SS-EN ISO 14971:2019 — Medical devices, application of risk management
The method for risk management across the whole life cycle of a medical device: risk analysis, evaluation, reduction and follow-up of residual risk in clinical use.
Register
- Designation
- SS-EN ISO 14971:2019
- Edition
- 2019
- Publisher
- Svenska institutet för standarder (SIS)
- Group
- Product, accessibility and medical devices
- Area
- Working life and health
- Read date
- 2026-09-09
Standards are not statute. They are purchased documents from SIS that parties agree to, or that regulations refer to. We carry the designation, edition and scope, never the text.
Official text
Buy the standard from SISSS-EN ISO 14971:2019
Used together with
- Medicintekniklagen · SFS 2021:600
- Patientsäkerhetslagen · SFS 2010:659
Product, accessibility and medical devices
- Medical devices, quality management systems
SS-EN ISO 13485:2016Svenska institutet för standarder (SIS)
The quality management requirements for manufacturers and suppliers of medical devices: design, traceability, production, sterility and post-market action.
- Accessibility requirements for ICT products and services
SS-EN 301 549Svenska institutet för standarder (SIS)
The European accessibility requirements for websites, apps, documents and digital equipment. It is the harmonised basis for public sector accessibility obligations and accessibility statements.
Swedish law
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