New PDF release: Le fil qui chante (Lucky Luke) (French Edition)

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Extra resources for Le fil qui chante (Lucky Luke) (French Edition)

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1 The medical device industry classifies these hazards by the source of the hazard and by the types of injuries that patients may experience as a result of nonperformance, misuse, or erroneous results (for example, with pregnancy test kits) of the device. 1 in Appendix B lists examples of hazards in medical devices. Physical Hazards Physical hazards can cause physical trauma to the patient. These hazards result from material failure or the unintentional use of nonconforming material. Biological Hazards Biological hazards can be of microbiological or nonmicrobiological origin.

Some individual ingredients and/or finished products have the potential to contain pathogens or allow development of microbial toxins that can cause mild to severe illness and even death. Additionally, permanent, lifelong debilitations can result from microbiological hazards. There are two types of pathogenic microorganisms: n ­on-­ spore-forming and s­pore-­ forming. indd 20 12/8/13 3:06 PM Chapter 3 Principle #1—Conduct Hazard Analysis 21 humans. ­Non-­spore-forming pathogens include viruses, parasites, and bacteria.

If the HACCP team does not know the answers to these questions, it should seek professional advice. State and federal regulatory agencies often publish epidemiological summaries or morbidity/­ mortality reports that establish the hazard profiles of different products. The severity of a risk is not lower just because the HACCP team is unfamiliar with the hazardous health consequences. Probability (or Likelihood) of Risk The final and most difficult part of the hazard analysis is the assessment of the probability of risk.

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