Health informatics — Categorial structure for terminological systems of surgical procedures

Information technology — 3D Printing and scanning — Medical image-based modelling — Part 1: General requirement

Health informatics — Introduction to Ayurveda

Genomics Informatics — Phenopackets: A Format for Phenotypic Data Exchange

Health informatics — Messages and communication — Web access reference manifest

Electronic Health Record-System Functional Model, Release 1.1

Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM)

Health informatics — Personal health device communication — Part 00103: Overview

Health informatics — Point-of-care medical device communication — Part 10101: Nomenclature

Health informatics — Point-of-care medical device communication — Part 10101: Nomenclature — Amendment 1: Additional definitions

Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature

Health informatics — Point-of-care medical device communication — Part 10102: Nomenclature — Annotated ECG

Health informatics — Point-of-care medical device communication — Part 10103: Nomenclature — Implantable device, cardiac

Health informatics — Point-of-care medical device communication — Part 10201: Domain information model

Health informatics — Device interoperability — Part 10201: Point-of-care medical device communication — Domain information model

Health informatics — Personal health device communication — Part 10207: Domain information and service model for service-oriented point-of-care medical device communication

Health informatics — Personal health device communication — Part 10404: Device specialization — Pulse oximeter

Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)

Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor

Health informatics — Personal health device communication — Part 10408: Device specialization — Thermometer

Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale

Health informatics — Personal health device communication — Part 10417: Device specialization — Glucose meter

Health informatics — Personal health device communication — Part 10417: Device specialization — Glucose meter

Health informatics — Personal health device communication — Part 10417: Device specialization — Glucose meter

Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor

Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor — Technical Corrigendum 1

Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump

Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump

Health informatics — Personal health device communication — Part 10420: Device specialization — Body composition analyzer

Health informatics — Personal health device communication — Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)

Health informatics — Personal health device communication — Part 10422: Device specialization — Urine analyser

Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE)

Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) — Technical Corrigendum 1

Health informatics — Personal health device communication — Part 10425: Device specialization — Continuous glucose monitor (CGM)

Health informatics — Personal health device communication — Part 10425: Device specialization — Continuous glucose monitor (CGM)

Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices

Health informatics — Personal health device communication — Part 10441: Device specialization — Cardiovascular fitness and activity monitor

Health informatics — Personal health device communication — Part 10442: Device specialization — Strength fitness equipment

Health informatics — Personal health device communication — Part 10471: Device specialization - Independant living activity hub

Health Informatics — Personal health device communication — Part 10472: Device specialization — Medication monitor

Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard

Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol

Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol — Amendment 1

Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol

Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol — Technical Corrigendum 1

Health informatics — Device interoperability — Part 20701: Point-of-care medical device communication — Service oriented medical device exchange architecture and protocol binding

Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services

Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected

Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected — Amendment 1

Health informatics — Point-of-care medical device communication — Part 30300: Transport profile — Infrared wireless

Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet

Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test

Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography

Health informatics — Medical waveform format — Part 92001: Encoding rules

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances

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

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

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement

Health informatics — Clinical stakeholder participation in the work of ISO TC 215

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

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)

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)

Health Informatics — Dynamic on-demand virtual private network for health information infrastructure

Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management

Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management

Health informatics — Principles of mapping between terminological systems

Health informatics — Guidelines for terminology development organizations

Health informatics — Principles and guidelines for the measurement of conformance in the implementation of terminological systems

Health informatics — Explicit time-related expressions for healthcare-specific problems

Business requirements for health summary records — Part 1: Requirements

Business requirements for health summary records — Part 2: Environmental scan

Health informatics — Service architecture — Part 1: Enterprise viewpoint

Health informatics — Service architecture (HISA) — Part 1: Enterprise viewpoint

Health informatics — Service architecture — Part 2: Information viewpoint

Health informatics — Service architecture (HISA) — Part 2: Information viewpoint

Health informatics — Service architecture — Part 3: Computational viewpoint

Health informatics — Service architecture (HISA) — Part 3: Computational viewpoint

Knowledge management of health information standards

Health informatics — Clinical knowledge resources — Metadata

Health informatics — Clinical knowledge resources — Metadata

Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language (ClaML)

Health informatics — Syntax to represent the content of healthcare classification systems — Classification Markup Language (ClaML)

