11.100 : Laboratory medicine
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DIN EN ISO 10993-4/A1:2024-04
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024), German and English version EN ISO 10993-4:2017/prA1:2024
4/1/2024 - PDF - English, German - DIN
Learn More€59.63 -
DIN EN ISO 7405:2024-04
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024), German and English version prEN ISO 7405:2024
4/1/2024 - PDF - English, German - DIN
Learn More€163.74 -
DIN 58987:2024-04
Haemostaseology - Reference method for the Von Willebrand Factor antigen, Text in German and English
4/1/2024 - PDF - English, German - DIN
Learn More€59.63 -
DIN 58988:2024-04
Haemostaseology - Reference method for the Von Willebrand Factor multimers, Text in German and English
4/1/2024 - PDF - English, German - DIN
Learn More€52.90 -
24/30472744 DC:2024
BS ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
3/18/2024 - PDF - English - BSI
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BS ISO 35001:2019+A1:2024
Biorisk management for laboratories and other related organisations
3/11/2024 - PDF - English - BSI
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BS EN ISO 20916:2024
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
3/7/2024 - PDF - English - BSI
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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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DIN EN ISO 15194:2024-02
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023), German and English version prEN ISO 15194:2023
2/1/2024 - PDF - English, German - DIN
Learn More€104.95 -
DIN EN ISO 15193:2024-02
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023), German and English version prEN ISO 15193:2023
2/1/2024 - PDF - English, German - DIN
Learn More€110.00 -
DIN EN ISO 5649:2024-02
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023), German and English version prEN ISO 5649:2023
2/1/2024 - PDF - English, German - DIN
Learn More€120.84 -
PR NF EN ISO 5649, S92-088PR (02/2024)
Laboratoires médicaux - Concepts et spécifications relatifs à la conception, au développement, à la mise en œuvre et à l'utilisation des tests développés en laboratoire
2/1/2024 - Paper - English, French - AFNOR
Learn More€115.50 -
PR NF EN ISO 15194, S92-020PR (02/2024)
Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée
2/1/2024 - Paper - English, French - AFNOR
Learn More€97.50 -
PR NF EN ISO 15193, S92-019PR (02/2024)
Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux procédures de mesure de référence
2/1/2024 - Paper - English, French - AFNOR
Learn More€107.50 -
DIN EN ISO 10993-17:2024-02
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023), German version EN ISO 10993-17:2023
2/1/2024 - PDF - German - DIN
Learn More€169.25 -
DIN 58932-3:2024-02
Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrocytes, Text in German and English
2/1/2024 - PDF - English, German - DIN
Learn More€99.35 -
UNE-EN ISO 10993-15:2024
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
1/17/2024 - PDF - Spanish - AENOR
Learn More€74.00 -
UNE-EN ISO 10993-15:2024
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
1/17/2024 - PDF - English - AENOR
Learn More€88.80 -
NF EN ISO 11979-7, S94-750-7 (01/2024)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7 : investigations cliniques de lentilles intraoculaires pour la correction de l'aphakie
1/1/2024 - Paper - French - AFNOR
Learn More€130.67 -
24/30463717 DC:2023
BS EN ISO 15193 In vitro diagnostic medical devices - Requirements for reference measurement procedures
12/26/2023 - PDF - English - BSI
Learn More€24.00 -
24/30463721 DC:2023
BS EN ISO 15194 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation
12/26/2023 - PDF - English - BSI
Learn More€24.00 -
24/30449670 DC:2023
BS EN ISO 5649 Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
12/25/2023 - PDF - English - BSI
Learn More€24.00 -
BS EN ISO 10993-17:2023 + Redline
