11.100 : Laboratory medicine
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NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)
Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals - Amendment 1
1/1/2022 - Paper - French - AFNOR
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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
Learn More€163.00 -
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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PD CEN/TS 17688-2:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated proteins
12/23/2021 - PDF - English - BSI
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PD CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated cellular RNA
12/23/2021 - PDF - English - BSI
Learn More€293.00 -
PD CEN/TS 17688-3:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated genomic DNA
12/23/2021 - PDF - English - BSI
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BS EN ISO 4307:2021 + Redline
Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
12/17/2021 - PDF - English - BSI
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BS EN ISO 17511:2021 + Redline
Tracked Changes. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
12/10/2021 - PDF - English - BSI
Learn More€454.00 -
DIN EN ISO 6717:2021-12
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021), German version EN ISO 6717:2021
12/1/2021 - PDF - German - DIN
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UNE-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) (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
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FD ISO/TR 21582, S99-513 (12/2021)
Pyrogénicité - Principes et méthodes d'essai pour la recherche des pyrogènes sur les dispositifs médicaux
12/1/2021 - Paper - French - AFNOR
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BS EN ISO 20184-3:2021 + Redline
Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated DNA
11/30/2021 - PDF - English - BSI
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BS EN ISO 6717:2021 + Redline
Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
11/23/2021 - PDF - English - BSI
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21/30379304 DC:2021
BS EN ISO 10993-17. Biological evaluation of medical devices Part 17. Toxicological risk assessment device constituents
11/22/2021 - PDF - English - BSI
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BS EN ISO 16256:2021 + Redline
Tracked Changes. 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
11/17/2021 - PDF - English - BSI
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BS EN ISO 10993-12:2021 + Redline
Tracked Changes. Biological evaluation of medical devices Sample preparation and reference materials
11/16/2021 - PDF - English - BSI
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BS EN IEC 61326-2-6:2021 + Redline
Tracked Changes. Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical
11/10/2021 - PDF - English - BSI
Learn More€235.00 -
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
Learn More€58.00 -
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
Learn More€58.00 -
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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BS EN ISO 4307:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
11/4/2021 - PDF - English - BSI
Learn More€180.00 -
NF EN ISO 4307, S92-076 (11/2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
11/1/2021 - Paper - French - AFNOR
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DIN EN ISO 17511:2021-11
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020), German version EN ISO 17511:2021
11/1/2021 - PDF - German - DIN
Learn More€163.74 -
DIN EN ISO 20184-3:2021-11
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021), German version EN ISO 20184-3:2021
11/1/2021 - PDF - German - DIN
Learn More€85.79 -
DIN EN ISO 20166-4:2021-11
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), German version EN ISO 20166-4:2021
11/1/2021 - PDF - German - DIN
Learn More€104.95 -
DIN 58912-1:2021-11
Haemostaseology - Determination of the antithrombin activity - Part 1: Reference measurement procedure using a synthetic peptide substrate, Text in German and English
11/1/2021 - PDF - English, German - DIN
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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
Learn More€89.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
BS 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
10/27/2021 - PDF - English - BSI
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UNE-EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
10/13/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
10/13/2021 - PDF - English - AENOR
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UNE-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)
10/6/2021 - PDF - Spanish - AENOR
Learn More€102.00 -
UNE-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)
10/6/2021 - PDF - English - AENOR
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DIN EN ISO 23162:2021-10
Basic semen examination - Specification and test methods (ISO 23162:2021), German version EN ISO 23162:2021
10/1/2021 - PDF - German - DIN
Learn More€110.00 -
NF EN ISO 16256, S92-012 (10/2021)
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
10/1/2021 - Paper - French - AFNOR
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PR NF EN ISO 18113-2, S92-010-2PR (10/2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2 : Réactifs de diagnostic in vitro à usage professionnel
