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Standards in development (105)

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Standard TitleStatus
BS EN ENISO 4797 conical ground jointsApproval
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 bottlesApproval
BS ENISO 10781 Electronic Health Record-System Functional Model, Release 2 (EHR FM) (ISO/HL7 CD 10781)Publication
BS ENISO 11073-10425 health device communication Part 10425: Device Specialization—Continuous Glucose Monitor (CGM)Approval
BS ENISO 11073-20601 health device communication Part 20601: Device Specialization—Optimized Exchange ProtocolApproval
BS ENISO 11073-20601:2011 Amd 1 Health informatics. Personal health device communication Application profile. Optimized exchange protocolApproval
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 usePublication
BS ENISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatusPublication
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 insulationApproval
BS ENISO 17523 Health informatics - Requirements for electronic prescriptionsPublic Comment
Opens a new windowBS ENISO 18618 Dentistry - Interoperability of CAD/CAM SystemsPublic Comment
BS 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 dataApproval
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 - BeakersApproval
BS ENISO 3826-4 Plastics collapsible containers for human blood and blood components Part 4: Aphaeresis blood bag systems with integrated featuresPublication
BS ENISO 384 Principles of design and construction of volumetric instrumentsApproval
BS ENISO 8362-1:2009/Amd 1 Injection containers and accessories Part 1: Injection vials made of glass tubing - Amendment 1Approval
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 vialsApproval
Opens a new windowBS ENISO 8536-13 Infusion equipment for medical use Part 13: Clamps, restrictors and flow regulators for transfusion and infusion setsPublic Comment
Opens a new windowBS ENISO 8536-14 Infusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contactPublic Comment
Opens a new windowBS ENISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testingPublic Comment
BS ISO 11040-1 Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridgesPublic Comment
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 1Publication
BS ISO 14199 Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) ModelApproval
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 testingApproval
BS ISO 17090-2.2 Health informatics - Public key infrastructure Part 2: Certificate profilePublication
BS ISO 17090-5 Health informatics - Public key infrastructure (PKI) Part 5: Authentication using Healthcare PKI credentialsAccepted
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 18675 Dental CAD/CAM Machinable Zirconia BlanksAccepted
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 20091 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for blood - Circulating cell free DNAAccepted
BS ISO 20164 Molecular in-vitro diagnostic examinations Specifications for pre-examination processes for FFPE tissue DNAAccepted
BS ISO 20165 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Extracted proteinsAccepted
BS ISO 20166 Molecular in-vitro diagnostic examinations Specifications for pre-examination processes for FFPE tissue - RNAAccepted
BS ISO 20167 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Extracted proteinsAccepted
BS ISO 20184 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - RNAAccepted
BS ISO 20185 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for blood - Genomic DNAAccepted
BS ISO 20186 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for blood - Cellular RNAAccepted
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 8536-6 Infusion equipment for medical use Part 6: Freeze drying closures for infusion bottlesAccepted
PD CEN CENISO/TS 13972 Health informatics - Detailed clinical models, characteristics and processesApproval
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 - RNAPublication
PD CEN/TS WI 16826-2 examinations - Specifications for preexamination processes for snap frozen tissue - ProteinsPublication
PD CEN/TS WI 16827-1 examinations - Specifications for preexamination processes for FFPE tissue - RNAPublication
PD CEN/TS WI 16827-2 examinations - Specifications for preexamination processes for FFPE tissue - ProteinsPublication
PD CEN/TS WI 16827-3 examinations - Specifications for preexamination processes for FFPE tissue - DNAPublication
PD CEN/TS WI 16835-2 examinations - Specifications for preexamination processes for blood - Genomic DNAApproval
PD CEN/TS WI 16835-3 examinations - Specifications for preexamination processes for blood - Circulating cell free DNAApproval
PD CENISO/TS 16791 international machine-readable coding of medicinal product package identifiersApproval
PD CENISO/TS 18530 identification and data capture marking and labelling - Subject of care and individual provider identificationApproval
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 anatomyApproval
PD ENISO 25237 Health informatics - PseudonymisationPublic Comment
PD ISO/TR 10895 Health Informatics: Business requirments for the reporting of pharmacist servicesIdea
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 16843-1 Health Informatics - Categorial structures for representation of acupuncture Part 1: Acupuncture pointsAccepted
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 consentApproval
PD ISO/TS 18062 Health Informatics - Categorial structures for representation of herbal medicaments in terminological systemsApproval
PD ISO/TS 18864 Quality metrics for detailed clinical modelsAccepted
PD ISO/TS 20440 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, routeAccepted
PD ISO/TS 20443 Health informatics Identification of Medicinal Products - Implementation Guide for ISO 11615 Data elements and structures for the unique identification and exchange of regulated medicinal product informationAccepted
PD ISO/TS 20451 Health informatics - Identification of medicinal products - implementation guide for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product informationAccepted
PD ISO/TS 22077-2 Health informatics - Medical waveform format Part 2: ElectrocardiographyPublication
PD ISO/TS 22077-3 Health informatics - Medical waveform format Part 3: Encoding rules, long term electrocardiogramPublication

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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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