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1、MAKROLON Rx1805Polycarbonate ResinLipid-Resistant, Radiation-Stabilized Medical GradeDescriptionMakrolon Rx1805 thermoplastic resin is a transparent polycarbonate formulated to provide increased resistance to chemical attack from IV (intravenous) fluid products, such as lipid emulsions. It also take
2、s advantage of proprietary technology to significantly reduce the discoloration associated with gamma radiation sterilization. The resin is available in clear tint (451118) and selected colors.ApplicationsMakrolon Rx1805 polycarbonate offers an outstanding balance of high strength, toughness, clarit
3、y, processibility, and bondability for medical device components. In addition, it offers improved resistance to chemicals typically encoun-tered in a hospital or clinical environment, particularly intravenous lipid emulsions (see table below). Typical IV applications include luer fittings, stopcocks
4、, “Y”-site medication ports, tubing connectors, spikes, and other critical components that may be subjected to high stresses while in contact with these chemicals.Chemical Compatibility with Lipids*Maximum % Elongation RetentionStrain LevelRx1805Standard Polycarbonate0%1191171%1191071.4%115922.5%104
5、5%64BiocompatibilityMakrolon Rx1805 resin is designated as “medical-grade” and has met the requirements of the FDA-Modified ISO 10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less.Only “medical-grade” products may be considered candidates
6、for applications requiring biocompatibility.Regrind resins must not be used in medical applications requiring biocompatibility.Product InformationManufacturers ResponsibilityIt is the responsibility of the medical device, biological product or pharmaceutical manufacturer (“Manufacturer”) to determin
7、e the suitability of all component parts and raw materials, including Makrolon Rx1805 polycarbonate, used in its final product in order to ensure safety and compliance with FDA requirements. This determination must include, as applicable, testing for suitability as an implant device and suitability
8、as to contact with and/or storage of human tissue and liquids including, without limitation, medication, blood, or other bodily fluids. Under no circumstances may Makrolon Rx1805 resin be used in any cosmetic, reconstructive, or reproductive implant applications. Nor may Makrolon Rx1805 be used in a
9、ny other bodily implant applications, or any applications involving contact with or storage of human tissue, blood, or other bodily fluids, for greater than 30 days, based on FDA-Modified ISO 10993, Part 1 “Biological Evaluation of Medical Devices” tests.The suitability of a Bayer resin in a given e
10、nd-use envi-ronment is dependent upon various conditions including, without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses, or external loads. It is the responsibility of the Manufacturer to evaluate its final product under actual end-use requir
11、e-ments and to adequately advise and warn purchasers and users thereof.Single-use medical devices made from a Bayer resin are not suitable for multiple uses. If the medical device is designed for multiple uses, it is the responsibility of the Manufacturer to determine the appropriate number of permi
12、ssible uses by evaluating the device under actual sterilization and end-use conditions and to adequately advise and warn purchasers and users thereof.* Test bars were soaked with gauze saturated with a 20% IV fat emulsion for 48 hours at 73 F. Some test bars broke before they could be measured (indi
13、cated by a dash in the table).Page 1 of 4 Document contains important information and must be read in its entirety.SterilizationParts molded from Makrolon Rx1805 resin are sterilizable using radiation, ethylene oxide, or steam autoclaving. When sterilizing with steam, germicides and detergents must
14、be rinsed thoroughly from polycarbonate parts prior to autoclaving. Failure to thoroughly remove germicides and detergents from the part prior to autoclaving may cause accelerated degradation of the polycarbonate.Steam sterilization temperatures for parts made of Makrolon polycarbonate must not exce
15、ed 250 F (121 C) to avoid part deformation. Please note that permanent immersion of polycarbonate parts in water above 140 F (60 C) or in steam causes loss of material properties and must be avoided. Furthermore, condensed steam should not be allowed to accumulate, as this may cause damage to the pa
