11.100 : Laboratory medicine
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NBN EN ISO 20916:2024
Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude (ISO 20916:2019)
3/6/2024 - PDF - French - NBN
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NBN EN ISO 20916:2024
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
3/6/2024 - PDF - English - NBN
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CEN/TS 17981-2:2023
Next Generation Sequencing (NGS)-Arbeitsabläufe für die In-vitro-Diagnostik - Teil 2: Untersuchung von menschlicher RNA
11/30/2023 - PDF - German - NBN
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CEN/TS 17981-1:2023
Next Generation Sequencing (NGS)-Arbeitsabläufe für die In-vitro-Diagnostik - Teil 1: Untersuchung von menschlicher DNA
11/30/2023 - PDF - German - NBN
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CEN/TS 17981-2:2023
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination
11/30/2023 - PDF - English - NBN
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CEN/TS 17981-1:2023
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
11/30/2023 - PDF - English - NBN
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NBN EN ISO 10993-17:2023
Évaluation biologique des dispositifs médicaux - Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux (ISO 10993-17:2023)
11/23/2023 - PDF - French - NBN
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NBN EN ISO 10993-17:2023
Biologische Beurteilung von Medizinprodukten - Teil 17: Toxikologische Risikobewertung von Medizinproduktbestandteilen (ISO 10993-17:2023)
11/23/2023 - PDF - German - NBN
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NBN EN ISO 10993-17:2023
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
11/23/2023 - PDF - English - NBN
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NBN EN ISO 15189:2022/A11:2023
Laboratoires médicaux - Exigences concernant la qualité et la compétence
11/15/2023 - PDF - French - NBN
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NBN EN ISO 15189:2022/A11:2023
Medical laboratories - Requirements for quality and competence
11/15/2023 - PDF - English - NBN
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€20.00
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NBN ISO 20658:2023
Exigences pour le prélèvement et le transport d’échantillons à des fins d’examens en laboratoire médical ISO 20658:2023
9/22/2023 - PDF - French - NBN
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NBN ISO 20658:2023
Requirements for the collection and transport of samples for medical laboratory examinations ISO 20658:2023
9/22/2023 - PDF - English - NBN
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NBN EN ISO 10993-18:2020/A1:2023
Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque - Amendement 1: Détermination du coefficient d'incertitude (ISO 10993-18:2020/Amd 1:2022)
7/26/2023 - PDF - French - NBN
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NBN EN ISO 10993-18:2020/A1:2023
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems - Änderung 1: Bestimmung des Unsicherheitsfaktors (ISO 10993-18:2020/Amd 1:2022)
7/26/2023 - PDF - German - NBN
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NBN EN ISO 10993-18:2020/A1:2023
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
7/26/2023 - PDF - English - NBN
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NBN EN ISO 10993-15:2023
Évaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages (ISO 10993-15:2019)
5/24/2023 - PDF - French - NBN
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NBN EN ISO 10993-15:2023
Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2019)
5/24/2023 - PDF - German - NBN
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NBN EN ISO 10993-15:2023
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
5/24/2023 - PDF - English - NBN
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NBN EN ISO 10993-10:2023
Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation cutanée (ISO 10993-10:2021)
2/8/2023 - PDF - French - NBN
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NBN EN ISO 10993-10:2023
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Hautsensibilisierung (ISO 10993-10:2021)
2/8/2023 - PDF - German - NBN
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NBN EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
2/8/2023 - PDF - English - NBN
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NBN ISO 21474-2:2023
Dispositifs médicaux de diagnostic in vitro – Tests moléculaires multiplex pour les acides nucléiques — Partie 2: Validation et vérification ISO 21474-2:2022
2/1/2023 - PDF - French - NBN
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NBN ISO 21474-2:2023
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification ISO 21474-2:2022
2/1/2023 - PDF - English - NBN
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NBN ISO 17593:2023
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy ISO 17593:2022
2/1/2023 - PDF - English - NBN
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NBN EN ISO 15189:2022
Laboratoires de biologie médicale - Exigences concernant la qualité et la compétence (ISO 15189:2022)
12/15/2022 - PDF - French - NBN
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NBN EN ISO 15189:2022
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2022)
12/15/2022 - PDF - German - NBN
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NBN EN ISO 15189:2022
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
12/15/2022 - PDF - English - NBN
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€184.00
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CEN ISO/TS 5798:2022
Systèmes d’essai pour diagnostic in vitro - Exigences et recommandations pour la détection du coronavirus 2 associé au syndrome respiratoire aigu sévère (SARS-CoV-2) par des méthodes d’amplification des acides nucléiques (ISO/TS 5798:2022)
12/1/2022 - PDF - French - NBN
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CEN ISO/TS 5798:2022
In-vitro-Diagnostika-Systeme - Anforderungen und Empfehlungen für Qualitätsverfahren für den Nachweis des Coronavirus 2 des Schweren Akuten Respiratorischen Syndroms (SARS-CoV-2) mittels Nukleinsäureamplifikation (ISO/TS 5798:2022)
12/1/2022 - PDF - German - NBN
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CEN ISO/TS 5798:2022
In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)
