Lok Sabha Question No. 3754 (UNSTARRED), answered on 2024-12-18
Subject: Development of Standards for Medical Assistive Technologies
Ministry: CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
Asked by: Shri Raju Bista

## Government of India Ministry of Consumer Affairs, Food and Public Distribution

## Department of Consumer Affairs

## LOK SABHA

## UNSTARRED QUESTION NO. 3754

TO BE ANSWERED ON 18.12.2024

## DEVELOPMENT OF STANDARDS FOR MEDICAL ASSISTIVE TECHNOLOGIES

## 3754.  SHRI RAJU BISTA:

Will  the  Minister  of CONSUMER AFFAIRS,  FOOD  AND  PUBLIC  DISTRIBUTION miHkksDrk ekeys] [kk| vkSj lkoZtfud forj.k jkT; ea=h be pleased to state:

- (a) the  specific  types  of  medical  assistive  technologies  for  which  the  Bureau  of  Indian  Standards (BIS) is currently developing standards;
- (b) the  timeline  set  by  BIS  for  the  completion  of  these  standards  particularly  for  the  214  critical medical devices identified in consultation with the Department of Pharmaceuticals (DoP);
- (c) the  measures  being  taken  by  BIS  to  ensure  that  these  standards  align  with  international benchmarks thereby enhancing the global competitiveness of Indian medical devices;
- (d) the strategies employed by BIS to engage with stakeholders including manufacturers, healthcare professionals and patient advocacy groups in the development of these standards to ensure that they meet the needs of end-users; and
- (e) whether there are any additional initiatives or collaborations planned by BIS to further improve the  quality,  safety  and  affordability  of  medical  assistive  technologies  in  India  beyond  the development of these standards and if so, the details thereof?

## ANSWER

## miHkksDrk ekeys] [kk| vkSj lkoZtfud forj.k jkT; ea=h (श्री बी.एल. वर्मा )

## THE MINISTER OF STATE CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION (SHRI B.L.VERMA)

(a)  :  Artificial  Limbs,  Rehabilitation  Appliances  and  Equipment  for  the  Persons  with  Disability' Sectional  Committee  on  Medical  and  Hospital  Planning  Department  (MHD)  9   of   Bureau  of  Indian Standards (BIS) is engaged in formulation of Indian Standards on assistive technologies. The scope of Committee  includes  formulation  of  Indian  Standards  for  artificial  limbs,  prosthetic  and  orthotic appliances,  and  rehabilitation  equipment.  The  list  of  standards  developed  with  respect  to  assistive technologies by MHD 9 Sectional Committee is given at Annexure-I.

Further, the Indian  Standards  on  following types of assistive technologies are currently  under development  by MHD 9 Sectional Committee:

(i)  Standards on Accessible Design:

- a)  Accessible Design Application of Braille on Signage Equipment and Appliances,
- b)  Accessible  design  information  contents  figuration  and  display  methods  of  tactile  guide maps

(ii) Standards identified by ICMR under the National List of Essential Assistive Products (NLEAP):

- a)      Electronic Travel Aids,
- b)      Portable Ramps
3. (iii)  Assistive products for walking (Crutches and Walking sticks)

(b)  :  The list of 214 medical devices identified in consultation with Departmental of Pharmaceuticals (DoP)  is  exclusive  of  the  subjects  relating  to  assistive  products.  The  214  devices  identified  in consultation with DoP have been segregated into Priority List-I and II. Development of Indian Standards on devices in Priority List-I is planned to be completed by March 2025. Development of Indian Standards on devices listed in  Priority  List-II  is  planned  to  be  completed  by  December  2025.  Priority  List-I  and Priority List-II are given at Annexure-II and Annexure-III respectively.

(c) :  BIS recognizes that harmonization of national standards with international standards is necessary to provide opportunities for Indian industries to be globally competitive and have market access. Therefore, Indian Standards are always developed to meet the particular needs in India, while aligning with global best  practices  and  benchmarks.  Rule  29  of BIS  Rules ,  2018  provides  for  adoption  of  International Standards developed by  ISO/IEC as  Indian Standards. Wherever,  International  Standard developed  by ISO/IEC exists for any specific medical device including for assistive products, the concerned technical committee  of  BIS  invariably  reviews  the  same  viz-a-viz  the  national  interest  and  requirements.  The International Standard is adopted as an Indian Standard wherever found suitable. Currently, out of 1102 number  of  product  standards  on  medical  devices,  404  numbers  of  Indian  Standards  are  identical  or technically equivalent adoption of ISO/IEC Standards.

