Aesculap AG Marketing Surgical Technologies Postfach 40 78501 Tuttlingen Germany lems irancon Whom it may concern General Performance: We assure that we will observe the DIN, ISO and ASTM standards listed in Annex 1 for the manufacturing of our produets in all our facilities (Germany, Spain, France, Poland, Malaysia, China) . Whereby we fulfill in many cases even higher requirements than those stipulated in the above mentioned standards in order to improve the mechanical properties, function and the corrosion resistance of our instruments. This includes: © Use of best possible mate standards (see Annex 2) Shape and dimension specifications with tolerances as close as possible Tight hardness tolerances Clear function definitions Highly corro: tant surface Individual, machine-readable laser encoding (Data Matrix Code 2.5 x 2.5 mm or smaller) ties given in the DIN and ISO mn-re: Further quality requirements are detailed in the attached Quality / Performance Requirements. Aesculap allows the client inspection of the production and quality assurance processes, including documentation, in the context of quality audits. Aesculap © operates a quality management system certified acc. to DIN ISO 9001: 2000; ISO 13485: 2003 Annex 2 of the directive in all our facilities. * has and uses an own test laboratory in Tuttlingen, Germany, which enables us to perform qualified incoming consignment controls of all raw materials used in manufacturing. All the raw material e.g, steels will be collected and tested or released against defined test specification in our own lab before releasing them to our manufacturing the facilities. In the case of metals for surgical instruments, such controls include e.g. the determination of the chemical composition and texture of the material. Apart from that, we have the capabilities 10 competently conduet in-process inspections and damage analyses in the context of complaints handling, Page 1 of 4 hsmen Seperate bt: ements a Act feecencasts cea Per ans eerkc) ee Ca St 8 266 Bee Ban Tete Sr ent Weep erevooss manta oo 00 Bena (WEE. DEesom2 SHI abe Betcosor sone 8 Sia s000tity / Performance for Aesculap Sur ity of Aesculap manufacturing faci is the manufacturer of the offered products through traceable manufacturing processes. All instrument raw parts are manufactured in Aesculap own forging department, using tools we produced ourselves in accordance with our own special construction guidelines. The work is carried out on state-of-the-art machines and equipment by qualified skilled workers, who we train ourselves. This guarantees for precise and specialized production resulting in a high quality and high pattern consistency is in possession of high-performance production facilities, ensuring the ability to meet required delivery deadlines even for large-volume orders. offers visits to production plants, to provide transparency regarding the development, manufacture and distribution of Aesculap surgical instruments, provides electronically, through the intemet, always up-to-date processing advisories acc. to DIN EN ISO 17664 for all products suitable for reprocessing, offers an extensive training program covering the application, processing and proper treatment of the products. offers qualified instrument consulting by specialist consultants with years of experience in the project business — including the option, at extra cost, of tray optimization consulting on site. operates a specialized inventory analysis team (with experience of more than 500 inventory analyses) to achieve transparency regarding the inventory’s value and quality, and to provide recommendations for action concerning the inventory of surgical instruments kept by the client. offers a computerized instrument management system with the option of database generation support (at extra cost) Page 2 of 4 Oni Soper Barts fs nt Coat fe: tains et Act ste RIERreayeae ER SETS nae ia arate, ite Bodin he weg acetone Suny seatuausant Geean sean rember aB/BRAUN Page 3 to the letter of April 04, 2014 to Quality / Performance for Aesculap Surgical Instruments Quality of Aesculap manufacturing facilities. Annex 1 Standards for surgical instrument manufacturing [DIN EN 10088 T.1-3 Stainless Steel | DIN EN ISO 7153-1 surgical instruments-Metallic materials-Part 1: $ [ASTM Designation: F 899-7 ‘Standard Specification for Wrought Stainless Steels for Surgical Instruments DIN EN ISO 13402 Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure DIN 58298 aterials, execution and examination of medical instruments Tweezers; wound hooks, wound retractors and abdominal retractors; probes; ligature needel ind elevators; ring forceps; needle holder; branch forceps: bone cutting forceps, rib rongeu! and punches; scalpels and knives; scissors; chisels, raspatories, curettes and bone curettes! -onchotomes; hammers; T.12 hand-saws, T.19 trocars, 7.20 instruments in use with trocars) iSO 7151 Surgical Instruments - Non cutting ethods iSO 7741 instruments for surgery - Scissors and shears General requirements and test methods |ASTM Designation: A 380-06 Standard Practice for Cleaning, Descaling and Passivation of Stainless Steel Parts, Equipment land Systems STM Designation: A 967-05el Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts _ inless Steel lated instruments, General requirements and test Page 3 of 4 Conan Sprint: Cote ag tn at se Reece tees REET ewtomis ero Sager eran a wats As a Croan Ware meses Ion ote er aosava e000 st Tage neue vate snoccvmns St setae Sn tte nk Sun se s008|