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Medical laboratory abroad

Medical laboratory abroad, Total:272 items.

In the international standard classification, Medical laboratory abroad involves: Laboratory medicine, Aircraft and space vehicles in general, Quality, Medical sciences and health care facilities in general, Microbiology, Applications of information technology, Construction technology, Construction industry, Vocabularies, Education, Furniture, Information sciences. Publishing, Protection of and in buildings, Radiation protection, Acoustics and acoustic measurements, Elements of buildings, Medical equipment, Electricity. Magnetism. Electrical and magnetic measurements, Electromagnetic compatibility (EMC).


Standard Association of Australia (SAA), Medical laboratory abroad

German Institute for Standardization, Medical laboratory abroad

  • DIN EN ISO 22367:2020-09 Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020); German version EN ISO 22367:2020
  • DIN EN ISO 15195:2004 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003); German version EN ISO 15195:2003
  • DIN EN ISO 22367:2020 Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
  • DIN 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
  • DIN 58985:2003 Laboratory medicine - Decision-marking criteria
  • DIN 58956-2:1986-01 Medical microbiology; medical microbiological laboratories; requirements for equipment
  • DIN 58956-3:1986-12 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
  • DIN EN ISO 15189:2023-03 Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022
  • DIN 58956-2:1986 Medical microbiology; medical microbiological laboratories; requirements for equipment
  • DIN 58956-10:1986 Medical microbiology; medical-microbiological laboratories; safety marking
  • DIN EN ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007); English version of DIN EN ISO 15189:2007-08
  • DIN EN ISO 15189:2023 Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
  • DIN EN ISO 15195:2019 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
  • DIN 58956-4:1986 Medical microbiology; medical-microbiological laboratories; waste disposal; safety requirements and testing
  • DIN EN ISO 15195:2019-07 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018); German version EN ISO 15195:2019
  • DIN 58956-5:1990 Medical microbiology; medical-microbiological laboratories; hygiene scheme requirements
  • DIN EN 1614:2006-12 Health informatics - Representation of dedicated kinds of property in laboratory medicine; English version EN 1614:2006
  • DIN 58937-7:1994 General laboratory medicine (clinical pathology); part 7: listing of features of in vitro diagnostic systems
  • DIN 58956-3:1986 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
  • DIN 58936-1:2000 Quality management in laboratory medicine - Part 1: Basic terminology
  • DIN 58936-2:2001 Quality management in laboratory medicine - Part 2: Terminology for quality and application of test procedure
  • DIN EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012); German version EN ISO 15189:2012
  • DIN EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use of profiles (ISO 18812:2003); German version EN ISO 18812:2003, text in English
  • DIN EN ISO 15189:2011 Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2011); German version prEN ISO 15189:2011
  • DIN EN ISO 15189:2014 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15); German version EN ISO 15189:2012
  • DIN 58940-10:1990 Medical microbiology; methods for the determination of susceptibility of pathogens (except mycrobacteria) to antimicrobial agents; criteria for the evaluation of the in vitro efficacy and the admission of new antimicrobial agents
  • DIN EN ISO 11546-1:2010-01 Acoustics - Determination of sound insulation performances of enclosures - Part 1: Measurements under laboratory conditions (for declaration purposes) (ISO 11546-1:1995); German version EN ISO 11546-1:2009

ES-UNE, Medical laboratory abroad

  • UNE-EN ISO 22367:2020 Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
  • UNE-ISO 15190:2022 Medical laboratories — Requirements for safety
  • UNE-EN ISO 15189:2023 Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
  • UNE-EN ISO 15195:2019 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
  • UNE-EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (Endorsed by AENOR in June of 2013.)

