MEDICAL DEVICE STANDARDS

What is a medical device?What is a medical device? According to IS 15579:2005/ISO 13485:2003, the definition of a According to IS 15579:2005/ISO 13485:2003, the definition of a

medical device ismedical device is Any instrument, apparatus, implement, machine, appliance, Any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more used, alone or in combination, for human beings for one or more of the specific purposes ofof the specific purposes of

Diagnosis, prevention, monitoring, treatment or alleviation of Diagnosis, prevention, monitoring, treatment or alleviation of disease,disease,

Diagnosis, monitoring, treatment, alleviation of or compensation Diagnosis, monitoring, treatment, alleviation of or compensation for an injuryfor an injury

Investigation, replacement, modification, or support of the Investigation, replacement, modification, or support of the anatomy or of a physiological processanatomy or of a physiological process

Supporting or sustaining life,Supporting or sustaining life, Control of conception,Control of conception, Disinfection of medical devices,Disinfection of medical devices, Providing information for medical purposes by means of in vitro Providing information for medical purposes by means of in vitro

examination of specimens derived from human body,examination of specimens derived from human body, And which does not achieve its primary intended action in or on And which does not achieve its primary intended action in or on

the human body by pharmacological, immunological or metabolic the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.means, but which may be assisted in its function by such means.

STANDARDIZATIONSTANDARDIZATION

FORMULTION OF FORMULTION OF STANDARDSSTANDARDS

ISSUING STANDARDSISSUING STANDARDS IMPLEMENTING IMPLEMENTING

STANDARDSSTANDARDS

FIRST DRAFT

CIRCULATION TO

COMMITTEE MEMBERS

P-DRAFT

COMMENTS

CIRCULATION TO

COMMITTEE MEMBERS

COMMENTS

WIDE

CIRCULATION

COMMENTS

NATIONALSTANDARD

NATIONALSTANDARD

NEW WORK ITEM

NEW WORK ITEM

MEETINGWC

DRAFT

ADOPTION BY DIVISION COUNCIL

F-DRAFTSTANDARD

MEETING

SCOPE OF MHDCSCOPE OF MHDC

““Standardization In the Field Of Standardization In the Field Of Medical Equipment, Surgical Medical Equipment, Surgical Dressings, Artificial Limbs, Dressings, Artificial Limbs, Rehabilitation Equipment, Rehabilitation Equipment, Diagnostic Kits, Veterinary Diagnostic Kits, Veterinary Surgery Instruments, Dental Surgery Instruments, Dental Equipment, Laboratory Equipment, Laboratory Instruments & Equipment and Instruments & Equipment and Hospital Planning”Hospital Planning”

Structure of a Sectional CommitteeStructure of a Sectional Committee

Members from:Members from: ManufacturersManufacturers Consumers, Government Consumers, Government

DepartmentsDepartments Technologists, Regulating Technologists, Regulating

Authorities, Testing Laboratories, Authorities, Testing Laboratories, Consultants, Universities, Other Consultants, Universities, Other Experts Experts

SECTIONAL COMMITTEESSECTIONAL COMMITTEES

MHD 01MHD 01 SURGICAL INSTRUMENTS SECTIONAL SURGICAL INSTRUMENTS SECTIONAL COMMITTEECOMMITTEE

MHD 02MHD 02 ORTHOPAEDIC INSTRUMENTS, IMPLANTS AND ORTHOPAEDIC INSTRUMENTS, IMPLANTS AND ACCESSORIES SECTIONAL COMMITTEEACCESSORIES SECTIONAL COMMITTEE

MHD 03MHD 03OBSTRETICS AND GYNAECOLOGICAL OBSTRETICS AND GYNAECOLOGICAL INSTRUMENTS AND APPLIANCES SECTIONAL INSTRUMENTS AND APPLIANCES SECTIONAL COMMITTEECOMMITTEE

