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Standards in development (104)

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Standard TitleStatus
BS EN ENISO 4797 conical ground jointsPublic Comment
BS EN ISO 11073-00000 Health Informatics - Analytical instruments - Point of Care medical device communication - Part 00000: Framework and overviewIdea
BS EN ISO 11073-20201 Health Informatics - Point of Care medical device communication - Application profile Part 20201: Polling modeAccepted
BS EN ISO 11073-20202 Health Informatics - Point of Care medical device communication - Application profile Part 20202: BaselineAccepted
BS EN ISO 13940-1 Health informatics — System of concepts to support continuity of care — Part 1: Basic conceptsAccepted
BS EN ISO 15189:2012/Cor quality and competencePublication
BS EN ISO 4796-1 Laboratory glassware - Bottles Part 1: Screw-neck bottlesPublic Comment
BS ENISO 10781 Electronic Health Record-System Functional Model, Release 2 (EHR FM) (ISO/HL7 CD 10781)Publication
BS ENISO 11073-30200:2004/Amd 1 informatics - Point-of-care medical device communication Part 30200: Transport profile - Cable connected - Amendment 1Approval
BS ENISO 1135-3 Transfusion equipment for medical use Part 3: Blood-taking setPublic Comment
BS ENISO 1135-4 Transfusion equipment for medical use Part 4: Transfusion sets for single usePublic Comment
BS ENISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatusPublic Comment
BS ENISO 12836:2012/Amd 1 for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy - Amendment 1Public Comment
BS ENISO 13940 Health informatics - System of concepts to support continuity of careTechnical Review
BS ENISO 15378 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)Public Comment
BS ENISO 16202-1 Dentistry - Classification and codification of oral anomalies Part 1: Structure of the classificationAccepted
BS ENISO 16202-2 Dentistry - Classification and codification of oral anomalies Part 2: Development disturbances of teethAccepted
BS ENISO 16496 vacuum-jacket insulationPublic Comment
Opens a new windowBS ENISO 17523 Health informatics - Requirements for electronic prescriptionsPublic Comment
BS ENISO 21549-5 Health informatics - Patient healthcard data Part 5: Identification dataPublic Comment
Opens a new windowBS ENISO 21549-7 Health informatics - Patient healthcard data Part 7: Medication dataPublic Comment
BS ENISO 22600-1 Health informatics - Privilege management and access control Part 1: Overview and policy managementPublication
BS ENISO 22600-2 Health informatics - Privilege management and access control Part 2: Formal modelsPublication
BS ENISO 22600-3 Health informatics - Privilege management and access control Part 3: ImplementationsPublication
Opens a new windowBS ENISO 27799 Health informatics - Information security management in health using ISO/IEC 27002Public Comment
BS ENISO 3819 Laboratory glassware - BeakersPublic Comment
BS ENISO 3826-4 Plastics collapsible containers for human blood and blood components Part 4: Aphaeresis blood bag systems with integrated featuresPublic Comment
BS ENISO 384 Principles of design and construction of volumetric instrumentsPublic Comment
Opens a new windowBS ENISO 8362-1:2009/Amd 1 Injection containers and accessories Part 1: Injection vials made of glass tubing - Amendment 1Public Comment
Opens a new windowBS ENISO 8362-2 Injection containers and accessories Part 2: Closures for injection vialsPublic Comment
Opens a new windowBS ENISO 8362-5 Injection containers and accessories Part 5: Freeze drying closures for injection vialsPublic Comment
BS ENISO 8536-10 Infusion equipment for medical use Part 10: Accessories for fluid lines for use with pressure infusion equipmentPublic Comment
BS ENISO 8536-11 Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipmentPublic Comment
BS ENISO 8536-8 Infusion equipment for medical use Part 8: Infusion equipment for use with pressure infusion apparatusPublic Comment
BS ENISO 8536-9 Infusion equipment for medical use Part 9: Fluid lines for use with pressure infusion equipmentPublic Comment
BS ISO 11040-1 Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridgesPublic Comment
BS ISO 11040-4 Prefilled syringes Part 4: Glass barrels for injectables and ready-to-use prefillable syringesApproval
BS ISO 11040-7 Prefilled syringes Part 7: packaging system for disposable ready-to-use syringesApproval
BS ISO 11040-8 Prefilled syringes Part 8: Requirements and test methods for the use of filled syringesAccepted
BS ISO 11073-60101 Health informatics -- Point-of-care medical device communication Part 60101: Application gateway -- HL7 (v2.x), observation reporting interface (ORI)Accepted
BS ISO 11418-5 Containers and accessories for pharmaceutical preparations Part 5: Dropper assembliesApproval
BS ISO 13606-2 Health informatics - Electronic health record communication Part 2: Archetype interchange specificationIdea
BS ISO 13606-3 Health informatics - Electronic health record communication Part 3: Reference archetypes and term listsAccepted
BS ISO 13606-4 Health informatics - Electronic health record communication Part 4: SecurityAccepted
BS ISO 13606-5 Health informatics - Electronic health record communication Part 5: Interface specificationAccepted
Opens a new windowBS ISO 13926-2:2011/Amd 1 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use - Amendment 1Public Comment
BS ISO 14199 Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) ModelPublic Comment
BS ISO 14199 Health Informatics – Information Model – CDISC – Biomedical Research Information Domain Group (BRIDG) ModelAccepted
Opens a new windowBS ISO 16782 Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testingPublic Comment
BS ISO 17090-2 Health informatics - Public key infrastructure Part 2: Certificate profilePublic Comment
BS ISO 17090-4 Health informatics - Public key infrastructure Part 4: Digital Signatures for healthcare documentsPublication
BS ISO 17583 Health informatics - Terminology constraints for coded data elements expressed in ISO Harmonized Data Types used in healthcare information interchangePublic Comment
