SharadGupta medical standard

8/7/2019 SharadGupta medical standard

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MEDICAL DEVICE STANDARDS


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What is a medical device?What is a medical device?

AccordingAccording toto ISIS 1557915579::20052005/ISO/ISO 1348513485::20032003,, thethe definitiondefinition ofof aamedicalmedical devicedevice isis

AnyAny instrument,instrument, apparatus,apparatus, implement,implement, machine,machine, appliance,appliance, implant,implant, ininvitrovitro reagentreagent oror calibrator,calibrator, software,software, materialmaterial oror otherother similarsimilar oror relatedrelatedarticle,article, intendedintended byby thethe manufacturermanufacturer toto bebe used,used, alonealone oror inincombination,combination, forfor humanhuman beingsbeings forfor oneone oror moremore of of thethe specificspecificpurposespurposes ofof

Diagnosis,Diagnosis, prevention,prevention, monitoring,monitoring, treatmenttreatment oror alleviationalleviation ofof disease,disease, Diagnosis,Diagnosis, monitoring,monitoring, treatment,treatment, alleviationalleviation ofof oror compensationcompensation forfor anan

injuryinjury

Investigation,Investigation, replacement,replacement, modification,modification, oror supportsupport ofof thethe anatomyanatomy ororofof aa physiologicalphysiological processprocess

SupportingSupporting oror sustainingsustaining life,life,

ControlControl ofof conception,conception, DisinfectionDisinfection ofof medicalmedical devices,devices,

ProvidingProviding informationinformation forfor medicalmedical purposespurposes byby meansmeans of of inin vitrovitroexaminationexamination ofof specimensspecimens derivedderived fromfrom humanhuman body,body,

AndAnd whichwhich doesdoes notnot achieveachieve itsits primaryprimary intendedintended actionaction inin oror onon thethehumanhuman bodybody byby pharmacological,pharmacological, immunologicalimmunological oror metabolicmetabolic means,means,

butbut whichwhich maymay bebe assistedassisted inin itsits functionfunction byby suchsuch meansmeans..


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STANDARDIZATIONSTANDARDIZATION

FORMULTION OF STANDARDSFORMULTION OF STANDARDS

ISSUING STANDARDSISSUING STANDARDS

IMPLEMENTING STANDARDSIMPLEMENTING STANDARDS


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FIRST

DRAFT

CIRCULATIONTO

COMMITTEE

MEMBERS

P-DRAFT

COMMENTS

CIRCULATION

TO

COMMITTEE

MEMBERS

COMMENTS

WIDE

CIRCULATION

COMMENTS

NATIONAL

STANDARD

NEW

WORK

ITEM

MEETINGWC

DRAFT

ADOPTION BY DIVISION

COUNCIL

F-DRAFT

STANDARD

MEETING


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SCOPEOF MHDCSCOPEOF MHDC

Standardization In the Field OfStandardization In the Field OfMedical Equipment, SurgicalMedical Equipment, Surgical

Dressings, Artificial Limbs,Dressings, Artificial Limbs,Rehabilitation Equipment,Rehabilitation Equipment,Diagnostic Kits, Veterinary SurgeryDiagnostic Kits, Veterinary Surgery

Instruments, Dental Equipment,Instruments, Dental Equipment,Laboratory Instruments &Laboratory Instruments &Equipment and Hospital PlanningEquipment and Hospital Planning


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Structure of a Sectional CommitteeStructure of a Sectional Committee

Members from:Members from:

ManufacturersManufacturers

Consumers, Government DepartmentsConsumers, Government Departments Technologists, Regulating Authorities,Technologists, Regulating Authorities,