To facilitate the adoption of international standards, it is necessary that national requirements get addressed at the time of development of international standards. Participating in Technical Committees and  Subcommittees  of  international  standards  bodies  (ISO/IEC)  enables  India  to  comment  on  draft standards and pursue the incorporation of requirements that are of interest of Indian stakeholders.  BIS represents India at the ISO/IEC Technical Committees that involve standardization of medical devices at the international level i.e. ISO/TC 173 'Assistive Products' .

(d) :  Development of Indian Standards including standards for medical devices is a collective output of the technical committees which are representative of a balance of stakeholder ranging from consumers, government/regulatory bodies, industry, industry/manufacturer associations, technologists, R&D organizations,  scientific  institutes,  academic  and  technical  institutions,  professional  bodies/institutes, testing/ calibration laboratories, accreditation bodies and individual experts.

Further, all draft Indian Standards are issued into wide circulation for a period of not less than one month and hosted on BIS website for free access to the public for comments. The comments received from  all  concerned  stakeholders  are  considered  and  resolved  by  the  concerned  technical  committee before the draft Indian Standard is finalized and adopted as an Indian Standards.

The process provides for consideration and validation of technical viewpoints and evaluation of comments and feedback from public consultations before the Indian Standard is finalized and published. This ensures that the provisions of the Indian Standard are acceptable to all stakeholders and meet the need of the end-users.

(e)    :  BIS  also  carries  out  Standard  promotion  activities  through  engagement  of  stakeholders  and awareness  programmes  for  consumers.  Conformity  assessment  activity  by  BIS  through  certification schemes also ensures the quality and safety of medical assistive technologies.

## ANNEXURE  REFERRED  TO  IN  REPLY  TO  PART  (a)  OF  LOK  SABHA  UNSTARRED QUESTION NUMBER NO.3754 FOR ANSWER ON 18.12.2024 REGARDING DEVELOPMENT OF STANDARDS FOR MEDICAL ASSISTIVE TECHNOLOGIES.

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## Details of Published Standards are as under:-

|   S.No. | IS No.                                   | Title                                                                                                                                  |
|---------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
|       1 | IS 10110 : 1982                          | Specification for table spoon terminal device for artificial limbs                                                                     |
|       2 | IS 10111 : 1982                          | Specification for table fork terminal device for artificial limbs                                                                      |
|       3 | IS 10537 : 1983                          | Specification for ankle bolt for sach foot                                                                                             |
|       4 | IS 10538 : 1983                          | Specification for kitchen knife terminal device for artificial limbs                                                                   |
|       5 | IS 10539 : 1983                          | Specification for sickle terminal device for artificial limbs                                                                          |
|       6 | IS 10926 : 1984                          | Specification for tweezer terminal device for artificial limbs                                                                         |
|       7 | IS 10928 : 1984                          | Specification for table, tilting, manual                                                                                               |
|       8 | IS 10929 : 1984                          | Specification for hook voluntary opening terminal device for artificial limbs                                                          |
|       9 | IS 10976 : 1993/ISO 6440                 | Wheelchairs - Nomenclature, terms and definitions (First Revision)                                                                     |
|      10 | IS 11242 : 1985                          | Specification for lumbo - Sacral flexion - Extension and lateral - Flexion control brace                                               |
|      11 | IS 11243 : 1985                          | Specification for thoraco - Lumbo - Sacral flexion - Extension and lateral - Flexion control brace                                     |
|      12 | IS 11279 : 1985                          | Specification for braille slate                                                                                                        |
|      13 | IS 11279 : 2024                          | Braille Slate -Specification                                                                                                           |
|      14 | IS 11316 : 1985                          | Specification for cosmetic hand, artificial limb                                                                                       |
|      15 | IS 11646 (Part 1) : 2003                 | Cane for visually handicapped - Specification: Part 1 rigid, long and white (First Revision)                                           |
|      16 | IS 11646 (Part 2) : 1986                 | Specification for cane for visually handicapped: Part 2 folding type                                                                   |
|      17 | IS 11647 : 1986                          | Specification for braille paper                                                                                                        |
|      18 | IS 11708 : 1986                          | Specification for hand, mechanical                                                                                                     |
|      19 | IS 12104 : 1987                          | Specification for abacus for visually handicapped                                                                                      |
|      20 | IS 12152 : 1987                          | Specification for pocket frame, braille writing                                                                                        |
|      21 | IS 12184 : 1987                          | Specification for stylus for braille writing                                                                                           |
|      22 | IS 12439 : 1988                          | Specification for signature guide for visually impaired                                                                                |
|      23 | IS 12664 (Part 1) : 2003                 | Artificial limbs - Sach foot for lower extremity prostheses: Part 1 design and dimensions (First Revision)                             |
|      24 | IS 12683 (Part 1) : 1989                 | Measuring devices for visually impaired persons - Specification: Part 1 scale, general purposes                                        |
|      25 | IS 12683 (Part 2) : 1989                 | Artificial limbs - Measuring devices for visually impaired persons: Part 2 type                                                        |
|      26 | IS 12683 (Part 3) : 2000                 | Measuring devices for visually impaired persons - Specification: Part 3 goniometer                                                     |
|      27 | IS 13017 : 1991                          | Rehabilitation equipment - Walker rollator - Specification                                                                             |
|      28 | IS 13822 : 1993                          | Braille duplicating sheet specification                                                                                                |
|      29 | IS 13837 : 1993                          | Braille duplicating machine specification                                                                                              |
|      30 | IS 13970 (Part 1) : 2023/ISO 8549-1:2020 | Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses First Revision           |
|      31 | IS 13970 (Part 2) : 2023/ISO 8549-2:2020 | Prosthetics and orthotics Vocabulary Part 2: Terms relating to external limb prostheses and wearers of these prostheses First Revision |

