Applicable standards for CE marking of Spinal Intervertebral Body Fixation Devices

S

Shibukallidukkil

Registered
#1
#1
Can anybody help me to identify applicable harmonized standards CE marking of "Spinal Intervertebral Body Fixation" device , there are not much standards related to spine implants are available in the harmonized standard list.
 
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bio_subbu

bio_subbu

Super Moderator
#2
#2
Re: Applicable standards for CE marking of Spinal Intervertebral Body Fixation Device

Shibukallidukkil said:
Can anybody help me to identify applicable harmonized standards CE marking of "Spinal Intervertebral Body Fixation" device , there are not much standards related to spine implants are available in the harmonized standard list.
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The use of European Harmonized Standards application is voluntary, if you do not found any relevant standards in the EU harmonized standards list, you may want to choose an alternative route to use applicable International Standards such as EN, CEN, ISO or IEC standards to justify the relevant ERs are satisfied in order to meet the mandatory essential health and safety requirements. Notified Bodies verify the appropriateness of the standards used when conducting evaluation.
 
somashekar

somashekar

Staff member
Super Moderator
#3
#3
Re: Applicable standards for CE marking of Spinal Intervertebral Body Fixation Device

ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F2193-02 (Reapproved 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
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These may be helpful to you
 
S

Shibukallidukkil

Registered
#4
#4
Re: Applicable standards for CE marking of Spinal Intervertebral Body Fixation Device

thanks a lot subbu & somashekar.

I also found these ASTM standards in FDA Recognized Consensus Standards, but was not sure whether i can use this for the CE Marking purpose. so now i believe that we can use this o justify the relevant ERs.
 
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