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  • ISO 15190:2003

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Medical laboratories Requirements for safety

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  26-02-2020

    Language(s):  English

    Published date:  27-10-2003

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 15190 (10/2003)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    PD CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue Isolated proteins
    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    PD CEN/TS 16827-3:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue Isolated DNA
    PD CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated cellular RNA
    UNE-CWA 16335:2014 Biosafety professional competence
    ISO/TS 20658:2017 Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
    I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
    CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins
    CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
    CEN/TS 16827-3:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA
    CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
    17/30331313 DC : 0 BS EN ISO 20186-2 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 2: ISOLATED GENOMIC DNA CORRECT
    16/30326649 DC : 0 BS EN ISO 20184-1 - MOLECULAR IN-VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FROZEN TISSUE - PART 1: ISOLATED RNA
    CSA PLUS 15189 : 2010 THE ISO 15189:2007 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 15189:2007 STANDARD FOR MEDICAL LABORATORIES
    PD CEN/TS 16827-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue Isolated RNA
    PD ISO/TS 17822-1:2014 In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions
    16/30331322 DC : 0 BS EN ISO 20166-2 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATIONS PROCESSES FOR FORMALIN-FIXED AND PARAFFIN-EMBEDDED (FFPE) TISSUE - PART 2: ISOLATED PROTEINS
    PD CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated proteins
    BS ISO 14470:2011 Food irradiation. Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
    CEN/TS 16945:2016 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
    ISO/TS 17822-1:2014 In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions
    IWA 19:2017 Guidance principles for the sustainable management of secondary metals
    PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    ECA ILAC G26 : 2012 GUIDANCE FOR THE IMPLEMENTATION OF A MEDICAL LABORATORY ACCREDITATION SYSTEM
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    CLSI GP17 A2 : 2ED 2004 CLINICAL LABORATORY SAFETY
    PD CEN/TS 16945:2016 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
    PD CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated RNA
    PD CEN/TS 16835-3:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated circulating cell free DNA from plasma
    16/30326643 DC : 0 BS EN ISO 20166-1 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FORMALIN-FIXED AND PARAFFIN-EMBEDDED (FFPE) TISSUE - PART 1: ISOLATED RNA
    S.R. CEN/TS 16835-3:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 3: ISOLATED CIRCULATING CELL FREE DNA FROM PLASMA
    ISO 14470:2011 Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
    S.R. CWA 16335:2011 BIOSAFETY PROFESSIONAL COMPETENCE
    S.R. CEN/TS 16827-2:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FFPE TISSUE - PART 2: ISOLATED PROTEINS
    S.R. CWA 15793:2011 LABORATORY BIORISK MANAGEMENT
    DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    S.R. CEN/TS 16826-1:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR SNAP FROZEN TISSUE - PART 1: ISOLATED RNA
    CLSI MM14 A : 1ED 2005 PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS
    PD CEN/TS 16835-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated genomic DNA
    11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    PD ISO/TS 20658:2017 Medical laboratories. Requirements for collection, transport, receipt, and handling of samples
    I.S. EN ISO 18113-1:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    06/30146511 DC : 0 BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    16/30331325 DC : 0 BS EN ISO 20166-3 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE- EXAMINATION PROCESSES FOR FORMALIN-FIXED AND PARAFFIN-EMBEDDED (FFPE) TISSUE - PART 3: ISOLATED DNA
    S.R. CEN/TS 16945:2016 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR METABOLOMICS IN URINE, VENOUS BLOOD SERUM AND PLASMA
    CSA Z15189 : 2003 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
    CEN/TS 16827-2:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
    17/30326658 DC : 0 BS EN ISO 20186-1 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 1: ISOLATED CELLULAR RNA
    S.R. CEN/TS 16827-3:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FFPE TISSUE - PART 3: ISOLATED DNA
    16/30331319 DC : 0 BS EN ISO 20184-2 - MOLECULAR IN-VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FROZEN TISSUE - PART 2: ISOLATED PROTEINS
    S.R. CEN/TS 16827-1:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FFPE TISSUE - PART 1: ISOLATED RNA
    S.R. CEN/TS 16826-2:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR SNAP FROZEN TISSUE - PART 2: ISOLATED PROTEINS
    S.R. CEN/TS 16835-1:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 1: ISOLATED CELLULAR RNA
    S.R. CEN/TS 16835-2:2015 MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 2: ISOLATED GENOMIC DNA
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    CEN/TS 16835-3:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
    CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA
    CEN/TS 16827-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61010-2-051:2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-051: Particular requirements for laboratory equipment for mixing and stirring
    BS 8800:1996 Guide to occupational health and safety management systems
    EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
    IEC TR 61010-3-051:1999 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-051: Conformity verification report for IEC 61010-2-051, Particular requirements for laboratory equipment for mixing and stirring
    CLSI M29 A2 : 2ED 2001 PROTECTION OF LABORATORY WORKERS FROM OCCUPATIONALLY ACQUIRED INFECTIONS
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    IEC 61010-2-032:2012 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-032: Particular requirements for hand-held and hand-manipulated current sensors for electrical test and measurement
    BS 7179-1:1990 Ergonomics of design and use of visual display terminals (VDTs) in offices Introduction
    AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    IEC TR 61010-3-010:1999 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-010: Conformity verification report for IEC 61010-2-010, Particular requirements for laboratory equipment for the heating of materials
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC TR 61010-3-061:1999 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-061: Conformity verification report for IEC 61010-2-061, Particular requirements for laboratory atomic spectrometers with thermal atomization and ionization
    BS 6324-1:1983 Terms relating to surgical implants Glossary of general medical terms
    IEC 61010-2-045:2000 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
    IEC 61010-2-041:1995 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes
    IEC 61010-2-020:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
    IEC 61010-2-043:1997 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory processes
    IEC 61010-031:2015 RLV Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test
    IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
    CLSI GP5 A : 1993 CLINICAL LABORATORY WASTE MANAGEMENT
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    IEC 61010-2-061:2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-061: Particular requirements for laboratory atomic spectrometers with thermal atomization and ionization
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    AS ISO 20658:2019 Medical laboratories - Requirements for collection, transport, receipt, and handling of samples
    IEC 61010-2-042:1997 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes
    CLSI GP17 A : 1ED 96 CLINICAL LABORATORY SAFETY
    IEC TR 61010-3-020:1999 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-020: Conformity verification report for IEC 61010-2-020:1992 Particular requirements for laboratory centrifuges
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