Testing Laboratories, Consultants,Testing Laboratories, Consultants,

Universities, Other ExpertsUniversities, Other Experts


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SECTIONAL COMMITTEESSECTIONAL COMMITTEES

MHD 01MHD 01 SURGICAL INSTRUMENTS SECTIONALSURGICAL INSTRUMENTS SECTIONALCOMMITTEECOMMITTEE

MHD 02MHD 02ORTHOPAEDIC INSTRUMENTS, IMPLANTS ANDORTHOPAEDIC INSTRUMENTS, IMPLANTS AND

ACCESSORIES SECTIONAL COMMITTEEACCESSORIES SECTIONAL COMMITTEE

MHD 03MHD 03OBSTRETICS AND GYNAECOLOGICALOBSTRETICS AND GYNAECOLOGICAL

INSTRUMENTS AND APPLIANCES SECTIONALINSTRUMENTS AND APPLIANCES SECTIONAL

COMMITTEECOMMITTEE

MHD 04MHD 04 EAR, NOSE AND THROAT SURGERYEAR, NOSE AND THROAT SURGERYINSTRUMENTS SECTIONAL COMMITTEEINSTRUMENTS SECTIONAL COMMITTEE

MHD 05MHD 05OPHTHALMIC INSTRUMENTS AND APPLIANCESOPHTHALMIC INSTRUMENTS AND APPLIANCES

SECTIONAL COMMITTEESECTIONAL COMMITTEE


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MHD 06MHD 06THORACIC AND CARDIOVASCULARTHORACIC AND CARDIOVASCULARSURGERY INSTRUMENTS SECTIONALSURGERY INSTRUMENTS SECTIONAL

COMMITTEECOMMITTEE

MHD 07MHD 07NEUROSURGERY INSTRUMENTS IMPLANTSNEUROSURGERY INSTRUMENTS IMPLANTS

AND ACCESSORIES SECTIONAL COMMITTEEAND ACCESSORIES SECTIONAL COMMITTEE

MHD 08MHD 08 DENTISTRY SECTIONAL COMMITTEEDENTISTRY SECTIONAL COMMITTEE

MHD 09MHD 09ARTIFICIAL LIMBS, REHABILITATIONARTIFICIAL LIMBS, REHABILITATIONAPPLIANCES AND EQUIPMENT FOR THEAPPLIANCES AND EQUIPMENT FOR THE

DISABLED SECTIONAL COMMITTEEDISABLED SECTIONAL COMMITTEE

MHD 10MHD 10MEDICAL LABORATORY INSTRUMENTSMEDICAL LABORATORY INSTRUMENTS

SECTIONAL COMMITTEESECTIONAL COMMITTEE


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MHD 11MHD 11ANAESTHETIC,RESUSCITATION AND ALLIEDANAESTHETIC,RESUSCITATION AND ALLIED

EQUIPMENT SECTIONAL COMMITTEEEQUIPMENT SECTIONAL COMMITTEE

MHD 12MHD 12HOSPITAL EQUIPEMNT SECTIONALHOSPITAL EQUIPEMNT SECTIONAL

COMMITTEECOMMITTEE

MHD 13MHD 13VETERINARY HOSPITAL PLANNING ANDVETERINARY HOSPITAL PLANNING AND

SURGICAL INTRUMENTS SECTIONALSURGICAL INTRUMENTS SECTIONAL

COMMITTEECOMMITTEE

MHD 14MHD 14 HOSPITAL PLANNING SECTIONAL COMMITTEEHOSPITAL PLANNING SECTIONAL COMMITTEE

MHD 15MHD 15ELECTROMEDICAL EQUIPMENT SECTIONALELECTROMEDICAL EQUIPMENT SECTIONAL

COMMITTEECOMMITTEE


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LaisionLaision with ISO/IECCommittees/Subwith ISO/IECCommittees/Sub--CommitteesCommittees