MHD 04MHD 04 EAR, NOSE AND THROAT SURGERY EAR, NOSE AND THROAT SURGERY INSTRUMENTS SECTIONAL COMMITTEEINSTRUMENTS SECTIONAL COMMITTEE

MHD 05MHD 05 OPHTHALMIC INSTRUMENTS AND APPLIANCES OPHTHALMIC INSTRUMENTS AND APPLIANCES SECTIONAL COMMITTEESECTIONAL COMMITTEE

SECTIONAL COMMITTEESSECTIONAL COMMITTEES

MHD 06MHD 06 THORACIC AND CARDIOVASCULARTHORACIC AND CARDIOVASCULAR SURGERY INSTRUMENTS SECTIONAL SURGERY INSTRUMENTS SECTIONAL COMMITTEECOMMITTEE

MHD 07MHD 07 NEUROSURGERY INSTRUMENTS IMPLANTS NEUROSURGERY INSTRUMENTS IMPLANTS AND ACCESSORIES SECTIONAL COMMITTEEAND ACCESSORIES SECTIONAL COMMITTEE

MHD 08MHD 08 DENTISTRY SECTIONAL COMMITTEEDENTISTRY SECTIONAL COMMITTEE

MHD 09MHD 09 ARTIFICIAL LIMBS, REHABILITATION ARTIFICIAL LIMBS, REHABILITATION APPLIANCES AND EQUIPMENT FOR THE APPLIANCES AND EQUIPMENT FOR THE DISABLED SECTIONAL COMMITTEEDISABLED SECTIONAL COMMITTEE

MHD 10MHD 10 MEDICAL LABORATORY INSTRUMENTS MEDICAL LABORATORY INSTRUMENTS SECTIONAL COMMITTEESECTIONAL COMMITTEE

SECTIONAL COMMITTEESSECTIONAL COMMITTEES

MHD 11MHD 11 ANAESTHETIC,RESUSCITATION AND ALLIED ANAESTHETIC,RESUSCITATION AND ALLIED EQUIPMENT SECTIONAL COMMITTEEEQUIPMENT SECTIONAL COMMITTEE

MHD 12MHD 12 HOSPITAL EQUIPEMNT SECTIONAL HOSPITAL EQUIPEMNT SECTIONAL COMMITTEECOMMITTEE

MHD 13MHD 13VETERINARY HOSPITAL PLANNING AND VETERINARY HOSPITAL PLANNING AND SURGICAL INTRUMENTS SECTIONAL SURGICAL INTRUMENTS SECTIONAL COMMITTEECOMMITTEE

MHD 14MHD 14 HOSPITAL PLANNING SECTIONAL COMMITTEEHOSPITAL PLANNING SECTIONAL COMMITTEE

MHD 15MHD 15 ELECTROMEDICAL EQUIPMENT SECTIONAL ELECTROMEDICAL EQUIPMENT SECTIONAL COMMITTEECOMMITTEE

SECTIONAL COMMITTEESSECTIONAL COMMITTEES

MHD 16 SURGICAL DRESSING AND DISPOSABLE MHD 16 SURGICAL DRESSING AND DISPOSABLE PRODUCTS SECTIONAL COMMITTEEPRODUCTS SECTIONAL COMMITTEE

MHD 17 HEALTH INFORMATICS SECTIONAL COMMITTEEMHD 17 HEALTH INFORMATICS SECTIONAL COMMITTEE

MHD 18 IMAGING AND RADIOTHERAPY EQUIPMENTMHD 18 IMAGING AND RADIOTHERAPY EQUIPMENT SECTIONAL COMMITTEESECTIONAL COMMITTEE