16、rts. Polycarbonate parts should also be protected from damage by substances such as alkaline corrosion inhibitors, which are frequently added to boiler feed water.The sterilization method and the number of sterilization cycles a part made from Makrolon Rx1805 resin can with-stand will vary depending
17、 upon type/grade of resin, part design, processing parameters, sterilization temperature, and chemical environment. Therefore, the Manufacturer must evaluate each device to determine the sterilization method and the number of permissible sterilization cycles appropriate for actual end-use requiremen
18、ts and must adequately advise and warn purchasers and users thereof.DryingAll polycarbonate resins are hygroscopic and must be thoroughly dried prior to processing. A desiccant dehumidifying hopper dryer is recommended. To achieve a moisture content of less than 0.02%, hopper inlet air temperature s
19、hould be 250 F (121 C) and inlet air dew point should be -20 F (-29 C) or lower. The hopper capacity should be sufficient to provide a minimum residence time of 4 hours. Additional information on drying procedures is available in the Bayer brochure General Drying Guide.ProcessingMakrolon Rx1805 resi
20、n may be easily processed on commercially available equipment suitable for polycar-bonate injection molding. Typical processing parameters are noted at right. Actual processing conditions will depend on machine size, mold design, material residence time, shot size, etc.Typical Injection Molding Cond
21、itionsBarrel Temperatures:Rear .465 510 F (241 266 C)Middle .515 550 F (268 288 C)Front .535 575 F (279 302 C)Nozzle .515 585 F (268 307 C)Melt Temperature .540 575 F (282 302 C)Mold Temperature .150 220 F (65 105 C)Injection Pressure .10,00020,000 psiHold Pressure .5070% Injection PressureBack Pres
22、sure .50100 psiScrew Speed .5075 rpmInjection Speed .Moderate to FastCushion .1/81/4 inClamp .35 ton/in2Additional information on processing may be obtained by consulting the Bayer publication Makrolon Polycarbon-ate A Processing Guide for Injection Molding and by contacting a Bayer technical servic
23、e representative.General Characteristics of PolycarbonateHydrolytic Stability. Parts molded from polycarbonate absorb only 0.15 to 0.19% water at room temperature and 50% relative humidity. Dimensional stability and mechanical properties remain virtually unaffected. Even with immersion in water, dim
24、ensional changes measure only about 0.5%. Although frequent, intermittent contact with hot water does not harm polycarbonate, continuous exposure to humidity or water at high temperatures (140 F/60 C) is not recommendeddue to hydrolytic degradation, which reduces impact strength and tensile properti
25、es.Gas Permeability. Steam permeability, measured on 100- m thick film, is 15 g/m224 h (0.97 g/100 in224 h). Significant permeability also exists for other gases, such as hydrogen, carbon dioxide, sulfur dioxide, helium, ethylene oxide, and oxygen.Chemical Resistance. Polycarbonate is resistant to m
26、ineral acids (even in high concentrations), a large number of organic acids, many oxidizing and reducing agents, neutral and acidic saline solutions, some greases and oils, saturated aliphatic and cycloaliphatic hydro-carbons, and most alcohols. It is important to note that polycarbonate is degraded
27、 by alkaline solutions, ammonia gas and its solutions, and amines. Polycarbonate dissolves in a number of organic solvents, such as halogenated hydrocarbons and some aromatic hydro-carbons. Other organic compounds cause polycarbonate to swell or stress-crack, e.g., acetone and methyl ethyl ketone. S
28、ince chemical resistance to various media is dependent on variables, such as concentration, time, temperature, part design, and residual stresses, the above information should serve only as a guideline.It is imperative that production parts be evaluated under actual application conditions prior to c
29、ommercial use.Page 2 of 4 Document contains important information and must be read in its entirety.Makrolon Rx1805ASTMResinTypical Properties*Test MethodU.S.SIfor Clear Tint Resin(Other)ConventionalMetricGeneralSpecific GravityD 7921.20DensityD 7920.043 lb/in31.20 g/cm3Specific VolumeD 79223.1 in3/l
