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The scope of ISO 21534

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QuaffReg

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Hi all,

Wish to everyone a happy and sweet new year !

I am having a doubt on the scope of ISO 21534 standard. Hope someone can help.
Indeed, it says : "This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant" "
And therefore, I am wondering if this standard is applicable for othopaedic screws and cement restrictors/plugs used with cemented prosthesis.

What do you think ?

Thanks in advance !
 
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