MHD 19 IMMUNO-BIOLOGICAL DIAGNOSTIC KITS MHD 19 IMMUNO-BIOLOGICAL DIAGNOSTIC KITS SECTIONAL COMMITTEESECTIONAL COMMITTEE

MHD20 MEDICAL BIOTECHNOLOGY AND MHD20 MEDICAL BIOTECHNOLOGY AND NANOTECHNOLOGY NANOTECHNOLOGY

MHD21 HOSPITAL BIO MEDICAL WASTE MANAGEMENT AND MHD21 HOSPITAL BIO MEDICAL WASTE MANAGEMENT AND INFECTION CINTROL INFECTION CINTROL

Laision with ISO/IEC Committees/Sub-CommitteesLaision with ISO/IEC Committees/Sub-Committees MHD 01 MHD 01 TC 170    Surgical instruments    Surgical instruments [P-member] [P-member] MH2 02/05/06/07 MH2 02/05/06/07 TC 150    Implants for surgery    Implants for surgery [P-member] [P-member] TC 150/SC 1 Materials Materials [P-member] [P-member] TC 150/SC 2    Cardiovascular implants and extracorporeal systems    Cardiovascular implants and extracorporeal systems [O- [O-

member]member] TC 150/SC 3 Neurosurgical implants Neurosurgical implants [O-member] [O-member] TC 150/SC 4    Bone and joint replacements    Bone and joint replacements [O- [O-

member]member] TC 150/SC 5    Osteosynthesis and spinal devices    Osteosynthesis and spinal devices     [P-member] [P-member] TC 150/SC 6    Active implants    Active implants    [O-member] [O-member] MHD03 MHD03 TC 157       Mechanical contraceptives Mechanical contraceptives [P-member] [P-member] MHD 04MHD 04 TC 172       Optics and photonics Optics and photonics    [O-member] [O-member] TC 172/SC 1    Fundamental standards    Fundamental standards [O-member] [O-member] TC 172/SC 3    Optical materials and components    Optical materials and components [O-member] [O-member]

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

MHD 08MHD 08 TC 106       Dentistry Dentistry    [P-member] [P-member]TC 106/SC 1    Filling and restorative materials    Filling and restorative materials     [O-member] [O-member]TC 106/SC 2    Prosthodontic materials    Prosthodontic materials    [O-member] [O-member]TC 106/SC 3    Terminology    Terminology     [O-member] [O-member]TC 106/SC 6    Dental equipmentTC 106/SC 6    Dental equipment     [O- [O-

member]member]TC 106/SC 7    Oral care productsTC 106/SC 7    Oral care products    [O- [O-

member]member]TC 106/SC 8    Dental implants TC 106/SC 8    Dental implants [O-member] [O-member]TC 194TC 194    Biological evaluation of medical devices    Biological evaluation of medical devices [O- [O-

member]member] MHD0 9MHD0 9 TC 173TC 173    Assistive products for persons with disability [O-member]    Assistive products for persons with disability [O-member]

TC 168TC 168    Prosthetics and orthotics      Prosthetics and orthotics   [P-member] [P-member]

Related ISO/IEC Committees/Sub-Committees(CONT.)Related ISO/IEC Committees/Sub-Committees(CONT.)

MHD 10 TC 84MHD 10 TC 84   Devices for administration of medicinal products Devices for administration of medicinal products [P-member] [P-member] and intravascular catheters and intravascular catheters

TC 76 TC 76    Transfusion, infusion and injection equipment for    Transfusion, infusion and injection equipment for [O-member] [O-member]

medical and pharmaceutical use  medical and pharmaceutical use  MHD 11MHD 11 TC 121TC 121 Anaesthetic and respiratory equipment Anaesthetic and respiratory equipment [P-member] [P-member]           TC121/SC6TC121/SC6   Medical gas systems   Medical gas systems    [P- [P-

member]member]           TC121/SC8TC121/SC8   Suction devices for hospital and   Suction devices for hospital and [O-member] [O-member]

emergency care useemergency care use MHD 12 TC198MHD 12 TC198    Sterilization of health care products    Sterilization of health care products [O-member] [O-member] MHD 14 TC210MHD 14 TC210    Quality management and corresponding    Quality management and corresponding [P-member] [P-member] general aspects for medical devices  general aspects for medical devices  MHD 15 IEC TC62 A: MHD 15 IEC TC62 A: Common aspects of Electrical Equipments used in Practice [O-member]Common aspects of Electrical Equipments used in Practice [O-member] First revision)First revision)

