This standard specifies the definition, requirements, design, manufacturing, inspection rules, sterilization and packaging, and information requirements provided by the manufacturer of additively manufactured (3D printing) customized orthopedic surgical guides (hereinafter referred to as guides). This standard applies to guide plates designed and manufactured through additive manufacturing (3D printing) customized technology and used to accurately guide surgical operations in orthopedics. Guide plates manufactured by other processing methods can refer to this standard.