ISO 14971-2019 EN ISO 149712019 ISOTR 249712020 医疗器械 风险管理对医疗器械的应用法规策划.docx

Confidentiality: ISO 14971:2019 EN ISO 14971:2019 ISO/TR 24971:2020 法规策划 状态 版本 A/0 签核 日期 编制： 审核： 批准： Confidentiality: PAGE88 / 91 ISO 14971: 2019 EN ISO 14971: 2019 ISO/TR 24971: 2020 Planning Program Purpose 目的 ISO 14971: 2019, EN ISO 14971: 2019 standards were released in 2019, and ISO/TR 24971: 2020 was released in 2020. Through planning, understand the changes between the latest standards and previous standards, evaluate the impact of this change on the company