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QUALITY & COMPLIANCE

Global Standards, Local Trust: Our Certifications

At Megasan, patient safety is non-negotiable. Our products and installation processes strictly adhere to the most rigorous international standards for Medical Gas Pipeline Systems (MGPLS) and critical care equipment.

CE Certified Products

All products conform to European Union health, safety, and environmental protection standards.

ISO 9001:2015

Certified Quality Management System for design, manufacturing, and service.

ISO 13485:2016

Specific quality standard for the design and production of medical devices.

Medical Gas Pipeline System Standards

We ensure that every component and final installation meets the global benchmarks required for safe and reliable patient care.

  • EN ISO 7396-1:2016
    Central standard for Medical Gas Pipeline Systems (MGPLS), covering design, installation, and performance.
  • EN ISO 9170-1/2
    Specific requirements for terminal units (gas outlets), ensuring non-interchangeability and safety.
  • HTM 02-01 (UK Standard)
    Compliance with the detailed UK Health Technical Memorandum for operational excellence and maintenance.

Technical and Safety Assurance

Beyond systems, our manufacturing and testing processes incorporate critical safety standards for all equipment and materials used.

  • EN ISO 15001
    Cleanliness of medical gas systems, ensuring components are free of contaminants.
  • Local Regulations (DGDA/Ministry)
    Full compliance with the Directorate General of Drug Administration and relevant Bangladesh government health standards.
  • Ghost/GOST-R Certification
    Quality mark demonstrating compliance for export and use in various international markets.

Need Official Documentation?

For tender submissions or compliance audits, you can request copies of our latest certificates directly.

Request Certificate Copies