12/1/2022 - PDF - English - NBN
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NBN EN ISO 10993-2:2022
Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives à la protection des animaux (ISO 10993-2:2022)
11/24/2022 - PDF - French - NBN
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NBN EN ISO 10993-2:2022
Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:2022)
11/24/2022 - PDF - German - NBN
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NBN EN ISO 10993-2:2022
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
11/24/2022 - PDF - English - NBN
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CEN/TS 17811:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
6/25/2022 - PDF - German - NBN
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CEN/TS 17811:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
6/25/2022 - PDF - English - NBN
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CEN/TS 17747:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
4/23/2022 - PDF - German - NBN
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CEN/TS 17747:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
4/23/2022 - PDF - English - NBN
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CEN/TS 17742:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
4/2/2022 - PDF - German - NBN
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CEN/TS 17742:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
4/2/2022 - PDF - English - NBN
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NBN EN ISO 20776-2:2022
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
1/22/2022 - PDF - French - NBN
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NBN EN ISO 20776-2:2022
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
1/22/2022 - PDF - German - NBN
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NBN EN ISO 20776-2:2022
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
1/22/2022 - PDF - English - NBN
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NBN EN ISO 10993-7:2008/A1:2022
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
1/15/2022 - PDF - French - NBN
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NBN EN ISO 10993-7:2008/A1:2022
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
1/15/2022 - PDF - English - NBN
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NBN EN ISO 10993-7:2008/A1:2022
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid Sterilisationsrückstände - Änderung 1: Anwendbarkeit zulässiger Grenzwerte für Neugeborene und Kleinkinder (ISO 10993 7:2008/Amd 1:2019)
1/15/2022 - PDF - German - NBN
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CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
12/24/2021 - PDF - German - NBN
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CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
12/24/2021 - PDF - English - NBN
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CEN/TS 17688-2:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins
12/24/2021 - PDF - English - NBN
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CEN/TS 17688-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA
12/24/2021 - PDF - English - NBN
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CEN/TS 17688-3:2021
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Feinnadelaspirate - Teil 3: Isolierte genomische DNA
12/24/2021 - PDF - German - NBN
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NBN EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
11/8/2021 - PDF - French - NBN
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NBN EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
11/8/2021 - PDF - German - NBN
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NBN EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
11/8/2021 - PDF - English - NBN
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NBN EN ISO 16256:2021
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
10/29/2021 - PDF - French - NBN
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NBN EN ISO 16256:2021
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
10/29/2021 - PDF - German - NBN
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NBN EN ISO 16256:2021
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
10/29/2021 - PDF - English - NBN
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NBN EN ISO 10993-9:2021
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
10/1/2021 - PDF - French - NBN
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NBN EN ISO 10993-9:2021
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
10/1/2021 - PDF - German - NBN
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NBN EN ISO 10993-9:2021
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
10/1/2021 - PDF - English - NBN
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NBN EN ISO 6717:2021
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
9/10/2021 - PDF - French - NBN
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NBN EN ISO 6717:2021
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
9/10/2021 - PDF - English - NBN
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NBN EN ISO 20166-4:2021
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
7/31/2021 - PDF - French - NBN
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NBN EN ISO 20166-4:2021
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
7/31/2021 - PDF - German - NBN
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NBN EN ISO 20166-4:2021
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
7/31/2021 - PDF - English - NBN
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NBN EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/16/2021 - PDF - French - NBN
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NBN EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/16/2021 - PDF - German - NBN
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NBN EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/16/2021 - PDF - English - NBN
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NBN EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
6/18/2021 - PDF - French - NBN
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NBN EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
6/18/2021 - PDF - German - NBN
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NBN EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