MHD 01MHD 01 TC 170TC 170 Surgical instrumentsSurgical instruments [P[P--member]member] MH2 02/05/06/07MH2 02/05/06/07 TC 150TC 150 Implants for surgeryImplants for surgery [P[P--member]member] TC 150/SC 1TC 150/SC 1 MaterialsMaterials [P[P--member]member] TC 150/SC 2TC 150/SC 2 Cardiovascular implants and extracorporeal systemsCardiovascular implants and extracorporeal systems [O[O--member]member] TC 150/SC 3TC 150/SC 3 Neurosurgical implantsNeurosurgical implants [O[O--member]member] TC 150/SC 4TC 150/SC 4 Bone and joint replacementsBone and joint replacements [O[O--member]member] TC 150/SC 5TC 150/SC 5 OsteosynthesisOsteosynthesis and spinal devicesand spinal devices [P[P--member]member] TC 150/SC 6TC 150/SC 6 Active implantsActive implants [O[O--member]member] MHD03MHD03 TC 157TC 157 Mechanical contraceptivesMechanical contraceptives [P[P--member]member] MHD 04MHD 04 TC 172TC 172 Optics and photonicsOptics and photonics [O[O--member]member] TC 172/SC 1TC 172/SC 1 Fundamental standardsFundamental standards [O[O--member]member] TC 172/SC 3TC 172/SC 3 Optical materials and componentsOptical materials and components [O[O--member]member]

TC 172/SC 6TC 172/SC 6 Geodetic and surveying instrumentsGeodetic and surveying instruments [O[O--member]member]TC 172/SC 7TC 172/SC 7 Ophthalmic optics and instrumentsOphthalmic optics and instruments [O[O--member]member]TC 172/SC 9TC 172/SC 9 ElectroElectro--optical systemsoptical systems [O[O--member]member]

MHD 08MHD 08 TC 106TC 106 DentistryDentistry [P[P--member]member]TC 106/SC 1TC 106/SC 1 Filling and restorative materialsFilling and restorative materials [O[O--member]member]TC 106/SC 2TC 106/SC 2 Prosthodontic materialsProsthodontic materials [O[O--member]member]TC 106/SC 3TC 106/SC 3 TerminologyTerminology [O[O--member]member]

TC 106/SC 6TC 106/SC 6 Dental equipmentDental equipment [O[O--member]member]TC 106/SC 7TC 106/SC 7 Oral care productsOral care products [O[O--member]member]TC 106/SC 8TC 106/SC 8 Dental implantsDental implants [O[O--member]member]TC 194TC 194 Biological evaluation of medical devicesBiological evaluation of medical devices [O[O--member]member]

MHD0 9MHD0 9 TC 173TC 173 Assistive products for persons with disability [O Assistive products for persons with disability [O--member]member]TC 168TC 168 Prosthetics and orthoticsProsthetics and orthotics [P[P--member]member]


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Related ISO/IECCommittees/SubRelated ISO/IECCommittees/Sub--Committees(CONT.)Committees(CONT.)

MHDMHD 1010 TCTC 8484 DevicesDevices forfor administrationadministration ofof medicinalmedicinal productsproducts [P[P--member]member] andand intravascularintravascular catheterscatheters

TCTC 7676 Transfusion,Transfusion, infusioninfusion andand injectioninjection equipmentequipment forfor [O[O--member]member]

medicalmedical andand pharmaceuticalpharmaceutical useuse MHDMHD 1111 TCTC 121121 AnaestheticAnaesthetic andand respiratoryrespiratory equipmentequipment [P[P--member]member] TCTC121121/SC/SC66 MedicalMedical gasgas systemssystems [P[P--member]member] TCTC121121/SC/SC88 SuctionSuction devicesdevices forfor hospitalhospital andand [O[O--member]member]

emergencyemergency carecare useuse MHDMHD 1212 TCTC198198 SterilizationSterilization ofof healthhealth carecare productsproducts [O[O--member]member] MHDMHD 1414 TCTC210210 QualityQuality managementmanagement andand correspondingcorresponding [P[P--member]member] generalgeneral aspectsaspects forfor medicalmedical devicesdevices MHDMHD 1515 IECIEC TCTC6262 AA:: CommonCommon aspectsaspects ofof ElectricalElectrical EquipmentsEquipments usedused inin PracticePractice [O[O--member]member] FirstFirst revision)revision)

