ASTM F1744-1996(2016) Standard Guide for Care and Handling of Stainless Steel Surgical Instruments《不锈钢外科器械保养与维护标准导则》.pdf

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1、Designation: F1744 96 (Reapproved 2016)Standard Guide forCare and Handling of Stainless Steel Surgical Instruments1This standard is issued under the fixed designation F1744; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year

2、of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide is intended to provide a better understandingof the care of stainless steel surgical instruments intende

3、d forreuse. This guide is not intended for use with electrical,pneumatic or other powered surgical instruments.2. Referenced Documents2.1 ASTM Standards:2F899 Specification for Wrought Stainless Steels for SurgicalInstrumentsF921 Terminology Relating to Hemostatic ForcepsF1026 Specification for Gene

4、ral Workmanship and Perfor-mance Measurements of Hemostatic ForcepsF1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF1079 Specification for Inserted and Noninserted SurgicalScissorsF1089 Test Method for Corrosion of Surgical InstrumentsF1325 Specification for Stainless Steel Sut

5、ure NeedleHolders-General Workmanship Requirements and Corre-sponding Test Methods3. General3.1 Stainless Steel TypesThe stainless steels most used aremartensitic and austenitic types such as those in SpecificationF899. Martensitic stainless steel contains iron, chromium, andsufficient carbon so tha

6、t 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 austenitic structureand a lower carbon content. Although it cannot be hardened byheat trea

7、tment, it can be work-hardened.3.2 PassivationStainless steel can spot, stain, and corrode.This is minimized by passivation which is a process used tocreate a protective chromium oxide surface layer while remov-ing surface carbon and iron. This is accomplished in theatmosphere slowly or through imme

8、rsion 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 acids such ashydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-taric.3.2.2 Avo

9、id contact with salt solutions such as aluminumchloride, mercury salts, and stannous chloride. Also avoidcontact with potassium thiocyanate and potassium permangan-ate and limit contact with iodine solutions to periods of lessthan 1 h.3.2.3 Chloride-bearing solutions such as blood and salinecan caus

10、e 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, an enzymatic solution, or a disinfectant bathimmediately after use so the blood or other material will notdr

11、y on them prior to transport to the designated cleaning/reprocessing area.4. General Care of Instruments4.1 GeneralUse instruments only for their intendedpurpose, such as cutting, holding, clamping, retracting, and soforth.Avoid undue stress or strain when handling and cleaning.Standard terminology

12、relating to Hemostatic Forceps andSurgical Scissors are found in Terminology F921 and Termi-nology F1078.4.1.1 Hemostatic ForcepsThese forceps are designed toclamp blood vessels. They should not be used to clamp towels,suction tubing, or as needle holders or pliers. Misuse generallyresults in misali

13、gnment 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 used.4.1.3 ScissorsDo not use scissors for the wrong job,otherwise, the tips will

14、 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.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials a

15、nd Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved Oct. 1, 2016. Published October 2016. Originallyapproved in 1997. Last previous edition approved in 2008 as F1744 96 (2008)1DOI: 10.1520/F1744-96R16.2For referenced ASTM standar

16、ds, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 1

17、9428-2959. United States14.1.4 Microsurgical InstrumentsMicrosurgical instru-ments are most susceptible to damage through misuse or roughhandling. Consequently, extra care must be taken to avoidcompromising their exacting performance. To minimizedamage, the following should be done:4.1.4.1 Inspect t

18、he 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 may be used to eliminatesnagging and breakage. (WarningWhen handling sharpinstrum

19、ents, 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 before packaging or stor-ing. Avoid using a washer decontaminator or an ultrasonicc

20、leaner (see Appendix X2).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 or chemical vaporshould be considered for these instruments.4.1.5 Instrument Ki

21、tsSelect an instrument tray which suitsthe 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 on thebottom and lightweight instruments on the top. Ring-handledinstruments sho

22、uld 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 them duringsterilization. Separate instruments of dissimilar metals byseparate pr

23、ocessing; 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. Sometimes it is necessary to userongeurs or osteotomes to chip bone away from bone

24、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 manufacturer should be processed andverified by the manufacturers specific instruction. In