MHD 16 TC 76MHD 16 TC 76 Transfusion, infusion and injection equipment for medical and [O-member]Transfusion, infusion and injection equipment for medical and [O-member] pharmaceutical use pharmaceutical use TC 84TC 84 Devices fpr administration of medical product and Devices fpr administration of medical product and intravascular catheters [P member]intravascular catheters [P member] MHD 17 TC 215MHD 17 TC 215 Health informatics & its subcommittee Health informatics & its subcommittee MHD 18 IEC SC 62B MHD 18 IEC SC 62B Diagnostic Imaging Equipment Diagnostic Imaging Equipment [O-member] [O-member]

IEC 62 CIEC 62 C Equipment for Radiotherapy Equipment for Radiotherapy [O-member] [O-member] MHD 19 TC 194MHD 19 TC 194 Biological; evaluation of medical devices [O-member] Biological; evaluation of medical devices [O-member] MHD 20 TC 229MHD 20 TC 229 Health safety & environmental aspects of [O-member] Health safety & environmental aspects of [O-member] nanotechnologynanotechnology

TOTAL TOTAL 3636P-MEMBERP-MEMBER 1111

O-MEMBERO-MEMBER 25 25

Some Important Standards published on Some 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 This standard covers the safety and performance requirements and test methods for direct-writing single-channel and multi-channel test methods for direct-writing single-channel and multi-channel electrocardiographselectrocardiographs

This standard includes the construction and general requirements, This standard includes the construction and general requirements, general safety requirements, marking requirements, performance general safety requirements, marking requirements, performance requirements and additional requirements for electrocardiographs to requirements and additional requirements for electrocardiographs to be used with pacemakers and defibrillators.be used with pacemakers and defibrillators.

In addition, this standard describes various tests methods, for In addition, this standard describes various tests methods, for example:example:

(i) Type Tests(Dry heat, damp heat, high voltage, stability, leakage (i) Type Tests(Dry heat, damp heat, high voltage, stability, leakage current) 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)

… …contdcontd

IS 8885:1994 Medical Electrical EquipmentIS 8885:1994 Medical Electrical Equipment Electromyograph-Specification( Electromyograph-Specification(first revisionfirst revision) )

Electromyography is a technique for evaluating and Electromyography is a technique for evaluating and recording the activation signal of muscles and it is recording the activation signal of muscles and it is performed using an instrument called an electromyograph. performed using an instrument called an electromyograph. The record produced i.e electromyogram will be a visual The record produced i.e electromyogram will be a visual display on the CRT augmented by a sufficiently loud sound display on the CRT augmented by a sufficiently loud sound pattern as an auditory signal output. pattern as an auditory signal output.

IS 8885:1994 covers the safety and performance IS 8885:1994 covers the safety and performance requirements and test methods for single and multi-channel requirements and test methods for single and multi-channel electromyographs. This standard also covers construction electromyographs. This standard also covers construction and general requirements and controls and connection of and general requirements and controls and connection of the electromyograph. the electromyograph.

IS 9286(Part 1):1988 Cardiac defibrillators-safety requirementsIS 9286(Part 1):1988 Cardiac defibrillators-safety requirementsIS 9286(Part 2):1988 Cardiac defibrillators-Construction and IS 9286(Part 2):1988 Cardiac defibrillators-Construction and

performance requirementsperformance requirements

Part 1 specifies requirements for the safety of cardiac Part 1 specifies requirements for the safety of cardiac defibrillators and cardiac defibrillator monitors incorporating defibrillators and cardiac defibrillator monitors incorporating a capacitive energy storage device.a capacitive energy storage device.

