1、Designation: F 1744 96 (Reapproved 2002)e1Standard Guide forCare and Handling of Stainless Steel Surgical Instruments1This standard is issued under the fixed designation F 1744; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y
2、ear of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTEWarning statements were corrected throughout in November 2002.1. Scope1.1 This guide is intended to provide a better
3、 understandingof the care of stainless steel surgical instruments intended forreuse. This guide is not intended for use with electrical,pneumatic or other powered surgical instruments.2. Referenced Documents2.1 ASTM Standards:F 899 Specification for Stainless Steels for Surgical Instru-ments2F 921 D
4、efinitions of Terms Relating to Hemostatic Forceps2F 1026 Specification for General Workmanship and Perfor-mance Measurements of Hemostatic Forceps2F 1078 Terminology for Surgical ScissorsInserted andNon-Inserted Blades2F 1079 Specification for Inserted and Non-Inserted SurgicalScissors2F 1089 Test
5、Method for Corrosion of Surgical Instruments2F 1325 Specification for Stainless Steel Suture NeedleHoldersGeneral Workmanship Requirements and Corre-sponding Test Methods23. General3.1 Stainless Steel TypesThe stainless steels most used aremartensitic and austenitic types such as those in Specificat
6、ionF 899. Martensitic stainless steel contains iron, chromium, andsufficient carbon so that when it is hardened by heat treatment,a substantial martensitic structure is the result. Austeniticstainless steel has better corrosion resistance and contains iron,chromium, and nickel. It has a substantial
7、austenitic structureand a lower carbon content. Although it cannot be hardened byheat treatment, it can be work-hardened.3.2 PassivationStainless steel can spot, stain, and cor-rode. This is minimized by passivation which is a process usedto create a protective chromium oxide surface layer whileremo
8、ving surface carbon and iron. This is accomplished in theatmosphere slowly or through immersion in oxidizing solutionor through an electro-polish process. Through repeated pro-cessing the passivation layer will thicken until a good protec-tive film is formed.3.2.1 Never expose instruments to strong
9、acids such ashydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-taric.3.2.2 Avoid contact with salt solutions such as aluminumchloride, mercury salts, stannous chloride. Also avoid contactwith potassium thiocyanate and potassium permanganate andlimit contact with iodine solutions to perio
10、ds less than 1 h.3.2.3 Chloride-bearing solutions such as blood and salinecan cause localized corrosion. Avoid prolonged exposure to orrinsing in saline solutions or corrosion and pitting will occur.Use demineralized or distilled water instead. Place instrumentsinto water, enzymatic solution, or dis
11、infectant bath immedi-ately after use so the blood or other material will not dry onthem prior to transport to designated cleaning/reprocessingarea.4. General Care of Instruments4.1 GeneralUse instruments only for their intended pur-pose, such as cutting, holding, clamping, retracting, and soforth.
12、Avoid undue stress or strain when handling and cleaning.Standard terminology relating to Hemostatic Forceps andSurgical Scissors are found in Definitions F 921 and Specifi-cation F 1078.4.1.1 Hemostatic ForcepsThese forceps are designed toclamp blood vessels. They should not be used to clamp towels,
13、suction tubing, or as needle holders or pliers. Misuse generallyresults in misalignment and even cracked box locks.4.1.2 Needle HoldersAlthough designed to withstandsome force, they are not to be used as pliers, jaw misalignmentsbeing the result. Select a needle holder matching the sizeneedle being
14、used.4.1.3 ScissorsDo not use scissors for the wrong job,otherwise, the tips will become misaligned and the blades willdull or chip. Delicate scissors should be particularly guardedagainst misuses. Use tissue scissors for tissue dissections only,not for cutting suture material or wires.4.1.4 Microsu
15、rgical InstrumentsMicrosurgical instru-ments are most susceptible to damage through misuse or rough1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Curren
16、t edition approved Oct. 10, 1996. Published January 1997.2Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.handling. Consequently, extra care must be taken to avoidcompromising their exacting p
17、erformance. To minimize dam-age, the following should be done:4.1.4.1 Inspect the instrument when purchased and aftereach use and cleaning, preferably under magnification.4.1.4.2 Only use for its intended purpose.4.1.4.3 After each use, remove blood and debris frominstrument. A non-fibrous sponge ma
18、y be used to eliminatesnagging and breakage. (WarningWhen handling sharpinstruments, use extreme caution to avoid injury; Consult withan infection control practitioner to develop and verify safetyprocedures appropriate for all levels of direct instrumentcontact.)4.1.4.4 Clean and thoroughly dry befo