Health Informatics — Clinical document registry federation

Health informatics — Telehealth services — Quality planning guidelines

Health informatics — Telehealth services — Quality planning guidelines

Health informatics — Sharing of OID registry information

Health informatics — Sharing of OID registry information

Health informatics — Electronic health record communication — Part 1: Reference model

Health informatics — Electronic health record communication — Part 1: Reference model

Health informatics — Electronic health record communication — Part 2: Archetype interchange specification

Health informatics — Electronic health record communication — Part 2: Archetype interchange specification

Health informatics — Electronic health record communication — Part 3: Reference archetypes and term lists

Health informatics — Electronic health record communication — Part 3: Reference archetypes and term lists

Health informatics — Electronic health record communication — Part 4: Security

Health informatics — Electronic health record communication — Part 4: Security

Health informatics — Electronic health record communication — Part 5: Interface specification

Health informatics — Electronic health record communication — Part 5: Interface specification

Health informatics — System of concepts to support continuity of care

Health informatics — System of concepts to support continuity of care — Amendment 1: .

Health informatics — Clinical information models — Characteristics, structures and requirements

Health informatics — Detailed clinical models, characteristics and processes

Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model

Health Informatics - Classification of purposes for processing personal health information

Health informatics — Personal health records — Definition, scope and context

Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment

Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment

Health informatics — Capacity-based eHealth architecture roadmap — Part 1: Overview of national eHealth initiatives

Health informatics — Capacity-based eHealth architecture roadmap — Part 2: Architectural components and maturity model

Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1

Medical devices — Quality management — Medical device nomenclature data structure

Medical devices — Quality management — Medical device nomenclature data structure

Health informatics — Interoperability of telehealth systems and networks — Part 1: Introduction and definitions

Health informatics — Interoperability of telehealth systems and networks — Part 2: Real-time systems

Health informatics — Interoperability of telelearning systems

Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine

Health informatics — Categorial structure for terminological systems of human anatomy

Health informatics — HL7 Personal Health Record System Functional Model, Release 1 (PHRS FM)

Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

Health informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points

Health informatics — Categorial structures for representation of acupuncture — Part 2: Needling

Health informatics — Categorial structures for representation of acupuncture — Part 3: Moxibustion

Health informatics — Categorial structures for representation of acupuncture — Part 4: Meridian and collateral channels

Health Informatics — Categorial structures for representation of acupuncture — Part 5: Cupping

Health informatics — Public key infrastructure — Part 1: Overview of digital certificate services

Health informatics — Public key infrastructure — Part 1: Framework and overview

Health informatics — Public key infrastructure — Part 1: Overview of digital certificate services

Health informatics — Public key infrastructure — Part 1: Overview of digital certificate services

Health informatics — Public key infrastructure — Part 2: Certificate profile

Health informatics — Public key infrastructure — Part 2: Certificate profile

Health informatics — Public key infrastructure — Part 2: Certificate profile

Health informatics — Public key infrastructure — Part 3: Policy management of certification authority

Health informatics — Public key infrastructure — Part 3: Policy management of certification authority

Health informatics — Public key infrastructure — Part 3: Policy management of certification authority

Health informatics — Public key infrastructure — Part 4: Digital Signatures for healthcare documents

Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents

Health informatics — Public key infrastructure — Part 5: Authentication using Healthcare PKI credentials

Health informatics — Vocabulary of compositional terminological systems

Health informatics — Representation of categorial structures of terminology (CatStructure)

Health informatics — Terminological resources — Part 1: Characteristics

Health informatics — Terminological resources — Part 2: Implementation Capability (TIC)

Health informatics — Controlled health terminology — Structure and high-level indicators

Health informatics - Health informatics profiling framework

Health informatics — Country identifier standards

Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products

Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products

Health informatics — Messages and communication — Web access to DICOM persistent objects

Health informatics — Development of terms and definitions for health informatics glossaries

Health informatics — Development of terms and definitions for health informatics glossaries

Health informatics — Provisions for health applications on mobile/smart devices

Health informatics — Requirements for electronic prescriptions

Health informatics — Guidance on standards for enabling safety in health software

Health informatics — Semantic network framework of traditional Chinese medicine language system

Health informatics — Traditional Chinese medicine literature metadata

Health informatics — Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information

