ZAPP MEDICAL ALLOYS MEDICAL TECHNOLOGY
Transcription
ZAPP MEDICAL ALLOYS MEDICAL TECHNOLOGY
ZAPP MEDICAL ALLOYS MEDICAL TECHNOLOGY CONTENTS 03 ZAPP MEDICAL ALLOYS 04 LOGISTICS AND QUALITY 05 PRODUCT PORTFOLIO 06 DELIVERY FORMS 07 SPECIAL IMPLANT MATERIALS 08 IMPLANT MATERIALS MADE OF TITANIUM 09 MATERIALS FOR INSTRUMENTS 10 MATERIALS FOR INSTRUMENTS – MARTENSITIC 11 SPECIAL MATERIALS FOR MEDICAL AND DENTAL 12 ADDRESSES ZAPP MEDICAL ALLOYS SOLUTION PROVIDER ZAPP MEDICAL ALLOYS YOUR PURCHASING DEPARTMENT BENEFITS For decades now, the companies of the Zapp Group have been supplying semi-finished metal products made of stainless steel, titanium and titanium alloys, nickel and cobalt-based alloys, as well as a large number of special materials. Building on this experience with a view to becoming a specialist in medical technology needs, the alignment of Zapp Medical Alloys’ organization is unique to the steel industry: it concentrates exclusively on your metal semi-finished product requirements. Our staff provides you with expert support to help you select the ideal material for your specific application. Across the complete spectrum of product forms – from wires, bars, profiles, strips and sheets to tubes – we offer a comprehensive, continuously expanding range of material solutions comprising our own products as well as trade activities. Along with our extremely broad product portfolio we are able to offer you the technical service and development capabilities of an established manufacturer, saving you the time and expense of a long search for the right partner. Joint developments to address special requirements are part of our everyday business. Take advantage of our expertise: PAGE 3/12 _ Comprehensive application engineering support from the initial idea right through to serial production _ Special material variants created by combining materialspecific product characteristics and sophisticated process engineering to induce particular mechanical/technological properties _ A sales team trained in commercial technology to support your product selection process ZAPP MEDICAL ALLOYS LOGISTICS AND QUALIT Y CERTIFIED TO ISO 9001 LOGISTICS QUALITY The comprehensive distribution and logistics network of the entire Zapp Group is your worldwide guarantee of outstanding service and of the availability of our semifinished products. From America to Scandinavia to China, in production facilities, service centers and sales offices around the globe, our own staff and affiliated partners are at your service to respond as quickly as possible to your delivery requests. We overcome timeconsuming logistical obstacles through the continuous expansion of our distribution network and service centers. Selected partners ensure reliable transport over land, air and sea to deliver our materials to your location on-time. Express delivery services are also available for direct delivery of samples and small lots to meet shortterm needs. We offer a wide range of packaging options specifically designed to facilitate transport and protect quality from the shipping department to the final destination. Products made to satisfy the highest quality demands form the core of our corporate philosophy. It takes raw materials from qualified production sources to manufacture safe and reliable products for the medical and dental industry. Zapp guarantees documented product traceability from the original melt right through to the final semi-finished product. The systematic archiving of documentation and retention samples enables us to assure you unequivocally of the quality of our products, even