19、re packaging or stor-ing. Avoid using a washer decontaminator or an ultrasoniccleaner (see Appendix X.2).4.1.4.5 Avoid metal-to-metal contact by using special racksdesigned to separate and protect.4.1.4.6 Do routine preventive maintenance such as sharpen-ing and realigning. Sterilization by dry heat
20、 or chemical vaporshould be considered for these instruments.4.1.5 Instrument KitsSelect an instrument tray whichsuits the size of the kit. Placing a large instrument kit in a smallinstrument tray may lead to broken instruments, bent tips, ordull scissors. Put heavier instruments such as retractors
21、on thebottom and light weight instruments on the top. Ring-handledinstruments should be kept open with a wire holder or pin.Curved clamps should all point in the same direction to protectthe tips. Scissors should be kept separate. Cupped instrumentsshould be placed so that water does not collect in
22、them duringsterilization. Separate instruments of dissimilar metals byseparate processing, otherwise galvanic corrosion or electro-lytic deposition may result.4.1.6 Other Sharp InstrumentsRongeurs, bone cuttingforceps, drill bits, reamers, and so forth should be used to cutbone, not wire or pins. So
23、metimes it is necessary to userongeurs or osteotomes to chip bone away from bone platesand screws, which may nick or dull the blades. An alternateapproach is to keep an older set of rongeurs or osteotomes forsuch orthopedic procedures. Instruments that are recommendedto be sharpened by the manufactu
24、rer should be processed andverified by the manufacturers specific instruction. Instrumentsshould be used only for their identified purpose. Carefulplanning is necessary for selection of the proper amount andtype of instruments needed for each surgical procedure.4.2 Care During Use:4.2.1 Handle instr
25、uments gently.4.2.2 Avoid dropping instruments or covering them withheavier instruments.4.2.3 Handle instruments individually or in small numbers.4.2.4 Protect instrument tips, especially sharp ones. Do notplace instruments down on their tips.4.2.5 Do not drop delicate or sharp instruments into anyc
26、leaning receptacle. Such practice may cause damage to theinstruments.4.2.6 After a surgical procedure, an instrument count shouldbe made to avoid sending any instruments to the laundry withthe soiled linen. Although they eventually may be returned,they create a injury hazard to laundry workers and m
27、any aredamaged beyond economical repair.4.3 MarkingDo not use a vibrating or impact type mark-ing devices on the box lock portion. If marking is necessary, doit on the shanks, otherwise the box locks may fail.5. Cleaning5.1 GeneralClean instruments as soon as possible afteruse. Do not allow blood an
28、d debris to dry on the instruments.If cleaning must be delayed, place groups of instruments in acovered container with appropriate detergent or enzymaticsolution to delay drying. Wash all instruments whether or notthey were used or were inadvertently contacted with blood orsaline solution.After surg
29、ery, open box locks and disassemble instrumentswith removable parts. Forceps and scissors should be cleanedand sterilized in the open position. This will limit blood dryingon the instruments which may cause them to corrode. Delicateand sharp instruments should be cleaned separately. This isespeciall
30、y true for eye and microsurgery instruments.(WarningWhen handling any sharp instruments, use ex-treme caution to avoid injury; Consult with an infection controlpractitioner to develop and verify safety procedures appropri-ate for all levels of direct instrument contact. Direct handlingand cleaning o
31、f instruments should be done only when indirectmethods, for example, tweezers, are not available or notpossible.) Sort instruments by similar metal for subsequentprocessing so that electrolytic deposition due to contact be-tween dissimilar metals will not occur.Prior to regular cleaning, soak in enz
32、yme solution or rinseinstruments in demineralized or distilled water to remove bloodand debris, especially those instruments with hollow tubes suchas suction tubes and curettes.Do not use abrasive pads or cleansers which will scratch thesurface allowing dirt and water deposits to collect. Abrasivecl
33、eaning will remove the passive layer. Do not use chlorinebleach at a higher concentration than recommended by themanufacturer to clean or disinfect stainless steel instruments,as pitting will occur. High concentrations of chlorine-basedsolutions are not recommended as pitting and subsequentdamage wi
34、ll occur. (See Appendix X3.)5.2 DetergentsThe detergent used should be in keepingwith the cleaning equipment manufacturers recommendations.Neutral pH detergents, between 7.0 and 8.5, which are lowsudsing, free rinsing, and have good wetting are best over allfor washer decontaminators and ultrasonic