10/1/2021 - Paper - English, French - AFNOR
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PR NF EN ISO 18113-3, S92-010-3PR (10/2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3 : Instruments de diagnostic in vitro à usage professionnel
10/1/2021 - Paper - English, French - AFNOR
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PR NF EN ISO 18113-4, S92-010-4PR (10/2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : Réactifs de diagnostic in vitro destinés aux autodiagnostics
10/1/2021 - Paper - English, French - AFNOR
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PR NF EN ISO 18113-5, S92-010-5PR (10/2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5 : Instruments de diagnostic in vitro destinés aux autodiagnostics
10/1/2021 - Paper - English, French - AFNOR
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PR NF EN ISO 18113-1, S92-010-1PR (10/2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1 : Termes, définitions et exigences générales
10/1/2021 - Paper - English, French - AFNOR
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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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DIN EN ISO 10993-23:2021-10
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021), German version EN ISO 10993-23:2021
10/1/2021 - PDF - German - DIN
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UNE-EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/22/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
9/22/2021 - PDF - English - AENOR
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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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BS EN ISO 6717:2021
In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
9/8/2021 - PDF - English - BSI
Learn More€180.00 -
NF EN ISO 6717, S92-036 (09/2021)
In vitro diagnostic medical devices - Single-use containers for the collection of specimens, other than blood, from humans
9/1/2021 - Paper - French - AFNOR
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DIN EN ISO 18113-1:2021-09
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021), German and English version prEN ISO 18113-1:2021
9/1/2021 - PDF - English, German - DIN
Learn More€148.04 -
DIN EN ISO 18113-2:2021-09
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021), German and English version prEN ISO 18113-2:2021
9/1/2021 - PDF - English, German - DIN
Learn More€85.79 -
DIN EN ISO 18113-3:2021-09
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021), German and English version prEN ISO 18113-3:2021
9/1/2021 - PDF - English, German - DIN
Learn More€72.80 -
DIN EN ISO 18113-4:2021-09
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021), German and English version prEN ISO 18113-4:2021
9/1/2021 - PDF - English, German - DIN
Learn More€79.72 -
DIN EN ISO 18113-5:2021-09
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021), German and English version prEN ISO 18113-5:2021
9/1/2021 - PDF - English, German - DIN
Learn More€72.80 -
NF EN ISO 10993-9, S99-501-9 (09/2021)
Biological evaluation of medical devices - Part 9 : Framework for identification and quantification of potential degradation products
9/1/2021 - Paper - French - AFNOR
Learn More€60.67 -
DIN 58931:2021-09
Haematology - Determination of haemoglobin concentration in blood - Reference method, Text in German and English
9/1/2021 - PDF - English, German - DIN
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21/30439273 DC:2021
BS EN ISO 10993-18 AMD1. Biological evaluation of medical devices Part 18. Chemical characterization device materials within a risk management process
8/17/2021 - PDF - English - BSI
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21/30416029 DC:2021
BS EN ISO 18113-1. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 1. Terms, definitions, and general requirements
8/11/2021 - PDF - English - BSI
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21/30416033 DC:2021
BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 2. reagents for professional use
8/11/2021 - PDF - English - BSI
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21/30416037 DC:2021
BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 3. instruments for professional use
8/11/2021 - PDF - English - BSI
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21/30416041 DC:2021
BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 4. reagents for self-testing
8/11/2021 - PDF - English - BSI
Learn More€24.00 -
21/30416045 DC:2021
BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 5. instruments for self-testing
8/11/2021 - PDF - English - BSI
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DIN EN ISO 23118:2021-08
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021), German version EN ISO 23118:2021
8/1/2021 - PDF - German - DIN
Learn More€92.62 -
ASTM F3515-21
Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications
8/1/2021 - PDF - English - ASTM
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ASTM F3515-21 + Redline
Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications
8/1/2021 - PDF - English - ASTM
Learn More€61.00 -
DIN EN ISO 10993-12:2021-08
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021), German version EN ISO 10993-12:2021
8/1/2021 - PDF - German - DIN
Learn More€99.35 -
DIN EN ISO 22442-1:2021-08
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020), German version EN ISO 22442-1:2020.
