The BSB EDGE Blog

Why Global Trust in Healthcare Depends on Standards
Healthcare and pharmaceuticals are far more than industries—they are the lifelines of public health. Every breakthrough in biotechnology, medical devices, and drug development must not only push the boundaries of science but also uphold the highest standards of safety, reliability, and global trust.

In the post‑pandemic era, medical priorities have been reshaped worldwide. From vaccine innovation to device safety, the sector now operates under unprecedented scrutiny. Standards provide the essential framework that ensures progress is not only rapid, but also secure, effective, and universally recognized.

While ISO 13485 (Medical Devices) remains central to quality management in medical device manufacturing, healthcare and pharma standards extend far beyond it. Some of the critical standards shaping the industry today include:

• ASTM D638 (Plastics Testing): Ensures the mechanical integrity of plastics used in medical devices, from syringes to surgical instruments.
• IEC 60601 (Medical Electrical Equipment): Governs safety and performance of devices like ventilators, imaging systems, and infusion pumps.
• IEEE 11073 (Health Informatics): Enables interoperability of medical devices and electronic health records, critical for connected healthcare.
• ISO 10993 Series (Biological Evaluation of Medical Devices): Provides frameworks for biocompatibility testing, ensuring patient safety.
• CSA Z317.2 (HVAC in Healthcare Facilities): Ensures air quality and infection control in hospitals and labs.
• DIN EN 455-4 (Medical Gloves): Specifies requirements for protective gloves used in healthcare settings.
• SAE J2601 (Fueling Protocols for Hydrogen Vehicles): Increasingly relevant as pharma logistics explore sustainable transport for sensitive materials.

Why These Standards Matter

• Patient Safety: Every syringe, ventilator, and pill must meet rigorous standards to protect lives.
• Global Trust: Standards ensure products are accepted across borders, enabling faster access to treatments.
• Innovation Enablement: Frameworks allow biotech and pharma companies to innovate without compromising safety.
• Sustainability: From energy-efficient hospital HVAC (heating, ventilation, and air conditioning) systems to recyclable medical plastics, standards embed sustainability into healthcare.

We, in partnership with leading SDOs, make these standards available to organisations worldwide. Whether you are building medical devices, designing pharma equipment, or ensuring hospital safety, we help you access the frameworks that matter most.

Reach out to BSB Edge to stay ahead in healthcare and pharma standards. Trust in standards is trust in care.