MHDMHD 1616 TCTC 7676 Transfusion,Transfusion, infusioninfusion andand injectioninjection equipmentequipment forfor medicalmedical andand [O[O--member]member] pharmaceuticalpharmaceutical useuse

TCTC 8484 DevicesDevices fprfpr administrationadministration ofof medicalmedical productproduct andandintravascularintravascular catheterscatheters [P[P member]member]

MHDMHD 1717 TCTC 215215 HealthHealth informaticsinformatics && itsits subcommitteesubcommittee MHDMHD 1818 IECIEC SCSC 6262BB DiagnosticDiagnostic ImagingImaging EquipmentEquipment [O[O--member]member]

IECIEC 6262 CC EquipmentEquipment forfor RadiotherapyRadiotherapy [O[O--member]member]

MHDMHD 1919 TCTC 194194 BiologicalBiological;; evaluationevaluation ofof medicalmedical devicesdevices [O[O--member]member] MHDMHD 2020 TCTC 229229 HealthHealth safetysafety && environmentalenvironmental aspectsaspects ofof [O[O--member]member] nanotechnologynanotechnology

TOTALTOTAL 3636PP--MEMBERMEMBER 1111OO--MEMBERMEMBER 2525


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Some Important Standards published onSome Important Standards published on

Medical DevicesMedical Devices

IS 8048:1985 Electrocardiograph(IS 8048:1985 Electrocardiograph(first revisionfirst revision))

This standard covers the safety and performance requirements and testThis standard covers the safety and performance requirements and testmethods for directmethods for direct--writing singlewriting single--channel and multichannel and multi--channelchannelelectrocardiographselectrocardiographs

This standard includes the construction and general requirements, generalThis standard includes the construction and general requirements, generalsafety requirements, marking requirements, performance requirements andsafety requirements, marking requirements, performance requirements andadditional requirements for electrocardiographs to be used with pacemakersadditional requirements for electrocardiographs to be used with pacemakersand defibrillators.and defibrillators.

In addition, this standard describes various tests methods, for example:In addition, this standard describes various tests methods, for example:(i) Type Tests(Dry heat, damp heat, high voltage, stability, leakage current)(i) Type Tests(Dry heat, damp heat, high voltage, stability, leakage current)(ii) Acceptance tests(High voltage, overload, accuracy of speed)(ii) Acceptance tests(High voltage, overload, accuracy of speed)(iii) Routine tests (Stability, time constant, linearity)(iii) Routine tests (Stability, time constant, linearity)


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contdcontd

IS 8885:1994 Medical Electrical EquipmentIS 8885:1994 Medical Electrical Equipment

ElectromyographElectromyograph--Specification(Specification(first revisionfirst revision

))

Electromyography is a technique for evaluating and recording theElectromyography is a technique for evaluating and recording theactivation signal of muscles and it is performed using an instrumentactivation signal of muscles and it is performed using an instrumentcalled an electromyograph. The record produced i.e electromyogramcalled an electromyograph. The record produced i.e electromyogram

will be a visual display on the CRT augmented by a sufficiently loudwill be a visual display on the CRT augmented by a sufficiently loudsound pattern as an auditory signal output.sound pattern as an auditory signal output.

IS 8885:1994 covers the safety and performance requirements andIS 8885:1994 covers the safety and performance requirements andtest methods for single and multitest methods for single and multi--channel electromyographs. Thischannel electromyographs. Thisstandard also covers construction and general requirements andstandard also covers construction and general requirements andcontrols and connection of the electromyograph.controls and connection of the electromyograph.


