Biomedical Equipment Maintenance Certification Scheme (BEMC) is an initiative of AMTZ in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).
Purpose
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.
This Scheme applies maintenance process certification which includes:
- 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.
This Scheme can be implemented by:
- Hospital through biomedical maintenance department.
- Biomedical maintenance by the manufacturer.
- Third-party maintenance provider.
This Scheme shall not cover:
- Implantable medical devices.
- Single-use or disposable medical devices.
- Medical equipment which does not require preventive maintenance as per the manufacturer.
This Scheme is developed in compliance with:
- 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.
Benefits of the Scheme:
- Ensure that equipment functions properly and that there are no malfunctioning or errors of the device.
- Reduce Risk & Improve Patient Safety.