|   32 | IS 13970 (Part 3) : 2023/ISO 8549-3: 2020     | Prosthetics and orthotics Vocabulary Part 3: Terms relating to orthoses First Revision                                                                                                         |
|------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   33 | IS 14429 : 1997                               | Braille shorthand machine - Specification                                                                                                                                                      |
|   34 | IS 14723 : 1999                               | Artificial limbs - Knee shin assembly - Specification                                                                                                                                          |
|   35 | IS 14879 : 2000                               | Anterior spinal hyperextension (ASH) brace - Specification                                                                                                                                     |
|   36 | IS 15376 (Part 1) : 2003/ISO 8670-1           | Ostomy collection bags: Part 1 vocabulary                                                                                                                                                      |
|   37 | IS 15376 (Part 2) : 2003/ISO 8670-2           | Ostomy collection bags: Part 2 requirements and test methods                                                                                                                                   |
|   38 | IS/ISO 16021 : 2000                           | Urine-Absorbing Aids -Basic Principles for Evaluation of Single-Use Adult-Incontinence-Absorbing Aids from the Perspective of Users and Caregivers                                             |
|   39 | IS 17034 : 2018                               | Specification for jaipur foot                                                                                                                                                                  |
|   40 | IS 17063 : 2018                               | Specification for Rehabilitation Equipment - Rough Terrain Active Wheelchairs, Folding, Rider-I, Adult and Child Size                                                                          |
|   41 | IS 17154 : 2019                               | Battery operated motorized tricycle - Specification                                                                                                                                            |
|   42 | IS 17154 : 2024                               | Battery Operated Motorized Tricycle - Specification (First Revision)                                                                                                                           |
|   43 | IS 17155 : 2019                               | Tricycle Single Hand Propelled Right Left Junior Size - Specification First Revision                                                                                                           |
|   44 | IS 17157 : 2019                               | Multi utility tricycle - Specification                                                                                                                                                         |
|   45 | IS 17194 : 2019                               | Surgical ankle boot with broad toe (Child And Adult Size) - Specification                                                                                                                      |
|   46 | IS 18295 : 2023/ISO 23600:2007                | Assistive products for persons with vision impairments and persons with vision and hearing impairments Acoustic and tactile signals for pedestrian traffic lights                              |
|   47 | IS 18296 : 2023/ISO 23599:2019                | Assistive products for blind and vision-impaired persons Tactile walking surface indicators                                                                                                    |
|   48 | IS 18428 (Part 1) : 2023/ISO/TR 11548- 1:2001 | Communication aids for blind persons Identifiers names and assignation to coded character sets for 8-dot Braille characters Part 1: General guidelines for Braille identifiers and shift marks |
|   49 | IS 18428 (Part 2) : 2023/ISOTR 11548- 2:2001  | Communication aids for blind persons Identifiers names and assignation to coded character sets for 8-dot Braille characters Part 2: Latin alphabet based character sets                        |
|   50 | IS 18559 (Part 1) : 2024/ISO 24415-1: 2009    | Tips for assistive products for walking Requirements and test methods Part 1: Friction of tips                                                                                                 |
|   51 | IS 18559 (Part 2) : 2024/ISO 24415-2: 2011    | Tips for assistive products for walking Requirements and test methods Part 2: Durability of tips for crutches                                                                                  |
|   52 | IS 18560 : 2024/ISO 9999:2022                 | Assistive products Classification and terminology                                                                                                                                              |
|   53 | IS 18651 (Part 1) : 2024/ISO 7176-1:2014      | Wheelchairs Part 1: Determination of static stability                                                                                                                                          |
|   54 | IS 18651 (Part 2) : 2024/ISO 7176-2:2017      | Wheelchairs Part 2: Determination of dynamic stability of electrically powered wheelchairs                                                                                                     |
|   55 | IS 18651 (Part 3) : 2024/ISO 7176-3:2012      | Wheelchairs Part 3: Determination of effectiveness of brakes                                                                                                                                   |
|   56 | IS 18651 (Part 4) : 2024/ISO 7176-4:2008      | Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range                                                                    |
|   57 | IS 18651 (Part 5) : 2024/ISO 7176-5:2008      | Wheelchairs Part 5: Determination of dimensions mass and manoeuvring space                                                                                                                     |
|   58 | IS 18651 (Part 6) : 2024/ISO 7176-6:2018      | Wheelchairs Part 6: Determination of maximum speed of electrically powered wheelchairs                                                                                                         |
|   59 | IS 18651 (Part 7) : 2024/ISO 7176-7:1998      | Wheelchairs Part 7: Measurement of seating and wheel dimensions                                                                                                                                |

