Standardized CRC
Standardized Clinical Reprocessing Cycles
Typical reprocessing parameters for healthcare facilities in the US and Canada differ significantly from those in the UK and European Union.
To address these differences, SteriLogix has established Standardized Clinical Reprocessing Cycles (SCRC) for laboratory studies that reflect the most commonly used parameters in these regions.
Recommended Standardized Cycles For Lab Studies In North America
Pre-Wash And Enzymatic Ultrasonic
- Tap Water Rinse
- Enzymatic Soak at 104ºF for 10 minutes
- Ultrasonic Wash at 104ºF for 15 minutes
- Hot Water Rinse
- Forced Air Dry
Enzymatic Autowash
- 2 Minute Prewash
- 10 Minute Neutral Enzyme Wash
- Critical Water Rinse / Thermal Disinfect
- 20 Minute Dry Cycle at 240ºF
Autoclave Steam Sterilization
- Pre-vacuum Sterilization for 4 Minutes at 273ºF
- 30 Minute Autoclave Dry Cycle
- Forced Air Cool
Recommended Standardized Cycles For Lab Studies In The European Union & United Kingdom
Pre-Wash And Enzymatic Ultrasonic
- Tap Water Rinse
- Enzymatic Soak at 104ºF for 10 minutes
- Ultrasonic Wash at 104ºF for 15 minutes
- Hot Water Rinse
- Forced Air Dry
Alkaline Autowash
- 2 Minute Prewash
- 10 Minute Alkaline Wash
- Critical Water Rinse / Thermal Disinfect
- 20 Minute Dry Cycle at 240ºF
Autoclave Steam Sterilization
- Pre-vacuum Sterilization for an 18-minute charge at 275ºF
- 30 Minute Autoclave Dry Cycle
- Forced Air Cool
Depending on where your device is marketed, we recommend conducting your test in accordance with the respective SCRC parameters described above.
Additional Information
Learn More About Steps & Services
Life Cycle Testing
Life cycle testing repeatedly exposes a device to the manufacturer’s prescribed reprocessing procedures (or accepted industry standard procedures), and thereby effectively ages the parts to simulate a lifetime of use. SteriLogix is exceedingly efficient at conducting these high-cycle tests for our clients.
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Regulatory Compliance
FDA guidelines state that labeling for reusable medical devices should either tell users the device's limits of reuse or inform the user how to tell when the device has reached the end of its lifecycle.
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Steps & Services
SteriLogix delivers a complete package of steps and services. By using Standardized Clinical Reprocessing Cycle testing of surgical instruments, your products and materials are brought to market more efficiently and you experience a higher level of confidence in the end result.
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