8/1/2021 - PDF - German - DIN
Learn More€115.33 -
DIN 58932-6:2021-08
Haematology - Determination of the concentration of blood corpuscles in blood - Part 6: Reference method for the determination of the concentration of CD4 positive lymphocytes, Text in German and English
8/1/2021 - PDF - English, German - DIN
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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
Learn More€121.00 -
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
Learn More€121.00 -
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
Learn More€121.00 -
BS EN ISO 20166-4:2021
Molecular in vitro diagnostic examinations. Specifications for preexamination processes formalin-fixed and paraffin-embedded (FFPE) tissue In situ detection techniques
7/28/2021 - PDF - English - BSI
Learn More€293.00 -
PD ISO/TR 21582:2021
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
7/28/2021 - PDF - English - BSI
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€293.00
-
NBN EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/16/2021 - PDF - French - NBN
Learn More€142.00 -
NBN EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/16/2021 - PDF - German - NBN
Learn More€142.00 -
NBN EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/16/2021 - PDF - English - NBN
Learn More€142.00 -
NF EN ISO 23162, S92-083 (07/2021)
Basic semen examination - Specification and test methods
7/1/2021 - Paper - French - AFNOR
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NF EN ISO 20166-4, S92-071-4 (07/2021)
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4 : In situ detection techniques
7/1/2021 - Paper - French - AFNOR
Learn More€86.67 -
BS EN ISO 10993-12:2021
Biological evaluation of medical devices Sample preparation and reference materials
6/21/2021 - PDF - English - BSI
Learn More€293.00 -
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
Learn More€121.00 -
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
Learn More€121.00 -
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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BS EN IEC 61326-2-6:2021
Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical
6/8/2021 - PDF - English - BSI
Learn More€180.00 -
BS EN ISO 23118:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
6/7/2021 - PDF - English - BSI
Learn More€250.00 -
BS 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
6/7/2021 - PDF - English - BSI
Learn More€348.00 -
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 - 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
Learn More€184.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
BS EN ISO 20184-3:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated DNA
6/1/2021 - PDF - English - BSI
Learn More€250.00 -
NF EN ISO 17511, S92-021 (06/2021)
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
6/1/2021 - Paper - French - AFNOR
Learn More€130.50 -
NF EN IEC 61326-2-6, C46-050-2-6 (06/2021)
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment
6/1/2021 - Paper - French - AFNOR
Learn More€88.33 -
NF EN ISO 23118, S62-084 (06/2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour l'analyse du métabolome dans l'urine et le sang veineux (sérum et plasma).
6/1/2021 - Paper - French - AFNOR
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PR NF EN ISO 20916, S92-082PR (06/2021)
Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
6/1/2021 - Paper - English, French - AFNOR
Learn More€148.00 -
NF EN ISO 10993-12, S99-501-12 (06/2021)
Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials - Évaluation biologique des dispositifs médicaux - Partie 12 : Préparation des échantillons et matériaux de référence
6/1/2021 - Paper - French - AFNOR
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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
Learn More€89.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
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
Learn More€121.00 -
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
Learn More€121.00 -
PD CEN/TS 17626:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
5/10/2021 - PDF - English - BSI
Learn More€293.00 -
CEN/TS 17626:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
5/8/2021 - PDF - 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
Learn More€163.00 -
ASTM D7372-21
Standard Guide for Analysis and Interpretation of Proficiency Test Program Results
5/1/2021 - PDF - English - ASTM
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ASTM D7372-21 + Redline
Standard Guide for Analysis and Interpretation of Proficiency Test Program Results
5/1/2021 - PDF - English - ASTM
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NF EN ISO 20184-3, S92-070-3 (05/2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3 : isolated DNA
5/1/2021 - Paper - French - AFNOR
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DIN EN ISO 20916:2021-05
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019), German and English version prEN ISO 20916:2021
5/1/2021 - PDF - English, German - DIN
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DIN EN ISO 10993-1:2021-05
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10), German version EN ISO 10993-1:2020
5/1/2021 - PDF - German - DIN
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DIN EN ISO 14155:2021-05
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020), German version EN ISO 14155:2020
5/1/2021 - PDF - German - DIN
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BS EN ISO 10993-23:2021
Biological evaluation of medical devices Tests for irritation
4/9/2021 - PDF - English - BSI
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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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DIN EN ISO 22442-2:2021-04
