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
€167.33
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
€75.00
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
€117.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€0.00
Medical device software - Software life-cycle processes
€128.67
Medical electrical equipment - Part 1-8 : general requirements for basic safety and essential performance - Collateral Standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
€28.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
€195.79
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
€369.00
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
€404.00
Acoustics. Reference zero for the calibration of audiometric equipment equivalent threshold sound pressure levels pure tones and supra-aural earphones
€193.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
€181.00
Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Systèmes de services de données médicales de très faible puissance (MEDS) fonctionnant dans la plage de fréquences 401 MHz à 402 MHz et 405 MHz à 406 MHz ; Norme harmonisée couvrant les exigences essentielles de l'article 3.2 de la Directive 2014/53/UE (V2.0.1)
€128.00
Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
€82.00
Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Dispositifs à courte portée (SRD) ; implants médicaux actifs de faible puissance (LP-AMI) et périphériques associés (LP-AMI-P) fonctionnant dans la plage de fréquences de 2 483,5 MHz à 2 500 MHz; Norme harmonisée couvrant les exigences essentielles de l'article 3.2 de la Directive 2014/53/UE
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
€187.00
