1、Listed below are all ANSI approved standards as of 3/23/2007. Many of these ANSI approved standards that are published areavailable in electronic format (PDF) via ANSIs Electronic Standards Store (ESS) at http:/webstore.ansi.org.ANSI Approved Standards3 (3-A Sanitary Standards, Inc.)AA (Aluminum Ass
2、ociation)ANSI H35.1/H35.1M-2006, AmericanNational Standard Alloy and TemperDesignation Systems for AluminumCovers systems for designating wroughtaluminum and wrought aluminum alloys,aluminum and aluminum alloys in the form ofcastings and foundry ingot, and the tempers inwhich wrought products and ca
3、stings areproduced. Covers both US Customary andMetric (SI) Units.ANSI H35.2(M)-2006, DimensionalTolerances for Aluminum Mill Products(Metric)This standard includes dimensional tolerancefor aluminum mill products accepted by boththe aluminum industry and users of the metal.They are the basis of dime
4、nsional tolerancesspecified in government, technical societiesand other specifications for aluminum.ANSI H35.2-2006, Dimensional Tolerancesfor Aluminum Mill ProductsThis standard includes dimensional tolerancefor aluminum mill products accepted by boththe aluminum industry and users of the metal.The
5、y are the basis of dimensional tolerancesspecified in government, technical societiesand other specifications for aluminum.ANSI H35.3-1997 (R2006), DesignationSystem for Aluminum HardenersCovers a system for designating aluminumhardeners used primarily for the addition ofalloying, or grain refining
6、elements, or modifiersto aluminum alloy melts.ANSI H35.4-2006, Designation System forUnalloyed AluminumThis Standard provides a system fordesignating unalloyed aluminum not made by arefining process and used primarily forremelting.ANSI H35.5-1993 (R2006), NomenclatureSystem for Aluminum Metal Matrix
7、Composite MaterialsCovers system for designating wrought andcast aluminum metal matrix compositematerials by appending suffixes to existingaluminum designation systems, includinggeneric tempers.AAMI (Association for theAdvancement of MedicalANSI/AAMI AT6-2005, AutologousTransfusion DevicesEstablishe
8、s labeling and performancerequirements, test methods, and terminologythat will help establish a reasonable level ofsafety and efficacy for autologous transfusiondevices. Specifically, includes requirements forsterile, disposable systems and associatedelectromechanical hardware designed to collectand
9、 filter or process, or both, extravasatedblood for reinfusion or erythrocytes or filteredwhole blood into the patients circulation.Aspects of these systems related to collection,anticoagulation (systemic and regional),storage, processing and filtration, andreinfusion are within the scope of this sta
10、ndard.ANSI/AAMI BE78-2002, BiologicalEvaluation of Medical Devices Part 10:Tests for Irritation and SensitizationGives guidance to agencies, manufacturers,research laboratories and others for evaluatingthe interactions of medical devices with blood.ANSI/AAMI BE78-2002/A1-2006, Biologicalevaluation o
11、f medical devices - Part 10:Tests for irritation and delayed-typehypersensitivity (Amendment 1)Changes clauses 4(d), 6.4.4.3.5, 6.4.5.3(e),7.5.4.3.1, and Annex B.ANSI/AAMI BE83-2006, Biologicalevaluation of medical devices - Part 18:Chemical characterization of materialsDescribes a framework for the
12、 identification ofa material and the identification andquantification of its chemical constituents.ANSI/AAMI BF64-2002, LeukocyteReduction FiltersContains labeling requirements, performancerequirements, test methods, and terminologyfor disposable filters used for the reduction ofleukocytes from bloo
13、d or blood componentsduring transfusion.ANSI/AAMI BF7-1989 (R2002), BloodTransfusion Micro-FiltersDescribes safety and performancerequirements for disposable microfilters usedfor the removal of microaggregates from bloodor blood products during transfusion.ANSI/AAMI BP22-1994 (R2006), BloodPressure
14、TransducersSpecifies safety and performance requirementsfor transducers, including cables, designed forblood pressure measurements through anindwelling catheter or direct puncture anddisclosure requirements to permit the user todetermine compatibility between the transducerand blood pressure monitor
15、.1ANSI Catalogwebstore.ansi.orgCopyright American National Standards Institute Provided by IHS under license with ANSI Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ANSI/AAMI DF80-2003, Medical electricalequipment - Part 2-4: Particularrequirements for the safety
16、 of cardiacdefibrillators (including automatedexternal defilrillators)Specifies requirements for the safety of medicalelectrical equipment intended to defibrillate theheart by an electrical pulse via electrodesapplied either to the patients skin (externalelectrodes) or to the exposed heart (internal
17、electrodes). This standard does not apply toimplantable defibrillators, remote controldefibrillators, external transcutaneouspacemakers, or separate cardiac monitors.This adoption of an international standard withmodifications was previously listed forcomment under AAMI/IEC 60601-2-4.ANSI/AAMI EC11-
