RAM Industry Regulations & Compliance 2

Question 1

Which MIL-HDBK-217 revision is most commonly referenced for electronic parts reliability prediction in US defense contracts?

Accepted Answer

MIL-HDBK-217F Notice 2

Answer

MIL-HDBK-217F Notice 2 is the most widely cited revision for electronic reliability prediction in defense procurement.

Question 2

Under FDA 21 CFR Part 820, what is the primary purpose of a Design History File (DHF)?

Accepted Answer

To record all design and development history of a finished device

Answer

A DHF contains the records that demonstrate the design was developed in accordance with the approved design plan and regulatory requirements.

Question 3

Which IECEE scheme provides a globally recognized path for demonstrating compliance with IEC standards for electrical and electronic equipment?

Accepted Answer

CB Scheme

Answer

The IECEE CB Scheme enables manufacturers to obtain a single test report accepted by member countries to reduce duplicative testing.

Question 4

What does the 'safe-life' design philosophy require, as regulated in aviation under FAA AC 25.571?

Accepted Answer

Components are retired before they can reach their endurance limit

Answer

Safe-life design mandates that a component is removed from service before it is statistically likely to fail from fatigue.

Question 5

ISO 13849-1 classifies safety function performance using Performance Levels (PL). Which PL corresponds to the highest reliability requirement?

Accepted Answer

PL e

Answer

PL e is the highest category in ISO 13849-1, associated with a probability of dangerous failure per hour (PFHd) below 10⁻⁸.

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