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Parent Category: Laboratory medicine

Standards in development (92)
Published standards (8)
Committees (4)

Standards in development (92)

Standard Title	Status
BS EN ISO 11073-00000 Health Informatics - Analytical instruments - Point of Care medical device communication - Part 00000: Framework and overview	Idea
BS EN ISO 11073-20201 Health Informatics - Point of Care medical device communication - Application profile Part 20201: Polling mode	Accepted
BS EN ISO 11073-20202 Health Informatics - Point of Care medical device communication - Application profile Part 20202: Baseline	Accepted
BS EN ISO 13940-1 Health informatics — System of concepts to support continuity of care — Part 1: Basic concepts	Accepted
BS EN ISO 4796-1 Laboratory glassware - Bottles Part 1: Screw-neck bottles	Accepted
BS EN ISO 4797 conical ground joints	Accepted
BS EN ISO 7405:2008/A1 D Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1	Publication
BS ENISO 10781 Electronic Health Record-System Functional Model, Release 2 (EHR FM) (ISO/HL7 CD 10781)	Public Comment
BS ENISO 13120 Health informatics - A syntax to represent the content of medical classification systems	Approval
BS ENISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)	Publication
BS ENISO 13606-1 record communication Part 1: Reference model	Accepted
BS ENISO 13940 Health informatics - System of concepts to support continuity of care	Public Comment
BS ENISO 15197 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus	Publication
BS ENISO 15841 Dentistry - Wires for use in orthodontics	Public Comment
BS ENISO 16202-1 Dentistry - Classification and codification of oral anomalies Part 1: Structure of the classification	Accepted
BS ENISO 16202-2 Dentistry - Classification and codification of oral anomalies Part 2: Development disturbances of teeth	Accepted
BS ENISO 16443 Dentistry - Terminology of oral implantology	Public Comment
BS ENISO 18104 Health informatics — Categorical structures for representation of nursin g diagnoses and nursing actions in terminological systems	Public Comment
BS ENISO 19001:2013/C 1 In vitro diagnostic medical devices - Information supplied by themanufacturer with in vitro diagnostic reagents for staining in biology	Publication
BS ENISO 21549-1 Health informatics - Patient healthcard data Part 1: General structure	Approval
BS ENISO 21549-2 Health informatics - Patient healthcard data Part 2: Common objects	Public Comment
BS ENISO 22600-1 Health informatics - Privilege management and access control Part 1: Overview and policy management	Public Comment
BS ENISO 22600-2 Health informatics - Privilege management and access control Part 2: Formal models	Public Comment
BS ENISO 22600-3 Health informatics - Privilege management and access control Part 3: Implementations	Public Comment
BS ENISO 3665 Photography - Intra-oral dental radiographic film and film packets - Manufacturer specification	Publication
BS ENISO 3826-1 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers	Publication
BS ENISO 8536-4:2010/A1 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed - Amendment 1	Publication
BS ISO 11040-4 Prefilled syringes Part 4: Glass barrels for injectables and ready-to-use prefillable syringes	Accepted
BS ISO 11040-7 Prefilled syringes Part 7: packaging system for disposable ready-to-use syringes	Accepted
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 1135-4 Transfusion equipment for medical use Part 4: Transfusion sets for single use	Accepted
BS ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus	Accepted
BS ISO 13606-2 Health informatics - Electronic health record communication Part 2: Archetype interchange specification	Idea
BS ISO 13606-3 Health informatics - Electronic health record communication Part 3: Reference archetypes and term lists	Accepted
BS ISO 13606-4 Health informatics - Electronic health record communication Part 4: Security	Accepted
BS ISO 13606-5 Health informatics - Electronic health record communication Part 5: Interface specification	Accepted
BS ISO 14199 Health Informatics – Information Model – CDISC – Biomedical Research Information Domain Group (BRIDG) Model	Accepted
BS ISO 16496 Laboratory glassware - Devices with vacuum-jacket insulation	Accepted
BS ISO 16527 Personal Health Record System Functional Model, Release 1 (PHRS FM)	Public Comment
BS ISO 16782 Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing	Idea
BS ISO 16864 Health Informatics - Data protection in trans-border flows of personal health information	Idea
BS ISO 17090-1 Health informatics - Public key infrastructure Part 1: Overview of digital certificate services	Approval
BS ISO 17090-2 Health informatics - Public key infrastructure Part 2: Certificate profile	Accepted
BS ISO 17090-4 Health informatics - Public key infrastructure Part 4: Digital Signatures for healthcare documents	Idea
BS ISO 17254 Dentistry - Springs for use in orthodontics	Idea
BS ISO 17518 Medical Laboratories - Guidance for users of reagents for staining in biology in medical laboratories	Idea
BS ISO 17523 Health informatics - Requirements for electronic prescriptions	Idea
BS ISO 17583 Health informatics - Terminology constraints for coded data elements expressed in ISO Harmonized Data Types used in healthcare information interchange	Accepted
BS ISO 17822 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens - General requirements and definitions	Idea
BS ISO 18559 Dentistry - Spatulas for dental materials	Accepted
BS ISO 18618 Dentistry - Interoperability of CAD/CAM Systems	Idea
