Login

Standardization · SIS/TK 331

Laboratoriemedicin

Laboratoriemedicinens uppdrag är att serva vården när det gäller hälsokontroller, diagnostik, uppföljning och behandlingskontroll av olika sjukdomar. Laboratoriemedicinens olika specialiteter lägger mycket stor vikt vid standardiserade arbetsmetoder och verksamheterna är ofta ackrediterade enligt olika standarder. Tekniska kommittén arbetar nu även med standardisering inom bioteknologi, som till exempel biobanker.

Den tekniska kommittén för laboratoriemedicin medverkar till att utarbeta standarder som ger säkra och effektiva system, rutiner inom kliniska laboratorier och för säkra produkter för in- vitro diagnostik. Arbetet syftar till att öka patientsäkerheten genom att utveckla standarder som gör diagnoser och analyser mer tillförlitliga. Europeiska standarder (EN) är en förutsättning för att som tillverkare kunna uppfylla IVDR 2017/745. Standarderna riktar sig också till laboratorier inom klinisk kemi, klinisk mikrobiologi, molekylärbiologi, transfusionsmedicin mm. Dessutom arbetar kommittéen med standarder för den patientnära analysverksamheten, dvs alla olika typer av analyser som utförs på apotek, mottagningar och vårdavdelningar av icke laborativt utbildad personal.

Bioteknologi SIS-TK 331/AG5 , via ISO/TC 276 Biotechnology ingår i tekniska kommitten och är aktiva i arbetgruppen som arbetar med biobanksverksamhet. Vi arbetar för att få med experter inom fler områden som Biotechnology gruppen innefattar, som till exempel analytiska metoder, bioprocessing, data informationsbehandling (validering, jämförbarhet, integration etc) samt metrologi.

Påverka nationellt och internationellt

Kommittén skapar den svenska plattformen för att aktivt kunna påverka den europeiska (CEN) och internationella (ISO) standardiseringen. Standarderna som kommittén medverkar till att utveckla underlättar vid både tillverkning, inköp och användande av produkterna. Standardiseringsarbetet säkerställer också att produkterna tillverkas efter samstämmiga krav där det finns koppling till EU-lagar, som exempelvis anbudsgivare kan hänvisa till redan i anbudsskedet. Arbetet skapar fri rörlighet och konkurrens av produkter och viss del tjänster mellan länder, vilket stödjer den svenska exportmarknaden. Det europeiska och internationella arbetet inom CEN och ISO inkluderar t.ex. kvalitetsledningssystem för laboratorier som vill ackreditera sin verksamhet och krav på olika odlingsmedier och andra produkter som ska användas inom laboratoriemedicinen.

More information about the committèes work:

