Standard Number: YY/T 0567.7-2016(YY/T0567.7-2016)
Chinese:医疗保健产品的无菌加工 第7部分：医疗器械及组合型产品的替代加工
English:Aseptic processing of health care products-Part7:Alternative processes for medical devices and combination products
Effective Date:2017-06-01
ICS:11.080.10
Standard Applicability:This standard specifies the requirements for alternative methods of simulated production for confirmation of aseptic processing performance in medical devices and combination products for which final sterilization is not possible and which are not applicable to the simulated production method of YY/T 0567.1-2013. This standard applies to the use of risk assessment to design simulated production studies for medical devices and combination products during the development of aseptic processing, when the direct use of culture media to replace the product is not permitted in the processing, or when the culture media cannot replace the actual aseptic processing.
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