Statement on STERRAD NX Sterilization of Richard Wolf Medical devices

December 2009

Dear Valued Customer,

This letter is to inform our customers that the Richard Wolf medical devices listed below
have been validated for use in the following STERRAD Systems, manufactured by
Advanced Sterilization Products, a Johnson & Johnson Company:
STERRAD 50 Systems
STERRAD 200 Systems
STERRAD 100S Systems
STERRAD NX Systems
Testing was performed in accordance with the AAMI TIR No. 12 guidelines, Designing,
Testing and Labeling Reusable Medical devices for Reprocessing in Health Care Facilities A
Guide for Medical device Manufacturers.
The STERRAD Systems 50, 200 and 100S have been approved for sterilization of Richard
Wolf instruments many years ago see the Manuals for Reprocessing of Richard Wolf heat
stable Instruments GA-J020 and Reprocessing of Richard Wolf heat sensitive Instruments
GA-J050.
Richard Wolf has also validated the material and functional compatibility of the listed medical
devices by 100 cycles in the STERRAD NX System. Prior to each use the medical device
should be inspected for damage. If any damage or deterioration of the medical device is
observed, its use must be discontinued and it must be sent to Richard Wolf for inspection.
By no means may the device be used in case of defects or damage noted during the
inspection the medical must not be used.
Medical devices that have successfully completed both compatibility and efficacy testing will
also be listed on ASPs Sterility Guide. http://www.sterradsterilityguide.com/
Please refer to the STERRAD System Users Guide for general reprocessing instructions,
including proper cleaning and drying, and packaging information prior to reprocessing any
medical device in a STERRAD System. Specific sterilization questions should be made
directly to Advanced Sterilization Products.
See: http://www.aspjj.com/Products_&_Services/STERRAD/
It is important to note that Richard Wolf GmbH cannot guarantee that any medical device
repaired by a third party company will be compatible in a STERRAD Sterilization System.

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If you have any questions concerning the reprocessing of your medical devices, please do
not hesitate to contact our Product Manager and Hygiene Expert, Helmi W. Henn at 00497043-35-144 or at helmi.henn@richard-wolf.com

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Medical devices validated for use in STERRADSystems

Fiberscopes
Fiberscopes which are purchased after 01.01.2009 are compatible to the STERRAD NX
System by 100 Cycles.
Note: Richard Wolf is not liable for any damage caused by the interaction between various
sterilization methods.

Dimensions
ID mm x WL mm

STERRAD
50, 200,
100S

7308.066
7308.0664
7325.071
7325.076
7325.122
7325.152
7325.172
7330.052
7330.072

Flexible Nasopharyngo-Laryngoscopes
Flexible Nasopharyngo-Laryngoscopes
Flexible Bronchoscope
Flexible Cystoscope
Flexible Cystoscope
Flexible Endoscope
Flexible Video-Cystoscope
Flexible Video-Cystoscope
Flexible Video-Cystoscope
Flexible Video-Cystoscope
Flexible Ureteroscope - Viper
Flexible Ureteroscope - Viper
Flexible Endoscope
Flexible Endoscope
Flexible Endoscope
Flexible Endoscope
Flexibe Endoscope

0 x 300
1,1 x 300
2,5 x 600
2,5 x 400
2,5 x 400
2,5 x 280
2,0 x 400
2,0 x 400
2,0 x 400
2,0 x 400
1,2 x 850
1,2 x 850
1,2 x 200
1,2 x 450
1,2 x 700
1,5 x 450
1,5 x 700

ww
OUS
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OUS
OUS
OUS
OUS
OUS
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OUS

ww
ww
ww
ww
ww
ww
ww
ww
ww
ww
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73100664
73100614

LED Video Cystoscope

LED Video Cystoscope

2,0 x 400
2,0 x 400

OUS
OUS

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Ref/Device
code

Device Name

7224.001
7223.001
7265.006
7305.001
7305.006
7305.011
7308.061

7308.0614

STERRAD
NX

Cameras
Ref/Product code

Product Name

85550.913
85550.975

HD Camera Head
HD Camera Head

ww= worldwide, OUS = Outside US only

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STERRAD
50, 200, 100S
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STERRADNX
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