6/18/2021 - PDF - English - NBN
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NBN ISO 17822:2021
In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide ISO 17822:2020
6/17/2021 - PDF - English - NBN
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NBN EN ISO 17511:2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
6/5/2021 - PDF - French - NBN
Learn More€184.00 -
NBN EN ISO 17511:2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
6/5/2021 - PDF - German - NBN
Learn More€184.00 -
NBN EN ISO 17511:2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
6/5/2021 - PDF - English - NBN
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NBN EN ISO 23118:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
6/5/2021 - PDF - French - NBN
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NBN EN ISO 23118:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
6/5/2021 - PDF - German - NBN
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NBN EN ISO 23118:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
6/5/2021 - PDF - English - NBN
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NBN ISO 15190:2021
Medical laboratories — Requirements for safety ISO 15190:2020
5/29/2021 - PDF - English - NBN
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NBN EN ISO 20184-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
5/28/2021 - PDF - French - NBN
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NBN EN ISO 20184-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
5/28/2021 - PDF - German - NBN
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NBN EN ISO 20184-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
5/28/2021 - PDF - English - NBN
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NBN ISO 21151:2021
In vitro diagnostic medical devices ? Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
5/13/2021 - PDF - French - NBN
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NBN ISO 21151:2021
In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples ISO 21151:2020
5/13/2021 - PDF - English - NBN
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NBN ISO 21474-1:2021
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation ISO 21474-1:2020
5/13/2021 - PDF - English - NBN
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CEN/TS 17626:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
5/8/2021 - PDF - German - NBN
Learn More€163.00 -
CEN/TS 17626:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
5/8/2021 - PDF - English - NBN
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NBN EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
4/2/2021 - PDF - French - NBN
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NBN EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
4/2/2021 - PDF - German - NBN
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NBN EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
4/2/2021 - PDF - English - NBN
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NBN EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/27/2021 - PDF - French - NBN
Learn More€89.00 -
NBN EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/27/2021 - PDF - German - NBN
Learn More€89.00 -
NBN EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/27/2021 - PDF - English - NBN
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NBN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
1/27/2021 - PDF - French - NBN
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NBN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
1/27/2021 - PDF - German - NBN
Learn More€163.00 -
NBN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
1/27/2021 - PDF - English - NBN
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NBN EN ISO 22442-1:2021
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
1/27/2021 - PDF - French - NBN
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NBN EN ISO 22442-1:2021
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
1/27/2021 - PDF - German - NBN
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NBN EN ISO 22442-1:2021
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
1/27/2021 - PDF - English - NBN
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NBN EN ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/23/2020 - PDF - French - NBN
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NBN EN ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/23/2020 - PDF - German - NBN
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NBN EN ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/23/2020 - PDF - English - NBN
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NBN EN ISO 20776-1:2020
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 20776-1:2019, including Corrected version 2019-12)
7/29/2020 - PDF - French - NBN
Learn More€121.00 -
NBN EN ISO 20776-1:2020
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 20776-1:2019, including Corrected version 2019-12)
7/29/2020 - PDF - German - NBN
Learn More€121.00 -
NBN EN ISO 20776-1:2020
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 20776-1:2019, including Corrected version 2019-12)
7/29/2020 - PDF - English - NBN
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NBN EN ISO 10993-18:2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
6/25/2020 - PDF - French - NBN
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NBN EN ISO 10993-18:2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
6/25/2020 - PDF - German - NBN
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NBN EN ISO 10993-18:2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
6/25/2020 - PDF - English - NBN
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NBN EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
4/29/2020 - PDF - French - NBN
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NBN EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
4/29/2020 - PDF - English - NBN
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NBN ISO 35001:2020
Biorisk management for laboratories and other related organisations
2/27/2020 - PDF - French - NBN
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NBN ISO 35001:2020
Biorisk management for laboratories and other related organisations
2/27/2020 - PDF - English - NBN
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CEN/TS 17390-2:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