Tracked Changes. Biological evaluation of medical devices Toxicological risk assessment device constituents
12/20/2023 - PDF - English - BSI
Learn More€490.00 -
BS EN ISO 15189:2022+A11:2023
Medical laboratories. Requirements for quality and competence
12/6/2023 - PDF - English - BSI
Learn More€377.00 -
PD CEN/TS 17981-1:2023
In vitro diagnostic Next Generation Sequencing (NGS) workflows Human DNA examination
12/4/2023 - PDF - English - BSI
Learn More€348.00 -
PD CEN/TS 17981-2:2023
In vitro diagnostic Next Generation Sequencing (NGS) workflows Human RNA examination
12/4/2023 - PDF - English - BSI
Learn More€348.00 -
XP S99-223 (12/2023)
Dispositifs médicaux - Gestion du rapport bénéfice/risque
12/1/2023 - Paper - French - AFNOR
Learn More€118.00 -
CEN/TS 17981-2:2023
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination
11/30/2023 - PDF - English - NBN
Learn More€184.00 -
CEN/TS 17981-1:2023
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
11/30/2023 - PDF - English - NBN
Learn More€184.00 -
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
Learn More€184.00 -
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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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
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 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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BS EN ISO 10993-17:2023
Biological evaluation of medical devices Toxicological risk assessment device constituents
11/23/2023 - PDF - English - BSI
Learn More€377.00 -
NBN EN ISO 15189:2022/A11:2023
Medical laboratories - Requirements for quality and competence
11/15/2023 - PDF - English - NBN
Learn More€20.00 -
NBN EN ISO 15189:2022/A11:2023
Laboratoires médicaux - Exigences concernant la qualité et la compétence
11/15/2023 - PDF - French - NBN
Learn More€20.00 -
€20.00
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NF EN ISO 15189/A11, S92-060/A11 (11/2023)
Laboratoires médicaux - Exigences concernant la qualité et la compétence
11/1/2023 - Paper - French - AFNOR
Learn More€25.67 -
NF EN ISO 10993-17, S99-501-17 (11/2023)
Évaluation biologique des dispositifs médicaux - Partie 17 : évaluation des risques toxicologiques des constituants des dispositifs médicaux
11/1/2023 - Paper - French - AFNOR
Learn More€144.50 -
NF EN 455-3, S97-001-3 (11/2023)
Gants médicaux non réutilisables - Partie 3 : exigences et essais pour évaluation biologique
11/1/2023 - Paper - French - AFNOR
Learn More€108.33 -
DIN EN ISO 10993-18:2023-11
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022), German version EN ISO 10993-18:2020 + A1:2023
11/1/2023 - PDF - German - DIN
Learn More€179.72 -
23/30449561 DC:2023
BS ISO 21474-3. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Part 3. Interpretation and reports
10/30/2023 - PDF - English - BSI
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UNE-EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
10/18/2023 - PDF - Spanish - AENOR
Learn More€112.00 -
UNE-EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
10/18/2023 - PDF - English - AENOR
Learn More€134.40 -
ASTM E3060-23
Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
10/1/2023 - PDF - English - ASTM
Learn More€66.00 -
ASTM E3060-23 + Redline
Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
10/1/2023 - PDF - English - ASTM
Learn More€79.00 -
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
Learn More€163.00 -
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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23/30478370 DC:2023
BS EN 18000-2 Animal health diagnostic analyses. Control of in-vitro reagents Part 2. Reagents for immunological techniques
9/21/2023 - PDF - English - BSI
Learn More€24.00 -
PD ISO/TS 11796:2023
Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
8/2/2023 - PDF - English - BSI
Learn More€293.00 -
DIN 58932-1:2023-08
Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, influence quantities, interference factors, Text in German and English
8/1/2023 - PDF - English, German - DIN
Learn More€45.98 -
BS EN ISO 10993-18:2020+A1:2023
Biological evaluation of medical devices Chemical characterization device materials within a risk management process
7/27/2023 - PDF - English - BSI
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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
Learn More€20.00 -
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
Learn More€20.00 -
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
Learn More€20.00 -
UNE-EN ISO 10993-2:2023
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
7/12/2023 - PDF - Spanish - AENOR
Learn More€70.00 -
UNE-EN ISO 10993-2:2023
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
7/12/2023 - PDF - English - AENOR
Learn More€84.00 -
DIN EN ISO 10993-15:2023-07
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019), German version EN ISO 10993-15:2023
7/1/2023 - PDF - German - DIN
Learn More€92.62 -
NF EN ISO 10993-18/A1, S99-501-18/A1 (07/2023)
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
7/1/2023 - Paper - French - AFNOR
Learn More€31.00 -
NF ISO 20658, S92-085 (06/2023)
Exigences pour le prélèvement et le transport d'échantillons à des fins d'examens en laboratoire médical
6/1/2023 - Paper - French - AFNOR
Learn More€119.00 -
€197.00
-
ASTM F3352/F3352M-23b
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
6/1/2023 - PDF - English - ASTM
Learn More€60.00 -
ASTM F3352/F3352M-23b + Redline
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
6/1/2023 - PDF - English - ASTM
Learn More€72.00 -
BS EN ISO 10993-15:2023 + Redline
Tracked Changes. Biological evaluation of medical devices Identification and quantification degradation products from metals alloys
5/26/2023 - PDF - English - BSI
Learn More€326.00 -
BS EN ISO 10993-15:2023
Biological evaluation of medical devices Identification and quantification degradation products from metals alloys
5/24/2023 - PDF - English - BSI
Learn More€250.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
BS ISO 20658:2023
Requirements for the collection and transport of samples for medical laboratory examinations
5/22/2023 - PDF - English - BSI
Learn More€348.00 -
€151.00
-
NF EN ISO 10993-15, S99-501-15 (05/2023)
Évaluation biologique des dispositifs médicaux - Partie 15 : identification et quantification des produits de dégradation issus des métaux et alliages
5/1/2023 - Paper - French - AFNOR
Learn More€108.33 -
€48.00
-
DIN EN ISO 10993-10:2023-04
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021), German version EN ISO 10993-10:2023
4/1/2023 - PDF - German - DIN
Learn More€141.96 -
ASTM E3152-23
Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents
4/1/2023 - PDF - English - ASTM
Learn More€60.00 -
ASTM E3152-23 + Redline
Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents
4/1/2023 - PDF - English - ASTM
Learn More€72.00 -
ASTM F2808-23
Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
4/1/2023 - PDF - English - ASTM
Learn More€78.00 -
ASTM F2808-23 + Redline
Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
4/1/2023 - PDF - English - ASTM
Learn More€93.00 -
ASTM E1302-23
Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
4/1/2023 - PDF - English - ASTM
Learn More€54.00 -
ASTM E1302-23 + Redline
Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids
4/1/2023 - PDF - English - ASTM
Learn More€65.00 -
DIN CEN ISO/TS 5798:2023-03
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), German version CEN ISO/TS 5798:2022
3/1/2023 - PDF - German - DIN
Learn More€109.44 -
DIN EN ISO 15189:2023-03
Medical laboratories - Requirements for quality and competence (ISO 15189:2022), German version EN ISO 15189:2022
3/1/2023 - PDF - German - DIN
Learn More€163.74 -
XP CEN ISO/TS 5798, S92-086 (03/2023)
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
3/1/2023 - Paper - French - AFNOR
Learn More€119.00 -
