A Complete Guide to PEEK Material Certificates

PEEK (Polyether Ether Ketone) is a high-performance engineering plastic widely used in medical devices, analytical instruments, aerospace, oil & gas, food processing, and semiconductor industries. Due to its critical applications, customers often ask for PEEK certificates before approving materials or finished components.

But what exactly are PEEK certificates? Are they mandatory? And which certificates really matter for your application?

This article provides a clear and practical explanation.

What Does "PEEK Certificate" Mean?

A PEEK certificate is not a single universal document. Instead, it refers to a set of compliance documents, test reports, and quality certifications that verify a PEEK material or PEEK component meets specific regulatory, industry, or customer requirements.

PEEK certificates typically fall into three categories:

• Material compliance certificates

• Quality and traceability certificates

• Application-specific certifications

Common Types of PEEK Certificates Explained

1. Certificate of Analysis (COA)

A Certificate of Analysis (COA) confirms the actual tested properties of a specific production batch, such as:

• Density

• Tensile strength

• Flexural strength

• Melt flow rate (MFR)

• Color or filler content (CF30, GF30, etc.)

COAs are essential when customers require batch traceability and consistent performance.

2. Certificate of Conformance (COC)

A Certificate of Conformance (COC) declares that the supplied PEEK material or part conforms to a referenced specification, such as:

• ASTM D6262

• ISO standards

• Customer-defined technical drawings

COCs are widely used for industrial, aerospace, and oil & gas projects.

3. FDA Compliance Certificates (Medical & Food Contact)

For medical and food-contact applications, PEEK materials may comply with:

• FDA 21 CFR 177.2415 – Food contact

• FDA Master File (MAF) – Medical device reference

• ISO 10993-1 – Biocompatibility evaluation

It is important to note:
FDA does not "certify" PEEK materials—suppliers provide compliance statements based on testing and regulatory alignment.

4. ISO Certifications (Supplier Level)

ISO certificates apply to the manufacturer, not the material itself. Common examples include:

• ISO 9001 – Quality management system

• ISO 13485 – Medical device manufacturing

These certificates demonstrate that the supplier follows controlled, auditable production processes.

5. NORSOK Certification (Oil & Gas)

For harsh offshore environments, PEEK materials may be tested according to:

• NORSOK M-710

This certification is critical for seals, valve parts, and gaskets exposed to chemicals, pressure, and high temperatures.

6. Aerospace & High-Reliability Standards

Some PEEK grades are qualified against:

• ASTM standards

• OEM-specific aerospace specifications

• Military or aviation material standards

These are usually required for structural or safety-critical components.

Do All PEEK Products Need Certificates?

Not necessarily.

The required PEEK certificates depend on end use, market regulations, and customer specifications.

Why PEEK Certificates Matter

PEEK certificates provide:

• Material traceability

• Regulatory confidence

• Risk reduction for end products

• Faster customer approval

• Support for audits and validation

For OEMs and distributors, certificates are often as important as the material itself.

How to Choose the Right PEEK Supplier

When sourcing PEEK materials or machined parts, choose suppliers who can:

• Provide batch-specific COA & COC

• Support FDA & ISO documentation

• Offer technical datasheets

• Maintain long-term traceability records

This ensures smoother qualification and fewer compliance risks.

Final Thoughts

PEEK certificates are not just paperwork—they are a critical bridge between material performance, regulatory compliance, and customer trust.

Understanding which certificates are required helps engineers, purchasers, and quality teams select the right PEEK material for the right application.