Korean Agency for Technology and Standards (KATS), Medical laboratory abroad

  • KS P 2068-2020 Protocol for interference testing in in-vitro diagnostic medical laboratory
  • KS P ISO 15195:2007 Laboratory medicine-Requirements for reference measurement laboratories
  • KS P ISO 15195:2014 Laboratory medicine — Requirements for reference measurement laboratories
  • KS P ISO 15195-2014(2019) Laboratory medicine — Requirements for reference measurement laboratories
  • KS P ISO TR 22869-2009(2019) Medical laboratories-Guidance on laboratory implementation of KS P ISO 15189:2006
  • KS P ISO 15190:2010 Medical laboratories-Requirements for safety
  • KS P ISO 15190:2021 Medical laboratories — Requirement for safety
  • KS P ISO 15190-2010(2016) Medical laboratories-Requirements for safety
  • KS P ISO TR 22869:2009 Medical laboratories-Guidance on laboratory implementation of KS P ISO 15189:2006
  • KS P 1977-2018 Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory
  • KS P 1975-2018 Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
  • KS P ISO 15189-2013(2019) Medical laboratories ─ Requirements for quality and competence
  • KS P 2069-2020 Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
  • KS P ISO 15189:2011 Medical laboratories-Particular requirements for quality and competence
  • KS P ISO 15189:2013 Medical laboratories ─ Requirements for quality and competence
  • KS P ISO TS 17518:2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
  • KS P ISO TS 20658:2021 Medical laboratories — Requirements for collection, transport,receipt, and handling of samples
  • KS P ISO TS 22367:2009 Medical laboratories-Reduction of error through risk management and continual improvement
  • KS P ISO TS 22367-2009(2019) Medical laboratories-Reduction of error through risk management and continual improvement
  • KS P ISO TR 18112:2009 Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer
  • KS P 2094-2020 Protocol for measurement procedures comparison and bias estimation using patient samples in in-vitro diagnostic medical laboratory
  • KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS P ISO 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
  • KS P ISO 15198:2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacture
  • KS P ISO 17593:2009 Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • KS X ISO 18812:2014 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
  • KS X ISO 18812:2005 Health informatics-Clinical analyzer interfaces to laboratory information systems-Use profiles
  • KS X ISO 18812:2016 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
  • KS C IEC 61223-2-5:2013 Evaluation and routine testing in medical imaging departments-Part 2-5:Constancy tests-Image display devices
  • KS C IEC 61223-2-4:2013 Evaluation and routine testing in medical imaging departments-Part 2-4:Constancy tests-Hard copy cameras
  • KS C IEC 61223-2-1:2005 Evaluation and routine testing in medical imaging departments-Part 2-1:Constancy tests-Film processors

European Committee for Standardization (CEN), Medical laboratory abroad

  • EN ISO 22367:2020 Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
  • EN ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
  • EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
  • EN ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence ISO 15189: 2003
  • EN ISO 15189:2022 Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
  • prEN ISO 15189:2021 Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021)
  • EN ISO/TS 22367:2010 Medical laboratories - Reduction of error through risk management and continual improvement
  • CEN ISO/TS 22367:2010 Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
  • EN ISO 18812:2003 Health informatics Clinical analyser interfaces to laboratory information systems Use profiles Supersedes ENV 13728:2000; ISO 18812:2003

Association Francaise de Normalisation, Medical laboratory abroad

  • NF S92-081*NF EN ISO 22367:2020 Medical laboratories - Application of risk management to medical laboratories
  • NF EN ISO 22367:2020 Laboratoires de biologie médicale - Application de la gestion des risques aux laboratoires de biologie médicale
  • NF S92-062:2004 Laboratory medicine - Requirements for reference measurement laboratories.
  • NF EN ISO 7787-1:2016 Médecine bucco-dentaire - Fraises de laboratoire - Partie 1 : fraises de laboratoire en acier
  • NF EN ISO 15189:2022 Laboratoires médicaux - Exigences concernant la qualité et la compétence
  • NF S97-512*NF EN 1614:2006 Health Informatics - Representation of dedicated kinds of property laboratory medicine
  • NF S92-060*NF EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence
  • NF S92-062*NF EN ISO 15195:2019 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
  • XP ISO/TS 20914:2020 Laboratoires de biologie médicale - Recommandations pratiques pour l'estimation de l'incertitude de mesure
  • NF S92-060:2007 Medical laboratories - Particular requirements for quality and competence.
  • XP ISO/TS 17518:2015 Laboratoire de biologie médicale - Réactifs pour la coloration de matériel biologique - Directives pour les utilisateurs
  • XP S92-042*XP ISO/TS 17518:2015 Medical Laboratories - Reagents for staining biological material - Guidance for users
  • NF EN ISO 15195:2019 Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence
  • NF S92-501:2013 Laboratoire de biologie médicale - Mesures anthroporadiométriques - Corps entier - Mesures des émissions gamma d'énergie supérieure à 100 keV
  • NF EN ISO 16256:2021 Laboratoires d'analyses de biologie médicale et systèmes de diagnostic in vitro - Méthode de référence de microdilution en milieu liquide pour soumettre à essai l'activité in vitro des agents antimicrobiens par rapport aux levures impliquées ...
  • NF S30-113:2020 Acoustics - Measurement of speech level reduction of furniture ensembles and enclosures - Part 1 : laboratory method
  • NF ISO 23351-1:2020 Acoustique - Mesure de la réduction du niveau de la parole par les ensembles de meubles et les enceintes - Partie 1 : méthode de laboratoire
  • NF EN ISO 11546-1:2009 Acoustique - Détermination de l'isolement acoustique des encoffrements - Partie 1 : mesurages dans des conditions de laboratoire (aux fins de déclaration)
  • NF EN IEC 61326-2-6:2021 Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2-6 : exigences particulières - Matériel médical de diagnostic in vitro (IVD)
  • NF C46-050-2-6*NF EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment
  • NF S92-502:2006 Medical biology analysis laboratory - Anthroporadiametric - Lungs countings - Measurements of low energy X and gamma emitters (less than 200 keV).
  • NF S92-502:2013 Laboratory of medical biology - Anthroporadiometric measurements - Lungs - Measurement of X-ray and gamma-ray emissions of energy less than 200 keV
  • NF C46-050-2-6*NF EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment

