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Medical testing, SS-EN ISO 15189:2022
Latest decision date: 2025-06-26
Clinical chemistry
Teknikområde
Metod/utrustning
Provtyp/System/Provmaterial
Parameter/Analys/Process/Undersökning
Mätprincip
Flex
Business unit
Coagulation
Sysmex CN
Human kroppsvätskor
Biochemical markers
Photometers
Endocrinology
Roche Cobas
Human kroppsvätskor
Biochemical markers
CLIA
Endocrinology
SCIEX QTRAP
Human kroppsvätskor
Biochemical markers
LC-MS/MS
Endocrinology
Siemens IMMULITE
Human kroppsvätskor
Biochemical markers
CLIA
Endogena metaboliter
SCIEX QTRAP
Human kroppsvätskor
Biochemical markers
LC-MS/MS
General chemistry
Advanced Instruments Osmometer
Human kroppsvätskor
Biochemical markers
Fryspunktsnedsättning
General chemistry
Roche Cobas
Human kroppsvätskor
Biochemical markers
CLIA
General chemistry
Roche Cobas
Human kroppsvätskor
Biochemical markers
Photometers
General chemistry
Roche Cobas
Human kroppsvätskor
Biochemical markers
Potentiometry
General chemistry
Roche Cobas
Human kroppsvätskor
Biochemical markers
Turbidimeters
General chemistry
Tosoh Bioscience Tosoh
Human kroppsvätskor
Biochemical markers
HPLC
Hematology
Sysmex XN
Human kroppsvätskor
Biochemical markers
Beräknad
Hematology
Sysmex XN
Human kroppsvätskor
Biochemical markers
Flow cytometry
Hematology
Sysmex XN
Human kroppsvätskor
Biochemical markers
Impedansmätning
Hematology
Sysmex XN
Human kroppsvätskor
Biochemical markers
Photometers
Protein Chemistry
Roche Cobas
Human kroppsvätskor
Biochemical markers
Turbidimeters
Clinical human genetics
Metod/utrustning
Provtyp/System/Provmaterial
Parameter/Analys/Process/Undersökning
Mätprincip
Flex
Business unit
Agilent Technologies TapeStation 2200
DNA
Detektion av fragmentlängder
Fragment length analysis
Agilent Technologies TapeStation 4150
DNA
Detektion av fragmentlängder
Fragment length analysis
Beckman Coulter Biomek i5
Human material
Extraktion av genomiskt DNA
Extraction
BIO-RAD CFX96
DNA
Detection of sequence variants
Alleldiskriminering (genotyp)
BIO-RAD PowerPac 300
DNA
Detektion av fragmentlängder
Fragment length analysis
BIO-RAD PowerPac Basic
DNA
Detektion av fragmentlängder
Fragment length analysis
Fluorescensmikroskop LEICA DM6 B
Human material
Detection of sequence variants
FISH
Fluorescensmikroskop LEICA DM6 B
Human material
Detektion av kopietalsvariation
FISH
Manual method
Human material
Extraktion av genomiskt DNA
Extraction
Manual method
Human material
Extraktion av RNA
Extraction
Mikroskop
Human material
Detektion av kopietalsvariation
Karyotypering
QIAGEN EZ1 Advanced XL
Human material
Extraktion av genomiskt DNA
Extraction
QIAGEN QIAsymphony SP
Human material
Extraktion av genomiskt DNA
Extraction
QIAGEN Rotor-Gene Q
RNA
Gene expression quantification
Real-time PCR
Thermo Fisher 3500 Genetic Analyzer
DNA
Detection of sequence variants
MLPA
Thermo Fisher 3500 Genetic Analyzer
DNA
Detection of sequence variants
Sanger sequencing
Thermo Fisher 3500 Genetic Analyzer
DNA
Detektion av fragmentlängder
Fragment length analysis
Thermo Fisher 3500 Genetic Analyzer
DNA
Detektion av fragmentlängder
Restriktionsklyvning
Clinical immunology and transfusion medicine
Teknikområde
Metod/utrustning
Provtyp/System/Provmaterial
Parameter/Analys/Process/Undersökning
Mätprincip
Flex
Business unit
Clinical immunology
BD FACS Canto
Human kroppsvätskor
Proteins
Flow cytometry
Clinical immunology
BD FACSLyric
Human kroppsvätskor
Cellular immunology
Flow cytometry
Clinical immunology
Euroimmun EUROBlotOne
Human kroppsvätskor
