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SPD Technician Sterilizing 3D Printed Medical Devices

Sterilize 3D Printed Materials in the V‑PRO™ maX 2 Low Temperature Sterilization System

The One and Only with 3D Specialty Cycles

  • The V-PRO maX 2 Low Temperature Sterilizer is the only healthcare sterilizer cleared and validated for select 3D printed materials.
  • Process a broader range of items, including 3D printed models and surgical guides*, often used within the sterile field during procedures.

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Examples of 3D Printed Medical Devices

3D printed orthopedic materials

ANATOMICAL MODELS help surgeons prepare for complex procedures, including Orthopedic and tumor excision surgeries.

3D printed surgical guides

PATIENT-SPECIFIC SURGICAL GUIDES help support increased accuracy and contribute to reduced surgery times.

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How to Sterilize 3D Printed Medical Devices

Based on the material type, there are three Specialty Cycle options to choose from: Specialty D Cycle, Specialty E Cycle, or Specialty F Cycle. Refer to the Operator Manual for additional details regarding cleared indications and cycle selection.

3D sterilization capabilities

3D Printed Medical Devices
Sterilized 3D Printed Medical Devices

The Specialty Cycle can sterilize patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures. Surgical guides and anatomical models should be printed in accordance with their FDA cleared indications for use and printed in accordance with the manufacturer’s printing and post-processing instructions to include printing, curing, removal of support material, and cleaning.

  • Devices should be thoroughly cleaned, rinsed, and dried before sterilization
  • Prolystica 2X Concentrate Neutral Detergent and Prolystica HP Neutral Detergent are validated for cleaning 3D printed medical devices in the Specialty Cycle
  • 3D printed devices must be single-pouched for processing
  • No other device load should be processed with 3D printed devices
  • After proper loading, select the appropriate Specialty Cycle on the sterilizer touchpad
  • Devices are available for immediate use after sterilization.

See Appendix V-PRO maX 2 Sterilizer Specialty Cycle Material Selection and Use in the V-PRO maX 2 Sterilizer Operator Manual (10085897) for complete Cycle Material Selection and Use. Find STERIS Operator Manuals Here

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APPROVED RESINS FOR 3D PROCESSING

STERIS has partnered with leading 3D printer manufacturers to offer this innovative and validated solution.

Material Printer(s) Manufacturer Specialty Cycle Lumen Inner Diameter (ID) x Length (L)
BioMed Amber Resin Form 3B, Form 3B+, Form 3BL Formlabs F ≥3 mm ID x ≤30 mm L
BioMed Clear Resin Form 3B, Form 3B+, Form 3BL Formlabs D ≥3 mm ID x ≤30 mm L
Biocompatible Clear MED610 J720™ Dental,
J750™ 3D,
J750™ Digital Anatomy,
J850™ Digital Anatomy
Stratasys E ≥3 mm ID x ≤20 mm L
Biocompatible Opaque MED615RGD J750™ 3D,
J750™ Digital Anatomy,
J850™ Digital Anatomy
Stratasys E ≥3 mm ID x ≤20 mm L
VeroGlaze™ MED620 J720™ Dental,
J750™ 3D
Stratasys E ≥3 mm ID x ≤20 mm L

*implants not included

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