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ISO 21534:2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Non-active surgical implants Joint replacement implants Particular requirements
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
01-10-2018
English, French
08-11-2002
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, hereinafter referred to as implants.
It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
Some tests required to demonstrate compliance with this International Standard are contained in or referenced in level 3 standards.
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