ISO 13485 Cleanroom Assembly: What Design Partners Should Expect

Medical and regulated products often require assembly in a controlled environment. Understanding the baseline helps design partners plan earlier.

Threegon operates an ISO 7 (Class 10,000) cleanroom for assembly when specified. This is suitable for many non-sterile medical housings and sub-assemblies.

Typical expectations include documented process controls, material traceability for critical components, and records that can support the client's design transfer or validation package.

The cleanroom is not an ISO 5 sterile core. Final sterilization (if required) is usually performed by a qualified third party or the legal manufacturer.

Early discussion of cleanroom needs during DFM avoids late changes to handling, packaging, or assembly sequence.

Result: Clearer project planning and documentation that aligns with ISO 13485 expectations without over-scoping the facility.