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IS 9286(Part 1):1988 Cardiac defibrillatorsIS 9286(Part 1):1988 Cardiac defibrillators--safety requirementssafety requirements

IS 9286(Part 2):1988 Cardiac defibrillatorsIS 9286(Part 2):1988 Cardiac defibrillators--Construction andConstruction and

performance requirementsperformance requirements

Part 1 specifies requirements for the safety of cardiac defibrillatorsPart 1 specifies requirements for the safety of cardiac defibrillatorsand cardiac defibrillator monitors incorporating a capacitive energyand cardiac defibrillator monitors incorporating a capacitive energystorage device.storage device.

Part 2 specifies construction and performance requirements ofPart 2 specifies construction and performance requirements ofcardiac defibrillators and cardiac defibrillators monitorscardiac defibrillators and cardiac defibrillators monitors

From the viewpoint of safety cardiac defibrillators and defibrillatorFrom the viewpoint of safety cardiac defibrillators and defibrillatormonitors pose special problems not only because of the possiblemonitors pose special problems not only because of the possibleshock hazard to the operator, but also because the defibrillator mustshock hazard to the operator, but also because the defibrillator must

deliver the selected output even after a long period of disuse,deliver the selected output even after a long period of disuse,otherwise the patient safety may be at risk. Therefore, cardiacotherwise the patient safety may be at risk. Therefore, cardiacdefibrillator must have a higher degree order of reliability.defibrillator must have a higher degree order of reliability.


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IS 11302(Part 1):1985 ElectroIS 11302(Part 1):1985 Electro--encephalograph(EEG)encephalograph(EEG)

Part 1 General and Safety Requirements &Part 1 General and Safety Requirements &

Part 2 Performance RequirementsPart 2 Performance Requirements

The brain normally produces tiny electrical signals that come from theThe brain normally produces tiny electrical signals that come from thebrain cells and nerves which send messages to each other.brain cells and nerves which send messages to each other.Electroencephalography (EEG)Electroencephalography (EEG) is the recording of electrical activityis the recording of electrical activityalong the scalp produced by the firing of neurons within the brain. Thealong the scalp produced by the firing of neurons within the brain. Theinstrument used for electroencephalography is calledinstrument used for electroencephalography is called

electroencephalograph.electroencephalograph.

Part 1 specifies general and safety requirements for electroPart 1 specifies general and safety requirements for electro--encephalographs and their associated accessories, intended for theencephalographs and their associated accessories, intended for theproduction of detachable graphic recording of electrical activity of theproduction of detachable graphic recording of electrical activity of thebrain for diagnostic purposes.brain for diagnostic purposes.

Part 2 specifies the particular performance requirements.Part 2 specifies the particular performance requirements. Special requirements concerning other requirements inSpecial requirements concerning other requirements in

electroencephalography (phonoelectroencephalography (phono--photic stimulators), EEGphotic stimulators), EEGtelemetry, EEG data storage and retrieval, EEG monitoring of thetelemetry, EEG data storage and retrieval, EEG monitoring of thecritically ill, etc, are not covered by these standard.critically ill, etc, are not covered by these standard.


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IS 11754:1986 Specification for Implantable VentricularIS 11754:1986 Specification for Implantable Ventricular

PacemakerPacemaker

A pacemakerA pacemaker is a medical device which uses electrical impulses,is a medical device which uses electrical impulses,delivered by electrodes contacting the heart muscles, to regulatedelivered by electrodes contacting the heart muscles, to regulatethe beating of the heart. The primary purpose of a pacemaker is tothe beating of the heart. The primary purpose of a pacemaker is tomaintain an adequate heart rate, either because the heart's nativemaintain an adequate heart rate, either because the heart's nativepacemaker is not fast enough, or there is a block in the heart'spacemaker is not fast enough, or there is a block in the heart's

electrical conduction systemelectrical conduction system

IS 11754:1986 applies exclusively to wholly implantable cardiacIS 11754:1986 applies exclusively to wholly implantable cardiacpacemakers, either of preset or the programmable type, and ispacemakers, either of preset or the programmable type, and isconforming to those aspects of pacemakers which are concernedconforming to those aspects of pacemakers which are concernedonly with stimulation of the ventricle(asynchronous pacing) and withonly with stimulation of the ventricle(asynchronous pacing) and withsensing and stimulation of the ventricle(ventricular inhibited orsensing and stimulation of the ventricle(ventricular inhibited orventricular trigerred pacing).ventricular trigerred pacing).