DIN ISO 4802-1:2023-03
Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification (ISO/DIS 4802-1:2022), Text in German and English
3/1/2023 - PDF - English, German - DIN
Learn More€79.72 -
DIN ISO 4802-2:2023-03
Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification (ISO/DIS 4802-2:2022), Text in German and English
3/1/2023 - PDF - English, German - DIN
Learn More€79.72 -
PD ISO/TR 10993-55:2023
Biological evaluation of medical devices Interlaboratory study on cytotoxicity
2/20/2023 - PDF - English - BSI
Learn More€250.00 -
BS EN ISO 10993-10:2023 + Redline
Tracked changes. Biological evaluation of medical devices Tests for skin sensitization
2/17/2023 - PDF - English - BSI
Learn More€454.00 -
BS EN ISO 10993-10:2023
Biological evaluation of medical devices Tests for skin sensitization
2/8/2023 - PDF - English - BSI
Learn More€348.00 -
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
Learn More€163.00 -
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
Learn More€163.00 -
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
Learn More€163.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
NF EN ISO 10993-10, S99-501-10 (02/2023)
Biological evaluation of medical devices - Part 10 : Tests for skin sensitization
2/1/2023 - Paper - French - AFNOR
Learn More€119.00 -
DIN EN ISO 10993-2:2023-02
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022), German version EN ISO 10993-2:2022
2/1/2023 - PDF - German - DIN
Learn More€79.72 -
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
Learn More€184.00 -
UNE-EN ISO 15189:2023
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
1/18/2023 - PDF - Spanish - AENOR
Learn More€126.00 -
UNE-EN ISO 15189:2023
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
1/18/2023 - PDF - English - AENOR
Learn More€151.20 -
ASTM F3089-23
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
1/1/2023 - PDF - English - ASTM
Learn More€60.00 -
ASTM F3089-23 + Redline
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
1/1/2023 - PDF - English - ASTM
Learn More€72.00 -
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
Learn More€184.00 -
NBN EN ISO 15189:2022
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2022)
12/15/2022 - PDF - German - NBN
Learn More€184.00 -
NBN EN ISO 15189:2022
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
12/15/2022 - PDF - English - NBN
Learn More€184.00 -
€184.00
-
NF EN ISO 15189, S92-060 (12/2022)
Laboratoires médicaux - Exigences concernant la qualité et la compétence
12/1/2022 - Paper - French - AFNOR
Learn More€144.67 -
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
Learn More€163.00 -
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
Learn More€163.00 -
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
Learn More€163.00 -
BS EN ISO 10993-2:2022
Biological evaluation of medical devices Animal welfare requirements
11/30/2022 - PDF - English - BSI
Learn More€250.00 -
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
Learn More€89.00 -
NBN EN ISO 10993-2:2022
Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:2022)
11/24/2022 - PDF - German - NBN
Learn More€89.00 -
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
Learn More€89.00 -
NF EN IEC 61010-2-101, C42-020-2-101 (11/2022)
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 : safety requirements for in vitro diagnostic (IVD) medical equipment
11/1/2022 - Paper - French - AFNOR
Learn More€88.33 -
NF EN IEC 61010-2-101/A11, C42-020-2-101/A11 (11/2022)
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101 : Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)
11/1/2022 - Paper - French - AFNOR
Learn More€88.33 -
NF EN ISO 10993-2, S99-502 (11/2022)
Biological evaluation of medical devices - Part 2 : Animal welfare requirements
11/1/2022 - Paper - French - AFNOR
Learn More€75.67 -
UNE-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) (Endorsed by Asociación Española de Normalización in January of 2023.)
