Healthcare
Safety and quality are non-negotiable in the medical devices industry.
Regulatory requirements for medical devices are increasingly stringent throughout every step of a product’s life cycle, including service and delivery.
The International Organization for Standardization (ISO) is an independent organization dedicated to publishing quality and risk management standards for product development in a variety of industries, including medical devices.
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Standards Library
Access the latest European Voluntary Standards. All documents are officially verified and regularly updated to reflect current regulations.
8
Standards
5
Categories
PDF
+ DOCX
Type
Name
Language
Format
NEW Healthcare, IEC
IEC 62083-2026 Vs ISO 62083-2010
Medical device software — Requirements for the safety of radiotherapy treatment planning systems
English
NEW Healthcare, ISO
ISO 8637-3 2024 Versus ISO 8637-3 2018
Extracorporeal systems for blood purification
Part 3: Plasmafilters
English
Healthcare, ISO
ISO 8637-1 2024 Versus ISO 8637-1 2017
Extracorporeal systems for blood purification
Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
English
Healthcare, ISO
ISO 7199-2024 Vs ISO 7199-2017
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
English
Healthcare, ISO
EN ISO 1135-5_2025 vs EN ISO 1135-5_2015
Transfusion sets for single use with pressure infusion apparatus
English