11.100.20 : Biological evaluation of medical devices
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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
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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
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PR NF EN ISO 10993-4/A1, S99-501-4/A1PR (04/2024)
Évaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang - Amendement 1
4/1/2024 - Paper - English, French - AFNOR
Learn More€64.50 -
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 -
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
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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
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XP S99-223 (12/2023)
Dispositifs médicaux - Gestion du rapport bénéfice/risque
12/1/2023 - Paper - French - AFNOR
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NBN EN ISO 10993-17:2023
Évaluation biologique des dispositifs médicaux - Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux (ISO 10993-17:2023)
11/23/2023 - PDF - French - NBN
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NBN EN ISO 10993-17:2023
Biologische Beurteilung von Medizinprodukten - Teil 17: Toxikologische Risikobewertung von Medizinproduktbestandteilen (ISO 10993-17:2023)
11/23/2023 - PDF - German - NBN
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BS EN ISO 10993-17:2023
Biological evaluation of medical devices Toxicological risk assessment device constituents
11/23/2023 - PDF - English - BSI
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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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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
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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
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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
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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
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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 - English - AENOR
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ASTM E3060-23
Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
10/1/2023 - PDF - English - ASTM
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ASTM E3060-23 + Redline
Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
10/1/2023 - PDF - English - ASTM
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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 -
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
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NBN EN ISO 10993-18:2020/A1:2023
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems - Änderung 1: Bestimmung des Unsicherheitsfaktors (ISO 10993-18:2020/Amd 1:2022)
7/26/2023 - PDF - German - NBN
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NBN EN ISO 10993-18:2020/A1:2023
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
7/26/2023 - PDF - English - NBN
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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
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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
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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 -
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
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NBN EN ISO 10993-15:2023
Évaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages (ISO 10993-15:2019)
5/24/2023 - PDF - French - NBN
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NBN EN ISO 10993-15:2023
Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2019)
5/24/2023 - PDF - German - NBN
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NBN EN ISO 10993-15:2023
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
5/24/2023 - PDF - English - NBN
Learn More€89.00 -
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
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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
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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
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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
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PD ISO/TR 10993-55:2023
Biological evaluation of medical devices Interlaboratory study on cytotoxicity
2/20/2023 - PDF - English - BSI
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BS EN ISO 10993-10:2023 + Redline
Tracked changes. Biological evaluation of medical devices Tests for skin sensitization
2/17/2023 - PDF - English - BSI
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BS EN ISO 10993-10:2023
Biological evaluation of medical devices Tests for skin sensitization
2/8/2023 - PDF - English - BSI
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NBN EN ISO 10993-10:2023
Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation cutanée (ISO 10993-10:2021)
2/8/2023 - PDF - French - NBN
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NBN EN ISO 10993-10:2023
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Hautsensibilisierung (ISO 10993-10:2021)
2/8/2023 - PDF - German - NBN
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NBN EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
2/8/2023 - PDF - English - NBN
Learn More€163.00 -
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
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BS EN ISO 10993-2:2022
Biological evaluation of medical devices Animal welfare requirements
11/30/2022 - PDF - English - BSI
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NBN EN ISO 10993-2:2022
Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives à la protection des animaux (ISO 10993-2:2022)
11/24/2022 - PDF - French - NBN
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NBN EN ISO 10993-2:2022
Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:2022)
11/24/2022 - PDF - German - NBN
