Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
Implants for surgery - Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (english version)
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
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (IEC 60601-1-6:2010) (english version)
Medical electrical equipment -- Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:2014) (english version)
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2007) (english version)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010) (english version)
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 (IEC 60601-1-8:2006 + A1:2012) (english version)
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)
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 (Amendment) (english version)
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 (Corrigendum) (english version)
Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013) (english version)
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014) (english version)
