Hazards in medical areas - Risks of detectable surface changes on invasive medical devices - Measures for risk control.

Norma vydaná dňa 1.10.2019

Biomaterials in medicine - Classification, requirements, and applications.

Norma vydaná dňa 1.5.2018

Medical device software - Medical SPICE - Process assessment model.

Norma vydaná dňa 1.1.2026

Medical device software - Medical SPICE - Qualification of developers and assessors.

Norma vydaná dňa 1.3.2023

Medical device software - Medical SPICE - Recommendations for software development.

Norma vydaná dňa 1.11.2024

Systematical development for a model-based testing of medical devices - Fundamentals.

Norma vydaná dňa 1.12.2021

Digital process chains in industrial medical technology - Production of custom-made devices.

Norma vydaná dňa 1.11.2022

Management of hygienically relevant surfaces in medical facilities - Classification and design of hygienically relevant surfaces - Classification.

Norma vydaná dňa 1.5.2024

Management of hygienically relevant surfaces in medical facilities - Classification and design of hygienically relevant surfaces - Design notes for different risk classes.

Norma vydaná dňa 1.5.2024

Retesting of active medical devices in medical use - Testing principles.

Norma vydaná dňa 1.2.2023