YY 0333-2010 Soft一tissue exPander device

Standard Number: YY 0333-2010(YY0333-2010)
Chinese:软组织扩张器
English:Soft一tissue exPander device

Effective Date:2012-06-01
ICS:11.040.30
Standard Applicability:This standard applies to single-use saline-fillable, soft-tissue expanders that are used intraoperatively or removed within 6 months of implantation. This Standard applies only to soft-tissue expanders made of elastomeric shells and does not include any customized soft-tissue expanders manufactured to other standards. For “expander/breast” combination devices, this standard applies (see also 4.3).

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