decades later. And, thanks to our expert staff’s many years of experience in research, development and manufacturing, we offer unsurpassed product reliability that satisfies the extremely sensitive demands placed on medical semi-finished products. We combine validated manufacturing processes with integrated test technology and continuous monitoring by our own trained team of specialists to maintain these high material quality standards. Our products are clearly designed to meet your specifications and comply with qualitative requirements from the relevant standards for medical semi-finished products. Beyond regulatory requirements, the highest quality levels are achieved through specifically targeted chemical compositions in combination with highly specialized process engineering technology. PAGE 4/12 ZAPP MEDICAL ALLOYS | LOGIS TIC S AND QUALITY MEDICAL ALLOYS – PRODUCT PORTFOLIO THESE ALLOYS Special Implant Materials Austenite, AISI 316LVM Austenite, Alloy 734 Austenite, nickel free Co-Ni-Cr-Mo-Alloy, Implant Co-Cr-Mo, Forging Alloy Co-Cr-W-Ni-Alloy Pure Titanium grade 1 Pure Titanium grade 2 Pure Titanium grade 3 Pure Titanium grade 4 Titanium Alloy Ti6AL4V ELI Titanium Alloy Ti15Mo Titanium Alloy Ti6AlNb7 Instrument grades Martensite 13 % Cr, AISI 420A Martensite 13 % Cr, AISI 420B Martensite 13 % Cr, AISI 420X Martensite 13 % Cr, AISI 420C Martensite 13 % Cr, AISI 420C (+S) Martensite 13 % Cr, AISI 420F mod. Martensite 17 % Cr, AISI 430F Martensite 17 % Cr, AISI 431 Martensite 17 % Cr, AISI 440A Martensite 17 % Cr, AISI 440B Martensite 17 % Cr Martensite 17 % Cr, AISI 440C Precipitation hardenable steels Special Alloy 17-4-PH Special Alloy 17-7-PH Special Alloy XM-16, Alloy 455 Austenite Special materials Austenite, nickel-free Co-Ni-Cr-Mo-Alloy, dental Ferrite Austenite Austenite Austenite Austenite Austenite 1.4441 1.4472 9.9007 9.9035 9.9135 9.9605 3.7025 3.7035 3.7055 3.7065 3.7165 9.9150 9.9367 DEVELOPED AND MANUFACTURED FOR YOU FOR YOUR APPLICATION Bars 0.7 - 100 mm drawn, peeled, ground, polished chamfered, centered, pointed annealed, cold worked, stress released straightness 0.5 mm/m on demand up to 0.2 mm/m special surface roughness up to Ra < 0.3 µm ISO 286-2 in tolerances ISO h11 to ISO h05 integrated crack detection bone screw bone nail bone plate intra-medullary nail joint replacement shoulder, hip, knee spinal implant endoprosthesis dental implant maxillofacial surgery vascular surgery cerclage fixation system surgical needle instrument bone saw abrasor rotating instrument dental burr dental cutter orthodontic brace scalpel scissors laboratory equipment stamping and bending part Fine Wire and Premium Wire 0.07 – 20 mm bright drawn, diamond drawn, specially coated ISO 286-2 in tolerances ISO h11 to ISO h05 crack detected products 1.4021 1.4028 1.4031 1.4034 1.4035 1.4197 1.4104 1.4057 9.9440 1.4112 1.4122 1.4125 Profiles 0.3 x 0.3 mm – 63 x 6.35 mm milled, rolled, drawn dull, bright, extreme bright square, hexagonal, octagonal ½, ⅓ and ¼ tube implant-special shapes »near net shape« precision profile according drawing water-jet-cut blank 1.4542 1.4568 1.4543 1.4310 Precision Strip thickness from 0.02 – 2.50 mm width from 2 – 1066 mm sheets up to 6.00 mm thickness cold worked, final annealed tempered 1.4456 9.9035 1.4105 1.4301 1.4303 1.4305 1.4306 1.4571 Plates square or in circular blanks water-jet-cut Tubes thin-walled, seamless < 20 mm drawn, ground PAGE 5/12 ZAPP MEDICAL ALLOYS | PRODUC T PORTFOLIO DELIVERY FORMS WIRE PREMIUM WIRE in coils, on metal carriers, in barrels, on spools in barrels, on spools BAR PROFILE in