The purpose of the scheme is to determine the efficacy of maintenance of medical equipment’s function after Installation, Servicing, and Repair are done by the organization in accordance with the applicable standards, regulatory and manufacturer’s requirements. However, maintenance service provider (AMC, CMC, Hospitals, Clinics, OEM etc) are responsible for the implementation of the schemerequirements on an ongoing basis.

• Testing and verification of Medical Equipment and System (combination of medical equipment).
• Parts of such equipment or systems, which need maintenance on a periodic basis.

• Hospital through biomedical maintenance department.
• Biomedical maintenance by the manufacturer.
• Third-party maintenance provider.

• Implantable medical devices.
• Single-use or disposable medical devices.
• Medical equipment which does not require preventive maintenance as per the manufacturer.

• International standard ISO/IEC 17065:2012. Conformity assessment. Requirements for bodies certifying products, processes and services.
• Published International Accreditation Forum (IAF) documents and existing best practices available across the Globe.

• Ensure that equipment functions properly and that there are no malfunctioning or errors of the device.
• Reduce Risk & Improve Patient Safety