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Iso 13485 Standard Articles & Analysis: Older

3 articles found

Ensuring ultra-pure air in a Mobidiag molecular diagnostics laboratory - Case Study

Ensuring ultra-pure air in a Mobidiag molecular diagnostics laboratory - Case Study

RESULTS The airborne particle measurements are being conducted regularly in the laboratory, according to ISO 14464-1. The laboratory has clean areas where the particle count is ISO 6 compliant The air in these laboratories is almost 100 % cleaner compared to the central area (sampling of 0.3 μm particles with 10 sampling locations). Genano Air ...

ByGenano Industrial Air Purification Solutions - Genano Ltd.


Technical and safety practices

Technical and safety practices

With digital capabilities and strict testing procedures currently governing the company’s core manufacturing processes, Zoda described, “Manufacturing quality processes certified according to ISO 13485:2003 Medical Device standards are implemented across all valves and regulators as a matter of course. ...

ByQED Environmental Systems


Technical and safety practices - Case Study

Technical and safety practices - Case Study

With digital capabilities and strict testing procedures currently governing the company’s core manufacturing processes, Zoda described, “Manufacturing quality processes certified according to ISO 13485:2003 Medical Device standards are implemented across all valves and regulators as a matter of course. ...

ByQED Environmental Systems

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