Guidance Legislation and Standards Flashcards

1
Q

Processing/ Life cycle of instrumentation

A
  1. cleaning
  2. disinfection
  3. inspection
  4. packaging
  5. sterilization
  6. transport
  7. storage
  8. use
  9. transport
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2
Q

Flow of LDU

A
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3
Q

What is medical device?

A
  • any instrument, apparatus, appliance, software, implant, reagent, material/ other article manufacturer to be used, alone or in combination, for human beings for one/more of the following specifics
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4
Q

Previous Guidance document for sterilization

A

SHTM 2010

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5
Q

Previous Guidance document for washer- disinfectors

A

SHTM 2030

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6
Q

Updated guidance

A

SHTM 01-01

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7
Q

Principle/ practice

A
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8
Q

5 stages of Washer- Disinfector operating cycles

A
  1. Pre-wash
  2. Wash
  3. Rinse
  4. Disinfection
  5. Drying
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9
Q
A
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