ISO 15190:2003
Withdrawn
Withdrawn
View Superseded by
Medical laboratories — Requirements for safety
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
10-27-2003
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
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Withdrawn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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| UNE-EN ISO 15189:2013 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| UNE-CWA 16335:2014 | Biosafety professional competence |
| 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) |
| 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 |
Summarise
US$96.00
Excluding Tax where applicable
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