Definition of "medical-grade" by Spec Services:
« Back to Glossary Index The term "medical-grade" refers to materials, equipment, or products that meet strict regulatory and quality standards required for use in medical environments. These standards ensure that the item is safe, effective, and suitable for healthcare applications, such as hospitals, clinics, and laboratories.
Medical-grade products are typically:
- Manufactured under strict quality controls (e.g., ISO 13485 certification).
- Made from biocompatible, non-toxic materials that do not cause harm to patients or healthcare workers.
- Designed for sterilization or high-level disinfection to prevent contamination and infection.
- Tested and approved by regulatory agencies such as the FDA (U.S.), CE (Europe), or Health Canada.
Examples of medical-grade items include surgical instruments, disinfectants, gloves, and air filtration systems used in healthcare settings.
