Operating Room / Clean Room Systems
Why DSD Medical?
Infection control-focused design
Pressure hierarchy, air exchange rates, HEPA filtration, and laminar flow configurations.
Compliance with Standards
ISO 14644-1 particle classes and operating room classification approach according to DIN 1946-4.
End-to-End Delivery
Design → production/procurement → assembly → testing & validation → training → periodic maintenance.
Solution Components
Partition
HPL, stainless steel, or glass surfaces; flush mounting, hygienic chamfer at corners.
Filtration
Tavan terminal üniteleri, HEPA H13/H14, laminer akış alanı, diferansiyel basınç izleme. (HTM 03-01)
Automation
Operating room control panel (clock, temperature-humidity, H/LP alarms), BMS integration, door interlocks.
Lighting
Lighting
Surgical lighting integration, dimmable general lighting, UGR control.
High Pressure Laminate
Impact and chemical resistant, long-lasting coating; color/texture options.
Ventilation Systems
Fresh air ratio, temperature-humidity control, positive/negative pressure rooms; quietness and energy efficiency. (HTM 03-01)
Modular Systems
Factory-made panels for quick installation; removable/reconfigurable structure.
Sanitary Systems
Non-porous surfaces, chemical resistance; hygienic skirting and floor-wall integrity.
Design & Project Management
Discovery and Risk Analysis
Clinical processes, inter-room pressure control. (HTM 03-01)
Engineering Design
Ventilation calculation, filter selection, panel placements, door interlock
Testing, Validation, and Commissioning
Smoke test, leak test, particle count (ISO 14644-1 class verification), acceptance tests, and user training.
Production / Supply and Assembly
Dust-free assembly procedures, clean work plan.
Standards & Compliance
Discovery & Needs Analysis – Determining clinical processes, load and capacity requirements.
Engineering Design – Flow/capacity calculations, line diagrams, equipment selection, layout, and detailed drawings. (We refer to HTM 02-01 Part A validation and commissioning principles.)
Material & Equipment Selection – Compliance certificates, traceability, and documentation.
Installation & Integration – Installation compliant with hygiene rules, testable, and open to expansion.
Testing, Validation, and Commissioning – Pressure tests, leak testing, flow and alarm validation; user training; delivery of as-built documentation. (In accordance with ISO 7396-1/HTM 02-01)
Compliance and Standards
ISO 7396-1: Design, performance, testing, and commissioning requirements for compressed medical gases and vacuum lines. ISO
HTM 02-01 (A/B): Guidance for design-installation-validation (A) and operation-maintenance (B). NHS England+1
(On request) SHTM 02-01 reference. National Services Scotland
Note: DSD Medical designs and documents projects in accordance with this guidance and these standards.