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020), German version EN ISO 22442-2:2020
4/1/2021 - PDF - German - DIN
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NF EN ISO 10993-23, S99-501-23 (03/2021)
Biological evaluation of medical devices - Part 23 : tests for irritation - Évaluation biologique des dispositifs médicaux - Partie 23 : Essais d'irritation
3/1/2021 - Paper - French - AFNOR
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UNE-EN ISO 20776-1:2021
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)
2/10/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 20776-1:2021
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)
2/10/2021 - PDF - English - AENOR
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BS ISO 17822:2020
In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide
1/29/2021 - PDF - English - BSI
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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
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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 - German - 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 - 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
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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 - 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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UNE-EN ISO 10993-18:2021
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
1/20/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 10993-18:2021
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
1/20/2021 - PDF - English - AENOR
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BS EN ISO 10993-1:2020 + Redline
Tracked Changes. Biological evaluation of medical devices Evaluation and testing within a risk management process
12/21/2020 - PDF - English - BSI
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BS EN ISO 10993-1:2020
Biological evaluation of medical devices Evaluation and testing within a risk management process
12/16/2020 - PDF - English - BSI
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BS EN ISO 22442-1:2020
Medical devices utilizing animal tissues and their derivatives Application of risk management
12/14/2020 - PDF - English - BSI
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BS EN ISO 22442-2:2020
Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling
12/14/2020 - PDF - English - BSI
Learn More€250.00 -
NF ISO 21151, S92-080 (12/2020)
In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples - Dispositifs médicaux de diagnostic in vitro - Mesurage de quantités dans les échantillons d'origine biologique - Exigences relatives aux protocoles d'harmonisation internationaux établissant la traçabilité métrologique des valeurs affectées aux étalons et aux échantillons humains
12/1/2020 - Paper - French - AFNOR
Learn More€86.67 -
DIN EN ISO 20776-1:2020-12
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), German version EN ISO 20776-1:2020
12/1/2020 - PDF - German - DIN
Learn More€85.79 -
NF EN ISO 10993-1, S99-501-1 (12/2020)
Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management process - Évaluation biologique des dispositifs médicaux - Partie 1 : Évaluation et essais au sein d'un processus de gestion du risque
12/1/2020 - Paper - French - AFNOR
Learn More€108.33 -
NF EN ISO 22442-1, S97-601-1 (12/2020)
Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management
12/1/2020 - Paper - French - AFNOR
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NF EN ISO 22442-2, S97-601-2 (12/2020)
Medical devices utilizing animal tissues and their derivatives - Part 2 : controls on sourcing, collection and handling
12/1/2020 - Paper - French - AFNOR
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ASTM F2212-20
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
12/1/2020 - PDF - English - ASTM
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ASTM F2212-20 + Redline
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
12/1/2020 - PDF - English - ASTM
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BS EN ISO 14155:2020
Clinical investigation of medical devices for human subjects. Good clinical practice
11/26/2020 - PDF - English - BSI
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BS ISO 15190:2020 + Redline
Tracked Changes. Medical laboratories. Requirements for safety
11/12/2020 - PDF - English - BSI
Learn More€492.00 -
UNE-EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
10/21/2020 - PDF - Spanish - AENOR
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UNE-EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
10/21/2020 - PDF - English - AENOR
Learn More€158.40 -
UNE-EN ISO 20186-3:2020
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)
9/23/2020 - PDF - Spanish - AENOR
Learn More€71.00 -
UNE-EN ISO 20186-3:2020
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)
9/23/2020 - PDF - English - AENOR
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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
Learn More€205.00 -
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
Learn More€205.00 -
DIN EN ISO 22367:2020-09
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020), German version EN ISO 22367:2020
9/1/2020 - PDF - German - DIN
Learn More€201.96 -
ASTM E1843-20
Standard Guide for Sexual Violence Investigation, Examination, and Evidence Collection Protocol
9/1/2020 - PDF - English - ASTM
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ASTM E1843-20 + Redline
Standard Guide for Sexual Violence Investigation, Examination, and Evidence Collection Protocol
9/1/2020 - PDF - English - ASTM
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BS ISO 21474-1:2020