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IS 13450(Part 2/Sec 7):2006 Medical Electrical EquipmentIS 13450(Part 2/Sec 7):2006 Medical Electrical Equipment--

Part 2 Particular requirements for the safety Section 7 HighPart 2 Particular requirements for the safety Section 7 High

voltage generators of diagnostic Xvoltage generators of diagnostic X--ray generatorsray generators

This standard applies to high voltage generatorsThis standard applies to high voltage generatorsof medical diagnostic Xof medical diagnostic X--ray generators and toray generators and totheir subtheir sub--assemblies including the following:assemblies including the following:

-- High voltage generators that are integrated withHigh voltage generators that are integrated withan Xan X--ray tube assemblyray tube assembly

-- High voltage generators of radiotherapyHigh voltage generators of radiotherapytreatment simulatorstreatment simulators

The object of this standard is to establishThe object of this standard is to establishparticular requirements to ensure safety and toparticular requirements to ensure safety and tospecify methods for demonstrating compliancespecify methods for demonstrating compliancewith those requirements.with those requirements.


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IS 13450(Part 2/Sec 45):2007 Medical Electrical EquipmentIS 13450(Part 2/Sec 45):2007 Medical Electrical Equipment

Part 2 Particular requirement for safety Section 45Part 2 Particular requirement for safety Section 45

Mammographic XMammographic X--ray equipment and mammographicray equipment and mammographic

Stereotactic devicesStereotactic devicesThis particular standard contains requirements for the safety of XThis particular standard contains requirements for the safety of X--ray equipment designed for mammography and mammographicray equipment designed for mammography and mammographicstereotactic devices.stereotactic devices.

The object of this standard is:The object of this standard is:-- To formulate appropriate design and manufacturing requirementsTo formulate appropriate design and manufacturing requirements

for the safety of mammographic Xfor the safety of mammographic X--ray equipment andray equipment andmammographic stereotactic devices, reflecting the particularmammographic stereotactic devices, reflecting the particularcharacteristics and circumstances of use of such equipment;characteristics and circumstances of use of such equipment;

-- To establish particular requirements to ensure safety and to specifyTo establish particular requirements to ensure safety and to specifymethods for demonstrating compliance with those requirementsmethods for demonstrating compliance with those requirements


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IS 13450(Part 2/Sec 44):2007 Medical Electrical EquipmentIS 13450(Part 2/Sec 44):2007 Medical Electrical Equipment

Part 2 Particular requirement for safety Section 44 XPart 2 Particular requirement for safety Section 44 X--rayray

equipment for computed tomographyequipment for computed tomography

This particular standard applies to XThis particular standard applies to X--ray equipment forray equipment forcomputed tomography (CT Scanners). It includes safetycomputed tomography (CT Scanners). It includes safetyrequirements for the Xrequirements for the X--ray generator, and those where highray generator, and those where high

voltage generators are integrated with an Xvoltage generators are integrated with an X--ray tuberay tubeassembly.assembly.