10/12/2022 - PDF - English - AENOR
Learn More€84.00 -
UNE-EN ISO 4307:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
9/21/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 4307:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
9/21/2022 - PDF - English - AENOR
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UNE-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)
9/21/2022 - PDF - Spanish - AENOR
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UNE-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)
9/21/2022 - PDF - English - AENOR
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DIN EN ISO 10993-7:2022-09
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019), German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
9/1/2022 - PDF - German - DIN
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22/30447779 DC:2022
BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples
8/3/2022 - PDF - English - BSI
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DIN CEN/TS 17747:2022-08
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins, German version CEN/TS 17747:2022
8/1/2022 - PDF - German - DIN
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DIN CEN/TS 17811:2022-08
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA, German version CEN/TS 17811:2022
8/1/2022 - PDF - German - DIN
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DIN EN ISO 24443:2022-08
Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021, Corrected version 2022-02), German version EN ISO 24443:2021
8/1/2022 - PDF - German - DIN
Learn More€126.26 -
UNE-EN ISO 23162:2022
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/27/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 23162:2022
Basic semen examination - Specification and test methods (ISO 23162:2021)
7/27/2022 - PDF - English - AENOR
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UNE-EN ISO 10993-7:2009/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)
7/27/2022 - PDF - Spanish - AENOR
Learn More€52.00 -
UNE-EN ISO 10993-7:2009/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)
7/27/2022 - PDF - English - AENOR
Learn More€62.40 -
PD CEN/TS 17811:2022
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
7/19/2022 - PDF - English - BSI
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NF ISO 21474-2, S92-084-2 (07/2022)
In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 2 : Validation and verification
7/1/2022 - Paper - French - AFNOR
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DIN CEN/TS 17688-3:2022-07
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA, German version CEN/TS 17688-3:2021
7/1/2022 - PDF - German - DIN
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DIN CEN/TS 17742:2022-07
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma, German version CEN/TS 17742:2022
7/1/2022 - PDF - German - DIN
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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
Learn More€121.00 -
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
Learn More€121.00 -
BS EN ISO 10993-9:2021 + Redline
Tracked Changes. Biological evaluation of medical devices Framework for identification and quantification potential degradation products
6/7/2022 - PDF - English - BSI
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DIN CEN/TS 17688-2:2022-06
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins, German version CEN/TS 17688-2:2021
6/1/2022 - PDF - German - DIN
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DIN CEN/TS 17688-1:2022-06
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA, German version CEN/TS 17688-1:2021
6/1/2022 - PDF - German - DIN
Learn More€92.43 -
UNE-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 (Endorsed by Asociación Española de Normalización in June of 2022.)
6/1/2022 - PDF - English - AENOR
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XP ISO/TS 10993-19, S99-501-19 (06/2022)
Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
6/1/2022 - Paper - French - AFNOR
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PD 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
5/26/2022 - PDF - English - BSI
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UNE-EN ISO 10993-9:2022
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
5/25/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 10993-9:2022
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
5/25/2022 - PDF - English - AENOR
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BS EN ISO 10993-9:2021
Biological evaluation of medical devices Framework for identification and quantification potential degradation products
5/19/2022 - PDF - English - BSI
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BS EN ISO 10993-7:2008+A1:2022 + Redline
Tracked Changes. Biological evaluation of medical devices Ethylene oxide sterilization residuals
5/19/2022 - PDF - English - BSI
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BS EN IEC 61010-2-011:2021+A11:2021
Safety requirements for electrical equipment measurement, control, and laboratory use Particular refrigerating
5/19/2022 - PDF - English - BSI
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BS ISO 21474-2:2022
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Validation and verification
5/17/2022 - PDF - English - BSI
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PD 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
5/11/2022 - PDF - English - BSI
Learn More€250.00 -
UNE-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 (Endorsed by Asociación Española de Normalización in May of 2022.)
5/1/2022 - PDF - English - AENOR
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DIN 58923:2022-05
Haemostaseology - Reference method for the ristocetin-cofactor activity of the VWF, Text in German and English
5/1/2022 - PDF - English, German - DIN
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DIN 58924:2022-05
Haemostaseology - Reference method for the determination of the collagen binding acitvity of the VWF, Text in German and English
5/1/2022 - PDF - English, German - DIN
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PD 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
4/26/2022 - PDF - English - BSI
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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
Learn More€142.00 -