Part 2 specifies construction and performance requirements Part 2 specifies construction and performance requirements of cardiac defibrillators and cardiac defibrillators monitors of cardiac defibrillators and cardiac defibrillators monitors

From the viewpoint of safety cardiac defibrillators and From the viewpoint of safety cardiac defibrillators and defibrillator monitors pose special problems not only defibrillator monitors pose special problems not only because of the possible shock hazard to the operator, but because of the possible shock hazard to the operator, but also because the defibrillator must deliver the selected also because the defibrillator must deliver the selected output even after a long period of disuse, otherwise the output even after a long period of disuse, otherwise the patient safety may be at risk. Therefore, cardiac defibrillator patient safety may be at risk. Therefore, cardiac defibrillator must have a higher degree order of reliability.must have a higher degree order of reliability.

IS 11302(Part 1):1985 Electro-encephalograph(EEG) IS 11302(Part 1):1985 Electro-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 The brain normally produces tiny electrical signals that come from the brain cells and nerves which send messages to each from the brain cells and nerves which send messages to each other. other. Electroencephalography (EEG)Electroencephalography (EEG) is the recording of is the recording of electrical activity along the scalp produced by the firing of electrical activity along the scalp produced by the firing of neurons within the brain. The instrument used for neurons within the brain. The instrument used for electroencephalography is called electroencephalograph.electroencephalography is called electroencephalograph.

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

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

electroencephalography (phono-photic stimulators), EEG electroencephalography (phono-photic stimulators), EEG telemetry, EEG data storage and retrieval, EEG monitoring of telemetry, EEG data storage and retrieval, EEG monitoring of the critically ill, etc, are not covered by these standard.the critically ill, etc, are not covered by these standard.

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

A pacemakerA pacemaker is a medical device which uses electrical is a medical device which uses electrical impulses, delivered by electrodes contacting the heart impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. The primary muscles, to regulate the beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart purpose of a pacemaker is to maintain an adequate heart rate, either because the heart's native pacemaker is not rate, either because the heart's native pacemaker is not fast enough, or there is a block in the heart's electrical fast enough, or there is a block in the heart's electrical conduction system conduction system

IS 11754:1986 applies exclusively to wholly implantable IS 11754:1986 applies exclusively to wholly implantable cardiac pacemakers, either of preset or the programmable cardiac pacemakers, either of preset or the programmable type, and is conforming to those aspects of pacemakers type, and is conforming to those aspects of pacemakers which are concerned only with stimulation of the which are concerned only with stimulation of the ventricle(asynchronous pacing) and with sensing and ventricle(asynchronous pacing) and with sensing and stimulation of the ventricle(ventricular inhibited or stimulation of the ventricle(ventricular inhibited or ventricular trigerred pacing).ventricular trigerred pacing).

IS 13450(Part 2/Sec 7):2006 Medical Electrical Equipment-IS 13450(Part 2/Sec 7):2006 Medical Electrical Equipment-Part 2 Particular requirements for the safety Section 7 High Part 2 Particular requirements for the safety Section 7 High

voltage generators of diagnostic X-ray generatorsvoltage generators of diagnostic X-ray generators

This standard applies to high voltage This standard applies to high voltage generators of medical diagnostic X-ray generators of medical diagnostic X-ray generators and to their sub-assemblies generators and to their sub-assemblies including the following:including the following:

- High voltage generators that are integrated High voltage generators that are integrated with an X-ray tube assemblywith an X-ray tube assembly

- High voltage generators of radiotherapy High voltage generators of radiotherapy treatment simulatorstreatment simulators

The object of this standard is to establish The object of this standard is to establish particular requirements to ensure safety and particular requirements to ensure safety and to specify methods for demonstrating to specify methods for demonstrating compliance with those requirements.compliance with those requirements.