18、1991 (R2001), DiagnosticElectrocardiographic DevicesEstablishes minimum safety and performancerequirements for electrocardiographic (ECG)systems with direct writing devices which areintended for use, under the operatingconditions specified in this standard, in theanalysis of rhythm and of detailed m
19、orphologyof complex cardiac complexes. Subject to thisstandard are all parts of theelectrocardiographic system necessary toobtain the signal from the surface of thepatients body, to amplify this signal, and todisplay it in a form suitable for diagnosing thehearts electrical activity.ANSI/AAMI EC12-2
20、000 (R2005),Disposable ECG ElectrodesThis standard contains minimum labeling,safety and performance requirements; testmethods; and terminology for disposableelectrocardiographic electrodes.ANSI/AAMI EC13-2002, Cardiac Monitors,Heart Rate Meters, and AlarmsEstablishes minimum safety and performancere
21、quirements for cardiac monitors, heart ratemeters, and alarms, which are used to acquireand/or display electrocardiographic signals withthe primary purposes of continuous detection ofcardiac rhythm.ANSI/AAMI EC38-1998, AmbulatoryElectrocardiographsEstablishes minimum safety and performancerequiremen
22、ts for long-term electrocardiographicmonitoring devices (ECGs), also commonlycalled ambulatory electrocardiographs(AECGs), that are intended for use under theoperating conditions specified in this standard,in the analysis of rhythm and of relevantmorphology of cardiac complexes.ANSI/AAMI EC53-1995 (
23、R2001), ECGCables and WiresCovers cables and patient leadwires used forsurface electrocardiographic (ECG) monitoringin cardiac monitors. This standard covers bothdisposable and reusable leadwires.ANSI/AAMI EC53A-1998 (R2001), ECGCables and WiresCovers cables and patient leadwires used forsurface ele
24、ctrocardiographic (ECG) monitoringin cardiac monitors. This standard covers bothdisposable and reusable leadwires.ANSI/AAMI EC57-1998 (R2003), Testingand Reporting Performance Results ofCardiac Rhythm and ST SegmentMeasurement AlgorithmsThis recommended practice establishes amethod for testing and r
25、eporting theperformance of algorithms used to detectcardiac rhythm disturbances, including the STsegment.ANSI/AAMI EC71-2001, StandardCommunications Protocol forComputer-Assisted ElectrocardiographyCovers the two-way digital transmission ofremote requests and results between digitalelectrocardiograp
26、hs (ECG carts) andheterogeneous computer systems (hosts). Itdocuments the common conventions requiredfor the cart-to-host as well as cart-to-cartinterchange of specific patient data(demographic, recording), ECG signal data,ECG measurement and ECG interpretationresults.ANSI/AAMI EQ56-1999 (R2004),Rec
27、ommended Practices for a MedicalEquipment Management ProgramSpecifies the minimum required characteristicsfor a management program designed tominimize certain risks associated withequipment that is used during routine care ofpatients in a health care organization. Thedocument addresses the structure
28、 of theprogram, the documentation that must beproduced by the program, and the staffing andresources allocated to those responsible formaintaining the medical equipment.ANSI/AAMI ES60601-1-2005, MedicalElectrical Equipment - Part 1: GeneralRequirements for Basic Safety andEssential PerformanceBaseli
29、ne of standards for the safety of allmedical electrical equipment used by or underthe supervision of qualified personnel in thegeneral medical and patient environment. Alsocontains certain requirements for reliableoperation to ensure safety.ANSI/AAMI HE48-2001, Human FactorsEngineering Guidelines an
30、d PreferredPractices for the Design of MedicalDevicesTo provide ergonomic information and humanfactors engineering guidance so that optimumuser and patient safety, system safety andperformance, and operator effectiveness will bereflected in medical device design.Specifically, the recommended practic
31、e dealswith the controls, displays, consoles, size,weight, and general user interface design ofmedical devices and is extensively illustrated.User instructions, manuals, software, andalgorithms associated with medical devices arealso discussed briefly.2ANSI Catalogwebstore.ansi.orgCopyright American
32、 National Standards Institute Provided by IHS under license with ANSI Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ANSI/AAMI ID26-2004, Medical ElectricalEquipment - Part 2: ParticularRequirements for the Safety of InfusionPumps and ControllersEstablishes minimu
33、m labeling, safety,performance, and testing requirements forelectromechanical infusion devices that have apumping or gravity-feed controlling function,that deliver fluid from either a separate or aself-contained source, and that are intended foruse with parenteral fluids for such purposes asparenter