commercial lengths, in special lengths in coils, in bars, on spools PRECISION STRIP PLATES in coils, on spools, in straightened bars, in sheets in commercial lengths, tailor made BLANKS TUBES in defined geometries, in circular blanks, tailor made in commercial lengths, in special lengths PAGE 6/12 ZAPP MEDICAL ALLOYS | DELIVERY FOR MS SPECIAL IMPLANT MATERIALS _ guarantee of optimized properties relative to corrosion (high PRE), bio-compatibility, fatigue strength and slag purity in re-melted materials _ substitution of nickel (by manganese and nitrogen) in special nickel-free materials for use with patients who have nickel allergies _ extremely high corrosion resistance through the use of special cobalt-based alloys OUTSTANDING QUALITY ADVANTAGES _ large and product-based selection of steel materials, non-ferrous metals, pure titanium and titanium alloys _ chemical compositions in compliance with the requirements of listed national and international standards _ inducement of customer-specific material properties through precisely targeted chemical analysis and special manufacturing processes SPECIAL IMPLANT MATERIALS Brand Name Ergste® 1.4441LA Ergste® 1.4472RN Ergste® 9.9007CN Ergste® 1.4456CA Brand Name Ergste® 9.9035 Ergiloy® 9.9135HL Ergiloy® 9.9605XL Materialnorms ASTM F138 ASTM F139 ISO 5832-1 ASTM F1586 ISO 5832-9 ASTM F2581 C min. max. min. max. min. max. Zappmin. Special Analysis max. Materialnorms ASTM F562 ISO 5832-6 ASTM F1537 (Alloy 1) ISO 5832-12 (Low C) ASTM F90 ISO 5832-5 min. max. min. max. min. max. Si Mn 0.030 0.75 0.080 0.75 0.15 0.20 0.25 0.60 0.10 1.00 C Si 2.00 0.025 0.01 17.00 13.00 2.25 19.00 15.00 3.00 - 2.00 4.25 0.025 0.01 9.50 12.50 0.020 0.01 16.00 20.00 0.05 0.05 19.50 9.00 2.00 22.00 11.00 3.00 16.50 2.70 18.00 0.05 3.70 16.00 1.80 20.00 0.20 2.50 0.25 0.80 - Mn 0.025 0.15 0.15 0.14 1.00 1.00 0.15 0.40 2.00 PAGE 7/12 Chemical Composition (Mass-%) S Cr Ni Mo Nb P P S Chemical Composition (Mass-%) Cr Ni Mo W 0.015 0.01 - 0.04 19.00 33.00 9.00 21.00 37.00 10.50 26.00 5.00 30.00 1.00 7.00 19.00 9.00 0.030 21.00 11.00 - Fe 1.00 0.75 14.00 16.00 3.00 Cu N 0.50 0.10 Fe bal 0.25 0.25 0.50 0.45 0.55 3.00 < 0.1 Ti N Co - bal 0.25 1.00 - - 0.25 - bal bal bal bal bal ZAPP MEDICAL ALLOYS | SPECIAL IMPLANTA T MA TERIALS IMPLANT MATERIALS MADE OF TITANIUM _ improved corrosion resistance properties through special Titanium-Molybdenum-Alloys _ Micro structural modification with extra fine grain size to promote special characteristics in the final product _ From production and ex-warehouse: tightest tolerances, above-average straightness characteristics and the highest surface conditions _ outstanding bio-compatibility OUTSTANDING QUALITY ADVANTAGES _ customized product range for medical devices and dental implants, pure titanium grades 1,2,3,4, remelted TiAl6V4, Ti-15Mo, TiA6lNb7 _ complete range of hardnesses and grain structures – from work hardened to final annealed _ improved mechanical technological properties through sophisticated process engineering, e.g. with pure titanium to increase fatigue strength IMPLANT MATERIALS MADE OF TITANIUM Brand Name Ergitan® 3.7025MG Ergitan® 3.7035MG Ergitan® 3.7055MG Ergitan® 3.7065MG Ergitan® 3.7165MG Ergitan® 9.9150MG Ergitan® 9.9367MG Materialnorms ASTM F67 ISO 5832-2 ASTM F67 ISO 5832-2 ASTM F67 ISO 5832-2 ASTM F67 ISO 5832-2 ASTM F136 ISO 5832-3 ASTM F2066 ISO 5832-14 ASTM F1295 ISO 5832-11 C min. max. min. max. min. max. min. max. min. max. min. max. min. max. Fe O H Chemical Composition (Mass-%) N Al V 0.080 0.20 0.18 0.0125 0.03 0.080 0.30 0.25 0.0125 0.03 0.080 0.30 0.35 0.0125 0.05 