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

Certifications & Validations

electropolishing stainless steel

ISO 9001

Download our ISO 9001 Certificate

electropolishing stainless steel

ISO 13485

Download our ISO 13485 Certificate

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ITAR Registration

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itar registration

Conflict Minerals

Download our Conflict Minerals Certificate of Compliance

electropolishing stainless steel

REACH

Download our REACH Certificate of Compliance

electropolishing stainless steel

RoHS

Download our RoHS Certificate of Compliance

prop 65

Proposition 65

Download our Prop 65 Certificate of Compliance

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BSE/TSE*

Download our Latex and Animal Derived Component (BSE/TSE*) Compliance Certificate