Detektion av antikroppar
Immunoblot
Clinical immunology
Fluorescensmikroskop Olympus CX41
Human kroppsvätskor
Detektion av antikroppar
IF
Clinical immunology
Roche cobas pro e 801
Human kroppsvätskor
Detektion av antikroppar
ECLIA
Clinical immunology
Siemens Atellica NEPH 630
Human kroppsvätskor
Proteins
Nephelometers
Clinical immunology
Thermo Fisher Phadia 250
Human kroppsvätskor
Detektion av antikroppar
EIA
Transfusion medicine
-
Human kroppsvätskor
Blood grouping
Direct agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Blood grouping
Indirect agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Compatibility testing
Direct agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Compatibility testing
Indirect agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Determination of erythrocyte antigen
Direct agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Determination of erythrocyte antigen
Indirect agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Direct antiglobulin test (DAT)
Direct agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Erytrocyt-antikroppsundersökning
Direct agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Erytrocyt-antikroppsundersökning
Indirect agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Kvantifiering av irregulära antikroppar mot erytrocytantigener
Direct agglutination technique
Transfusion medicine
-
Human kroppsvätskor
Kvantifiering av irregulära antikroppar mot erytrocytantigener
Indirect agglutination technique
Transfusion medicine
BD FACSLyric
Human kroppsvätskor
Komponentkontroll
Flow cytometry
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Blood grouping
Direct agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Blood grouping
Indirect agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Compatibility testing
Direct agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Compatibility testing
Indirect agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Determination of erythrocyte antigen
Direct agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Determination of erythrocyte antigen
Indirect agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Direct antiglobulin test (DAT)
Direct agglutination technique
Transfusion medicine
QuidelOrtho ORTHO VISION Analyzer
Human kroppsvätskor
Erytrocyt-antikroppsundersökning
Indirect agglutination technique
Clinical microbiology
Teknikområde
Metod/utrustning
Provtyp/System/Provmaterial
Parameter/Analys/Process/Undersökning
Mätprincip
Flex
Business unit
Clinical bacteriology
Standard method
Främmande kroppsmaterial
Detektion av relevanta bakterier
Odling
Clinical bacteriology
Standard method
Främmande kroppsmaterial
Detektion av relevanta bakterier
Real-time PCR
Clinical bacteriology
Standard method
Främmande kroppsmaterial
Identifikation
Odling
Clinical bacteriology
Standard method
Främmande kroppsmaterial
Resistensbestämning
Odling
Clinical bacteriology
Standard method
Human material
Detektion av antikroppar
Agglutinationstest
Clinical bacteriology
Standard method
Human material
Detektion av antikroppar
Buljongspädning
Clinical bacteriology
Standard method
Human material
Detektion av antikroppar
CLIA
Clinical bacteriology
Standard method
Human material
Detektion av antikroppar
EIA
Clinical bacteriology
Standard method
Human material
Detektion av relevanta bakterier
CLIA
Clinical bacteriology
Standard method
Human material
Detektion av relevanta bakterier
Microscopic diagnostics
Clinical bacteriology
Standard method
Human material