BS ISO 17822-1 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens - General requirements and definitionsAccepted
BS ISO 18559 Dentistry - Spatulas for dental materialsAccepted
BS ISO 18618 Dentistry - Interoperability of CAD/CAM SystemsAccepted
BS ISO 18675 Dental CAD/CAM Machinable Zirconia BlanksIdea
BS ISO 18739 Dentistry - Terminology of process chain for CAD/CAM systemsAccepted
BS ISO 18845 Dentistry - CAD/CAM systems - Accuracy of machined indirect restorations - Test methods and markingAccepted
BS ISO 19231 Health informatics - Survey of mHealth projects in low to middle income countries (LMIC)Publication
BS ISO 19293 Health Informatics - Requirements for a record of the dispense of a medicinal productIdea
BS ISO 19294 Health informatics - Data elements and structures for identification of extemporeanous and magistral (compound) pharmaceutical preparations without marketing authorisationIdea
Opens a new windowBS ISO 21298 Health informatics - Functional and structural rolesPublic Comment
BS ISO 22077-1 Health informatics - Medical waveform format Part 1: Encoding rulesApproval
BS ISO 25237 Health informatics - PseudonymisationIdea
BS ISO 28680 Application of risk management for IT - Networks incorporating medical devicesnull
BS ISO 8536-13 Infusion equipment for medical use Part 13: Clamps, restrictors and flow regulators for transfusion and infusion setsAccepted
BS ISO 8536-14 Infusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contactAccepted
BS ISO/HL721731 Health informatics HL7 version 3 -- Reference information model -- Release 1Approval
BS ISO/TS 17518 Medical Laboratories - Guidance for users of reagents for staining in biology in medical laboratoriesAccepted
PD CEN ISO/TS 13972 Health informatics - Detailed clinical models, characteristics and processesApproval
PD CEN/TS WI 00140088 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for selected types of sampleAccepted
PD CEN/TS WI 00140090 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for snap frozen tissue - RNAIdea
PD CEN/TS WI 00140091 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for blood - Circulating cell free DNAIdea
PD CEN/TS WI 00140092 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for blood - Cellular RNAIdea
PD CEN/TS WI 00140093 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for FFPE tissue - RNAIdea
PD CEN/TS WI 00140094 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for metabolomics in urine, serum and plasmaIdea
PD CEN/TS WI 00140095 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for FFPE tissue - DNAIdea
PD CEN/TS WI 00140096 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for blood - Genomic DNAIdea
PD CEN/TS WI 00140097 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for FFPE tissue - ProteinsIdea
PD CEN/TS WI 00140098 Molecular in-vitro diagnostic examinations - Specifications for preexamination processes for snap frozen tissue - ProteinsIdea
PD ENISO 16278 Health informatics — Categorial structure for terminologies systems of human anatomyAccepted
PD ISO/TR 10895 Health Informatics: Business requirments for the reporting of pharmacist servicesIdea
PD ISO/TR 12310 Health informatics - Principles and guidelines for the measurement of conformance in the implementation of terminological systemsIdea
PD ISO/TR 13581 Health Informatics - Guidance for maintenance of object identifiers OIDIdea
PD ISO/TR 14639-2 eHealth architecture roadmap Part 2: Architectural components and maturity modelApproval
PD ISO/TR 14872 Health informatics - Identification of Medicinal Products - Core Principles for Maintenance of Identifiers and TermsIdea
PD ISO/TR 17522 Health informatics - Provisions for Health Applications on Mobile/Smart DevicesPublication
PD ISO/TR 18638 Components of Education to Ensure Health Information PrivacyAccepted
PD ISO/TR 19727 Medical devices - Pump tube spallation test - General procedureAccepted
PD ISO/TR 28380-3 Communication - IHE Global Standards Adoption Process Part 3: DeploymentAccepted
PD ISO/TS 16277-1 Health Informatics - Categorial structures of clinical findings in traditional medicine Part 1: Traditional Chinese, Japanese and Korean medicineApproval
PD ISO/TS 16843-2 Health Informatics - Categorial structures for representation of acupuncture Part 2: NeedlingIdea
PD ISO/TS 17117-1 Health informatics - Terminological resources Part 1: CharacteristicsIdea
PD ISO/TS 17251 Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal productsIdea
PD ISO/TS 17439 Health informatics - Structure and maintenance of the health informatics glossaryPublication
PD ISO/TS 17975 Health informatics - Principles and data structures for consent in the collection, use, or disclosure of personal health information - Patient consentAccepted
PD ISO/TS 18062 Health Informatics - Categorial structures for representation of herbal medicaments in terminological systemsApproval
PD ISO/TS 18528 Functional classification of health informatics standardsIdea
PD ISO/TS 18790-1 Framework and Classification for Traditional Medicine informatics standards development Part 1: Traditional Chinese MedicineAccepted
PD ISO/TS 18864 Quality metrics for detailed clinical modelsAccepted
PD ISO/TS 19256 Health informatics - Requirements for medicinal product dictionariesIdea
PD ISO/TS 19844 Health informatics - Identification of medicinal products - Implementation guide for data elements and structures for the unique identification and exchange of regulated information on substancesIdea
PD ISO/TS 22077-2 Health informatics - Medical waveform format Part 2: ElectrocardiographyAccepted
PD ISO/TS 22077-3 Health informatics - Medical waveform format Part 3: Encoding rules, long term electrocardiogramAccepted

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Committees (4)

Sort by: Reference | Name

Committee ReferenceTitle
CH/106Dentistry
IST/35Health informatics
CH/212IVDs
LBI/1/2Laboratory Equipment

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