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
Learn More€142.00 -
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
Learn More€121.00 -
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
Learn More€121.00 -
DIN EN ISO 20776-2:2022-04
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), German version EN ISO 20776-2:2022
4/1/2022 - PDF - German - DIN
Learn More€92.62 -
ASTM F2952-22
Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
4/1/2022 - PDF - English - ASTM
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ASTM F2952-22 + Redline
Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
4/1/2022 - PDF - English - ASTM
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ASTM F3088-22
Standard Practice for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
4/1/2022 - PDF - English - ASTM
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ASTM F3088-22 + Redline
Standard Practice for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
4/1/2022 - PDF - English - ASTM
Learn More€61.00 -
BS ISO 17593:2022 + Redline
Tracked Changes. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
3/28/2022 - PDF - English - BSI
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UNE-EN ISO 6717:2022
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
3/16/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 6717:2022
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
3/16/2022 - PDF - English - AENOR
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UNE-EN ISO 20166-4:2022
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)
3/16/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 20166-4:2022
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)
3/16/2022 - PDF - English - AENOR
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BS ISO 17593:2022
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
3/15/2022 - PDF - English - BSI
Learn More€348.00 -
€133.00
-
UNE-EN ISO 17511:2022
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
3/2/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 17511:2022
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
3/2/2022 - PDF - English - AENOR
Learn More€148.80 -
UNE-EN ISO 20184-3:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
3/2/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 20184-3:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
3/2/2022 - PDF - English - AENOR
Learn More€84.00 -
UNE-EN ISO 23118:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
3/2/2022 - PDF - Spanish - AENOR
Learn More€70.00 -
UNE-EN ISO 23118:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
3/2/2022 - PDF - English - AENOR
Learn More€84.00 -
DIN EN ISO 10993-9:2022-03
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019), German version EN ISO 10993-9:2021
3/1/2022 - PDF - German - DIN
Learn More€79.72 -
UNE-EN ISO 10993-12:2022
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
2/16/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 10993-12:2022
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
2/16/2022 - PDF - English - AENOR
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BS EN ISO 10993-11:2018
Biological evaluation of medical devices Tests for systemic toxicity
2/2/2022 - PDF - English - BSI
Learn More€331.00 -
DIN EN ISO 4307:2022-02
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021), German version EN ISO 4307:2021
2/1/2022 - PDF - German - DIN
Learn More€79.72 -
DIN EN ISO 16256:2022-02
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), German version EN ISO 16256:2021
2/1/2022 - PDF - German - DIN
Learn More€85.79 -
UNE-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 (Endorsed by Asociación Española de Normalización in February of 2022.)
2/1/2022 - PDF - English - AENOR
Learn More€76.00 -
UNE-CEN/TS 17688-2:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins (Endorsed by Asociación Española de Normalización in February of 2022.)
2/1/2022 - PDF - English - AENOR
Learn More€70.00 -
UNE-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 (Endorsed by Asociación Española de Normalización in February of 2022.)
2/1/2022 - PDF - English - AENOR
Learn More€75.00 -
BS EN ISO 20776-2:2021 + Redline
Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility devices Evaluation against reference broth micro-dilution
2/1/2022 - PDF - English - BSI
Learn More€326.00 -
BS EN ISO 23118:2021 + Redline
Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
1/27/2022 - PDF - English - BSI
Learn More€326.00 -
BS EN ISO 10993-7:2008+A1:2022
Biological evaluation of medical devices Ethylene oxide sterilization residuals
1/26/2022 - PDF - English - BSI
Learn More€377.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
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
Learn More€89.00 -
BS EN ISO 20776-2:2021
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility devices Evaluation against reference broth micro-dilution
1/21/2022 - PDF - English - BSI
Learn More€250.00 -
UNE-EN ISO 22442-1:2022
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
1/19/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 22442-1:2022
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
1/19/2022 - PDF - English - AENOR
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UNE-EN ISO 22442-2:2022
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/19/2022 - PDF - Spanish - AENOR
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UNE-EN ISO 22442-2:2022
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/19/2022 - PDF - English - AENOR
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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
Learn More€20.00 -
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
Learn More€20.00 -
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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DIN CEN/TS 17626:2022-01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA, German version CEN/TS 17626:2021
1/1/2022 - PDF - German - DIN
Learn More€92.43 -
NF EN ISO 20776-2, S92-053-2 (01/2022)
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test - Part 2 : Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution - Systèmes d'essais en laboratoire et de diagnostic in vitro - Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 2 : Évaluation des performances des dispositifs pour antibiogrammes par rapport à une méthode de référence de
1/1/2022 - Paper - French - AFNOR
Learn More€75.67