0.080 0.50 0.40 0.0125 0.05 0.080 0.25 0.13 0.0120 0.05 0.100 0.10 0.20 0.0150 0.05 0.080 0.25 0.20 0.0090 0.05 PAGE 8/12 Mo Nb Ti - - - - bal - - - - bal - - - - bal - - - - bal 5.5 6.5 - 3.5 4.5 - - - bal - bal 5.5 6.5 - 14.0 16.0 - 6.5 7.5 bal ZAPP MEDICAL ALLOYS | IMPLANT MATERIALS MA DE OF TITA NIUM MATERIALS FOR INSTRUMENTS OUTSTANDING QUALITY ADVANTAGES _ greatest possible variety of hardenable and temperable materials to match the broad spectrum of instruments, mainly for use and applications within the ASTM F 899 _ increased corrosion resistance of grades with 17 %chromium content versus grades with 13 %-chromium _ best corrosion resistance of martensitic grades based on the combination of precision ground surface and induration process _ optimal machinability with slight loss of corrosion resistance in materials containing sulfur _ from production ex-warehouse, especially for rotating instruments: tightest tolerances, above-average straightness characteristics and highest surface conditions _ special high-tech-grades for surgical needles, bone saws, orthodontic braces, reamer and files, burrs, cutters, and much more _ unique special materials, e.g. garde1.4310FE (re-melted), 1.4034YK (high chromium content), or 1.4028MO(+Mo) MARTENSITIC GRADES 13 % Chrome 17 % Chrome Precipitation hardenable austenitic steels 1.4125 1.4125 +S 1.4112 1.4112 +S Hardenability 9.9440 1.4035 +S 1.4123 1.4034 1.4122 1.4031 +S 1.4028 1.4543 1.4310 1.4568 1.4057 1.4197 +S 1.4542 1.4021 Corrosion resistance * hardness according to specific heat treatment from the solution annealed condition PAGE 9/12 ZAPP MEDICAL ALLOYS | MATERIAL S FOR INS TRU ME NTS MATERIALS FOR INSTRUMENTS – MARTENSITIC MATERIALS FOR INSTRUMENTS - MARTENSITIC Brand Name Type ∼ C Ergste® 1.4021YB Ergste® 1.4028YN Ergste® 1.4028MO Ergste® 1.4031YC Ergste® 1.4034YN Ergste® 1.4034YK Ergste® 1.4035YU Ergste® 1.4197YU Ergste® 1.4104YU Ergste® 1.4057YN Ergste® 9.9440YA Ergste® 1.4112YL AISI 420A min. max. AISI 420B min. max. AISI 420B (+Mo) min. max. AISI 420X min. max. AISI 420C min. max. AISI 420C min. max. AISI 420C (+S) min. max. AISI 420F mod. min. max. AISI 430F min. max. AISI 431 min. max. AISI 440A min. max. 0.16 0.25 0.26 0.35 0.34 0.38 0.36 0.42 0.42 0.50 0.43 0.50 0.43 0.50 0.20 0.26 0.10 0.17 0.12 0.22 0.60 0.75 AISI 440B 0.75 0.95 0.33 0.45 0.35 0.50 0.95 1.20 Ergste® 1.4122YL Ergste® 1.4123YL (X15-TN) Ergste® 1.4125YL Si AISI 440C min. max. min. max. min. max. min. max. Mn P Chemical Composition (Mass-%) S Cr Ni Mo 1.00 1.00 0.040 0.030 1.00 1.50 0.040 0.030 1.00 1.00 0.040 0.030 1.00 1.00 0.040 0.030 1.00 1.00 0.040 0.030 1.00 1.00 0.040 1.00 1.00 0.040 1.00 2.00 0.040 1.00 1.50 0.040 0.030 0.15 0.30 0.15 0.27 0.15 0.35 1.00 1.50 0.040 0.030 1.00 1.00 0.040 0.030 1.00 1.00 0.040 0.030 1.00 1.50 0.040 0.030 1.00 1.00 0.040 0.015 1.00 1.00 0.040 0.030 PAGE 10/12 12.00 14.00 12.00 14.00 13.00 14.00 12.50 14.50 12.50 14.50 13.00 14.50 12.50 14.50 12.50 14.50 15.50 17.50 15.50 17.00 16.00 18.00 17.00 19.00 15.50 17.50 14.00 16.00 16.00 18.00 1.00 - 1.00 - 1.00 1.00 1.00 0.75 1.50 - Instruments, abrasors - Bone saws, rotating instruments, cutter Instruments, abrasors, bone saws Surgical needles 0.90 1.10 1.00 1.50 - 1.50 2.50 - - - 0.95 1.30 0.80 1.30 1.00 2.50 0.40 0.80 1.00 0.50 - Typical Application - 0.75 Instrument handholds, abrasors, cutter Instrument handholds, abrasors, burrs Precision instruments, cutter Dental burrs, dental cutter, surgical needles Instrument handholds Medical instruments, cutting tools Dental applications, dental instruments, surgical instruments Instrument