IS 13450(Part 2/Sec 45):2007 Medical Electrical Equipment IS 13450(Part 2/Sec 45):2007 Medical Electrical Equipment Part 2 Particular requirement for safety Section 45 Part 2 Particular requirement for safety Section 45

Mammographic X-ray equipment and mammographic Mammographic X-ray equipment and mammographic Stereotactic devicesStereotactic devices

This particular standard contains requirements for the This particular standard contains requirements for the safety of X-ray equipment designed for mammography and safety of X-ray equipment designed for mammography and mammographic stereotactic devices.mammographic stereotactic devices.

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

requirements for the safety of mammographic X-ray requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances reflecting the particular characteristics and circumstances of use of such equipment;of use of such equipment;

- To establish particular requirements to ensure safety and to To establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those specify methods for demonstrating compliance with those requirements requirements

IS 13450(Part 2/Sec 44):2007 Medical Electrical Equipment IS 13450(Part 2/Sec 44):2007 Medical Electrical Equipment Part 2 Particular requirement for safety Section 44 X-ray Part 2 Particular requirement for safety Section 44 X-ray

equipment for computed tomographyequipment for computed tomography

This particular standard applies to X-ray equipment This particular standard applies to X-ray equipment for computed tomography (CT Scanners). It includes for computed tomography (CT Scanners). It includes safety requirements for the X-ray generator, and safety requirements for the X-ray generator, and those where high voltage generators are integrated those where high voltage generators are integrated with an X-ray tube assembly.with an X-ray tube assembly.

The object of this standard is to establish particular The object of this standard is to establish particular requirements to ensure safety and to specify requirements to ensure safety and to specify methods for demonstrating compliance with those methods for demonstrating compliance with those requirements, for CT scanners requirements, for CT scanners

STANDARDS ON DENTISTRYSTANDARDS ON DENTISTRY

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

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

bending-Shape, dimensions and testsbending-Shape, dimensions and tests

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

IS 10664:2003 Dental rotary instruments-Steel and carbide IS 10664:2003 Dental rotary instruments-Steel and carbide

finishing bursfinishing burs

STANDARDS ON OPTHALMIC STANDARDS ON OPTHALMIC INSTRUMENTSINSTRUMENTS

IS 12947:1990 Eye surgery instruments- TonometersIS 12947:1990 Eye surgery instruments- Tonometers

- Specification- Specification

IS 8257:1976 OpthalmoscopeIS 8257:1976 Opthalmoscope

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

lachrymal sac Muller’s pattern (modified) lachrymal sac Muller’s pattern (modified)

- Specification- Specification

IS 9688:1992 Eye surgery instruments-Hook, strabismus-IS 9688:1992 Eye surgery instruments-Hook, strabismus-Culler’s Culler’s

PatternPattern

…….contd.contd

IS 5226:1989 Eye surgery instruments-Forceps, eye, corneo- IS 5226:1989 Eye surgery instruments-Forceps, eye, corneo-

scleral disc, Elliot’s pattern(modified)-Specification scleral disc, Elliot’s pattern(modified)-Specification

(second revision)(second revision)

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

Green’s pattern(modified)-Specification(second Green’s pattern(modified)-Specification(second

revision)revision)

IS 5232:1990 Eye surgery instruments-Forceps, eye cilia, Beer’s IS 5232:1990 Eye surgery instruments-Forceps, eye cilia, Beer’s

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

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

capsular, arruga’s and Elschnig’s capsular, arruga’s and Elschnig’s pattern(modofied)-pattern(modofied)-

Specification (Second revision)Specification (Second revision)

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 Orthopaedic Implants of different materials (in 18

parts)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 60601-Ultrasonic Therapy Equipment (IS 13020/IEC 60601-

2-5)2-5) Syringes (IS 3235/ISO 59512)Syringes (IS 3235/ISO 59512)

……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 60601-2-12)Safety of Lung Ventillator (IS 11661/IEC 60601-2-12)

THANK YOUTHANK YOU