YY/T 0567.6-2022 Active
YY/T 0567.6-2022 Aseptic processing of health care products—Part 6:Isolator systems
Abstract
This document specifies the requirements for isolator systems used in the aseptic processing of healthcare products, including aspects such as standardization, selection, validation, biological decontamination, confirmation, operation, and control, and provides relevant guidelines.
This document applies to isolator systems used in the aseptic processing of healthcare products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not specify requirements for isolators used in aseptic inspections, but some principles and information contained in this document can also be applied to related applications.
This document does not apply to biosafety protection.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0567.6-2022 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2024-03-01 |