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

Regulatory Compliance Documentation