Cleanroom Classification for Medical Devices – Understanding ISO 14644 Standards

In the medical device industry, product quality and patient safety depend on strict contamination control. A properly designed cleanroom ensures that every instrument or component is manufactured under controlled particle, temperature, and humidity conditions. Dersion, with 20 years of cleanroom experience and CE, ISO, and UL certifications, provides one-stop cleanroom design and installation solutions for medical device manufacturers worldwide.

Why Cleanroom Classification Matters in Medical Device Manufacturing

Cleanroom classification determines how clean the air inside your production environment must be. For medical devices—especially implantable and high-risk products—even a single dust particle or microorganism can cause severe consequences.

According to ISO 14644-1 Cleanroom Classification Standard, cleanrooms are divided into classes (ISO Class 1 – ISO Class 9) based on the maximum allowable number of particles per cubic meter.

For example:
– ISO Class 5: Ultra-clean environment suitable for implantable device assembly.
– ISO Class 7: Common for general medical device manufacturing.
– ISO Class 8: Often used for packaging or less critical stages.

Dersion engineers design environments that comply with FDA cleanroom requirements and ISO 13485 quality management standards, ensuring every cleanroom meets regulatory expectations.

ISO 5–8 Cleanroom Levels Explained

Learn more about cleanroom classification in the official ISO 14644 Cleanroom Guide 

ISO 7 vs ISO 8 Cleanroom – Key Differences

ISO 7 offers tighter contamination control and is ideal for medical device assembly or sterilization areas. ISO 8 is more economical and suits packaging, storage, or pre-cleaning areas.

How Dersion Designs Compliant Cleanrooms for Medical Device Production

Dersion combines German TRUMPF sheet metal fabrication, a 20,000 m² smart cleanroom factory, and a 1,000 m² ISO Class 7 assembly workshop to deliver turnkey medical cleanrooms worldwide.

Key Advantages:

- Modular Cleanroom System – flexible layout, 98% reusable materials, rapid installation.
– Intelligent HVAC Control – automatic air volume, pressure, and humidity adjustment.
– Energy-Saving Solutions – smart FFU and lighting systems reduce energy use.
– One-Stop Service – from layout design and validation to on-site certification.
– Regulatory Compliance – CE / ISO / UL certified components ensure global acceptance.

Visit our Medical Cleanroom Solutions Page to explore our design portfolio.

FAQ: Common Questions about Cleanroom Classifications

• Q: What cleanroom class is needed for medical devices?

A: Most medical device manufacturers require ISO 7 or ISO 8, but implantable or sterile devices may need ISO 5 or ISO 6.

• Q: How often should a cleanroom be validated?

A: According to ISO 14644-2, validation should occur at least every 6 months or after any major modification.

• Q: What are the FDA cleanroom requirements for medical device manufacturing?

A: The FDA requires compliance with 21 CFR Part 820 and integration with ISO 13485 quality systems.

• Q: Can cleanroom modular panels be reused or relocated?

A: Yes—Dersion modular cleanrooms achieve 98% reuse rate, making expansion or relocation fast and sustainable.

Conclusion: Build a Smarter, Cleaner Future with Dersion

As global medical device standards evolve, cleanroom compliance becomes a competitive advantage. Partnering with Dersion means gaining access to professional engineering, intelligent control systems, and global certification expertise—all in one trusted supplier.

Ready to design your compliant cleanroom?

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