1/24/2020 - PDF - German - NBN
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CEN/TS 17390-2:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
1/24/2020 - PDF - English - NBN
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CEN/TS 17390-3:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
1/24/2020 - PDF - German - NBN
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CEN/TS 17390-3:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
1/24/2020 - PDF - English - NBN
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CEN/TS 17390-1:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
1/24/2020 - PDF - German - NBN
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CEN/TS 17390-1:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
1/24/2020 - PDF - English - NBN
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NBN EN ISO 20186-3:2019
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
11/28/2019 - PDF - French - NBN
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NBN EN ISO 20186-3:2019
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
11/28/2019 - PDF - German - NBN
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NBN EN ISO 20186-3:2019
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
11/28/2019 - PDF - English - NBN
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NBN EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
4/17/2019 - PDF - French - NBN
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NBN EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
4/17/2019 - PDF - German - NBN
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NBN EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
4/17/2019 - PDF - English - NBN
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NBN EN ISO 20186-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
4/17/2019 - PDF - French - NBN
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NBN EN ISO 20186-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
4/17/2019 - PDF - German - NBN
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NBN EN ISO 20186-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
4/17/2019 - PDF - English - NBN
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NBN EN ISO 20166-3:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
2/27/2019 - PDF - French - NBN
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NBN EN ISO 20166-3:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
2/27/2019 - PDF - German - NBN
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NBN EN ISO 20166-3:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
2/27/2019 - PDF - English - NBN
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NBN EN ISO 15195:2019
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
2/27/2019 - PDF - French - NBN
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NBN EN ISO 15195:2019
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
2/27/2019 - PDF - German - NBN
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NBN EN ISO 15195:2019
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
2/27/2019 - PDF - English - NBN
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NBN EN ISO 20166-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)
1/30/2019 - PDF - French - NBN
Learn More€121.00 -
NBN EN ISO 20166-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)
1/30/2019 - PDF - German - NBN
Learn More€121.00 -
NBN EN ISO 20166-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)
1/30/2019 - PDF - English - NBN
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NBN EN ISO 20184-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
1/30/2019 - PDF - French - NBN
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NBN EN ISO 20184-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
1/30/2019 - PDF - German - NBN
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NBN EN ISO 20184-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
1/30/2019 - PDF - English - NBN
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NBN EN ISO 20184-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
1/30/2019 - PDF - French - NBN
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NBN EN ISO 20184-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
1/30/2019 - PDF - German - NBN
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NBN EN ISO 20184-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
1/30/2019 - PDF - English - NBN
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NBN EN ISO 20166-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)
1/30/2019 - PDF - French - NBN
Learn More€121.00 -
NBN EN ISO 20166-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)
1/30/2019 - PDF - German - NBN
Learn More€121.00 -
NBN EN ISO 20166-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)
1/30/2019 - PDF - English - NBN
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NBN EN ISO 7405:2018
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
12/19/2018 - PDF - French - NBN
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NBN EN ISO 7405:2018
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
12/19/2018 - PDF - German - NBN
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NBN EN ISO 7405:2018
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
12/19/2018 - PDF - English - NBN
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NBN EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
6/20/2018 - PDF - English - NBN
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NBN EN ISO 10993-11:2018
Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:2017)
6/20/2018 - PDF - French - NBN
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NBN EN ISO 10993-11:2018
Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2017)
6/20/2018 - PDF - German - NBN
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CWA 17253-2:2018
Joint implants - Part 2: Tiered toolkit approach to evaluate the biological impact of wear particles from joint replacements and related devices
3/30/2018 - PDF - English - NBN
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NBN EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
1/30/2018 - PDF - French - NBN
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NBN EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
1/30/2018 - PDF - German - NBN
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NBN EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