International Organization for Standardization (ISO), Medical laboratory abroad

  • ISO 22367:2020 Medical laboratories — Application of risk management to medical laboratories
  • ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories
  • ISO/TR 22869:2005 Medical laboratories - Guidance on laboratory implementation of ISO 15189:2003
  • ISO 15190:2003 Medical laboratories - Requirements for safety
  • ISO 15190:2020 Medical laboratories — Requirements for safety
  • ISO 15189:2012 Medical laboratories - Requirements for quality and competence
  • ISO 15195:2018 Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
  • ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence
  • ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence
  • ISO 15189:2022 Medical laboratories — Particular requirements for quality and competence
  • ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
  • ISO/TS 22367:2008 Medical laboratories - Reduction of error through risk management and continual improvement
  • ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
  • ISO/TR 18112:2006 Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer
  • ISO/TS 11796:2023 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
  • ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
  • ISO/TS 22367:2008/cor 1:2009 Medical laboratories - Reduction of error through risk management and continual improvement; Technical Corrigendum 1
  • ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
  • ISO 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • ISO 23351-1:2020 Acoustics — Measurement of speech level reduction of furniture ensembles and enclosures — Part 1: Laboratory method
  • ISO 16283-3:2016 Acoustics - Field measurement of sound insulation in buildings and of building elements - Part 3: Fa?ade sound insulation

British Standards Institution (BSI), Medical laboratory abroad

  • BS EN ISO 22367:2020 Medical laboratories. Application of risk management to medical laboratories
  • BS EN ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories
  • 19/30391662 DC BS ISO 22367. Medical laboratories. Application of risk management to medical laboratories
  • BS ISO 15190:2003 Medical laboratories - Requirements for safety
  • BS ISO 15190:2020 Tracked Changes. Medical laboratories. Requirements for safety
  • BS EN ISO 15189:2022 Medical laboratories. Requirements for quality and competence
  • 18/30377030 DC BS ISO 15190. Medical laboratories. Requirements for safety
  • BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
  • PD ISO/TS 20914:2019 Medical laboratories. Practical guidance for the estimation of measurement uncertainty
  • DD ENV 1613-1996 Medical informatics. Messages for exchange of laboratory information
  • BS DD ENV 1613:1996 Medical informatics - Messages for exchange of laboratory information
  • 21/30386856 DC BS EN ISO 15189. Medical laboratories. Requirements for quality and competence
  • 22/30447779 DC BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples
  • PD ISO/TS 20658:2017 Medical laboratories. Requirements for collection, transport, receipt, and handling of samples
  • BS DD CEN ISO/TS 22367:2008 Medical laboratories - Reduction of error through risk management and continual improvement
  • BS DD ISO/TS 22367:2008 Medical laboratories - Reduction of error through risk management and continual improvement
  • PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
  • BS EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
  • DD ENV 13609-2:2000 Healthcare informatics. Messages for maintenance of supporting information in healthcare systems. Updating of medical laboratory-specific information
  • PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
  • PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
  • BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • BS EN ISO 15195:2019 Tracked Changes. Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
  • BS ISO 23351-1:2020 Acoustics. Measurement of speech level reduction of furniture ensembles and enclosures - Laboratory method
  • BS DD ENV 13609-2:2000 Healthcare informatics - Messages for maintenance of supporting information in healthcare systems - Updating of medical laboratory-specific information
  • BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • 21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
  • BS EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
  • BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
  • BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
  • BS EN IEC 61010-2-101:2022+A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Safety requirements for in vitro diagnostic (IVD) medical equipment
  • BS EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
  • 19/30376812 DC BS ISO 23351-1. Acoustics. Measurement of speech level reduction of furniture ensembles and enclosures. Part 1. Laboratory method

