Biological Sciences

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Across
  1. 3. Any event where the use of a medical device is suspected to have resulted in an adverse outcome for a patient
  2. 5. a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects
  3. 7. An analytical technique used by a manufacturing responsible engineer/team as a means to assure that, to the extent possible, potential process failure modes and their associated causes/mechanisms have been considered and addressed
  4. 9. the absence of all forms of microbial life, including spores
  5. 10. Substances that could cause cancer, change the genetic material of an organism, or cause adverse effects on sexual function and fertility
  6. 12. An event that is contrary to a standard or requirement whether intended or specified
  7. 14. Good Manufacturing Practice
  8. 16. Substance that is released from a medical device or material during its clinical use
  9. 17. A multistep process carried out on a used contaminated device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device
Down
  1. 1. Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled
  2. 2. Confirmation, through provision of objective evidence, that the specified requirements have been fulfilled
  3. 4. Biological Sciences team
  4. 5. Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man and animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals
  5. 6. the ability of a material to perform with an appropriate host response in a specific situation
  6. 8. Substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles. The extraction solvents and/or extraction conditions that are expected to be at least as aggressive as the conditions of intended use
  7. 11. Combination of the probability of occurrence of harm and the severity of that harm
  8. 13. A bottom–up (inductive) risk analysis technique in which the consequences of a potential individual failure mode are identified and evaluated
  9. 15. A chemical substance or microorganism intended to destroy, deter, render harmless, or exert a controlling effect on organisms that are harmful to human health or the environment
  10. 18. Compulsory User Needs