- Convenant veilige toepassing medische technologie versie 2.0
- UK Medical Devices Regulation and Safety
- FDA General Principles of Software Validation.
- IMDRF juni 2013, International Medical Device Regulators Forum NEN-EN-IEC 62304/A1 Medical device software - Software life-cycle processes
- NEN-EN-ISO 14971 Medical devices - Application of risk management to medical devices.
- Medical Device Regulation (MDR)
- Handreiking Overheid
- Meddev 2.1/6, jan. 2012 Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices
- Standaard Service Overeenkomst versie 3.1
- WINT 2.0 Rapport werkgroep instroom nieuwe technologie
- Website ZBC Kennisbank Checklist opstellen SLA
Normen op het gebied van informatiebeveiliging
NEN-ISO/IEC 27001+C11+C1+C2 (nl) Informatietechnologie - Beveiligingstechnieken - Managementsystemen voor informatiebeveiliging- Eisen Information technology - Security techniques -Information security management systems - Requirements. December 2015.
NEN-ISO/IEC 27002+C1+C2 (nl) Informatietechnologie - Beveiligingstechnieken - Praktijkrichtlijn met beheersmaatregelen op het gebied van informatiebeveiliging december 2015
NEN-ISO/IEC 27005 (en) Information technology - Security techniques - Information security risk management juni 2011
NEN 7510 (nl) Medische informatica – Informatiebeveiliging in de zorg. Nederlandse norm oktober 2011.
Normen op het gebied van koppeling van medische apparatuur aan IT-Netwerken
NEN-EN-IEC 80001-1 (en) Application of risk management for IT-networksincorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010, IDT) april 2011.
NPR-IEC/TR 80001-2-8 (en) Application of risk management for IT-networksincorporating medical devices - Part 2-8: Application guidance
- Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 (IEC/TR 80001-2-8:2016, IDT) mei 2016.
NPR-IEC/TR 80001-2-1 (en) Application of risk management for IT-networks incorporating medical devices - Part 2-1: Stepby-step risk management of medical ITnetworks - Practical applications and examples(IEC/TR 80001-2-1:2012, IDT) juli 2012.
NPR-IEC/TR 80001-2-3 (en) Application of risk management for ITnetworksincorporating medical devices -
Part 2-3: Guidance for wireless networks (IEC/TR 80001-2-3:2012, IDT) juli 2012.
NPR-IEC/TR 80001-2-5 (en) Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems NPR-ISO/TR 80001-2-6 (en) Toepassing van risicomanagement voor ITnetwerken en medische hulpmiddelen - Deel 2-6: Toepassingsrichtlijn - Richtlijn voor overeenstemming over verantwoordelijkheden (ISO/TR 80001- 2-6:2014, IDT).
NPR-ISO/TR 80001-2-7 (en) Toepassing van risicomanagement voor IT -netwerken met medische hulpmiddelen - Toepassingshandleiding - Deel 2-7 : Handleiding voor zorginstellingen om zelf conformiteit metIEC 80001-1 te beoordelen.
Normen op het gebied van medische apparatuur
NEN-EN-IEC 60601 Medical electrical equipment: General requirements for basic safety and essential performance NEN-EN-IEC 60601-1-8: en. Medical electrical equipment - Part 1-8: General equirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.