|   60 | IS 18651 (Part 9) : 2024/ISO 7176-9:2009   | Wheelchairs Part 9: Climatic tests for electric wheelchairs                                                  |
|------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------|
|   61 | IS 18651 (Part 10) : 2024/ISO 7176-10:2008 | Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs          |
|   62 | IS 18651 (Part 11) : 2024/ISO 7176-11:2012 | Wheelchairs Part 11: Test dummies                                                                            |
|   63 | IS 18651 (Part 13) : 2024/ISO 7176-13:1989 | Wheelchairs Part 13: Determination of coefficient of friction of test surfaces                               |
|   64 | IS 18651 (Part 15) : 2024/ISO 7176-15:1996 | Wheelchairs Part 15: Requirements for information disclosure documentation and labelling                     |
|   65 | IS 18651 (Part 19) : 2024/ISO 7176-19:2022 | Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles                                          |
|   66 | IS 18653 (Part 1) : 2024/ISO 11199-1: 2021 | Assistive products for walking manipulated by both arms Requirements and test methods Part 1: Walking frames |
|   67 | IS 18653 (Part 2) : 2024/ISO 11199-2:2021  | Assistive products for walking manipulated by both arms - Requirements and test methods Part 2 Rollators     |
|   68 | IS 18653 (Part 3) : 2024/ISO 11199-3:2005  | Walking aids manipulated by both arms Requirements and test methods Part 3: Walking tables                   |
|   69 | IS 18660 : 2024/ISO 19029:2016             | Accessible design Auditory guiding signals in public facilities                                              |
|   70 | IS 18665 : 2024/ISO 10328:2016             | Prosthetics -Structural Testing of Lower-Limb Prostheses - Requirements and Test Methods                     |
|   71 | IS 18831 : 2024/ISO 17966:2016             | Assistive products for personal hygiene that support users - Requirements and Methods of Test                |
|   72 | IS/ISO 21856 : 2022                        | Assistive products General requirements and test methods                                                     |
|   73 | IS/ISO 22523 : 2006                        | External limb prostheses and external orthoses - Requirements and test methods                               |
|   74 | IS/ISO 22675 : 2016                        | Prosthetics - Testing of ankle - Foot devices and foot units - Requirements and test methods                 |
|   75 | IS 4534 : 1980                             | Specification for adapter for terminal devices, artificial limbs (First Revision)                            |
|   76 | IS 4535 : 1968                             | Specification for saw - Grip terminal device for artificial limbs                                            |
|   77 | IS 4554 : 1968                             | Specification for hammers terminal devices, ball pein and claw, for artificial limbs                         |
|   78 | IS 4555 : 1980                             | Specification for biprong terminal device, draughtsman, for artificial - Limbs (First Revision)              |
|   79 | IS 4556 : 1968                             | Specification for typing finger terminal device for artificial limbs                                         |
|   80 | IS 4567 : 1968                             | Specification for pliers terminal device, quick - Grip, for artificial limbs                                 |
|   81 | IS 4577 : 1980                             | Specification for spade - Grip terminal device for artificial limbs (First Revision)                         |
|   82 | IS 4609 : 1980                             | Specification for pencil - Holding device for artificial limbs (First Revision)                              |
|   83 | IS 4675 : 1968                             | Specification for light split - Hook device for artificial limbs                                             |
|   84 | IS 4677 : 1968                             | Specification for steering appliance for artificial limbs                                                    |
|   85 | IS 5015 : 1969                             | Specification for knife - Terminal device for artificial limbs                                               |
|   86 | IS 5143 : 1988                             | Specification for adjustable axillary crutches (Second Revision)                                             |
|   87 | IS 5143 : 2024                             | Specification for metal forearm crutches (Canadian Pattern) (First Revision)                                 |
|   88 | IS 5144 : 1980                             | Specification for metal forearm crutches (Canadian Pattern) (First Revision)                                 |
|   89 | IS 5145 : 1969                             | Specification for walking sticks                                                                             |
|   90 | IS 5150 : 1969                             | Specification for rubber tips for crutches and walking sticks                                                |