25、strumentsshould 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 instruments gently.4.2.2 Avoid dropping instruments or covering them withheavier instr

26、uments.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 anycleaning receptacle. Such practice may cause damage to theinstruments.4.2.6 After

27、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 many aredamaged beyond economical repair.4.3 MarkingDo not use a vibrating or impa

28、ct-type mark-ing device 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 and debris to dry on the instruments.If cleaning must be delayed, place groups of in

29、struments 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 surgery, open box locks and disassemble instrumentswith removable parts. Forceps and s

30、cissors 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 isespecially true for eye and microsurgery instruments.(WarningWhen handling any sharp instru

31、ments, 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 of instruments should be done only when indirectmethods (for example, tweezers) are

32、 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 enzyme solution or rinseinstruments in demineralized or distilled water to remove blo

33、odand 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. Abrasivecleaning will remove the passive layer. Do not use chlorinebleach at a higher conce

34、ntration 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 will occur. (See Appendix X3.)5.2 DetergentsThe detergent used should be in keeping

35、with 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 overall forwasher decontaminators and ultrasonic cleaners. High-sudsingdetergents must be thoroughly rinsed or instruments will spo

36、tor 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 time, the pressure of the deliveredsolution, and the pH of the detergent solution, and

37、 thus mayrequire prior brushing.F1744 96 (2016)25.3.1 Be familiar with equipment manufacturers use andoperating instructions. Be aware that loading detergent watertemperature and other external factors may change the effec-tiveness of the equipment. (See X4.5.)5.3.2 Arrange heavier instruments on bo

38、ttom, disassembleinstruments 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 completely. Concentrated detergents placed on theinstruments may cause corrosion

39、.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 after decontamination, theejector may be fouled. If fouled, foreign matter r

40、emains 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 instruments being cleaned. Follow the equipmentmanufacturers instructions o

41、r descaling detergent manufactur-ers instructions to clean decontaminator walls.5.4 Ultrasonic CleanerUltrasonic cleaners, when usedwith hot water per the manufacturers recommended tempera-ture and specially formulated detergents, are very effective andthorough. Debris of all sizes can be removed ev

42、en fromcrevices and corners in five minutes. After ultrasonic cleaning,the instruments cleaned still need to be sterilized.5.4.1 Follow the manufacturers instructions when using anultrasonic cleaner. Be aware that loading patterns, instrumentcassettes, water temperature, and other external factors m

43、aychange 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 if they come in contact with other metal surfaces.5.4.3 Plated in

44、struments should not be cleaned in an ultra-sonic cleaner since the ultrasonic vibration and the presence ofother sharp instrument edges may crack or rupture the plating.When the plating is ruptured ultrasonic energy will accelerateflaking. Any plated instrument with ruptured plating should beremove

45、d 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 the manufacturers recommendations forproper cleaning solution, or use cleaning solution formulatedspecifically for ultrasonic cleaners. Neutral deterg

46、ents or prod-ucts with less than 2 % available alkalinity are suitable forultrasonic cleaning. Acidic or alkaline products with more than2 % available alkalinity are not recommended for ultrasonicsystems because they cannot be properly neutralized.5.4.6 Rinse instruments thoroughly after cleaning.5.

47、4.7 Check screws of instruments after cleaning to ensurethat they have not loosened through vibration.5.4.8 Keep the cleaning solution particulate-free by chang-ing often or changing the filter per the manufacturers recom-mendations.5.5 LubricationTo protect instruments during sterilizationand stora

48、ge from staining and rusting, they should be lubri-cated with a water-soluble, preserved lubricant after eachcleaning. Since effective ultrasonic cleaning removes alllubricant, re-lubrication of the instruments is important. Thelubricant should contain a chemical preservative to preventbacterial gro

49、wth in the lubricant bath. The bath solution shouldbe made with demineralized water. A lubricant containing arust inhibitor helps prevent electrolytic corrosion of points andedges. Immediately after cleaning, instruments should beimmersed completely for 30 s and allowed to drain, not wipedoff. A lubricant film will remain through sterilization to protectthem during storage. “Frozen” box locks can be immersedovernight and the joint then worked free.5.6 InspectionAfter lubrication, instruments should beinspected. Incompletely cleaned instruments should