ISO 15190:2003
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical laboratories Requirements for safety
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
26-02-2020
Superseded by
Language(s)
English
Published date
27-10-2003
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.
| DevelopmentNote |
Supersedes ISO/DIS 15190 (10/2003)
|
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| NEN ISO 15190 : 2003 | Identical |
| BS ISO 15190:2003 | Identical |
| 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 | <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> 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 |
| 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<br> |
| 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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