Medical device software Validation of for medical quality systems
€404.00
Medical electrical equipment Guidance and interpretation. for writers of particular standards when creating alarm system-related requirements
€269.00
Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
€259.00
Dispositifs à courte portée (SRD);Implants médicaux actifs de puissance ultra basse de type membrane (ULP-AMI-M) et périphériques (ULP-AMI-M-P) fonctionnant dans la plage de fréquences de 30 MHz à 37,5 MHz;Norme harmonisée couvrant les exigences essentielles de l'article 3, paragraphe 2, de la Directive 2014/53/UE (V2.1.6)
€125.00
Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
€176.00
Medical electrical equipment Guidance and interpretation. medical systems employing a degree of autonomy
ISO 13485:2016 - Medical devices - A practical guide
€121.00
Medical device software Part 2: Validation of software for medical device quality systems
€261.00
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
€250.00
Short range devices (SRD) - Ultra low power active medical membrane implants (ULP-AMI-M) and peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 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 puissance ultra-basse de type membrane (ULP-AMI-M) et périphériques (ULP-AMI-M-P) fonctionnant dans la plage de fréquences de 30 MHz à 37,5 MHz;Norme européenne (EN) harmonisée couvrant les exigences essentielles de l'article 3,
€106.00
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
€231.00
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
€418.00
Use and maintenance of medical devices - Risk management système for risks associated with the use of medical devices
€141.33
Application of risk management for it-networks incorporating medical devices guidance. Guidance use security assurance cases to demonstrate confidence in IEC TR 80001-2-2 capabilities
€316.00
Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic disturbances - Requirements and tests - Appareils électromédicaux
€237.33