34、al nutrition and administration of drugsand routine fluids. Public review of this reviseddocument was originally announced in the May21 2004 edition of ANSI Standards Action, andclosed on July 20 2004. Comments receivedby a member of the documents authoringcommittee prompted the two additionalrevisi
35、ons encompassed in the current review.ANSI/AAMI ID54-1996 (R2005), EnteralFeeding Set Connectors and AdaptersSpecifies safety requirements for enteralfeeding set connectors and adapters.ANSI/AAMI II36-2004, Infant IncubatorsEstablishes safety requirements for babyincubators with the view to minimizi
36、ng hazardsto the patient and user. It also specifies tests bywhich compliance requirements can be verified.It does not apply to transport incubators norinfant radiant warmers which are covered inother publications.ANSI/AAMI II51-2004, Medical electricalequipment - Part 2: Particularrequirements for
37、safety of transportincubatorsSpecifies safety requirements for transportincubators with the view to minimizing hazardsto the patient and user. It also specifies tests bywhich compliance requirements can be verified.It does not apply to infant incubators nor infantradiant warmers which are covered in
38、 otherpublications.ANSI/AAMI NS14-1995 (R2002),Implantable Spinal Cord StimulatorsThis standard establishes safety andperformance requirements for internally and/orexternally powered implantable spinal cordstimulators. This standard covers all electrodeconfigurations and all elements of the spinalco
39、rd stimulation system. The system consistsof an implanted pulse generator, connectedelectrodes placed over the spinal cord, and anexternal transmitter or programmer fortransmitting energy and/or information acrossthe patients skin to the implanted pulsegenerator.ANSI/AAMI NS15-1995 (R2002),Implantab
40、le Peripheral Nerve StimulatorsEstablishes safety and performancerequirements for internally and/or externallypowered implantable peripheral nervestimulators. This standard covers all elementsof the peripheral nerve stimulation system,which consists of an implanted pulse generator,connecting electro
41、des placed on or around thenerve, and an external transmitter orprogrammer for transmitting energy and/orinformation across the patients skin to theimplanted pulse generator.ANSI/AAMI NS28-1988 (R2006),Intracranial Pressure Monitoring DevicesEstablishes minimum labeling, safety, andperformance requi
42、rements for intracranialpressure monitoring devices, whetherpercutaneous, fully implantable, or noninvasive.Also covered by this standard are test andcalibration methods needed to establishcompliance with the standard.ANSI/AAMI PAC49-1993 (R2000),Pacemaker Emergency InterventionSystemSpecifies label
43、ing and performancerequirements for a pacemaker emergencyintervention system (EIS), which consists of amagnet and a bradycardial pacemaker. When apacemaker conforming to this standard isperceived to be operating in a nonstandardway, or in a way that is not understood by theexaminer, the magnet can b
44、e used toreprogram the pacemaker to a standard modeas specified by the standard. An EIS isintended to be used in emergency rooms,clinics, or other medical locations where aphysician skilled in pacemakers is notimmediately available. Follow-up to use of theEIS should always occur so that the pacemake
45、rcan be reprogrammed to an optimum setting bya physician skilled in the use of pacemakers.ANSI/AAMI PB70-2003, Liquid BarrierPerformance and Classification ofProtective Apparel and Drapes Intendedfor Use in Health Care FacilitiesEstablishes a barrier performance classificationsystem for protective a
46、pparel and drapes usedin health care facilities. It providesmanufacturers with a consistent basis forcreating device labeling claims regardingbarrier efficacy against liquid-bornemicroorganisms. Through labelingrequirements, the standard is also intended toassist end-users in selecting the appropria
47、teprotective apparel and drapes to inhibit thetransfer of microorganisms associated withblood, body fluids, and other potentiallyinfections materials (OPIM). The standarduses industry-accepted laboratory test methodsto form the basis for barrier claims.ANSI/AAMI PC69-2000, Active ImplantableMedical
48、Devices - ElectromagneticCompatibility - EMC Test Protocols forImplantable Cardiac Pacemakers andImplantable Cardioverter DefibrillatorsSpecifies test methods appropriate to theinterference frequencies at issue. The standardmay specify performance limits or requiredisclosure of performance in the pr
49、esence ofelectromagnetic emitters where appropriate.Provides manufacturers of electromagneticemitters with information about the level ofimmunity to be expected from activeimplantable cardiovascular devices.3ANSI Catalogwebstore.ansi.orgCopyright American National Standards Institute Provided by IHS under license with ANSI Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ANSI/AAMI RD16-1996 (R2005), First-UseHemodialyzersEstablishes labeling requirements, safety
