ASTM F1744-1996(2008)e1 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指南》.pdf

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1、Designation: F 1744 96 (Reapproved 2008)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 () indicates an editorial change since the last revision or reapproval.e1NOTEEditorial changes were made throughout in June 2008.1. Scope1.1 This guide is intended to provide a better understand

3、ingof 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:2F 899 Specification for Wrought Stainless Steels for Surgi-cal InstrumentsF 921 Term

4、inology Relating to Hemostatic ForcepsF 1026 Specification for General Workmanship and Perfor-mance Measurements of Hemostatic ForcepsF 1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF 1079 Specification for Inserted and Noninserted SurgicalScissorsF 1089 Test Method for Corros

5、ion of Surgical InstrumentsF 1325 Specification for Stainless Steel Suture 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 SpecificationF 899. Martensi

6、tic 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 austenitic structu

7、reand 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 whileremoving surface carbo

8、n 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 acids such ashydro

9、chloric, aqua regia, dilute sulphuric, carbonic, and tar-taric.3.2.2 Avoid contact with salt solutions such as aluminumchloride, mercury salts, and stannous chloride. Also avoidcontact with potassium thiocyanate and potassium permanga-nate and limit contact with iodine solutions to periods of lessth

10、an 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 disinfectant

11、bath immedi-ately after use so the blood or other material will not dry onthem prior to transport to the 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.Avoid u

12、ndue stress or strain when handling and cleaning.Standard terminology relating to Hemostatic Forceps andSurgical Scissors are found in Terminology F 921 and Termi-nology F 1078.4.1.1 Hemostatic ForcepsThese forceps are designed toclamp blood vessels. They should not be used to clamp towels,suction t

13、ubing, 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 used.4.1.

14、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.1This guide is under t

15、he jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1997. Last previous edition approved in 2002 as

16、 F 1744 96 (2002)12For referenced ASTM standards, 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.1Copyright ASTM International, 100 Barr Har

17、bor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.4 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 minimize dam-ag

18、e, 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 may be used to eliminatesnagging

19、 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 before packaging or stor-ing. Avoi

20、d 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 or chemical vaporshould be co

21、nsidered 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 on thebottom and lightweight i

22、nstruments 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 them duringsterilization. Separ

23、ate 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. Sometimes it is necessary to user

24、ongeurs 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 manufacturer should be processed andveri

25、fied 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 instruments gently.4.2.2 Avoid dropp

26、ing 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 anycleaning receptacle. Such practi

27、ce 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 many aredamaged beyond economica

28、l repair.4.3 MarkingDo not use a vibrating or impact-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 instrumen

29、ts.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 surgery, open box locks and disassem

30、ble 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 isespecially true for eye and microsurgery

31、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 of instruments should be done onl

32、y 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 enzyme solution or rinseinstruments

33、 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. Abrasivecleaning will remove the passive

34、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 will occur. (See Appendix X3.)5.2

35、 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 overall forwasher decontaminators and ultrasonic cleaners. High-sudsingdetergents

36、 must be thoroughly rinsed or instruments will spotor 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 delivereds

37、olution, and the pH of the detergent solution, and thus mayrequire prior brushing.5.3.1 Be familiar with equipment manufacturers use andoperating instructions. Be aware that loading detergent waterF 1744 96 (2008)e12temperature and other external factors may change the effec-tiveness of the equipmen

38、t. (See X4.5.)5.3.2 Arrange heavier instruments on bottom, 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 de

39、tergents 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 after decontamination,

40、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 instruments being clea

41、ned. Follow the equipmentmanufacturers instructions or 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 effecti

42、ve 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 the manufacturers instructions when using anultrasonic cleaner. Be aware that loading patterns, instrumentcasse

43、ttes, 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 if they come

44、 in contact with other metal surfaces.5.4.3 Plated instruments 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 pl

45、ated instrument with ruptured plating should beremoved 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 formulate

46、dspecifically for ultrasonic cleaners. Neutral detergents 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

47、.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 the manufacturers recommen-dations.5.5 LubricationTo pr

48、otect 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-cant should cont

49、ain 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 immersedcompletely for 30 s and allowed to drain, 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 lubrication, instruments shoul