Health informatics — Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information

Health informatics — Categorial structure for representation of herbal medicaments in terminological systems

Health informatics — Integration of a reference terminology model for nursing

Health informatics — Categorial structures for representation of nursing diagnoses and nursing actions in terminological systems

Health informatics — Categorial structures for representation of nursing diagnoses and nursing actions in terminological systems

Health Informatics — Messages and communication — Format of length limited globally unique string identifiers

Health informatics — Interoperability and compatibility in messaging and communication standards — Key characteristics

Health informatics — Requirements for an electronic health record architecture

Health informatics — Requirements for an electronic health record architecture

Health informatics — Automatic identification and data capture marking and labelling — Subject of care and individual provider identification

Health Informatics — Automatic identification and data capture marking and labelling — Subject of care and individual provider identification

Health informatics — Guidance on health information privacy education in healthcare organizations

Health informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine

Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles

Health informatics — Quality metrics for detailed clinical models

Health informatics — Survey of mHealth projects in low and middle income countries (LMIC)

Health informatics — Requirements for medicinal product dictionary systems for health care

Health informatics — Requirements for a record of a dispense of a medicinal product

Health informatics — Re-usable component strategy for use case development

Health informatics — Identification of medicinal products — Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances

Health informatics — Identification of medicinal products — Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances

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

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

Health informatics — Person-owned document repository for PHR applications and health information exchange

Health informatics — Health cards — General characteristics

Health informatics — Health cards — General characteristics

Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers

Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers

Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers

Health informatics — Framework of event data and reporting definitions for the safety of health software

Health informatics — Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records

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

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

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

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

Health informatics — Electronic health record — Definition, scope and context

Health informatics — Medication management concepts and definitions

Health informatics — Trusted end-to-end information flows

Health informatics — Trusted end-to-end information flows

Health informatics — Harmonized data types for information interchange

Health informatics — Directory services for healthcare providers, subjects of care and other entities

Health informatics — Directory services for security, communications and identification of professionals and patients

Health informatics — Functional and structural roles

Health informatics — Functional and structural roles

Health informatics — Cloud computing considerations for the security and privacy of health information systems

Genomics informatics — Omics Markup Language (OML)

Genomics informatics — Whole Genomics Sequence Markup Language (WGML)

Health informatics — Metadata repository requirements (MetaRep)

Health informatics — Security requirements for archiving of electronic health records — Principles

Health informatics — Security requirements for archiving of electronic health records — Guidelines

Health informatics — Patient healthcard data — Part 1: General structure

Health informatics — Patient healthcard data — Part 1: General structure

Health informatics — Patient healthcard data — Part 2: Common objects

Health informatics — Patient healthcard data — Part 2: Common objects

Health informatics — Patient healthcard data — Part 3: Limited clinical data

Health informatics — Patient healthcard data — Part 3: Limited clinical data

Health informatics — Patient healthcard data — Part 4: Extended clinical data

Health informatics — Patient healthcard data — Part 4: Extended clinical data

Health informatics — Patient healthcard data — Part 5: Identification data

Health informatics — Patient healthcard data — Part 5: Identification data

Health informatics — Patient healthcard data — Part 6: Administrative data

Health informatics — Patient healthcard data — Part 7: Medication data

Health informatics — Patient healthcard data — Part 7: Medication data

Health informatics — Patient healthcard data — Part 8: Links

Health Informatics — Terminology resource map quality measures (MapQual)

Health informatics — Health indicators conceptual framework

Health informatics — Health indicators conceptual framework

Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for the management of unintentional electromagnetic interference with medical devices

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

Health informatics — HL7 version 3 — Reference information model — Release 1

Health informatics — HL7 version 3 — Reference information model — Release 4

Health informatics — Personal health data generated on a daily basis

Health Informatics — Reference standards portfolio (RSP) — Clinical imaging

Health informatics — Medical waveform format — Part 1: Encoding rules

Health informatics — Medical waveform format — Part 1: Encoding rules

Health informatics — Medical waveform format — Part 2: Electrocardiography

Health informatics — Medical waveform format — Part 3: Long term electrocardiography

Health informatics — Medical waveform format — Part 4: Stress test electrocardiography

Health informatics — Medical waveform format — Part 5: Neurophysiological signals

