Question

b) Why are medical devices manufactured in a cleanroom if they must undergo sterilization anyway? (1 mark) c) Explain how radiation sterilization works, starting with the radioactive source (normally cobalt-60). (3 marks) d) Radiation sterilization can affect materials in different ways. What types of materials are most and least affected by radiation sterilization? (3 marks) e) What approach should be used for the validation of custom-built equipment? Explain this approach by naming and explaining the documentation used to record each step. (8 pieces of work should be explained - User Requirement Specification being one.) (16 marks)

          b) Why are medical devices manufactured in a cleanroom if they must undergo sterilization anyway?
(1 mark)

c) Explain how radiation sterilization works, starting with the radioactive source (normally cobalt-60).
(3 marks)

d) Radiation sterilization can affect materials in different ways. What types of materials are most and least affected by radiation sterilization?
(3 marks)

e) What approach should be used for the validation of custom-built equipment? Explain this approach by naming and explaining the documentation used to record each step. (8 pieces of work should be explained - User Requirement Specification being one.)
(16 marks)

b why are medical devices manufactured in a cleanroom if they must undergo sterilisation anyway 1 marks c explain how radiation sterilisation works starting with the radioactive source norma 83766

Added by Jose Luis J.

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