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NBN EN ISO 10993-2:2022
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
11/24/2022 - PDF - English - NBN
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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
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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
Learn More€71.00 -
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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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
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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 - English - AENOR
Learn More€62.40 -
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
Learn More€326.00 -
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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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
Learn More€68.00 -
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
Learn More€81.60 -
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
Learn More€250.00 -
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
Learn More€492.00 -
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 -
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
Learn More€454.00 -
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 -
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 -
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 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
Learn More€85.00 -
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 - English - AENOR
Learn More€102.00 -
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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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
Learn More€43.50 -
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
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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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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
Learn More€24.00 -
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
Learn More€382.00 -
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
Learn More€126.00 -
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
Learn More€151.20 -
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
Learn More€122.40 -
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
Learn More€58.00 -
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
Learn More€58.00 -
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
Learn More€174.39 -
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
Learn More€165.60 -
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 -
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
Learn More€24.00 -
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
Learn More€51.00 -
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 -
PD ISO/TR 21582:2021
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
7/28/2021 - PDF - English - BSI
Learn More€250.00 -
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
Learn More€121.00 -
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
Learn More€86.67 -
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
Learn More€131.96 -
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
Learn More€201.96 -
BS EN ISO 10993-23:2021
Biological evaluation of medical devices Tests for irritation
4/9/2021 - PDF - English - BSI
Learn More€377.00 -
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
Learn More€184.00 -
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
Learn More€184.00 -
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
Learn More€184.00 -
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
Learn More€92.62 -
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
Learn More€144.67 -
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
Learn More€74.00 -
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
Learn More€88.80 -
NBN EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/27/2021 - PDF - French - NBN
Learn More€89.00 -
NBN EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/27/2021 - PDF - German - NBN
Learn More€89.00 -
NBN EN ISO 22442-2:2021
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
1/27/2021 - PDF - English - NBN
Learn More€89.00 -
NBN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
1/27/2021 - PDF - French - NBN
Learn More€163.00 -
NBN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
1/27/2021 - PDF - German - NBN
Learn More€163.00 -
NBN EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
1/27/2021 - PDF - English - NBN
Learn More€163.00 -
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
Learn More€121.00 -
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
Learn More€121.00 -
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
Learn More€121.00 -
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
Learn More€129.00 -
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
Learn More€154.80 -
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
Learn More€432.00 -
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
Learn More€331.00 -
BS EN ISO 22442-1:2020
Medical devices utilizing animal tissues and their derivatives Application of risk management
12/14/2020 - PDF - English - BSI
Learn More€293.00 -
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 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
Learn More€86.67 -
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
Learn More€75.67 -
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 -
BS EN ISO 14155:2020
Clinical investigation of medical devices for human subjects. Good clinical practice
11/26/2020 - PDF - English - BSI
Learn More€377.00 -
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
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 - English - NBN
Learn More€205.00 -
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
Learn More€154.67 -
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
Learn More€75.67 -
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 -
