PELOPOR TEKNOLOGI IMPLANTINDO Ww propor rexnotost heart i IMPLANTINDO ASSURANCE Jl. Raya Cinandang No. 100, Desa Cinandang, Kec. Dawar Blandong, Kab. Mojokerto DEPARTMENT eterensi No Inspection Gertfeate EN 10204-3.1 B cuetomer Pages) lorderNo. = Product TENSILE TEST BAR FORIMPLANT —[DrawingNo.:~ FrechnicalRea. =~ castngTolerance ASTM EBM Materia Aisi gt6L Revision ~ Mechanical Test ASTMA3TO Machining Tolerance =: ASTM EBM eting Process = High Frequency Induction Fumace Melting eat Treatment: Homogenizing (Heating until 1100 °C; Holding for 60 mins; Water Quenching) Wateral Testing Report Produc: Dewvery Conciot Chemical Composition Mechanical Properties Tem] Heat] Ouantiy] Un cpa pm). )>s)ca N «| w VS] TS | EL | AB No No. (Pes) | Weight wt | %wt | %wt | %wt | % wt % wt wt wt (Pa) % (9) Iirin [ 0,0000[ 0.0000] 0,000] 0,000] 0,0000| 17,0000) 13,0000] 2.2500] Imax | 0.0300] 0.7500] 2.0000] 0.0250] 0.0100] 19.0000] —15 0000} 3.0000 7 [508006 0.0232] 0.6900] 0.7910] o,024e| 0.0051] 16,0800] 13.1200] 2.5500 317,000 | Sea-140 | 0,800] 175 [te penton Conon Tes OSE TS COST ays Fest eS ZABOTT TAR Ta Min Tat as Te Date Prepared by, Independent ifopector Apri 08,2019 (Spectrgfacter Analyst) (QAD Manager) SQraAD-O0SAT z z= = = I e I 7 I * ‘Sy PT. PELOPOR TEKNOLOGI MACHINING t IMPLANTINDO DRAWING | DRAWING b 1.75 Leo ou 1 0 2.80 min, ee / tol y \ og Ts & DETAIL B 3 SCALE 8:1 +0.058 3.50+0.010 4.62 DETAIL C SCALE 4:1 = 14,16, 18,20, 22, 24,26, 28,50, 32.34, 38,40, A Ab 8, 5,52 54,56, 58, 60 62.64, 68, 70,7274, 76, 7,80, 82, 64,66, BB, 90. 92,94, 96,98 100, 102,104, 106, ww Pm Pe pow Preaertine Ta a a — RT Tanne] PaperS = | =|» | = | | » |Cortex Screw 4.5mm © Gortex 4: Smm fully - A4 aaa [ae a [eg a ae 7] wae c ae pe =m 316L iki 0.00 | 2:1 Ta = = | ne rior oy Crags {pty | cst Areva" Sil 7 I z T z z ¢ z I ? I z showing holst hee revlon Fistory 'SQ4-ENG-00Tb/R7 INSPECTION RECORD SHEET [No Doe = IRS NP-0018/Rev 00 PELOPOR TEKNOLOG! [Process = Final inspection No. Rev + Cortex Seren IMPLANTING © [Date/ Shit: 1-Jub19 PartNo 1 Cones Seren 4S mm Machine No: Final inspection [Drawing No: OWG-IMP-5008, NO] INSPECTION TOOLS) [REGISTRATION NUNGER| NEXT CALIBRATION 1 | D.Caper 360 mm ‘OK_i_NOTOK 2 ‘OKs NOTOK 3.