NEE Qualified Process List
New England Electropolishing
NEE’s processes are fully conforming to the following recognized standards and specifications:
ISO 9001: Quality Management Systems – Requirements
ISO 13485: Medical Devices – Quality Management Systems – Requirements for regulatory purposes
ISO 15730: Metallic and Other Inorganic Coatings – Electropolishing as a means of smoothing and passivation of stainless steel
FDA 21 CFR 820: Food and Drugs – Medical Devices – Quality System Regulation
ASTM B912: Standard Specification for Passivation of Stainless Steels Using Electropolishing
ASTM A967: Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts
ASTM A380: Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
ASTM F86: Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
ASTM F1089: Standard Test Method for Corrosion of Surgical Instruments
QQ-P-35 C: Federal Specification Passivation Treatments for Corrosion-Resistant Steel
ASME BPE: Bioprocessing Equipment
AD-1033: Naval Air Systems Command Department of the Navy Advisory Instructions for Electropolishing
SAE AMS2700: Passivation of Corrosion Resistant Steels
AMS-STD-753: Corrosion-Resistant Steel Parts: Sampling, Inspection and Testing for Surface Passivation
PRC-5009 (NASA): Process Specification for Electropolishing of Corrosion Resistant Steel