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 -
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
Learn More€250.00 -
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 -
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 -
BS EN ISO 10993-6:2016 + Redline
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
2/24/2020 - PDF - English - BSI
Learn More€432.00 -
€121.96
-
DIN EN ISO 7405:2019-03
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12), German version EN ISO 7405:2018
3/1/2019 - PDF - German - DIN
Learn More€126.26 -
PD ISO/TS 21726:2019
Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
2/5/2019 - PDF - English - BSI
Learn More€180.00 -
UNE-EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
12/26/2018 - PDF - Spanish - AENOR
Learn More€90.00 -
UNE-EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
12/26/2018 - PDF - English - AENOR
Learn More€108.00 -
ASTM E2805-18
Standard Practice for Measurement of the Biological Activity of Ricin
12/1/2018 - PDF - English - ASTM
Learn More€57.00 -
ASTM E2805-18 + Redline
Standard Practice for Measurement of the Biological Activity of Ricin
12/1/2018 - PDF - English - ASTM
Learn More€68.00 -
BS EN ISO 7405:2018
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
11/28/2018 - PDF - English - BSI
Learn More€348.00 -
NF EN ISO 7405, S91-224 (11/2018)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
11/1/2018 - Paper - French - AFNOR
Learn More€115.12 -
DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
9/1/2018 - PDF - English - DIN
Learn More€150.93 -
DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017), German version EN ISO 10993-11:2018
9/1/2018 - PDF - German - DIN
Learn More€120.84 -
ISO 10993-1:2018
Biological evaluation of medical devices
Part 1: Evaluation and testing within a risk management process
8/17/2018 - Paper - French - ISO
Learn More€199.00 -
NF EN ISO 10993-4, S99-501-4 (07/2018)
Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood - Evaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang
7/1/2018 - Paper - French - AFNOR
Learn More€144.50 -
NBN EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
6/20/2018 - PDF - English - NBN
Learn More€142.00 -
NBN EN ISO 10993-11:2018
Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:2017)
6/20/2018 - PDF - French - NBN
Learn More€142.00 -
NBN EN ISO 10993-11:2018
Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2017)
6/20/2018 - PDF - German - NBN
Learn More€142.00 -
UNE-EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
5/16/2018 - PDF - Spanish - AENOR
Learn More€70.00 -
UNE-EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
5/16/2018 - PDF - English - AENOR
Learn More€84.00 -
VDI 5701:2018-05
Biomaterials in medicine - Classification, requirements, and applications
5/1/2018 - PDF - English, German - VDI
Learn More€176.13 -
NF EN ISO 10993-11, S99-501-11 (05/2018)
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
5/1/2018 - Paper - French - AFNOR
Learn More€99.33 -
CWA 17253-2:2018
Joint implants - Part 2: Tiered toolkit approach to evaluate the biological impact of wear particles from joint replacements and related devices
3/30/2018 - PDF - English - NBN
Learn More€163.00 -
DIN EN ISO 10993-16:2018-02
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
2/1/2018 - PDF - English - DIN
Learn More€107.48 -
DIN EN ISO 10993-16:2018-02
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017), German version EN ISO 10993-16:2017
2/1/2018 - PDF - German - DIN
Learn More€85.79 -
NBN EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
1/30/2018 - PDF - French - NBN
Learn More€89.00 -
NBN EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
1/30/2018 - PDF - German - NBN
Learn More€89.00 -
NBN EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
1/30/2018 - PDF - English - NBN
Learn More€89.00 -
UNE-EN ISO 10993-4:2018
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
1/24/2018 - PDF - Spanish - AENOR
Learn More€131.00 -
UNE-EN ISO 10993-4:2018
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
1/24/2018 - PDF - English - AENOR
Learn More€157.20 -
DIN EN ISO 10993-4:2017-12
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
12/1/2017 - PDF - English - DIN
Learn More€230.75 -
DIN EN ISO 10993-4:2017-12
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017), German version EN ISO 10993-4:2017
12/1/2017 - PDF - German - DIN
Learn More€184.58 -
NF EN ISO 10993-16, S99-501-16 (12/2017)
Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
12/1/2017 - Paper - French - AFNOR
Learn More€75.50 -
NBN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
11/22/2017 - PDF - French - NBN
Learn More€184.00 -
NBN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
11/22/2017 - PDF - German - NBN
Learn More€184.00 -
NBN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
11/22/2017 - PDF - English - NBN
Learn More€184.00 -
UNE-EN ISO 10993-6:2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
10/25/2017 - PDF - Spanish - AENOR
Learn More€88.00 -
UNE-EN ISO 10993-6:2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
10/25/2017 - PDF - English - AENOR
Learn More€105.60 -
ISO 10993-11:2017
Biological evaluation of medical devices
Part 11: Tests for systemic toxicity
9/14/2017 - Paper - French - ISO
Learn More€174.00 -
DIN EN ISO 10993-6:2017-09
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
9/1/2017 - PDF - English - DIN
Learn More€144.02 -
DIN EN ISO 10993-6:2017-09
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016), German version EN ISO 10993-6:2016
9/1/2017 - PDF - German - DIN
Learn More€115.33 -
FD ISO/TR 10993-22, S99-501-22 (08/2017)
Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
8/1/2017 - Paper - French - AFNOR
Learn More€144.67 -
PD ISO/TR 10993-22:2017
Biological evaluation of medical devices Guidance on nanomaterials
7/19/2017 - PDF - English - BSI
Learn More€377.00 -
ISO/TR 10993-22:2017
Biological evaluation of medical devices
Part 22: Guidance on nanomaterials
7/14/2017 - Paper - French - ISO
Learn More€223.00 -
BS EN ISO 10993-4:2017
Biological evaluation of medical devices Selection tests for interactions with blood
5/25/2017 - PDF - English - BSI
Learn More€377.00