What is the ISO standard for air showers? | Cleanroom Guide 2026

In precision manufacturing, biopharmaceuticals, and semiconductor industries—where environmental requirements are “fastidious”—the Air Shower serves as an indispensable “Cleanliness Gatekeeper.” While many recognize its importance, few fully grasp the ISO standards behind it.

Today, we will break down what the ISO standards for air showers actually mean and how companies like Boben Modular Cleanroom Manufacturers turn these technical requirements into reality.

I. What Are the Core ISO Standards for Air Showers?

The design and validation of air showers primarily follow two major ISO frameworks: ISO 14644 and ISO 13485. These standards define requirements from the perspectives of “Controlled Environments” and “Medical Industry Compliance.”

1.ISO 14644-1: Classification of Air Cleanliness

This is the “Constitution” of the cleanroom industry. It classifies cleanrooms into 9 levels (ISO Class 1 to ISO Class 9) based on airborne particle concentrations. As the “throat” of the cleanroom, an air shower’s efficiency directly determines whether pollutants are prevented from entering the core production zone.

• The Requirement: Before personnel or materials enter, the air shower must remove over 99.9% of particles ≥0.5μm within a specified time (typically 15-30 seconds).

2.ISO 14644-3: Test Methods

This standard specifies how to verify performance. To ensure uniformity and effectiveness, engineers must:

• Use Laser Particle Counters to test concentrations at various points (nozzles, standing areas, exits).
• Use Anemometers to verify nozzle velocity, which is typically required to be between 20–30 m/s.

3.ISO 13485: Quality Management for Medical Devices

For air showers used in medical device or biotech sectors, compliance with ISO 13485 is mandatory.

• Materials: Surfaces (Stainless Steel, tempered glass) must be corrosion-resistant, easy to sanitize, and non-particle-shedding.
• Traceability: Control systems must be able to record data such as shower duration and wind speed to meet stringent GMP (Good Manufacturing Practice) audit requirements.

II. What Do These Standards Mean in Practice?

Clients often ask: “I just need an air shower; why make it so complicated?” In reality, these standards are not just paperwork—they are the lifeline of product quality and corporate compliance.

• In Medical Device Plants: If nozzle velocity fails to meet ISO standards, micro-dust on an operator could contaminate an implantable device. This leads to entire batch rejections and severe regulatory penalties.
• In Semiconductor Fabs: Efficiency directly affects “yield rates.” Even a single microscopic particle can destroy a silicon wafer worth tens of thousands of dollars.

This is why professional firms like Boben Modular Cleanroom Manufacturers design air showers based on strict ISO protocols rather than simply building a “box that blows air.”

III. How Boben Modular Cleanroom Manufacturers Implements ISO Standards

At Boben, we believe the value of a standard lies in its execution. We translate ISO requirements into every engineering detail:

• Premium Material Selection: We use SUS 304 or 316L Stainless Steel. It is corrosion-resistant, easy to clean, and zero-shedding, perfectly meeting ISO 14644 material safety codes.
• Precision Nozzle Engineering: Our 360° adjustable stainless steel nozzles ensure uniform airflow. With wind speeds stabilized at 25 m/s, we achieve maximum dust removal in minimal time.
• Intelligent PLC Control: Equipped with smart control systems, our units allow for preset durations and automated data logging, satisfying the data traceability requirements of ISO 13485.
• Modular Flexibility: Unlike traditional fixed units, Boben’s modular air showers can be custom-configured and rapidly installed based on factory layout, ensuring stable performance with a shorter project lifecycle.

The ISO standards for air showers represent an industry commitment to quality and a responsibility toward product safety. They are not barriers to entry but a lighthouse guiding us toward excellence.

In an era of increasing cleanliness demands, partnering with a manufacturer like Boben Modular Cleanroom Manufacturers—who truly understands and practices ISO standards—is the smartest way for a business to protect its quality and win customer trust.