1/30/2018 - PDF - English - NBN
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NBN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
11/22/2017 - PDF - French - NBN
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NBN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
11/22/2017 - PDF - German - NBN
Learn More€184.00 -
NBN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
11/22/2017 - PDF - English - NBN
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NBN EN ISO 10993-6:2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
1/27/2017 - PDF - French - NBN
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NBN EN ISO 10993-6:2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
1/27/2017 - PDF - German - NBN
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NBN EN ISO 10993-6:2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
1/27/2017 - PDF - English - NBN
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NBN EN ISO 23640:2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
7/24/2015 - PDF - French - NBN
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NBN EN ISO 23640:2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
7/24/2015 - PDF - German - NBN
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NBN EN ISO 23640:2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
7/24/2015 - PDF - English - NBN
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NBN EN ISO 15197:2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
7/24/2015 - PDF - French - NBN
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NBN EN ISO 15197:2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
7/24/2015 - PDF - German - NBN
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NBN EN ISO 15197:2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
7/24/2015 - PDF - English - NBN
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NBN EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
11/28/2014 - PDF - French - NBN
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NBN EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
11/28/2014 - PDF - German - NBN
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NBN EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
11/28/2014 - PDF - English - NBN
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NBN EN ISO 19001:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
6/21/2013 - PDF - French - NBN
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NBN EN ISO 19001:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
6/21/2013 - PDF - English - NBN
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NBN EN ISO 18113-5:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
12/14/2011 - PDF - French - NBN
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NBN EN ISO 18113-5:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
12/14/2011 - PDF - German - NBN
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NBN EN ISO 18113-5:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
12/14/2011 - PDF - English - NBN
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NBN EN ISO 18113-3:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
12/14/2011 - PDF - French - NBN
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NBN EN ISO 18113-3:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
12/14/2011 - PDF - German - NBN
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NBN EN ISO 18113-3:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
12/14/2011 - PDF - English - NBN
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NBN EN ISO 18113-4:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
12/14/2011 - PDF - French - NBN
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NBN EN ISO 18113-4:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
12/14/2011 - PDF - German - NBN
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NBN EN ISO 18113-4:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
12/14/2011 - PDF - English - NBN
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NBN EN ISO 18113-2:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
12/14/2011 - PDF - French - NBN
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NBN EN ISO 18113-2:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
12/14/2011 - PDF - German - NBN
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NBN EN ISO 18113-2:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
12/14/2011 - PDF - English - NBN
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NBN 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)
12/14/2011 - PDF - French - NBN
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NBN 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)
12/14/2011 - PDF - German - NBN
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NBN 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)
12/14/2011 - PDF - English - NBN
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€58.00
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€58.00
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€58.00
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NBN EN ISO 13079:2011
Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
9/23/2011 - PDF - French - NBN
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NBN EN ISO 13079:2011
Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
9/23/2011 - PDF - German - NBN
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NBN EN ISO 13079:2011
Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
9/23/2011 - PDF - English - NBN
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NBN EN ISO 29701:2010
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
10/29/2010 - PDF - French - NBN
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NBN EN ISO 29701:2010
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
10/29/2010 - PDF - German - NBN
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NBN EN ISO 29701:2010
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
10/29/2010 - PDF - English - NBN
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NBN EN ISO 10993-13:2010
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
7/30/2010 - PDF - French - NBN
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NBN EN ISO 10993-13:2010
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
7/30/2010 - PDF - German - NBN
Learn More€89.00
