health informatics — Medical waveform format — Part 3: Long-term electrocardiography
Category
Standard
Organisation
ISO
ID
ISO 22077-3:2023
Type
Standard
Access
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Status
Active
Created
August 2023
This standard defines the application of medical waveform format encoding rules (MFER) to describe long-term electrocardiography waveforms measured in physiological laboratories and healthcare clinics.
Health informatics — Privilege management and access control — Part 1: Overview and policy management
Category
Standard
Organisation
ISO
ID
ISO 22600-1:2014
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
October 2014
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.
Health informatics — Privilege management and access control — Part 2: Formal models
Category
Standard
Organisation
ISO
ID
ISO 22600-2:2014
Type
Standard
Version
1
Access
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Status
Active
Created
October 2014
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-2:2014 introduces the underlying paradigm of formal high-level models for architectural components.
Health informatics — Privilege management and access control — Part 3: Implementations
Category
Standard
Organisation
ISO
ID
ISO 22600-3:2014
Type
Standard
Version
1
Access
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Status
Active
Created
October 2014
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-3:2014 instantiates requirements for repositories for access control policies and requirements for privilege management infrastructures.
Health informatics — Guidelines on data protection to facilitate transborder flows of personal health data
Category
Standard
Organisation
ISO
ID
ISO 22857:2013
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
December 2013
This standard provides guidance on data protection requirements to facilitate the transfer of personal health data across national or jurisdictional borders.
Healthcare organization management — Vocabulary
Category
Standard
Organisation
ISO
ID
ISO 22886:2020
Type
Standard
Version
1
Access
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Status
Active
Created
August 2020
This standard defines terms used in healthcare organisation management.
Healthcare organization management — Requirements for patient-centred staffing
Category
Standard
Organisation
ISO
ID
ISO 22956:2021
Type
Standard
Version
1
Access
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Status
Active
Created
June 2021
This standard provides requirements for patient-centred staffing in healthcare settings. It is generic and applicable to any healthcare organisation.
Healthcare organization management — Hand hygiene performance
Category
Standard
Organisation
ISO
ID
ISO 23447:2023
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
October 2023
This standard specifies hand hygiene training, compliance benchmarking, performance/feedback, and facility requirements for healthcare facilities that operate hand hygiene systems.
Health informatics — Interoperability and integration reference architecture — Model and framework
Category
Standard
Organisation
ISO
ID
ISO 23903:2021
Type
Standard
Version
1
Access
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Status
Active
Created
April 2021
This standard enables the advancement of interoperability from the data/information exchange paradigm to knowledge sharing at decreasing level of abstraction.
Health informatics — Genomic Sequence Variation Markup Language (GSVML)
Category
Standard
Organisation
ISO
ID
ISO 25720:2009
Type
Standard
Version
1
Access
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Status
Active
Created
August 2009
This standard applies to the data exchange format that is designed to facilitate the exchange of the genomic sequence variation data around the world, without forcing change of any database schema.
Health informatics — Audit trails for electronic health records
Category
Standard
Organisation
ISO
ID
ISO 27789:2021
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
October 2021
This standard specifies a common framework for audit trails for electronic health records, in terms of audit trigger events and audit data, to keep the complete set of personal health information auditable across information systems and domains.
Health informatics — Framework for healthcare and related data reporting
Category
Standard
Organisation
ISO
ID
ISO 29585:2023
Type
Standard
Version
1
Access
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Status
Active
Created
June 2023
This standard deals with the reporting of data to support improved public health, more effective health care and better health outcomes. It provides guidance and requirements for those developing or deploying a healthcare data reporting service, addressing data capture, processing, aggregation and data modelling, and architecture and technology approaches.
Health informatics — Standard communication protocol — Computer-assisted electrocardiography
Category
Standard
Organisation
ISO
ID
ISO 41064:2023
Type
Standard
Version
1
Access
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Status
Active
Created
June 2023
This standard specifies the common conventions needed for the interchange of specific patient data (such as on demographics and recording conditions), electrocardiogram (ECG) signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results.
Genomics informatics — Phenopackets: A format for phenotypic data exchange
Category
Standard
Organisation
ISO
ID
ISO 4454:2022
Type
Standard
Version
1
Access
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Status
Active
Created
July 2022
This standard specifies a uniform, machine-readable, phenotypic description of an individual, patient or sample in the context of rare disease, common/complex disease or cancer.
Healthcare organization management — Pandemic response (respiratory) — Drive-through screening station
Category
Standard
Organisation
ISO
ID
ISO 5258:2022
Type
Standard
Version
1
Access
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Status
Active
Created
2022
This standard specifies the operation of a drive-through screening station (DTSS) for mass testing as part of pandemic response management.
Healthcare organization management — Pandemic response (respiratory) — Walk-through screening station
Category
Standard
Organisation
ISO
ID
ISO 5472:2022
Type
Standard
Version
1
Access
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Status
Active
Created
2022
This standard specifies the operation of a walk-through screening station (WTSS) for mass testing as part of pandemic response management (for example, during the COVID-19 pandemic).