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Regulations and Standards Flashcards

6 cards from real SPD practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 Regulations and Standards flashcards as text
  1. What is the role of AAMI in sterile processing?

    Answer: AAMI develops consensus standards and recommended practices that define how medical devices should be reprocessed

    AAMI is the primary standards development organization for sterile processing, creating the recommended practices and technical standards that guide reprocessing procedures.

  2. How does the FDA regulate the reprocessing of medical devices?

    Answer: The FDA requires device manufacturers to provide validated reprocessing instructions and clears sterilization equipment and chemical agents

    The FDA ensures that device manufacturers provide validated reprocessing instructions and that sterilization equipment and chemicals meet safety and efficacy standards.

  3. What does OSHA require specifically related to SPD workplace safety?

    Answer: OSHA mandates bloodborne pathogen protection, hazard communication, PPE provision, ergonomic safety, and exposure monitoring for SPD staff

    OSHA sets legally enforceable workplace safety standards that directly apply to SPD environments.

  4. What is the significance of Joint Commission standards for SPD operations?

    Answer: Joint Commission accreditation standards include specific requirements for infection control and environment of care that directly govern SPD operations

    Joint Commission accreditation standards mandate specific infection control and environment of care practices that directly apply to sterile processing.

  5. What are CMS Conditions of Participation and how do they relate to SPD?

    Answer: CMS Conditions of Participation are federal requirements for Medicare/Medicaid participation that include infection control standards governing instrument reprocessing

    CMS Conditions of Participation are legally binding federal requirements that hospitals must meet to receive Medicare/Medicaid reimbursement.

  6. What is the significance of IEC/ISO 17665 for steam sterilization?

    Answer: It is the international standard specifying requirements for the development, validation, and routine control of steam sterilization processes

    ISO 17665 provides the international framework for validating and monitoring steam sterilization processes.

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Sources & references

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  1. myhspa.org — Eligibility, fees, exam format, passing score, renewal, retake fee, retake policy, test dates, time limit, score validity · verified Oct 2026
  2. prometric.com — Test delivery · verified Oct 2026