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements acid quality evaluation
8/24/2020 - PDF - English - BSI
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NF EN ISO 14155, S99-201 (08/2020)
Clinical investigation of medical devices for human subjects - Good clinical practice - Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques
8/1/2020 - Paper - French - AFNOR
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ASTM F619-20
Standard Practice for Extraction of Materials Used in Medical Devices
8/1/2020 - PDF - English - ASTM
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ASTM F619-20 + Redline
Standard Practice for Extraction of Materials Used in Medical Devices
8/1/2020 - PDF - English - ASTM
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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
Learn More€121.00 -
BS EN ISO 20776-1:2020
Susceptibility testing of infectious agents and evaluation performance antimicrobial susceptibility test devices Broth micro-dilution reference method for the in vitro activity against rapidly growing aerobic bacteria involved diseases
7/7/2020 - PDF - English - BSI
Learn More€250.00 -
NF EN ISO 20776-1, S92-053-1 (07/2020)
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 - Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 1 : Méthode de référence de microdilution en bouillon pour la détermination de la sensibilité in vitro aux agents antimicrobiens des bactéries aérobies à croissance rapide
7/1/2020 - Paper - French - AFNOR
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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
Learn More€184.00 -
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
Learn More€184.00 -
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
Learn More€184.00 -
BS ISO 21151:2020
In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
5/27/2020 - PDF - English - BSI
Learn More€250.00 -
BS EN ISO 22367:2020
Medical laboratories. Application of risk management to medical laboratories
5/6/2020 - PDF - English - BSI
Learn More€377.00 -
DIN CEN/TS 17390-1:2020-05
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA, German version CEN/TS 17390-1:2020
5/1/2020 - PDF - German - DIN
Learn More€73.93 -
DIN CEN/TS 17390-3:2020-05
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, German version CEN/TS 17390-3:2020
5/1/2020 - PDF - German - DIN
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DIN CEN/TS 17390-2:2020-05
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA, German version CEN/TS 17390-2:2020
5/1/2020 - PDF - German - DIN
Learn More€79.63 -
NF EN ISO 10993-18, S99-501-18 (05/2020)
Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
5/1/2020 - Paper - French - AFNOR
Learn More€144.67 -
NBN EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
4/29/2020 - PDF - French - NBN
Learn More€205.00 -
NBN EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
4/29/2020 - PDF - English - NBN
Learn More€205.00 -
ASTM F2944-20
Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
4/1/2020 - PDF - English - ASTM
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ASTM F2944-20 + Redline
Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
4/1/2020 - PDF - English - ASTM
Learn More€65.00 -
DIN EN ISO 20186-3:2020-04
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), German version EN ISO 20186-3:2019
4/1/2020 - PDF - German - DIN
Learn More€85.79 -
DIN 58903:2020-04
Haemostaseology - Deficient plasma - Requirements, preparation, Text in German and English
4/1/2020 - PDF - English, German - DIN
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DIN 58909-1:2020-04
Haemostaseology - Determination of factor VIII coagulant activity (FVIII:C) - Part 1: Reference measurement procedure for the one-stage method, Text in German and English
4/1/2020 - PDF - English, German - DIN
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DIN 58909-2:2020-04
Haemostaseology - Determination of factor VIII coagulant activity (FVIII:C) - Part 2: Reference measurement procedure using a synthetic peptide substrate, Text in German and English
4/1/2020 - PDF - English, German - DIN
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ASTM F719-20e1
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
4/1/2020 - PDF - English - ASTM
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ASTM F719-20e1 + Redline
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
4/1/2020 - PDF - English - ASTM
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BS EN ISO 10993-16:2017
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
3/30/2020 - PDF - English - BSI
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PD ISO/TS 10993-19:2020
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization materials
3/16/2020 - PDF - English - BSI
Learn More€250.00 -
€377.00
-
NF EN ISO 22367, S92-081 (03/2020)
Medical laboratories - Application of risk management to medical laboratories
3/1/2020 - Paper - French - AFNOR
Learn More€154.50 -
NF EN ISO 21043-2, X50-906 (03/2020)
Forensic sciences - Part 2 : recognition, recording, collecting, transport and storage of items
3/1/2020 - Paper - French - AFNOR
Learn More€75.50 -
BS EN ISO 15195:2019 + Redline
Tracked Changes. Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
2/28/2020 - PDF - English - BSI
Learn More€235.00 -
NBN ISO 35001:2020
Biorisk management for laboratories and other related organisations
2/27/2020 - PDF - French - NBN
Learn More€121.00 -
NBN ISO 35001:2020
Biorisk management for laboratories and other related organisations
2/27/2020 - PDF - English - NBN
Learn More€121.00 -
PD ISO/TR 15499:2016 + Redline
Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
2/26/2020 - PDF - English - BSI
Learn More€326.00