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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 overviewAccepted
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 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 11073-10417:2014 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meterPublication
BS ENISO 11073-20601 health device communication Part 20601: Device Specialization—Optimized Exchange ProtocolIdea
BS ENISO 11073-20601:2011 Amd 1Approval
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 useApproval
BS ENISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatusApproval
BS ENISO 12836 Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracyApproval
BS ENISO 12836:2012/Amd 1 for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy - Amendment 1Approval
BS ENISO 13940 Health informatics - System of concepts to support continuity of careApproval
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)Approval
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
BS ENISO 17523 Health informatics - Requirements for electronic prescriptionsPublic Comment
Opens a new windowBS ENISO 18739 for CAD/CAM systemsPublic Comment
BS ENISO 21298:2014 Health informatics - Functional and structural rolesPublic Comment
BS ENISO 21549-5 Health informatics - Patient healthcard data Part 5: Identification dataPublic Comment
BS ENISO 21549-7 Health informatics - Patient healthcard data Part 7: Medication dataPublic Comment
BS 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 featuresApproval
BS ENISO 384 Principles of design and construction of volumetric instrumentsPublic Comment
BS ENISO 8362-1:2009/Amd 1 Injection containers and accessories Part 1: Injection vials made of glass tubing - Amendment 1Public Comment
BS ENISO 8362-2 Injection containers and accessories Part 2: Closures for injection vialsApproval
BS 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 equipmentPublication
BS ENISO 8536-11 Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipmentPublication
BS ENISO 8536-13 Infusion equipment for medical use Part 13: Clamps, restrictors and flow regulators for transfusion and infusion setsAccepted
BS ENISO 8536-14 Infusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contactAccepted
BS ENISO 8536-8 Infusion equipment for medical use Part 8: Infusion equipment for use with pressure infusion apparatusPublication
BS ENISO 8536-9 Infusion equipment for medical use Part 9: Fluid lines for use with pressure infusion equipmentPublication
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 syringesPublication
BS ISO 11040-7 Prefilled syringes Part 7: packaging system for disposable ready-to-use syringesPublication
BS ISO 11040-8 Prefilled syringes Part 8: Requirements and test methods for the use of filled syringesPublic Comment
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 11418-1 Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottlesPublic Comment
BS ISO 11418-2 Containers and accessories for pharmaceutical preparations Part 2: Screw-neck glass bottles for syrupsPublic Comment
BS ISO 11418-3 Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage formsPublic Comment
BS ISO 11418-7 Containers and accessories for pharmaceutical preparations Part 7: Screw-neck vials made of glass tubing for liquid dosage formsPublic Comment
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
BS ISO 13926-2:2011/Amd 1 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use - Amendment 1Approval
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
BS 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 17583 Health informatics - Terminology constraints for coded data elements expressed in ISO Harmonized Data Types used in healthcare information interchangePublic Comment
BS ISO 18618 Dentistry - Interoperability of CAD/CAM SystemsAccepted
BS ISO 18675 Dental CAD/CAM Machinable Zirconia BlanksIdea
BS ISO 18845 Dentistry - CAD/CAM systems - Accuracy of machined indirect restorations - Test methods and markingAccepted
BS ISO 19293 Health Informatics - Requirements for a record of the dispense of a medicinal productIdea
BS ISO 22077-1 Health informatics - Medical waveform format Part 1: Encoding rulesPublication
BS ISO 28680 Application of risk management for IT - Networks incorporating medical devicesnull
BS ISO 35001 Laboratory biorisk management system - RequirementsIdea
BS ISO 3950 Dentistry - Designation system for teeth and areas of the oral cavityPublic Comment
BS ISO 4802-1 Glassware - Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classificationPublic Comment
BS ISO 4802-2 Glassware - Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classificationPublic Comment
BS ISO/IEEE 11073-00103 Health informatics — Personal health device communication Part 00103: OverviewPublication
BS ISO/IEEE 11073-10425 health device communication Part 10425: Device Specialization—Continuous Glucose Monitor (CGM)Idea
BS ISO/TS 17518 Medical Laboratories - Guidance for users of reagents for staining in biology in medical laboratoriesPublication
PD CEN ISO/TS 13972 Health informatics - Detailed clinical models, characteristics and processesApproval
PD CEN/TS 16791 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiersAccepted
PD CEN/TS 16835-1 Molecular in vitro diagnostic examinations - Specifications for pre- examination processes for venous whole blood Part 1: Isolated cellular RNAApproval
PD CEN/TS 19844 medicinal products - Implementation guide for data elements and structures for the unique identification and exchange of regulated information on substancesApproval
PD CEN/TS WI 16826-1 examinations - Specifications for preexamination processes for snap frozen tissue - RNAApproval
PD CEN/TS WI 16826-2 examinations - Specifications for preexamination processes for snap frozen tissue - ProteinsApproval
PD CEN/TS WI 16827-1 examinations - Specifications for preexamination processes for FFPE tissue - RNAApproval
PD CEN/TS WI 16827-2 examinations - Specifications for preexamination processes for FFPE tissue - ProteinsApproval
PD CEN/TS WI 16827-3 examinations - Specifications for preexamination processes for FFPE tissue - DNAApproval
PD CEN/TS WI 16835-2 examinations - Specifications for preexamination processes for blood - Genomic DNAAccepted
PD CEN/TS WI 16835-3 examinations - Specifications for preexamination processes for blood - Circulating cell free DNAAccepted
PD EN ENISO/TS 19256 medicinal product dictionariesAccepted
PD ENENISO/TS 17251 requirements for a syntax to exchange structured dose information for medicinal productsAccepted
PD ENISO 16278 Health informatics — Categorial structure for terminologies systems of human anatomyAccepted
PD ISO 25237 Health informatics - PseudonymisationAccepted
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 systemsApproval
PD ISO/TR 13581 Health Informatics - Guidance for maintenance of object identifiers OIDIdea
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 20055 Health informatics - Person-owned document repository for PHR applications and health information exchangeIdea
PD ISO/TS 16277-1 Health Informatics - Categorial structures of clinical findings in traditional medicine Part 1: Traditional Chinese, Japanese and Korean medicinePublication
PD ISO/TS 16843-1 Health Informatics - Categorial structures for representation of acupuncture Part 1: Acupuncture pointsAccepted
PD ISO/TS 16843-2 Health Informatics - Categorial structures for representation of acupuncture Part 2: NeedlingAccepted
PD ISO/TS 17117-1 Health informatics - Terminological resources Part 1: CharacteristicsIdea
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 18790-1 Framework and Classification for Traditional Medicine informatics standards development Part 1: Traditional Chinese MedicineApproval
PD ISO/TS 18864 Quality metrics for detailed clinical modelsAccepted
PD ISO/TS 22077-2 Health informatics - Medical waveform format Part 2: ElectrocardiographyApproval
PD ISO/TS 22077-3 Health informatics - Medical waveform format Part 3: Encoding rules, long term electrocardiogramApproval

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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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