PCB Regulatory Frameworks & Compliance 5

Question 1

A PCB designed for a Class III medical device in the US must be manufactured under which regulatory framework?

Accepted Answer

FDA 21 CFR Part 820 (Quality System Regulation)

Answer

FDA 21 CFR Part 820 (Quality System Regulation, now harmonized with ISO 13485) governs the manufacture of medical devices including their PCBs.

Question 2

Which IPC specification document (slash sheet) would a designer reference when specifying FR-4 laminate material properties?

Accepted Answer

IPC-4101/21

Answer

IPC-4101 with slash sheet /21 specifies the requirements for FR-4 (woven E-glass, epoxy) base laminate materials.

Question 3

What is the maximum concentration of hexavalent chromium (Cr VI) permitted under RoHS in homogeneous materials?

Accepted Answer

1000 ppm

Answer

RoHS limits hexavalent chromium to 1000 ppm (0.1%) by weight in homogeneous materials, the same threshold as lead and mercury.

Question 4

In IPC-A-600 acceptability criteria, what does a 'target condition' represent?

Accepted Answer

The preferred, near-perfect condition exceeding minimum requirements

Answer

IPC-A-600 defines target condition as the preferred, near-perfect state that enhances reliability but is not always achievable in production.

Question 5

Which agency administers the ITAR (International Traffic in Arms Regulations) that affects PCB designs for defense applications?

Accepted Answer

Department of State (DDTC)

Answer

ITAR is administered by the Directorate of Defense Trade Controls (DDTC) within the US Department of State, controlling defense-related exports.

PCB - Design Practice Test