ISO Standards Related to Modular Operating Rooms (Modular OR)

Key Fact: ISO does not have a single standard specifically dedicated to “Modular Operating Rooms.” A modular operating room is mainly based on a combination of cleanroom technology (ISO 14644) + medical ventilation requirements + medical gas systems + electrical safety standards. Typical operating room cleanliness requirements are ISO Class 5 for the operating field and ISO Class 7 for surrounding areas.

I. Core ISO 14644 Series — Cleanrooms and Associated Controlled Environments

Standard Title Significance for Modular Operating Rooms Reference File
ISO 14644-1:2015 Classification of air cleanliness by particle concentration The most important standard: defines ISO Cleanroom Classes 1–9. Operating areas typically require ISO Class 5, surrounding areas ISO Class 7. ISO_14644-1_2015.pdf ✅ 44 pages complete version · Download
ISO 14644-2:2015 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Defines routine monitoring plans, testing frequency, alert/action limits, and performance verification. ISO_14644-2_2015.pdf ✅ 22 pages complete version (with comparison notes) · Download
ISO 14644-3:2019 Test methods Covers HEPA filter integrity testing, airflow measurement, pressure difference testing, recovery time, etc. Official sample available only; full version requires purchase
ISO 14644-3:2005 Test methods (previous edition) Similar testing requirements. Still referenced in some projects and tenders. ISO_14644-3_2005.pdf ✅ 72 pages complete version · Download
ISO 14644-4:2022 Design, construction and start-up Directly applicable to modular wall systems, ceilings, HVAC systems, installation, commissioning, and validation. ISO_14644-4_2022.pdf ⚠️ Official extract (15 pages); full standard 57 pages requires purchase · Download extract
ISO 14644-5:2004 Operations Covers operation procedures, cleaning, disinfection, personnel management, and maintenance. ISO_14644-5_2004.pdf ✅ 52 pages complete scanned version · Download
ISO 14644-7:2004 Separative devices (clean air hoods, glove boxes, isolators, micro-environments) Relevant for isolators, pass-through boxes, laminar flow equipment, and local clean environments. ISO_14644-7_2004_full.pdf ✅ 56 pages complete version · Download
ISO 14644-6:2007 Vocabulary Defines cleanroom terminology. —
ISO 14644-8:2013 Classification of air cleanliness by chemical concentration (ACC) Covers molecular contamination. Usually not applicable to operating rooms. —
ISO 14644-9:2022 Classification of surface cleanliness by particle concentration Applies to cleanliness evaluation of wall and ceiling surfaces. —
ISO 14644-14:2016 Assessment of suitability for use of equipment by airborne particle concentration Used for evaluating particle emission from equipment, surgical lights, medical devices, etc. —
ISO 14644-16:2019 Energy efficiency in cleanrooms Provides guidance for energy-saving cleanroom HVAC design. —

II. Biological Contamination Control (Microbial Control)

Standard Title Status
ISO 14698-1/-2:2003 Cleanrooms and associated controlled environments — Biocontamination control (General principles and evaluation methods) Withdrawn. Replaced by EN 17141:2020. ISO is developing a new unified revision.
EN 17141:2020 Cleanrooms and associated controlled environments — Biocontamination control Current European standard, including guidance for healthcare-related applications.

III. ISO Standards Related to Operating Room Supporting Systems

Standard Title Coverage
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum Design, installation, testing, and commissioning of oxygen, vacuum, compressed air, etc.
ISO 7396-2:2007 Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems Anaesthetic gas waste removal systems.
ISO 9170-1/-2 Terminal units for medical gas pipeline systems Medical gas outlets and terminal units.
ISO 11197:2019 Medical supply units Requirements for medical supply units and surgical pendants.
ISO 14971:2019 Medical devices — Application of risk management to medical devices General medical device risk management requirements.
IEC 60601-1 Medical electrical equipment — General requirements for basic safety and essential performance Electrical safety requirements, including isolated power systems used in operating rooms.

IV. Common Healthcare Ventilation Standards Used Together with ISO 14644 (Non-ISO)

  • ASHRAE 170 (USA) Healthcare ventilation standard covering air changes, temperature, humidity, pressure relationships, and filtration requirements.

  • DIN 1946-4 (Germany) Ventilation standard specifically for hospitals and operating rooms.

  • HTM 03-01 (UK) Healthcare Technical Memorandum for specialised ventilation systems in healthcare facilities.

  • GB 50333-2013 (China) Technical Code for Building of Hospital Clean Operating Department — the most directly applicable standard for Chinese hospital cleanroom projects.

V. Reference Documents — Download Links

All documents below are available for direct download from this site.

VI. Standards Without Free Full Versions — Legal Purchase Channels

  • ISO 14644-3:2019 Test methods Official purchase: https://www.iso.org/standard/60598.html Price: CHF 225

  • ISO 14644-4:2022 Design, construction and start-up Official purchase: https://www.iso.org/standard/72379.html Price: CHF 225

  • EN 17141:2020 Available through AFNOR / BSI / DIN.

  • China Healthcare Projects: GB 50333-2013 — Technical Code for Building of Hospital Clean Operating Department.