The object of this standard is to establish particularThe object of this standard is to establish particular

requirements to ensure safety and to specify methods forrequirements to ensure safety and to specify methods fordemonstrating compliance with those requirements, for CTdemonstrating compliance with those requirements, for CTscannersscanners


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STANDARDS ON DENTISTRYSTANDARDS ON DENTISTRY

IS 5941:1970 Specification for Dental Engine, ElectricIS 5941:1970 Specification for Dental Engine, Electric

IS 6829:1991 Dental InstrumentsIS 6829:1991 Dental Instruments--Orthodontic pliers, angle wireOrthodontic pliers, angle wire

bendingbending--Shape, dimensions and testsShape, dimensions and tests

IS 10663:2003 Dental rotary instrumentsIS 10663:2003 Dental rotary instruments--Steel and carbid bursSteel and carbid burs

IS 10664:2003 Dental rotary instrumentsIS 10664:2003 Dental rotary instruments--Steel and carbideSteel and carbidefinishing bursfinishing burs


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STANDARDS ON OPTHALMICSTANDARDS ON OPTHALMIC

INSTRUMENTSINSTRUMENTSIS 12947:1990 Eye surgery instrumentsIS 12947:1990 Eye surgery instruments-- TonometersTonometers

-- SpecificationSpecification

IS 8257:1976 OpthalmoscopeIS 8257:1976 Opthalmoscope

IS 6420:1989 Eye surgery instrumentsIS 6420:1989 Eye surgery instruments--Retractor, eye,Retractor, eye,

lachrymal sac Mullers pattern (modified)lachrymal sac Mullers pattern (modified)

-- SpecificationSpecification

IS 9688:1992 Eye surgery instrumentsIS 9688:1992 Eye surgery instruments--Hook, strabismusHook, strabismus--CullersCullers

PatternPattern


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.contd.contd

IS 5226:1989 Eye surgery instrumentsIS 5226:1989 Eye surgery instruments--Forceps, eye, corneoForceps, eye, corneo--scleral disc, Elliots pattern(modified)scleral disc, Elliots pattern(modified)--SpecificationSpecification

(second revision)(second revision)

IS 5231:1990 Eye surgery instrumentsIS 5231:1990 Eye surgery instruments--Forceps, eye tarsal cyst,Forceps, eye tarsal cyst,

Greens pattern(modified)Greens pattern(modified)--Specification(secondSpecification(second

revision)revision)

IS 5232:1990 Eye surgery instrumentsIS 5232:1990 Eye surgery instruments--Forceps, eye cilia, BeersForceps, eye cilia, Beers

pattern(modified)pattern(modified)-- Specification(second revision)Specification(second revision)

IS 5233:1990 Eye surgery instrumentsIS 5233:1990 Eye surgery instruments--Forceps, eye intraForceps, eye intra--

capsular, arrugas and Elschnigs pattern(modofied)capsular, arrugas and Elschnigs pattern(modofied)--

Specification (Second revision)Specification (Second revision)


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Other Standards on Medical DevicesOther Standards on Medical Devices

Hypodermic needles (IS 3317)Hypodermic needles (IS 3317) Cystoscope (IS 5738)Cystoscope (IS 5738)

Medical endoscopes(IS 15732/ISO 8600)Medical endoscopes(IS 15732/ISO 8600)

Orthopaedic Implants of different materials (in 18 parts)Orthopaedic Implants of different materials (in 18 parts)

(IS 5347/ISO 5832)(IS 5347/ISO 5832) IUD (IS 12418)IUD (IS 12418)

Rubber condoms (IS/ISO 4074)Rubber condoms (IS/ISO 4074)

Intra ocular lenses (IS 14323)Intra ocular lenses (IS 14323)

Ultrasonic Therapy Equipment (IS 13020/IEC 60601Ultrasonic Therapy Equipment (IS 13020/IEC 60601--22--5)5) Syringes (IS 3235/ISO 59512)Syringes (IS 3235/ISO 59512)


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contdcontd

Dental Explorers (IS/ISO 7492)Dental Explorers (IS/ISO 7492)

Hot air sterilizers (IS 3119)Hot air sterilizers (IS 3119)

Incubators (IS 3118)Incubators (IS 3118)

Safety of Lung Ventillator (IS 11661/IEC 60601Safety of Lung Ventillator (IS 11661/IEC 60601--22--12)12)


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