ISO standards on healthcare enhance patient safety, help streamline supply chains, and foster innovation in digital health and sustainable healthcare solutions.

Insights

Healthcare cybersecurity: Diagnosing risks, prescribing solutions

Cyber-attacks can severely impact personal lives and put patients at risk of harm. That’s why cybersecurity is vital for healthcare organizations to protect patient wellbeing and privacy at all times.

Remote patient monitoring: A guide for healthcare specialists

Regular, accurate and timely information is crucial for managing health conditions and monitoring patient progress. This is true for physicians everywhere: from busy hospital wards to self-run practices.

Healthcare’s digital transformation: Telemedicine, data protection and cybersecurity

Health is what we all have in common. When it’s protected, it empowers people to prosper; but when it’s neglected, it can have devastating consequences, not just for individuals but for entire communities.

Top standards

Standard
ISO 14971:2019
Medical devices
Application of risk management to medical devices
Standard
ISO 14644-12:2018
Cleanrooms and associated controlled environments
Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration
Standard
ISO 7101:2023
Healthcare organization management
Management systems for quality in healthcare organizations

Requirements

Standard
ISO 14155:2020
Clinical investigation of medical devices for human subjects
Good clinical practice
Standard
ISO 15189:2022
Medical laboratories
Requirements for quality and competence
Standard
IEC 62304:2006
Medical device software
Software life cycle processes