01
steam / ETO
Sterilization
Reusable devices and housings need validation of heat, ETO and cleaning agents.
post-sterilization
MEDICAL DEVICES
Cleanability, sterilization and reliable molding
Medical housings, injection pens and masks require a structured review of biocompatibility, sterilization, chemical resistance and optical clarity.
Class IIa
CM9610PF source direction
V-0
@1.5 mm
<0.1%
PPO water absorption
FDA
PX54F0HR data
Operating conditions
Four critical conditions for Medical devices
Each section follows the failure path for this application. Final targets depend on part design, wall thickness and the customer test plan.
02
ISO 10993
Biocompatibility
Contact duration and route determine the required biological tests.
ISO 10993
03
low defect
Clarity and appearance
Injection pens, masks and windows need clarity, low haze and stable color.
precision molding
04
low extraction
Chemical cleaning
Alcohols and disinfectants must not cause stress cracking or unacceptable extraction.
chemical resistance
Recommended materials
Recommended grades and data for Medical devices
Data is sourced from product pages and technical documents. The series, suffix, color and thickness must be locked in the controlled TDS.
FR route
CM9610PF
PFAS-free FR PC · FR medical-device housing
Key data
FR route
CM9610PF
PFAS-free FR PC · FR medical-device housing
- Flame
- V-0 @1.5 mm
- Regulation
- PFAS/PTFE/bromine-free
- Sterilization
- autoclave direction
- Compliance
- RoHS / REACH / SCIP / UL
Product data identifies Class IIa medical and autoclave directions; verify the final color and biocompatibility report.
Low-absorption option
PX54F0HR
Modified PPO / PPE · Control bays and precision medical structures
- Flame
- UL94 V-0
- Water absorption
- <0.1%
- Certification
- FDA / RoHS / REACH / ELV
- Electrical
- low dielectric loss
Medical devices are listed in the product page, but contact class and sterilization still require verification.
Project validation
CM2610
PC · Transparent, colorable medical platform
- Base
- polycarbonate
- FR family
- HB / V2
- Appearance
- natural, black, custom
- Compliance
- RoHS / REACH
A candidate PC platform; medical grade, ISO 10993 and sterilization claims require the matching suffix TDS.
CM9610PF · Source: content-inventory: CM9610PF product page
PX54F0HR · Source: content-inventory: PX54F0HR product page
CM2610 · Source: content-inventory: CM2610 product page
Validation & certification
Define contact classification before selecting a grade
Biocompatibility, sterilization cycles, cleaning agents and clarity are project inputs; 'medical grade' alone is insufficient.
ISO 10993
Biocompatibility
Select tests by contact duration and route.
Steam / ETO
Sterilization
Validate dimensions, color, mechanics and chemistry after cycling.
V-0 @1.5 mm
Flame
CM9610PF product direction; confirm by housing standard.
FDA / RoHS / REACH
Compliance
Match certificates and migration data to the final part.
ISO9001:2015IATF16949RoHSREACH
Public data and certificates do not replace project validation. Results apply only to the tested grade, color, thickness, specimen and conditions.
Technical data request
Request the controlled TDS for CM9610PF
Share the part, operating conditions and targets. A specialist will verify suffix, thickness, regulations and test conditions before sending the document.
Application inquiry
Discuss Medical devices with our team
More complete inputs move the project faster into sample and validation work.
- Device class and contact
- Sterilization method and cycles
- Clarity and color
- Disinfectant exposure
Need general material guidance or company information?