GOSTR, Medical laboratory abroad

CEN - European Committee for Standardization, Medical laboratory abroad

  • EN ISO 15195:2019 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
  • DD ENV 1613-1995 Medical Informatics - Messages for exchange of laboratory information
  • EN ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical laboratory abroad

  • GB/Z 30154-2013 Medical laboratories.Guidance on laboratory implementation of GB/T 22576-2008
  • GB 19781-2005 Medical laboratories.Requirements for safety
  • GB/T 27409-2010 Application of proficiency testing in the medical laboratory
  • GB/T 21919-2008 Laboratory medicine.Requirements for reference measurement laboratories
  • GB/T 22576-2008 Medical laboratories.Particular requirements for quality and competence
  • GB/T 42060-2022 Medical laboratories—Requirements for collection, transport, receipt, and handling of samples
  • GB/T 21919-2022 Laboratory medicine—Requirements for the competence of calibration laboratories using reference measurement procedures
  • GB 15193.2-2014 National Food Safety Standard Food Toxicology Laboratory Practice

TH-TISI, Medical laboratory abroad

  • TIS 2277-2006 Laboratory medicine.requirements for reference measurement laboratories
  • TIS 2276-2006 Medical laboratories.requirements for safety
  • TIS 2154-2004 Medical laboratories.particular requirements for quality and competence

RU-GOST R, Medical laboratory abroad

  • GOST R ISO 15195-2006 Laboratory medicine. Requirements for reference measurement laboratories
  • GOST R ISO 15189-2006 Medical laboratories. Particular requirements for quality and competence
  • GOST R ISO 15189-2015 Medical laboratories. Particular requirements for quality and competence
  • GOST R 59722-2021 Medical laboratories. Reagents for staining biological material. Guidance for users
  • GOST R 52960-2008 Forensic science laboratories accreditation. Guidance on the application of GOST R ISO/IEC 17025
  • GOST R 56395-2015 Medical laboratories. Reduction of errors through risk management and continual improvement
  • GOST R 53133.4-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Part 4. Rules for conducting of clinical audit of efficiency of laboratory provision of medical institution activity
  • GOST R 53133.2-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Part 2. Rules for intra-laboratory quality control of quantitative methods of clinical laboratory tests using control materials
  • GOST 19550-1993 Desks for foreign language studies. Types and functional dimensions
  • GOST R 53022.1-2008 Medical laboratory technologies. Requirements for quality of clinical laboratory tests. Part 1. Quality management regulations of clinical laboratory tests
  • GOST R 53079.1-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 1. Rules for description of methods of clinical laboratory tests
  • GOST R ISO 18812-2015 Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles
  • GOST ISO 17593-2011 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
  • GOST R 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical
  • GOST R IEC 61326-2-6-2014 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment

Military Standards (MIL-STD), Medical laboratory abroad

Group Standards of the People's Republic of China, Medical laboratory abroad

  • T/SZAS 10-2019 Medical laboratories management standard
  • T/SZAS 11-2019 Medical laboratories evaluation standard
  • T/CNMIA 0034-2021 Third-party medical testing (immunization) laboratory
  • T/CAME 15-2020 Building technical specifications for medical laboratories
  • T/NAHIEM 27-2020 Basic Requirements for the Design and Construction of Medical Laboratories
  • T/CBDA 60-2022 Technical specification for decoration of green medical laboratory
  • T/CECS 662-2020 Technical standards for construction of medical biosafety secondary laboratories
  • T/GDPHA 034-2021 Regulation and implementing measure for grade evaluation of medical research laboratory in Guangdong Province

KR-KS, Medical laboratory abroad

  • KS P ISO 15190-2021 Medical laboratories — Requirement for safety
  • KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P 2170-2022 Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
  • KS P ISO TS 20914-2022 Medical laboratories — Practical guidance for the estimation of measurement uncertainty
  • KS P ISO TS 17518-2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
  • KS P ISO TS 20658-2021 Medical laboratories — Requirements for collection, transport,receipt, and handling of samples

