Medical Device Cleanrooms | ISO-Compliant Cleanroom Solutions

Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

■ Constructed on anodized extruded aluminum frame with sealed sandwich panel, HPL, acrylic or tempered-glass infill. ■ Suitable for ISO 5–8 per ISO 14644-1; positive or negative pressure cascade available. ■ Flush double-glazed observation windows, steel cleanroom doors with drop-down bottom seal. ■ Panels: rock-wool / glass-magnesium / paper-honeycomb / aluminum-honeycomb / PU core options. ■ HEPA H14 (EN 1822) as standard; ULPA U15/U16 option. ESD-safe conductive finish for electronics.

Deiiang Cleanroom Technology Co., Ltd. specializes in the R&D, manufacturing, and sales of LED cleanroom lighting, backed by professional after-sales support.

The ductless fume hood series complies with the Chinese standard JG/T 385-2012. Designed to protect laboratory personnel during experimental operations, it prevents operators from inhaling toxic, harmful, pathogenic, or unknown-toxicity chemical substances.

The Applicability Assessment Table is used to determine the type of primary emissions emitted by the user in the experiment, in order to determine the most appropriate combination of chemical filters to achieve the best filtration effect.

JIS A 5908 is the Japanese Industrial Standard that specifies the quality, dimensions, and testing methods for particleboards used in construction and furniture manufacturing.

Metal-faced Magnesium Oxide (MGO) Rock Wool Sandwich Cleanroom Partition Panel

ASHRAE 52.2 specifies a laboratory test procedure for measuring the performance of general ventilation air cleaners, establishing the Minimum Efficiency Reporting Value (MERV) to rate their ability to remove airborne particles based on size.

ISO 22196:2011 specifies a method for evaluating the antibacterial activity of treated plastics and other non-porous surfaces by measuring the quantitative reduction of bacterial growth over a 24-hour period.

ISO 2812-1:2017 specifies methods for determining the resistance of individual or multi-layer coating systems to the effects of liquids other than water through partial or total immersion testing.

IEC 61340-5-1:2024 establishes the international requirements for an electrostatic discharge (ESD) control program, specifying the administrative and technical measures needed to protect sensitive electronic devices and assemblies from damage caused by electrostatic phenomena.

SIST EN 1081:2019 specifies test methods for determining the electrical resistance of resilient floor coverings, including resistance to earth, vertical resistance, and resistance between points, to ensure effective static control in sensitive industrial and laboratory settings.

SIST EN 1815:2016 specifies a standardized walking test method for measuring the body voltage produced when a person walks on resilient or laminate floor coverings, used to assess the flooring's static electrical propensity.

EN 17242:2024 (the most significant European update for this period) establishes harmonized safety and performance requirements for recirculatory filtration fume cabinets (RFFCs), defining rigorous test methods for containment efficiency and filtration capacity to ensure the safe handling of hazardous chemicals in laboratories.

SIST EN 13697:2023 specifies a quantitative surface test method for evaluating the bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic, and institutional areas on non-porous surfaces without mechanical action.

ISO 4624:2023 specifies a method for evaluating the adhesion of paints, varnishes, and related products by measuring the minimum tensile stress required to detach or rupture a coating system perpendicular to its substrate using a pull-off test.

IEC 61340-4:2010 is the 4th part of the IEC 61340 international electrostatics standard series, which specifies standardized test methods for specific electrostatic discharge (ESD) protection applications to validate the performance of static control products and protect sensitive electronic components from electrostatic damage in laboratory and manufacturing environments.

Title: "Specification for Recirculating Filter Fume Hoods". Scope: Performance and testing methods, maintenance and filter replacement guidance. Note: The status may have been "withdrawn," but the content remains influential in UK practice and procurement standards.

"Laboratory Ventilation – Ductless Fume Hoods – Part 1: Safety and Performance Requirements." Scope: Harmonized requirements in Europe for the safety, performance classification, testing, and marking of ductless fume hoods. This framework is being increasingly adopted across Europe.

"Laboratory Fume Hoods – Ductless Filtered Fume Hoods – Classification, Performance, and Test Methods." Scope: Ductless fume hoods are classified according to filtration type (e.g., organic vapors, acids, formaldehyde). Test methods include airtightness, filtration efficiency, breakthrough time, and safety requirements. Widely used as a core technology reference by manufacturers in Europe and globally.

