YY/T 0567.7-2016 Active
YY/T 0567.7-2016 Aseptic processing of health care products—Part 7:Alternative processes for medical devices and combination products
Abstract
This standard specifies the requirements and provides guidance for the simulation production alternative method for confirming the sterile processing performance of medical devices and combination products that cannot be subjected to final sterilization and are not suitable for the simulation production method specified in YY/T 0567.1-2013.
This standard applies to the use of risk assessment to design simulation production studies for medical devices and combination products during the development of sterile processing, when it is not allowed to directly use culture media substitutes in the processing or when culture media cannot substitute for actual sterile processing.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0567.7-2016 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2017-06-01 |