ASTM D638: Standard Test Method for Tensile Properties of Plastics

Recognized editions of ASTM D638

FDA recognitions of ASTM D638, newest first (FDA database snapshot of 2026-09-01)

Recognition	Edition	Entered	Extent	Transition ends
8-403	ASTM D638-14	2016-04-04	Complete	—

Regulations

FDA lists these classification regulations against ASTM D638: 21 CFR 888.3160, 21 CFR 888.3310, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3390, 21 CFR 888.3410, 21 CFR 888.3490, 21 CFR 888.3500, 21 CFR 888.3510, 21 CFR 888.3520, 21 CFR 888.3530, 21 CFR 888.3535, 21 CFR 888.3540, 21 CFR 888.3560, 21 CFR 888.3650, 21 CFR 888.3660, 21 CFR 888.3670, 21 CFR 888.3800, 21 CFR 888.3810.

Product codes that cite ASTM D638

36 FDA product codes cite ASTM D638, including HRY, HSX, JDB, JDI, JWH.

• HRY
• HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
• JDB
• JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
• JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
• JWI
• JWJ
• KMB
• KMC
• KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
• KRR
• KTX
• KWM
• KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
• KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
• KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
• KWZ
• KXE
• KYK
• LGE
• LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
• MAY
• MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
• MBL
• MBV
• MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
• NJD
• NPJ
• OCG
• OIY
• OQG
• OQH
• OQI
• PAO
• PBI

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.