Detektion av relevanta bakterier
Odling
Clinical bacteriology
Standard method
Human material
Detektion av relevanta bakterier
Real-time PCR
Clinical bacteriology
Standard method
Human material
Detektion av relevanta bakterier
Sanger sequencing
Clinical bacteriology
Standard method
Human material
Detektion av specifika gener
LAMP
Clinical bacteriology
Standard method
Human material
Identifikation
Odling
Clinical bacteriology
Standard method
Human material
Resistensbestämning
Buljongspädning
Clinical bacteriology
Standard method
Human material
Resistensbestämning
Odling
Clinical bacteriology
Standard method
Human material
Resistensbestämning
Real-time PCR
Clinical bacteriology
Standard method
Isolate
Detektion av specifika gener
LAMP
Clinical bacteriology
Standard method
Isolate
Identifikation
MALDI-TOF
Clinical bacteriology
Standard method
Isolate
Identifikation
Sanger sequencing
Clinical bacteriology
Standard method
Isolate
Resistensbestämning
Buljongspädning
Clinical bacteriology
Standard method
Isolate
Resistensbestämning
Diskdiffusion
Clinical bacteriology
Standard method
Isolate
Resistensbestämning
Gradienttest
Clinical mycology
Standard method
Främmande kroppsmaterial
Detektion av relevanta jästsvampar
Odling
Clinical mycology
Standard method
Främmande kroppsmaterial
Identifikation
Odling
Clinical mycology
Standard method
Human material
Detektion av relevanta dermatofyter
Odling
Clinical mycology
Standard method
Human material
Detektion av relevanta jästsvampar och mögel
Odling
Clinical mycology
Standard method
Human material
Identifikation
Microscopic diagnostics
Clinical mycology
Standard method
Human material
Identifikation
Odling
Clinical mycology
Standard method
Human material
Resistensbestämning
Odling
Clinical mycology
Standard method
Isolate
Resistensbestämning
Buljongspädning
Clinical mycology
Standard method
Isolate
Resistensbestämning
Gradienttest
Clinical parasitology
Abbott Alinity i
Human material
Tissue parasites
CMIA
Clinical parasitology
BD BD MAX
Human material
Intestinal parasites
Real-time PCR
Clinical parasitology
Mikroskop
Human material
Blood parasites
Microscopic diagnostics
Clinical parasitology
Mikroskop
Human material
Intestinal parasites
Microscopic diagnostics
Clinical virology
Abbott Alinity i
Human material
Antigen detection
CMIA
Clinical virology
Abbott Alinity i
Human material
Detektion av antikroppar
CMIA
Clinical virology
Abbott Alinity m
Human material
Virus DNA and RNA
Real-time PCR
Clinical virology
Aidian 105100 Reagena ReaScan+ PUUMALA IgM
Human material
Detektion av antikroppar
Immunokromatografi
Clinical virology
BD BD MAX
Human material
Virus DNA and RNA
Real-time PCR
Clinical virology
BIO-RAD Geenius
Human material
Detektion av antikroppar
Immunokromatografi
Clinical virology
Cepheid GeneXpert
Human material
Virus DNA and RNA
Real-time PCR
Clinical virology
DiaSorin LIAISON XL
Human material
Detektion av antikroppar
CLIA
Clinical virology
Manual method
Human material
Detektion av antikroppar
IFA
Clinical virology
Roche cobas 5800
Human material
Virus DNA and RNA
Real-time PCR
Clinical virology
TECAN Sunrise
Human material
Detektion av antikroppar
EIA
Clinical virology
Thermo Fisher ABI 7500
Human material
Virus DNA and RNA
Real-time PCR
Clinical virology
Thermo Fisher QuantStudio 5
Human material
Virus DNA and RNA
Real-time PCR
Infection control diagnostics
Standard method
Luft
Detektion av relevanta bakterier
Odling
Infection control diagnostics
Standard method
Vatten
Detektion av legionella
Odling
Infection control diagnostics