Health Informatics — Identification of subjects of health care

Health informatics — Identification of subjects of health care

Health informatics - Good principles and practices for a clinical data warehouse

Health informatics — Electronic reporting of adverse drug reactions

Health Informatics - Methodology for analysis of business and information needs of health enterprises to support standards based architectures

Health informatics — Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)

Health informatics — Classification of traditional Chinese medicine data sets

Health informatics — Privilege management and access control — Part 1: Overview and policy management

Health informatics — Privilege management and access control — Part 1: Overview and policy management

Health informatics — Privilege management and access control — Part 2: Formal models

Health informatics — Privilege management and access control — Part 2: Formal models

Health informatics — Privilege management and access control — Part 3: Implementations

Health informatics — Privilege management and access control — Part 3: Implementations

Health informatics — Token-based health information sharing

Genomics informatics— Quality control metrics for DNA sequencing

Genomics Informatics — Structured clinical gene fusion report in electronic health records

Health informatics — Guidance on the identification and authentication of connectable Personal Healthcare Devices (PHDs)

Health informatics — Requirements for medication safety alerts

Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes

Health Informatics — Categorial structures for the representation of the decocting process in traditional Chinese medicine

Health informatics — Conceptual framework for patient findings and problems in terminologies

Health informatics — Functional characteristics of prescriber support systems

Health informatics — Information model of combination of decoction pieces in Chinese medicines

Health informatics — Guidelines on data protection to facilitate trans-border flows of personal health information

Health informatics — Guidelines on data protection to facilitate trans-border flows of personal health data

Traditional Chinese medicine — Pulse waveform format

Health informatics — Categorial structure for Chinese materia medica products manufacturing process

Genomics Informatics - Clinical genomics data sharing specification for next generation sequencing

Health informatics — Guidance for establishing standardized measurement data in cardiac examination reports – Japan SEAMAT Case Study

Health informatics — Requirements for customer-oriented health cloud service agreements

Health Informatics — Categorial structure for representation of 3D human body position system — Part 1: Bones

Health informatics — Interoperability and integration reference architecture – Model and framework

Health informatics — Identification of medicinal products — Class name and attribute translations and synonyms for the identification of medicinal products for ISO 11615

Health informatics — Hierarchical File Structure Specification for Secondary Storage of Health Related Information

Health informatics — Applications of machine learning technologies in imaging and other medical applications

Health informatics - Guidance on Security for Gateways Used in Personal Health Care Systems

Health informatics — Pseudonymization

Health informatics — Pseudonymization

Health informatics — Classification of safety risks from health software

Health informatics — Business requirements for an international coding system for medicinal products

Health informatics — Genomic Sequence Variation Markup Language (GSVML)

Health informatics — International patient summary

Health informatics — Provider identification

Health informatics — Audit trails for electronic health records

Health informatics — Audit trails for electronic health records

Health informatics — Document registry framework

Health informatics — Information security management in health using ISO/IEC 27002

Health informatics — Information security management in health using ISO/IEC 27002

Health informatics — Measures for ensuring patient safety of health software

Data Exchange Standards — Health Level Seven Version 2.5 — An application protocol for electronic data exchange in healthcare environments

Data Exchange Standards — HL7 Clinical Document Architecture, Release 2

Health informatics — Common terminology services, release 1

Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting

Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR

Health informatics — IHE global standards adoption — Part 1: Process

Health informatics — IHE global standards adoption — Part 2: Integration and content profiles

Health informatics — IHE global standards adoption — Part 3: Deployment

Information technology — User interface accessibility — Part 1: User accessibility needs

Information technology — Accessibility considerations for people with disabilities — Part 1: User needs summary

Information technology — Accessibility considerations for people with disabilities — Part 2: Standards inventory

Information technology — Accessibility considerations for people with disabilities — Part 3: Guidance on user needs mapping

Health informatics — Deployment of a clinical data warehouse

Medical device software — Software life cycle processes

Medical device software — Software life cycle processes — Amendment 1

Health software — Software life cycle processes

Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software — Part 1: Application of risk management

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

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

Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks

Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations

Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems

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

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

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

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

Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

Medical device software — Part 2: Validation of software for medical device quality systems

Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts

Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle

Health software — Part 1: General requirements for product safety

Health software — Part 2: Health and wellness apps—Quality and reliability