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1. Recommendations on requirements for clean rooms production of medical equipment.
ISO 13485 is a management system standard for the field of manufacturing medical devices and supplies. The clean room requirement is one of the important requirements to note in this standard.
Clean room is divided into 4 levels:
- Type A: Low risk.
- Type B: Low average risk.
- Type C: High average risk level.
- Type D: High level of risk.
For in-depth reference and details, Customers can visit the link: http://icert.vn/khuyen-cao-ve-yeu-cau-phong-sach-san-xuat-trang-thiet-bi-y-te.htm