Standards on Health
(1 sub sectors)
European standards and International standards for healthcare, health services, medical devices, medical equipment, medicines, pharma, pharmaceuticals, in-vitro diagnostic, in vitro, active medical devices
(1 sub sectors)
European standards and International standards for healthcare, health services, medical devices, medical equipment, medicines, pharma, pharmaceuticals, in-vitro diagnostic, in vitro, active medical devices
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
99.60 Withdrawal effective
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
99.60 Withdrawal effective
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
99.60 Withdrawal effective
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
99.60 Withdrawal effective
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
99.60 Withdrawal effective
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
99.60 Withdrawal effective
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
60.60 Standard published
Medical laboratories - Requirements for quality and competence
60.60 Standard published
Medical devices — Quality management systems — Requirements for regulatory purposes
90.20 Standard under periodical review
Medical laboratories — Requirements for quality and competence
60.60 Standard published
European and International standards on medical devices, medical equipment and healthcare. The European Committee for Standardization (CEN) and the European Committee for Electrotechnical standardization (CENELEC) have developed a complete set of standards in support of the Medical Devices Regulation and the In Vitro Diagnostic Regulation (EU) 2017/426 (IVDR).
Most of these European standards are adoptions of the International standards for medical devices developed by the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC). These standards cover a wide range of topics, from Quality management systems for Medical Devices, Medical Equipment , Health Care Services, Biotechnology, Medical Informatics, medical device software, Health IT, or Ageing or disabilities.