scope:

Medical and Surgical Materials and Devices-standards address metals, polymers, and ceramics for implants; prostheses; medical and surgical devices; devices used in arthroplasty and osteosynthesis; silicone elastomers, gels, and foams in medical applications; and tissue engineered medical products. Each standard typically covers manufacture, chemical requirements, mechanical requirements, special tests, and certification. Accompanying the specifications are test methods, practices, guides, classifications, and terminology.

Anesthetic and Respiratory Equipment-specifications cover anesthesia machines and monitors, laryngoscopes, bronchoscopes, ventilators, and associated equipment.

Manufacture of Pharmaceutical Products-covers the application of process analytical technology (PAT) within the pharmaceutical industry, highlighting PAT system management, implementation, and practices.