parts, scalpels Chisels, abrasors, cutting instruments Burrs, cutter, reamer, screwdrivers Surgical instruments, blades ZAPP MEDICAL ALLOYS | MATERIAL S FOR INS TRU ME NTS - MARTE NSITIC SPECIAL MATERIALS FOR MEDICAL AND DENTAL OUTSTANDING QUALITY ADVANTAGES – . PRECIPITATION-HARDENABLE MATERIALS _ The hardenable austenitic steels are characterized by increased corrosion resistance with generally lower hardenability potential versus martensitic steels. PRECIPITAION-HARDENABLE MATERIALS FOR MEDICAL AND DENTAL Brand Name Type C Ergste® 1.4310FB Ergste® 1.4310FE* Ergste® 1.4542GG Ergste® 1.4568GA Ergste® 1.4543GG (Alloy 455) AISI 301 AISI 630 17-4-PH AISI 631 17-7-PH XM-16 min. max. min. max. min. max. min. max. Si Mn P Chemical Composition (Mass-%) S Cr Ni Mo Ti 0.05 0.15 1.20 2.00 0.045 0.030 0.07 1.00 1.00 0.040 0.030 0.09 1.00 1.00 0.040 0.030 0.03 0.50 0.50 0.015 0.015 16.00 8.00 19.00 10.00 15.00 3.00 17.50 5.00 16.00 6.50 18.00 7.75 11.00 7.50 12.50 9.50 0.50 Al Cu Nb - - - - - - - 0.75 1.50 - 3.00 5.00 - 0.15 0.45 - 1.50 2.50 0.10 0.50 0.90 1.40 OUTSTANDING QUALITY ADVANTAGES – MATERIALS FOR MEDICAL AND DENTAL _ Derived over many years market analysis and development work, the advanced properties of these special materials are far superior to those of conventional commercial grades. SPECIAL MATERIALS FOR MEDICAL AND DENTAL Brand Name Type Ergste® 1.4310FB Ergste® 1.4310FE* Ergste® 1.4456CA AISI 301 Ergste® 9.9035 MP-35-N Ergste® 1.4105IU AISI 430F Ergste® 1.4303SA AISI 305(L) Ergste® 1.4305UA AISI 303 min. max. min. max. min. max. min. max. min. max. min. max. C Si 0.05 0.15 1.20 0.10 1.00 0.025 0.15 0.08 1.50 0.06 1.00 0.12 1.00 Mn P Chemical Composition (Mass-%) S Cr Ni Mo Typical Application 16.00 2.00 0.045 0.030 19.00 16.00 16.00 20.00 0.050 0.050 20.00 19.00 0.15 0.015 0.01 21.00 0.15 16.00 1.50 0.040 0.35 18.00 17.00 2.00 0.045 0.030 19.00 0.15 17.00 2.00 0.060 0.35 19.00 8.00 10.00 - High-strength wire, root canalfiles, dental instruments 1.80 Nickel-free dental wire, 0.20 2.50 surgical needles 33.00 9.00 Orthodontic wire 37.00 10.50 Shafts for rotating instruments 11.00 13.00 8.00 10.00 - Dental applications made by precision strip Surgical instruments, dental 0.70 instruments, parts for braces * re-melted grade PAGE 11/12 ZAPP MEDICAL ALLOYS | SPECIAL MATERIALS ZAPP MEDICAL ALLOYS MEDICAL TECHNOLOGY Zapp Medical Alloys GmbH Letmather Straße 69 58239 Schwerte P.O. BOX 17 20 58212 Schwerte Germany Phone +49 2304 79-540 Fax +49 2304 79-482 medicalalloys@zapp.com Zapp (GB) Ltd. 12 Parkway Close Sheffield S9 4WJ U.K. Phone +44 114 278-8822 Fax +44 114 278-8833 medicalalloys-uk@zapp.com Zapp Precision Wire, Inc. 475 International Circle Summerville, South Carolina 29483 U.S.A. Phone +1 843 851-0700 Fax +1 843 851-0010 Toll-free +1 888-777-3962 medicalalloys-usa@zapp.com Service Centers | Sales Offices: www.zapp.com The illustrations, drawings, dimensional and weight data and other information included in this brochure are intended only for the purposes of describing our products and represent non-binding average values. They do not constitute quality data, nor can they be used as the basis for any guarantee of quality or durability. The applications presented serve only as illustrations and can be construed neither as quality data nor as a guarantee in relation to the suitability of the material. This cannot substitute for comprehensive consultation on the selection of our products and on their use in a specific application. The brochure is not subject to change control. Last revision: January 2012 PAGE 12/12 ZAPP MEDICAL ALLOYS | ADDRESS ES