Requirements for the design, construction, filtration performance, testing, monitoring, and labeling of ductless (filter-free) fume hoods and exhaust hoods used in laboratories. Filtration efficiency, airtightness, face velocity, alarm systems, and filtration saturation.

Deiiang Laboratory Furniture Equipment Product Catalog is a comprehensive product reference document that details Deiiang’s full portfolio of professional laboratory furniture and equipment — including fume hoods, lab workbenches, chemical storage units and safety fixtures — with complete technical specifications and customizable solutions for scientific research, pharmaceutical, industrial testing and cleanroom laboratory applications.

SIST EN 14175-3:2019 is the Slovenian national adoption of European standard EN 14175-3:2019, which specifies formal type test methodologies to verify the fume containment safety and operational performance of laboratory fume cupboards connected to dedicated exhaust air systems, as the testing complement to the mandatory performance requirements defined in EN 14175-2.

EN 17242:2025 is a European standard for recirculatory filtration fume cabinets (RFFCs) that specifies uniform design, manufacturing, type testing and on-site testing requirements, to ensure effective containment and filtration of hazardous airborne contaminants before exhaust air is recirculated back into the laboratory, and harmonizes safety performance benchmarks for filtered fume enclosures across Europe.

EN 12792:2003 is a European standard that defines unified terminology, measurement units, and graphical symbols for building ventilation and air-conditioning systems, providing a consistent lexical and visual reference for all ventilation-related European standards and engineering practices.

ANSI/ASSP Z9.5-2022 is an American National Standard focused on laboratory ventilation, which establishes minimum requirements and industry best practices for ventilation system design, fume hood performance testing, and formal Laboratory Ventilation Management Plans, to protect laboratory personnel from physical harm and overexposure to hazardous airborne contaminants.

The OSHA Laboratory Standard (29 CFR 1910.1450) is a U.S. federal occupational safety regulation that protects laboratory workers from health hazards caused by exposure to hazardous chemicals, by requiring laboratories to establish a written Chemical Hygiene Plan and implement corresponding safety training, exposure monitoring and risk control measures.

SIST EN 16611:2023 (EN 16611:2023) specifies methods and test procedures for assessing the surface resistance of furniture to microscratching and evaluating surface durability. ([sis.se](https://www.sis.se/en/produkter/domestic-and-commercial-equipment-entertainment-sports/furniture/ss-en-166112023/?utm_source=openai))

EN 61010 specifies safety requirements for electrical equipment for measurement, control, and laboratory use to protect users and property from electrical, mechanical, and thermal hazards.

ISO 846:2019 specifies laboratory methods for evaluating the resistance of plastics to the action of microorganisms (fungi and bacteria) under controlled conditions.

ISO 16232 specifies test methods for assessing particulate contamination (particle extraction, counting, sizing, and analysis) on components of fluid systems in road vehicles to ensure cleanliness and performance.

ISO 14644-9:2022 specifies methods for assessing and classifying the cleanliness of surfaces in cleanrooms and associated controlled environments based on particle concentration. ([iso.org](https://www.iso.org/standard/76889.html?utm_source=openai))

ISO 14644-7:2004 specifies classification, design, testing, and operational requirements for separative devices (isolators, minienvironments, clean air hoods and suits) used to provide localized controlled environments.

ISO 14644-5 provides requirements and recommendations for the operation of cleanrooms and associated controlled environments, covering procedures for cleaning, maintenance, personnel, gowning, and monitoring to maintain contamination control.

ISO 14644-4:2022 provides international requirements and guidance for the design, construction, and start-up of cleanrooms and associated controlled environments to ensure they meet contamination control and performance criteria.

ISO 14644 defines the standards for cleanrooms and associated controlled environments, covering their classification by air cleanliness, design, operation, monitoring, and testing to ensure effective contamination control.

EN 779 specifies a test method and classification system for particulate air filters used in general ventilation, rating their performance based on particle removal efficiency and pressure drop.

ISO 16890-3:2016 specifies test procedures for determining the gravimetric efficiency and air flow resistance of air filters for general ventilation, supporting their classification based on particulate matter size fractions.