BS ISO 18675 Dental CAD/CAM Machinable Zirconia Blanks	Idea
BS ISO 18739 Dentistry - Terminology of process chain for CAD/CAM systems	Idea
BS ISO 20301 Health informatics - Health cards - General characteristics	Public Comment
BS ISO 21549-3 Health informatics - Patient healthcard data Part 3: Limited clinical data	Public Comment
BS ISO 21549-4 Health informatics - Patient healthcard data Part 4: Extended clinical data	Public Comment
BS ISO 21549-7 Health informatics - Patient healthcard data Part 7: Medication data	Idea
BS ISO 22077-1 Health informatics - Medical waveform format Part 1: Encoding rules	Public Comment
BS ISO 22857 Health informatics - Guidelines on data protection to facilitate trans-border flows of personal health information	Public Comment
BS ISO 28680 Application of risk management for IT - Networks incorporating medical devices	null
BS ISO 3819 Laboratory glassware - Beakers	Accepted
BS ISO 3826-4 Plastics collapsible containers for human blood and blood components Part 4: Aphaeresis blood bag systems with integrated features	Accepted
BS ISO 384 Laboratory glass and plastics ware - Principles of design and construction of volumetric instruments	Accepted
BS ISO 8536-12:2007/AMD 1 Infusion equipment for medical use Part 12: Check valves - Amendment 1	Publication
BS ISO 8536-13 Infusion equipment for medical use Part 13: Clamps, restrictors and flow regulators for transfusion and infusion sets	Accepted
BS ISO HL7 13449 Health informatics- Clinical genomics pedigree topic	Public Comment
BS ISO21731 Health informatics HL7 version 3 -- Reference information model -- Release 1	Public Comment
PD CEN ISO/TS 13972 Health informatics - Detailed clinical models, characteristics and processes	Accepted
PD CEN ISO/TS 14265 Health Informatics - Classification of purposes for processing personal health information	Approval
PD CEN/TR 15872 Health informatics - Guidance on Patient identification and Cross-referencing of identities	Publication
PD CEN/TS WI 00140088 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for selected types of sample	Idea
PD EN CEN ISO/TS 14441 Health Informatics: Security and privacy requirements for compliance testing of EHR systems	Approval
PD ISO/TR 10895 Health Informatics: Business requirments for the reporting of pharmacist services	Idea
PD ISO/TR 16278 Health Informatics - Identification of the status of structures for representation of human anatomy within healthcare terminological systems	Accepted
PD ISO/TR 17522 Health informatics - Provisions for Health Applications on Mobile/Smart Devices	Idea
PD ISO/TR 17791 Health informatics - Guidance on Standards for Enabling Safety in Health Software	Accepted
PD ISO/TR 18638 Components of Education to Ensure Health Information Privacy	Idea
PD ISO/TR 28380-1 Health Informatics - IHE Global Standards Adoption Part 1: Process	Approval
PD ISO/TR 28380-1 Health informatics - IHE global standards adoption Part 1: Process	Accepted
PD ISO/TR 28380-2 Health Informatics: IHE Global Standards Adoption – Part 2: Integration and content profiles	Accepted
PD ISO/TS 13582 Health Informatics - Sharing of OID registry information	Approval
PD ISO/TS 16223 Health Informatics - Standards convergence to promote EHR interoperability	Idea
PD ISO/TS 16791 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers	Accepted
PD ISO/TS 17117-1 Health informatics - Controlled health terminology - Structure and high-level indicators	Idea
PD ISO/TS 17439 Health informatics - Structure and maintenance of the health informatics glossary	Idea
PD ISO/TS 17938 Health informatics - Semantic network framework and coding of traditional Chinese medicine - Language System	Accepted
PD ISO/TS 17948 Traditional Chinese medicine literature metadata	Accepted
PD ISO/TS 17975 Health informatics - Principles and data structures for consent in the collection, use, or disclosure of personal health information - Patient consent	Idea
PD ISO/TS 18062 Health Informatics - Categorial structures for representation of herbal medicaments in terminological systems	Idea
PD ISO/TS 18528 Functional classification of health informatics standards	Idea
PD ISO/TS 18530 Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification	Accepted
PD ISO/TS 22911 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods	Accepted

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Published standards (8)

Sort by: Reference | Title | Status

Standard reference	Name	Status
BS EN ISO 18812:2003	Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles	Current
BS EN ISO 15195:2003	Laboratory medicine. Requirements for reference measurement laboratories	Current
BS EN ISO 15189:2003	Medical laboratories. Particular requirements for quality and competence	Withdrawn
BS EN ISO 15189:2007	Medical laboratories. Particular requirements for quality and competence	Withdrawn
DD CEN ISO/TS 22367:2010	Medical laboratories. Reduction of error through risk management and continual improvement	Current
BS EN ISO 15189:2012	Medical laboratories. Requirements for quality and competence	Current
BS ISO 15190:2003	Medical laboratories. Requirements for safety	Current
BS EN ISO 22870:2006	Point-of-care testing (POCT). Requirements for quality and competence	Current

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Committees (4)

Sort by: Reference | Name

Committee Reference	Title
CH/106	Dentistry
IST/35	Health informatics
CH/212	IVDs
LBI/1/2	Laboratory glassware and related apparatus

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