30、b0.83 cm3/gMold ShrinkageD 9550.0060.008 in/in0.0060.008 mm/mmWater Absorption, Immersion at 73 F (23 C):D 57024 Hours0.12%Equilibrium0.30%Melt Flow Ratea at 300 C/1.2-kg LoadD 12386.5 g/10 minOpticalTransmittance at 0.125-in (3.2-mm) ThicknessD 100376%MechanicalTensile Stress at YieldD 6389,400 lb/
31、in265 MPaTensile Stress at BreakD 63810,200 lb/in270 MPaTensile Elongation at YieldD 6386%Tensile Elongation at BreakD 638120%Flexural Stress at 5% StrainD 79013,000 lb/in286 MPaFlexural ModulusD 790340,000 lb/in22.4 GPaImpact Strength, Notched Izod:D 25673 F (23 C)0.125-in (3.2-mm) Thickness18 ftlb
32、/in960 J/mThermalDeflection Temperature, Unannealed:D 6480.250-in (6.4-mm) Thickness264-psi (1.82-MPa) Load259 F126 C66-psi (0.46-MPa) Load273 F134 CVicat Softening Temperature: 50N; 50K/hD 1525291 F144 C* These items are provided as general information only. They are approximate values and are not
33、part of the product specifications. Type and quantity of pigments or additives used to obtain certain colors and special effects can affect material properties.a For information on using melt flow as a quality control procedure, see the Bayer publication Makrolon Polycarbonate A Processing Guide for
34、 Injection Molding.Regulatory Compliance InformationSome of the end uses of the products described in this bulletin must comply with applicable regulations, such as FDA, NSF, USDA, and CPSC. If you have any questions on the regulatory status of this product, contact your Bayer representative or Baye
35、rs Regulatory Affairs Manager in Pittsburgh, Pa.Health and Safety InformationAppropriate literature has been assembled which provides information concerning the health and safety precautions that must be observed when handling Makrolon Rx1805 resin. Before working with this product, you must read an
36、d become familiar with the available information on its hazards, proper use, and handling. This cannot be overemphasized. Information isavailable in several forms, e.g., material safety data sheets and product labels. Consult your Bayer MaterialSciencerepresentative or contact Bayers Product Safety
37、and Regulatory Affairs Department in Pittsburgh, Pa.Page 3 of 4 Document contains important information and must be read in its entirety.Note: The information contained in this bulletin is current as of December 2002. Please contact Bayer MaterialScience to determine whether this publication has bee
38、n revised.Bayer MaterialScience LLC100 Bayer RoadPittsburgh, PA 15205-9741Phone: 1-800-662-2927www.BayerMaterialScienceNAFTA .comThe manner in which you use and the purpose to which you put and utilize our products, technical assistance and information (whether verbal, written or by way of productio
39、n evaluations), including any suggested formulations and recommendations are beyond our control. Therefore, it is imperative that you test our products, technical assistance and information to determine to your own satisfaction whether they are suitable for your intended uses and applications. This
40、application-specific analysis must at least include testing to determine suitability from a technical as well as health, safety, and environmental standpoint. Such testing has not necessarily been done by us. Unless we otherwise agree in writing, all products are sold strictly pursuant to the terms
41、of our standard conditions of sale. All information and technical assistance is given without warranty or guarantee and is subject to change without notice. It is expressly understood and agreed that you assume and hereby expressly release us from all liability, in tort, contract or otherwise, incur
42、red in connection with the use of our products, technical assistance, and information. Any statement or recommendation not contained herein is unauthorized and shall not bind us. Nothing herein shall be construed as a recommendation to use any product in conflict with patents covering any material o
43、r its use. No license is implied or in fact granted under the claims of any patent.Sales Offices17320 Redhill Avenue, Suite 175, Irvine, CA 92614-5660 1-949-833-2351 Fax: 1-949-752-13061000 Route 9 North, Suite 103, Woodbridge, NJ 07095-1200 1-732-726-89882401 Walton Boulevard, Auburn Hills, MI 48326-1957 1-248-475-7700 Fax: 1-248-475-7701199 12/02Print