AENOR, Medical laboratory abroad

  • UNE-ISO/TR 22869:2007 IN Medical laboratories. Guidance on laboratory implementation of ISO 15189: 2003. (ISO/TR 22869:2005)
  • UNE-EN ISO 15195:2004 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
  • UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

Shanghai Provincial Standard of the People's Republic of China, Medical laboratory abroad

US-CLSI, Medical laboratory abroad

Professional Standard - Commodity Inspection, Medical laboratory abroad

  • SN/T 3302-2012 Code for architectural design of medical vector laboratories at frontier ports
  • SN/T 2776-2011 Management requirements for medical vector biological testing laboratories at frontier ports
  • SN/T 1608-2005 Codes for preservation and management of blood specimens in clinical laboratories at frontier port
  • SN/T 4279-2015 Management specifications for laboratories for DNA barcode identification of medical vector insects at frontier ports
  • SN/T 3955.4-2014 Breeding method of important vectors at frontier ports.Part 4:Breeding method of Musca domestica (Muscina Stabulans)
  • SN/T 3955.1-2014 Breeding method of important vectors at frontier ports.Part 1:Breeding method of Anopheles sinensis (An.anthropophagus)
  • SN/T 3955.2-2014 Breeding method of important vectors at frontier ports.Part 2:Breeding method of Aedes albopictus (Aedes aegypti)
  • SN/T 3955.5-2014 Breeding method of important vectors at frontier ports.Part 5:Breeding method of Blattella germanica (Periplaneta americana, Periplaneta australasiae , Periplaneta brunnea)
  • SN/T 3955.6-2014 Breeding method of important vectors at frontier ports.Part 6:Breeding method of Xenopsylla cheopis (Pulex irritans, Citellophilus tesquorum)
  • SN/T 1862-2007 Standard of biosafety for pathogens test in medical vector laboratory entry-exit ports

Professional Standard - Medicine, Medical laboratory abroad

  • YY/T 1172-2010 Medical laboratory quality management term
  • YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Canadian Standards Association (CSA), Medical laboratory abroad

  • CSA ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories (Adopted ISO 22367:2020, first edition, 2020-02)
  • CAN/CSA-Z15190-2005 Medical laboratories - Requirements for safety (First Edition)
  • CSA PLUS 15189-2005 Les principes essentiels de la norme ISO 15189:2003 Un guide pratique pour la mise en uvre de la norme ISO 15189:2003 dans les laboratoires d analyses de biologie médicale

Guizhou Provincial Standard of the People's Republic of China, Medical laboratory abroad

  • DB52/T 1565-2021 Acceptance specification for medical laboratory ventilation system

Danish Standards Foundation, Medical laboratory abroad

  • DS/EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence
  • DS/EN ISO 15189:2008 Medical laboratories - Particular requirements for quality and competence
  • DS/ENV 13609-2:2000 Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 2: Updating of medical laboratory-specific information
  • DS/EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
  • DS/EN ISO 11546-1:2009 Acoustics - Determination of sound insulation performances of enclosures - Part 1: Measurements under laboratory conditions (for declaration purposes)

Indonesia Standards, Medical laboratory abroad

  • SNI ISO 15189:2012 Medical laboratories - Requirements for quality and competence
  • SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

Beijing Provincial Standard of the People's Republic of China, Medical laboratory abroad

Professional Standard - Hygiene , Medical laboratory abroad

  • WS/T 255-2005 Clinical laboratory medicine Reguirements for reference measurement laboratories
  • WS 233-2002 General biosafety standard for microbiological and biomedical laboratories
  • WS 457-2014 Basic requirements of radiological protection for using unsealed radioactive material in medical and biological laboratory

VN-TCVN, Medical laboratory abroad

  • TCVN 7782-2008 Medical laboratories.Particular requirements for quality and competence

Lithuanian Standards Office , Medical laboratory abroad

  • LST EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
  • LST EN ISO 15195:2004 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
  • LST L ENV 13609-2-2002 Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 2: Updating of medical laboratory-specific information

NZ-SNZ, Medical laboratory abroad

  • NZS/ISO 15189:2007 Medical Laboratories - Particular Requirements for Quality and Competence

