TCVN TIEU CHUAN QUOC GIA TCVN 8027:2009 ISO/TR 16142 : 2006 Xudt ban lan 4 TRANG THIET BI Y TE - HUONG DAN LUA CHON TIEU CHUAN HO TRO’ NGUYEN TAC THIET YEU VE AN TOAN VA TINH NANG CUA TRANG THIET BI Y TE Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices HA NO! - 2009TCVN 8027 : 2009 Muc tye Loi noi dau... “ Loi gidi thiéu... 1 Pham vi ap dung.... 7 2 Thuat ng@ va dinh nghia 7 3 Nguyén tdc thiét yu vé an toan va tinh nding cia trang thidt bi y t6.. 8 4. Sir dung cc tidu chudn va chi dan hé tre cdc yéu cu ludt dinh..... 8 5 Nguyén téc thiét yéu vign dan tiéu chudn hoge chi dn lién quan. 6 Céch tim cac tiéu chuan.. Phy tye A (tham khdo) - Bang lin quan gira cdc nguyén tc co ban va tiéu chuén.... Phy luc B (tham khdo) - Cac vi dy vién dan vé tiéu chuan o¢ bain... Phy luc C (tham khdo) - Danh sach cac trang web vé cac tiéu chudn phi hgp voi khu vyc trang thiét bj y té va mye dich anh gid. Phy luc D (tham khao) - Théng tin v8 Global Harmonization Task Force. ‘Thur myc tai ligu tham khdo.TCVN 8027 : 2009 Lei noi dau TCVN 8027 : 2009 hoan toan tuong duong véi ISO/TR 16142:2006. TCVN 8027 : 2009 do Vién Trang thiét bj va Céng trinh y té bién soan, BO Y té a8 nghi, Téng cyc Tiéu chudn Bo luéng Chat lvgng thdm dinh, B6 Khoa hee va Céng nghé cong bd.