Standard method
Vatten
Endotoxin
Photometers
Clinical pathology
Teknikområde
Metod/utrustning
Provtyp/System/Provmaterial
Parameter/Analys/Process/Undersökning
Mätprincip
Flex
Business unit
-
-
Human material
Hematopatologi
Microscopic diagnostics
-
BD FACSLyric
Human material
Hematopatologi
Flow cytometry
Morphological Diagnostics
-
Cells
Exfoliativ cytologi cervixcytologi
Microscopic diagnostics
Morphological Diagnostics
-
Tissue
-
Digital image diagnostics
Morphological Diagnostics
-
Tissue
-
Microscopic diagnostics
Morphological Diagnostics
-
Tissue
Bröstdiagnostik
Digital image diagnostics
Morphological Diagnostics
-
Tissue
Bröstdiagnostik
Microscopic diagnostics
Morphological Diagnostics
-
Tissue
Urologisk diagnostik urinvägar, endast tumörsjukdomar
Digital image diagnostics
Morphological Diagnostics
-
Tissue
Urologisk diagnostik urinvägar, endast tumörsjukdomar
Microscopic diagnostics
Pharmaceuticals and Toxicology
Teknikområde
Metod/utrustning
Provtyp/System/Provmaterial
Parameter/Analys/Process/Undersökning
Mätprincip
Flex
Business unit
Alcohol analyses
Agilent GC 6890
Human kroppsvätskor
Alcohols
GC
Alcohol analyses
Agilent GC 7820A
Human kroppsvätskor
Alcohols
GC
Alcohol analyses
PerkinElmer AutoSystem XL
Human kroppsvätskor
Alcohols
GC
Alcohol analyses
Roche cobas 6000
Human kroppsvätskor
Alcohols
Photometers
Alcohol analyses
Roche cobas pro
Human kroppsvätskor
Alcohols
Photometers
Alcohol analyses
Roche cobas pure
Human kroppsvätskor
Alcohols
Photometers
Alcohol analyses
SCIEX Triple Quad 4500
Human kroppsvätskor
Alcohols
LC-MS/MS
Alcohol analyses
Shimadzu Prominence LC-20A
Human kroppsvätskor
Alcohols
HPLC
Drug analysis
Roche cobas 6000
Human kroppsvätskor
Drugs
KIMS
Drug analysis
Roche cobas 6000
Human kroppsvätskor
Pharmaceuticals
EMIT
Drug analysis
Roche cobas 6000
Human kroppsvätskor
Pharmaceuticals
KIMS
Drug analysis
Roche cobas 6000
Human kroppsvätskor
Pharmaceuticals
Photometers
Drug analysis
Roche cobas pro
Human kroppsvätskor
Drugs
KIMS
Drug analysis
Roche cobas pro
Human kroppsvätskor
Pharmaceuticals
ECLIA
Drug analysis
Roche cobas pro
Human kroppsvätskor
Pharmaceuticals
EMIT
Drug analysis
Roche cobas pro
Human kroppsvätskor
Pharmaceuticals
KIMS
Drug analysis
Roche cobas pro
Human kroppsvätskor
Pharmaceuticals
Photometers
Drug analysis
Roche cobas pure
Human kroppsvätskor
Pharmaceuticals
EMIT
Drug analysis
Roche cobas pure
Human kroppsvätskor
Pharmaceuticals
KIMS
Drug analysis
Roche cobas pure
Human kroppsvätskor
Pharmaceuticals
Photometers
Drug analysis
SCIEX API 4000
Human kroppsvätskor
Drugs
LC-MS/MS
Drug analysis
Sciex QTRAP 5500
Human kroppsvätskor
Drugs
LC-MS/MS
Drug analysis
SCIEX QTRAP 6500+
Human kroppsvätskor
Drugs
LC-MS/MS
Drug analysis
SCIEX Triple Quad 4500
Human kroppsvätskor
Drugs
LC-MS/MS
Drug analysis
Thermo Fisher TSQ Quantis Plus
Human kroppsvätskor
Drugs
LC-MS/MS
Pre-analysis
Teknikområde
Provtyp/System/Provmaterial
Flex
Business unit
Sampling
Human material
The accredited body has been granted flexible scope. The body shall be able to provide an updated list of the current scope of accreditation upon request.
Type 2 of flexibility:
Introduce new version of standard method and make editorial changes to non-standard method - Introduce new version and modifications of non-standard method. The procedure must be equivalent - Introduce new parameter/component/characteristics - Introduce new measurement range - Introduce new material/new products/matrices - Introduce new method equivalent to methods already in the accreditation decision