SIST EN 1822-2:2010 defines aerosol production, measuring equipment, and testing methods used to determine the efficiency and classification of high-efficiency air filters (HEPA/ULPA) in cleanroom and contamination control applications.

SIST EN 1822-4:2001 specifies the test methods and requirements for determining local filter efficiencies and leakages of high-efficiency air filters (HEPA/ULPA), ensuring reliable performance in critical cleanroom and contamination control applications.

ISO 16890:2022 establishes a test and classification system for air filters used in general ventilation, rating their efficiency based on particulate matter size fractions (PM1, PM2.5, and PM10) to better reflect real-world outdoor air conditions.

ISO 16889:2022 specifies a multi-pass test method for evaluating the performance of filters used in hydraulic fluid power systems, including particle removal efficiency and dirt-holding capacity under defined operating conditions.

ASHRAE 52.2 specifies the method of testing air-cleaning filters for ventilation air, providing Minimum Efficiency Reporting Values (MERV) to rate filter performance by particle size and removal efficiency.

EU GMP Annex 15 (2015) provides detailed guidance on qualification and validation for pharmaceutical manufacturing, covering equipment, facilities, utilities, processes, and cleaning to ensure consistent product quality and regulatory compliance.

USP <800> establishes standards for the safe handling of hazardous drugs to protect healthcare workers, patients, and the environment through appropriate facility design, engineering controls, and work practices.

This document provides detailed technical information, specifications, and application guidelines to support the correct selection, design, and use of the referenced cleanroom-related product or system.

EU GMP Volume 4 Annex 1 (2022) sets out detailed regulatory requirements and guidance for the manufacture of sterile medicinal products, focusing on contamination control, cleanroom classification, and robust aseptic processing.

Federal Standard 209 defines the classification of cleanrooms based on airborne particulate cleanliness, providing foundational criteria for designing, operating, and validating controlled environments.

Deiiang Laminar Flow Hoods provide ultra-clean, unidirectional airflow with low noise and stable performance, ensuring reliable product protection and contamination control in critical work areas.

Deiiang Downflow Booth provides a controlled, vertical laminar airflow zone that efficiently captures and removes contaminants, ensuring operator safety, product protection, and a clean working environment.

Deiiang FFU delivers high-efficiency, low-noise laminar airflow with stable performance and easy integration, providing reliable clean air protection for critical environments.

Our HVAC air filters deliver high-efficiency particulate removal, low pressure drop, and reliable protection for clean, healthy, and energy-efficient indoor environments.

Deiiang's pass-through window series includes static and dynamic models, fully compliant with GMP and ISO14644 standards, and sizes are customizable.

IEST-RP-CC026 is an industry recommended practice that provides guidelines and best practices for the operation and management of cleanrooms and other controlled environments.

A collection of Deiiang cleanroom project case studies, visually showcasing the overall completed cleanroom results.

Deiiang cleanroom-specific PVC flooring is made of homogeneous material, making it durable, comfortable underfoot, and can be treated with anti-static agents upon request.

Deiiang's air showers are fully automatic and sensor-operated, with nozzle airflow speeds of 30m/s. This effectively removes dust particles adhering to people and goods, ensuring a safe and healthy cleanroom environment.

Deiiang's cleanroom-specific observation window features double-layer insulation, inert gas flushing to prevent fogging, an internal stainless steel frame, and an elegant design. It has passed UL and CE certification tests.

Designed by Deiiang experts, these doors meet international cleanroom standards, support GMP compliance, and enhance the safety, durability, and energy efficiency of pharmaceutical, biotechnology, electronics, and medical environments.

Deiiang's cleanroom-grade aluminum profiles are sturdy, durable, easy to clean, and available in various colors and styles including natural, electrophoretic, and anodized aluminum. They meet GMP and FDA certification standards.

Explore Deiiang Cleanroom Panels Systems engineered for airtight performance, durability, and GMP-compliant cleanliness across critical environments.

Deiiang Construction has been plowing into the field of engineering construction for more than 20 years, and is a leading EPC service provider in the field of high-tech industrial construction in China

Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

Cleanroom design specifications define the structural, airflow, filtration, and cleanliness requirements needed to control contamination in a controlled environment.