ZA-SANS, Medical laboratory abroad

  • SANS 15189:2009 Medical laboratories - Particular requirements for quality and competence
  • SANS 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles

国家质量监督检验检疫总局, Medical laboratory abroad

  • SN/T 3955.3-2014 Laboratory breeding methods of important medical vector organisms at border ports Part 3: Laboratory breeding methods of Culex pipiens (Culex quinquefasciatus)

国家市场监督管理总局、中国国家标准化管理委员会, Medical laboratory abroad

  • GB/T 22576.7-2021 Medical laboratories—Requirements for quality and competence—Part 7:Requirements in the field of transfusion medicine
  • GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1: General requirements
  • GB/T 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4: Requirements in the field of clinical chemistry examination
  • GB/T 22576.2-2021 Medical laboratories—Requirements for quality and competence—Part 2: Requirements in the field of clinical hematological examination
  • GB/T 22576.5-2021 Medical laboratories—Requirements for quality and competence—Part 5: Requirements in the field of clinical immunology examination
  • GB/T 22576.6-2021 Medical laboratories—Requirements for quality and competence—Part 6: Requirements in the field of clinical microbiological examination
  • GB/T 22576.3-2021 Medical laboratories—Requirements for quality and competence—Part 3: Requirements in the field of urine examination

IT-UNI, Medical laboratory abroad

CN-STDBOOK, Medical laboratory abroad

  • 图书 3-9474 Compilation of Common Standards for Microbiology and Biomedical Laboratories (Part 2) (Second Edition)
  • 图书 3-9473 Compilation of Common Standards for Microbiology and Biomedical Laboratories (Part 1) (Second Edition)

PL-PKN, Medical laboratory abroad

  • PN-EN ISO 15195-2019-04 P Laboratory medicine -- Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
  • PN F06010-02-1988 School furniture Laboratory benches for scholas, tables for drawing and for learing foreign languages Basic functional dimensions

American Society for Testing and Materials (ASTM), Medical laboratory abroad

  • ASTM E1492-92(1999) Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory
  • ASTM E1492-11(2017) Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory

Acoustical Society of America (ASA), Medical laboratory abroad

  • ASA S1.15 PART 1-2021 AMERICAN NATIONAL STANDARD Electroacoustics - Measurement microphones - Part 1: Specifications for laboratory standard microphones

American National Standards Institute (ANSI), Medical laboratory abroad

  • ANSI/ASA S1.15-2-2021 AMERICAN NATIONAL STANDARD Electroacoustics - Measurement microphones - Part 1: Specifications for laboratory standard microphones

US-DOC, Medical laboratory abroad

  • DOC 15 CFR PT 255-2008 FELLOWSHIPS IN LABORATORY STANDARDIZATION AND TESTING FOR QUALIFIED CITIZENS OF OTHER AMERICAN REPUBLICS
  • DOC 15 CFR PT 255-2009 FELLOWSHIPS IN LABORATORY STANDARDIZATION AND TESTING FOR QUALIFIED CITIZENS OF OTHER AMERICAN REPUBLICS
  • DOC 15 CFR PT 255-2010 FELLOWSHIPS IN LABORATORY STANDARDIZATION AND TESTING FOR QUALIFIED CITIZENS OF OTHER AMERICAN REPUBLICS

未注明发布机构, Medical laboratory abroad

  • DIN EN ISO 16256:2022 Laboratory medical examinations and in vitro diagnostic systems – Broth microdilution reference method for testing the in vitro activity of antimicrobial substances against budding fungi that cause infectious diseases

Underwriters Laboratories (UL), Medical laboratory abroad

  • UL 61010A-2-041 (ND)-2002 National Differences For UL 61010A-2-041 Standard for Electrical Equipment for Laboratory Use; Part 2: Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials and for Laboratory Processes (First Edition)
  • UL 61010A-2-042 (ND)-2002 National Differences For UL 61010A-2-042 Standard for Electrical Equipment for Laboratory Use; Part 2: Particular Requirements for Autoclaves and Sterilizers Using Toxic Gas for the Treatment of Medical Materials@ and for Laboratory Processes (First Editi

European Committee for Electrotechnical Standardization(CENELEC), Medical laboratory abroad

  • EN IEC 61326-2-6:2021 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Japanese Industrial Standards Committee (JISC), Medical laboratory abroad

  • JIS C 61326-2-6:2023 Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 2-6: Particular requirements -- In vitro diagnostic (IVD) medical equipment




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