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FDA standards > FDA Standards > Flashcards

FDA Standards Flashcards

1
Q

IEC 60601-1 is …?

A

General requirements for basic safety and essential performance

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2
Q

IEC 60601-1-2 is…?

A

General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests

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3
Q

IEC 60601-1-6 is …?

A

General requirements for basic safety and essential performance – Collateral standard: Usability

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4
Q

IEC 60601-1-8 is …?

A

General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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5
Q

IEC_60601-1-11 is …?

A

General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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6
Q

IEC 60601-2-24

A

Particular requirements for the basic safety and essential performance of infusion pumps and controllers

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7
Q

IEC 62304

A

Medical Device Software Life cycle processes

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8
Q

IEC 62366-1

A

Application of usability engineering to medical devices

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9
Q

Application of usability engineering to medical devices

A

IEC 62366-1

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10
Q

Medical Device Software Life cycle processes

A

IEC 62304

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11
Q

basic safety and essential performance of infusion pumps and controllers

A

IEC 60601-2-24

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12
Q

Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

A

IEC 60601-1-11

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13
Q

IEC 60601-2-39

A

Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

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14
Q

Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

A

IEC 60601-2-39

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15
Q

IEC 60601-2-39

A

Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

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16
Q

basic safety and essential performance of infusion pumps and controllers

A

IEC 60601-2-24

17
Q

Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

A

IEC 60601-1-11

18
Q

tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

A

IEC 60601-1-8

19
Q

Collateral standard: Usability

A

IEC 60601-1-6

20
Q

Collateral standard: Electromagnetic disturbances – Requirements and tests

A

IEC 60601-1-2

21
Q

General requirements for basic safety and essential performance

A

IEC 60601-1

22
Q

Protocols for EtO sterilization are found in?

A

ISO 11135:2014

23
Q

ISO 11135:2014 contains what?

A

Protocols for EtO sterilization

FDA standards (1 decks)

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