|__ inspeaton Ji ‘Oki NOTOK 4 OK {NOT OK Skeich 3] opt pre, 60. fo LPL AL DED. 8 No | Control item STANDARD var uxur f ACTURL BENSON T [800 |OmensrnAsKOANTARA_7=5 a0 D.Calper_| 790 | 780 | 790 2 [2.80 [onsensi anna 200 D.Calper_| 2.80 | 280 | 290 3 [450 [ontens nASuKDANTARA 45450 D.Galper | 450 | 440 | 4.45 4 [Panjang [Omens rawawa scAew SeSuN D.Caler | 35 | 35 | 35 ir JouKuR MENGUNAKAN THREAD RING GAUGE DENGAN SESUAIOMENSIAS ‘Thread Ring 5] ui zn eau | oK | o« | ox 7 | Warking | ERORPAT WARRING PADA PERMUKAAN BENDA KERIA Visual ox | 0K | ox © | _Surtace ” YSUALPERIGAN ROR FOUSRNG TOK OPERGGTERANAGRSTATERT | —veuay | OK | OK | OK ‘OTYTOTAL| GTYOK Reject ae ‘SPv.a6 Seting [Machine] wan [Maer S00; - . - 7-7] - 1504 ENG 0017 Rev. 00vy) PPO TEMG fe eam ences IMPLANTINDO © tequn prasetyoept-pti.com Pengujian Komposisi Material **""" Measure Date Tine | Recalculation Date Time | Method Name ‘ram0%9 1000.36AM | 2022010 10:17:50 AM Fear Sample Name Sample id Furnace Inspector ‘ality sant ‘502006 30 Bag ‘NSTSTL implant Elements Cone. cs c St Mn P 5 or Me % % % % % % % Gone. Gone. ‘Cone. Gone. Cone. Gone. ‘Cone. 7 0022 64 0701 0076 0.0082 2004 255 2 0241 0638 072 0.026 ‘0.0055 2007 255 cs 00? 088 ‘ore 006 ‘o005% Ta98 255 Mo Ni a o cu Nb T v % % % % % % % Cone. Cone. Cone. Cone. one. Cone. Cone. 1 23 ‘0.084 008 47s ‘ow? ows 006% 2 a2 1.0050 0309 as ‘0.0087 ow oosi7 ccd a2 0.0072 0408 0975 ‘0.0800 oor? 0.0617 W.max 15.00 0.500 Ta w Pb Sn Ae Ca Sb ‘Se % % % % % % % Cone. Cone. Cone. Cone. Cone. ‘Cone. ‘Cone. 7 D018 0007 a1 ante aa007 ante 0082 2 aoise 07a oie =0.0020 ‘0018 ‘eau? 0.0088 Prepared Approval | > __Angda PrasetyoK __Auffaur Rahman A.KEMENTERIAN RISET, TEKNOLOGI DAN PENDIDIKAN TING! LABORATORIUM METALURGI DEPARTEMEN TEKNIK MESIN FTI-ITS ‘Kampus ITS Keputth Sukolio Surabaya 60111 ‘Telpifax: 031 591 5060 email: metalmesin@me.its.c id HAN TESTING REPORT Se ‘Tanggal Nomar taoran | os4Ms - METILP 2019 is 26 Februari 2019 Dibuat untuk | PT. PELOPOR TEKNOLOGI IMPLANTINDO Conducted for _ | Desa Cinandang, Dawar Blandong ~ Kab. Mojokerto Proyek QC ‘Material ‘Material AISI 316 L Kode |, Hl, Ill ‘Tempat Pengujian Laboratorium Metalurgi, DepartemenTeknik Mesin FTI —ITS Place of testing _ ‘Tanggal Pequjian | Mulai ‘Selesai Date oftestng | Start 25 Februari 2019 Co ettetion 26 Februari 2019 denis Pe jian ‘Type of test Uji Tarik Material - Ee Mesin Uji Universal“ WOLPERT” Kapasitas 300 kN HASIL PENGUJIAN RESULT | | No Nama Barang Yield | Tensile | Elongation (Nim?) | (Nimm) | (%) I AIST 316L 317.00 | 592.14 [408 HalamanIMPLANTINDO teguh.prasetyo@pt-pticom Yo PELOPOR TEKNOLOGL © Soares ae Meets Yang Bertanda tangan dibawah ini Nama Auliaur Rahman Aminuddin Jabatan : Penanggung Jawab Teknis Alamat Perusahaan : Desa Cinandang, Kec. Dawar Blandong, Kab. Mojokerto Berdasarkan hasil uji komposisi dan test uji Tarik maka menyatakan bahwa produk telah memenuhi standar ASTM Medical Device. Auliaur Rahman Aminuddin