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PEEK Medical Grades
PEEK (polyetheretherketone) is the reference polymer for load-bearing medical implants. It is radiolucent so implants appear clearly under X-ray, inert in body fluid, and retains its mechanical properties at autoclave temperatures. This page lists 5 medical grades from 1 manufacturers with the specific standards each one is qualified to.
All PEEK Grades from medical (5)
5 grades indexed for MEDICAL PEEK. Each grade page lists its document set (TDS / SDS / UL / COA) and supply terms.
| Grade | URL slug |
|---|---|
| VESTAKEEP i4 PL (板/棒) PEEK Medical Grade | vestakeep-i4-pl |
| VESTAKEEP iC 4506 R (6% 硫酸钡) PEEK Medical Grade | vestakeep-ic-4506-r-6 |
| VESTAKEEP iC 4800 R PEEK Medical Grade | vestakeep-ic-4800-r |
| VESTAKEEP iC4800 3DF (3D 打印丝, 含磷酸钙) PEEK Medical Grade | vestakeep-ic4800-3df-3d |
| VESTAKEEP iC4800 G (高粘) PEEK Medical Grade | vestakeep-ic4800-g |
Grades and Their Compliance
| Grade | Manufacturer | Standards | Typical applications |
|---|---|---|---|
| VESTAKEEP iC4800 G (高粘) | Evonik Industries AG | ISO 10993 (Part 3/5/6/10/11/12) USP Class VI | 永久植入, 脊椎, 骨科 |
| VESTAKEEP iC 4506 R (6% 硫酸钡) | Evonik Industries AG | ISO 10993 (Part 3/5/6/10/11/12) USP Class VI | 牙科 X 光可见, 牙齿应用 |
| VESTAKEEP i4 PL (板/棒) | Evonik Industries AG | ASTM F2026 ISO 10993 (Part 3/5/6/10/11/12) USP Class VI | 永久植入, 脊椎融合器 |
| VESTAKEEP iC 4800 R | Evonik Industries AG | ISO 10993 (Part 3/5/6/10/11/12) USP Class VI | 永久植入 |
| VESTAKEEP iC4800 3DF (3D 打印丝, 含磷酸钙) | Evonik Industries AG | ISO 10993 USP Class VI ASTM F2026 | 3D 打印骨整合植入物 (脊椎/面部/支架/瓣膜) |
Standards Covered
| Standard | Grades | Qualifying grades |
|---|---|---|
| ASTM F2026 | 2 | VESTAKEEP i4 PL (板/棒), VESTAKEEP iC4800 3DF (3D 打印丝, 含磷酸钙) |
| ISO 10993 | 1 | VESTAKEEP iC4800 3DF (3D 打印丝, 含磷酸钙) |
| ISO 10993 (Part 3/5/6/10/11/12) | 4 | VESTAKEEP iC4800 G (高粘), VESTAKEEP iC 4506 R (6% 硫酸钡), VESTAKEEP i4 PL (板/棒), VESTAKEEP iC 4800 R |
| USP Class VI | 5 | VESTAKEEP iC4800 G (高粘), VESTAKEEP iC 4506 R (6% 硫酸钡), VESTAKEEP i4 PL (板/棒), VESTAKEEP iC 4800 R, VESTAKEEP iC4800 3DF (3D 打印丝, 含磷酸钙) |
What ISO 10993 and USP Class VI Cover
- ISO 10993 — the international biocompatibility series. Part 3 covers cytotoxicity, Part 5 sensitization, Part 6 local intolerance, and Parts 10–12 cover irritation, systemic toxicity and pyrogen testing. Implant grades are qualified across all of them.
- USP Class VI — the US Pharmacopeia biological evaluation for plastics used in drug packaging and medical devices, requiring complete toxicity studies on the finished polymer.
- ASTM F2026 — standard specification for PEEK surgical implant systems, covering extrinsic contaminants and the sterilisation and packaging performance the finished implant must survive.
- FDA filings — 21 CFR 177.2410 covers PEEK resin for medical devices; individual grades additionally appear in 510(k) device clearances.
Related PEEK Compliance
For the full PEEK documentation index across all manufacturers, see PEEK compliance documents.
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