The BSB EDGE Blog

 Standards Driving Quality in Cancer Care
On World Cancer Day, the global community reflects on progress in cancer prevention, diagnosis, and treatment. The 2026 theme, “United by Unique”, highlights the importance of personalised care. For industry professionals, this is a reminder that behind every unique patient journey lies a framework of standards that ensure safety, accuracy, and consistency.

ISO Standards in Diagnostics and Devices

• ISO 15189 (Medical Laboratories) defines competence and quality requirements for medical labs. In cancer care, this ensures pathology and screening results are reliable, reproducible, and globally comparable.
• ISO 13485 (Medical Devices) governs the design, manufacture, and servicing of medical devices such as imaging systems, radiotherapy equipment, and surgical instruments. Compliance ensures devices meet stringent safety and performance benchmarks.
• ISO/IEC 27001 (Information Security) safeguards sensitive patient data, supporting cancer registries, digital health platforms, and personalised treatment plans.

Beyond ISO: A Global Ecosystem of Standards

ISO forms the backbone, but cancer care is reinforced by a wider ecosystem of international and national standards bodies:

• IEC standards (IEC 60601 for medical electrical equipment, IEC 62304 for medical device software) ensure the safety and performance of imaging systems, radiotherapy machines, and oncology software.
• IEEE frameworks like IEEE 11073 enable interoperability between medical devices and health informatics systems, vital for integrated cancer care.
• UL standards, including UL 2900 for medical device cybersecurity, protect sensitive oncology data and safeguard connected equipment.
• CSA Group and DIN provide region‑specific standards for radiation safety and imaging quality assurance, strengthening diagnostic reliability.
• BSI and JSA adopt and adapt ISO/IEC standards for their regions, ensuring consistency across borders.
• IPC standards for electronics reliability support the components inside diagnostic and treatment devices.

Together, these Standards Development Organizations (SDOs) create a global framework of trust. They ensure that whether a patient is undergoing a biopsy in Delhi, radiotherapy in Toronto, or imaging in Tokyo, the systems supporting their care meet the same rigorous benchmarks.

Standards as Enablers of Personalised Care

Personalised cancer care requires systems that adapt to individual needs while maintaining global consistency. Standards provide the backbone:

• Clinical trial protocols aligned with standard guidelines ensure therapies are tested ethically and consistently.
• Quality management systems (QMS) in hospitals and pharma companies create frameworks for safe, scalable, patient‑specific treatments.

On this World Cancer Day, let us recognise that standards are not just compliance tools — they are the behind-the-scene infrastructure enabling reliable diagnostics, safe devices, and secure data. For industry leaders, aligning with these standards is not optional; it is the path to innovation, trust, and global impact in cancer care.Partner with BSB Edge to strengthen your compliance frameworks and contribute to a world where quality cancer care is accessible and resilient.