35、cleaners. High-sudsing detergents must be thoroughly rinsed or instrumentswill spot or stain. (See Appendix X2.)5.3 Washer DecontaminatorEquipment of this type willwash and decontaminate instruments. Complete removal ofsoil from serrations and crevices depends on instrumentconstruction, exposure tim
36、e, pressure of delivered solution, andpH of the detergent solution, and thus may require priorbrushing.5.3.1 Be familiar with equipment manufacturers use andoperation instructions. Be aware that loading detergent watertemperature and other external factors may change the effec-tiveness of the equipm
37、ent. (See X4.5.)5.3.2 Arrange heavier instruments on bottom, disassembleF 1744 96 (2002)e12instruments with removable parts, open box locks, and protectcutting edges.5.3.3 Follow equipment manufacturers recommendationsfor detergent, preferably a liquid one. Solid detergents may notdisperse as comple
38、tely. Concentrated detergents placed on theinstruments may cause corrosion.5.3.4 Install a water softener if the water is hard and thewater supply is not already treated. This will minimize scumformation. Deionized water is recommended for rinsing toprevent spotting.5.3.5 If instruments are dirty af
39、ter decontamination, theejector may be fouled. If fouled, foreign matter remains todeposit on the instruments. The ejector must be cleaned andextraneous matter removed.5.3.6 Regularly cleaning decontaminator walls will removerust and mineral deposits and avoid transfer of this type ofdebris to the i
40、nstruments being cleaned. Follow the equipmentmanufacturers instructions or descaling detergent manufactur-ers instructions to clean decontaminator walls.5.4 Ultrasonic CleanerUltrasonic cleaners, when usedwith hot water per manufacturers recommended temperatureand specially formulated detergents, a
41、re very effective andthorough. Debris of all sizes can be removed even fromcrevices and corners in five minutes. After ultrasonic cleaning,the instruments cleaned still need to be sterilized.5.4.1 Follow manufacturers instructions when using anultrasonic cleaner. Be aware that loading patterns, inst
42、rumentcassettes, water temperature, and other external factors maychange the effectiveness of the equipment. (See X4.5.)5.4.2 Arrange instruments with box locks open and cuttingedges protected. Do not clean delicate instruments in anultrasonic cleaner since the vibrations can cause the tips towear i
43、f they come in contact with other metal surfaces.5.4.3 It is not recommended to clean plated instruments inan ultrasonic cleaner since the ultrasonic vibration and thepresence of other sharp instrument edges may crack or rupturethe plating. When the plating is ruptured ultrasonic energy willaccelera
44、te flaking. Any plated instrument with ruptured platingshould be removed from use and refurbished or discarded.5.4.4 Use hot water per manufacturers recommended tem-perature (usually 90 to 140F or 30 to 75C).5.4.5 Follow manufacturers recommendations for propercleaning solution, or use cleaning solu
45、tion formulated specifi-cally for ultrasonic cleaners. Neutral detergents or productswith less than 2 % available alkalinity are suitable for ultra-sonic cleaning. Acidic or alkaline products with more than 2 %available alkalinity are not recommended for ultrasonic sys-tems because they cannot be pr
46、operly neutralized.5.4.6 Rinse instruments thoroughly after cleaning.5.4.7 Check screws of instruments after cleaning to ensurethat they have not loosened through vibration.5.4.8 Keep cleaning solution particulate-free by changingoften or changing the filter per manufacturers recommenda-tions.5.5 Lu
47、bricationTo protect instruments during sterilizationand storage from staining and rusting, they should be lubri-cated with a water-soluble, preserved lubricant after eachcleaning. Since effective ultrasonic cleaning removes all lubri-cant, re-lubrication of the instruments is important. The lubri-ca
48、nt should contain a chemical preservative to prevent bacterialgrowth in the lubricant bath. The bath solution should be madewith demineralized water. A lubricant containing a rust inhibi-tor helps prevent electrolytic corrosion of points and edges.Immediately after cleaning, instruments should be im
49、mersedcompletely for 30 s and allowed to drain off, not wiped off. Alubricant film will remain through sterilization to protect themduring storage. “Frozen” box locks can be immersed overnightand the joint then worked free.5.6 InspectionAfter lubricating, instruments should beinspected. Incompletely cleaned instruments should be re-cleaned, and those that need repair set aside. For complexinstruments, the manufacturers inspection and testing recom-mendations should be followed.5.6.1 For hinged instruments such as clamps and forceps,lock stiffness, jaw a
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