Standard Number: YY/T 0726-2020(YY/T0726-2020)
Chinese:无源外科植入物联用器械 通用要求
English:Instrumentation for use in association with non-active surgical implants – General requirements
Effective Date:2021-06-01
ICS:11.040.40
Standard Applicability:This standard specifies general requirements for passive surgical implant-linked devices, including requirements for expected performance, design attributes, material selection, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information. This standard applies to newly manufactured devices and devices returned for repair and resupply, as well as to devices coupled to power-driven systems. This standard does not apply to power-driven systems per se or to instruments coupled to dental implants, transcanal implants and ophthalmic implants.
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