[ISO 13485 Cl 6.4.2] 

Clause 6.4.2 Control of Contamination: This clause ensures that medical device manufacturers prevent contamination during product realization processes, especially for products requiring sterile or clean environments. This clause is linked with other clauses mainly

7.5.2.1: Sterile medical devices – adds more specific controls for sterilisation validation

8.2.4: Environmental monitoring as part of process control

7.5.3: Identification, handling, and preservation – includes contamination prevention

The clause is mainly focussing cleanliness on

• Cleanliness of facilities

• Personnel hygiene and clothing

• Air quality (e.g., HEPA filters)

• Cleaning and disinfection protocols

• Environmental monitoring (temperature, humidity, bioburden)

• Cross-contamination prevention (segregation, unidirectional flow)