Arbetsgrupp för biobanker och bioteknologi Aktiv
Now working on 49 standards
ISO 20184-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA
EN ISO 17511, In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019)
ISO 24190, Biotechnology - General Requirements for Massive Parallel Sequencing - Part 1: Part 1: Nucleic acid and library preparation
ISO 20397-1, Biotechnology - General Requirements for Massive Parallel Sequencing - Part 1: Part 1: Nucleic acid and library preparation
ISO 21474-2, In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 2: Part 2 - Validation and Verification
EN ISO 22367, Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22367:2019)
CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
EN ISO 20776-1, Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO/DIS 20776-1:2018)
ISO/TS 23565, Biotechnology - Bioprocessing - General requirements and considerations for equipment systems used in manufacturing of cellular therapeutic products
ISO 15190, Medical laboratories - Requirements for safety
ISO 20688-1, Biotechnology - Nucleic acid synthesis - Part 1: General definitions and requirements for the production and quality control of synthesized oligonucleotides
ISO 20166-4, Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: in situ detection techniques
ISO 21474-1, In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation
EN ISO 20186-3, Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from plasma (ISO/DIS 20186-3:2018)
ISO 20186-3, Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from plasma
ISO/TS 22859, Biotechnology - Biobanking - Quality requirements for human mesenchymal stem cells
ISO 22860, Biotechnology - Metadata specifications for human mesenchymal stem cells
ISO 20776-1, Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference methods for testing the in vitro activity of antimicrobial agents against rapidly groving aerobic bacteria involved in infectious diseases
ISO 23162, Basic semen analysis - Specification and test methods
ISO 20391-2, Biotechnology - Cell Counting - Part 2: Experimental design and statistical analysis to quantify counting method performance
ISO 23118, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
ISO 23105, Biotechnology - Biobanking - The collection, processing, conservation and Distribution requirements for plant genetic resources
ISO 20388, Biotechnology - Biobanking - The Collection, processing, storage and transportation criteria for animal genetic resources
ISO 23033, Biotechnology - Cell Characterization - General guide for characterization of human cells for therapeutic applications
ISO/IEC TR 22758, Biotechnology - Biobanking - Implementation guide for ISO 20387
ISO 21709, Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
ISO 21710, Biotechnology - Data management and publication in microbial biological resource centers
ISO 20691, Biotechnology - Requirements for data formatting and description in the life sciences for downstream data processing and integration workflows
ISO 21899, Biotechnology - Biobanking - General requirements for the validation and verification of processing methods for biological material in biobanks
ISO 20397, Biotechnology - Methods to evaluate the quality of the massive sequencing data
ISO/IEC TS 22583, Guidance for supervisors and operators of point-of-care testing (POCT) devices
EN ISO 20186-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO/FDIS 20186-2:2018)
EN ISO 20186-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO/FDIS 20186-1:2018)
ISO 20688, Biotechnology - Nucleic acid synthesis - General definitions and requirements for the production and quality control of synthetic nucleic acids
ISO 21973, Biotechnology - General requirements for transportation of cells for therapeutic use
ISO 17822-3, Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens - Part 3: Quality practices for nucleic acid amplification
ISO/TR 20386, Inventory of biotechnology-related terms
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
ISO 20395-1, Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - Part 1: qPCR and dPCR
ISO 21474, In vitro diagnostic medical devices - General requirements and terminology for multiplex molecular testing
ISO 17511, In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
ISO 21151, In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples
ISO/TS 20914, Medical laboratories - Practical guide for the estimation of measurement uncertainty
ISO 20916, In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
ISO 17822-2, In vitro diagnostic test systems - Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 2: Quality practices for nucleic acid amplification
ISO 20167 , Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Extracted proteins
ISO 35001, Biorisk management for laboratories and other related organisations
ISO 22367, Medical laboratories - Application of risk management to medical laboratories
ISO PRF 16782, Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
Show more Show less
Published 47 standards
Show more Show less
Working group 2 workgroups
SIS/TK 331/AG 04, Patientnära analyser
SIS/TK 331/AG 05, Bioteknologi och Biobanker
Participants 22 companies and organizations
Alere AB, Kista
Aleris Diagnostik AB Aleris Medilab, Täby
ANOVA Karolinska Universitetssjukhuset, Stockholm
Centrallasarettet, Växjö
Cepheid AB, Solna
Equalis AB, Uppsala
Folkhälsomyndigheten, Solna
Laboratoriemedicin NU-sjukvården, Klinisk kemi NÄL, Trollhättan
Landstinget Gävleborg, Gävle
Länssjukhuset i Kalmar, Kalmar
Länssjukhuset Ryhov, Jönköping
Nationella vävnadsrådet/SKL, Stockholm
Region Västerbotten, Skellefteå
Sahlgrenska Universitetssjukhuset, Göteborg
Sahlgrenska Universitetssjukhuset, Mölndal
Sarstedt AB, Helsingborg
Styrelsen för ackreditering & teknisk kontroll Swedac, Borås
Styrelsen för Ackreditering & Teknisk Kontroll SWEDAC, Bromma
Unilabs AB, Skövde
Universitetssjukhuset Örebro, Örebro
Universitetssjukhuset Örebro, Örebro
Vårdförbundet, Stockholm
Show more Show less
International participation 13 international committees
ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems
ISO/TC 212/WG 1, Quality and competence in the medical laboratory
ISO/TC 212/WG 2, Reference systems
ISO/TC 212/WG 3, In vitro diagnostic products
ISO/TC 212/WG 4, Microbiology and molecular diagnostics
ISO/TC 276, Biotechnology
ISO/TC 276/WG 1, Terminology
ISO/TC 276/WG 2, Methods of test
ISO/TC 276/WG 3, Analytical methods
ISO/TC 276/WG 4, Bioprocessing
ISO/TC 276/WG 5, Data processing and integration
CEN/TC 140, In vitro diagnostic medical devices
CEN/TC 140/WG 3, Quality management in the medical laboratory
Show more Show less
Financing
Arbetet styrs och finansieras av de organisationer som deltar i kommittén. Projektavgiften beror på arbetsform och omfattning, samt antal deltagare.
Ett värdefullt arbete Aktiv

Subjects

Health care technology Laboratory medicine In vitro diagnostic test systems Other