|   91 | IS 5586 : 1970   | Specification for metal component for sectional forearm                                                                 |
|------|------------------|-------------------------------------------------------------------------------------------------------------------------|
|   92 | IS 5594 : 1983   | Specification for wrist unit, rotary, for hand prosthesis (First Revision)                                              |
|   93 | IS 5603 : 1983   | Specification for mechanical elbow joint (First Revision)                                                               |
|   94 | IS 5607 : 1970   | Specification for semi - Automatic elbow joint                                                                          |
|   95 | IS 5665 : 1982   | Specification for shoulder wheel (First Revision)                                                                       |
|   96 | IS 5745 : 1986   | Specification for heel socket and plate for orthosis (First Revision)                                                   |
|   97 | IS 5796 : 1970   | Specification for disc type weight set for physio - Therapy exercisers other than pulley arrangements                   |
|   98 | IS 5809 : 1986   | Specification for ankle joint for orthosis (First Revision)                                                             |
|   99 | IS 5810 : 1986   | Specification for knee joint with lock for orthosis (First Revision)                                                    |
|  100 | IS 5827 : 1982   | Specification for paraffin wax bath (First Revision)                                                                    |
|  101 | IS 5956 : 1986   | Specification for hip joint with lock for orthosis (First Revision)                                                     |
|  102 | IS 5963 : 1971   | Specification for knee joint without lock for steel orthopaedic calipers                                                |
|  103 | IS 5964 : 1971   | Specification for round spur for orthopaedic calipers                                                                   |
|  104 | IS 6069 : 1971   | Specification for sliding seat exerciser                                                                                |
|  105 | IS 6099 : 1991   | Rehabilitation equipement - Invalid walkers with crutches - Specification (Second Revision)                             |
|  106 | IS 6205 : 1982   | Specification for stationary cycle exerciser for adults (First Revision)                                                |
|  107 | IS 6221 : 1971   | Specification for pelvic band for steel orthopaedic calipers and braces                                                 |
|  108 | IS 6222 : 1971   | Specification for thigh band for orthopaedic calipers and braces                                                        |
|  109 | IS 6223 : 1971   | Specification for calf band for orthopaedic calipers and braces                                                         |
|  110 | IS 6224 : 1980   | Specification for tuber band for orthopaedic calipers and braces                                                        |
|  111 | IS 6275 : 1971   | Specification for lower extremity full length brace with joints with locks                                              |
|  112 | IS 6302 : 1971   | Specification for whirlpool bath                                                                                        |
|  113 | IS 6414 : 1972   | Specification for parallel walking bars, adult and child sizes, for the handicapped                                     |
|  114 | IS 6571 : 1991   | Rehabilitation equipment - Wheelchairs, non - Folding, adult size, institutional model - Specification (First Revision) |
|  115 | IS 6624 : 1972   | Specification for basic hand splint, palmar arch support                                                                |
|  116 | IS 6625 : 1972   | Specification for basic hand splint component                                                                           |
|  117 | IS 6626 : 1972   | Specification for basic hand splint, forearm piece                                                                      |
|  118 | IS 6781 : 1972   | Specification for staple ankle joint                                                                                    |
|  119 | IS 6802 : 1986   | Specification for prosthetic hip joint (First Revision)                                                                 |
|  120 | IS 6809 : 1990   | Rehabilitation equipment - Fixed height walking frame - Specification (First Revision)                                  |
|  121 | IS 6810 : 1990   | Rehabilitation equipment - Metal tripod and tetrapod sticks - Specification (First Revision)                            |
|  122 | IS 6812 : 2003   | Knee joint, uniaxial for below knee prostheses - Specification (Second Revision)                                        |
|  123 | IS 6979 : 1973   | Specification for cerebral palsy chai, tubula, institutional model                                                      |
|  124 | IS 6992 : 1982   | Specification for cerebral palsy chair, domestic model (First Revision)                                                 |
|  125 | IS 6993 : 1973   | Specification for pan knee joint                                                                                        |

|   126 | IS 6995 : 1973                | Specification for cruciform below - Knee joint                                                                                       |
|-------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
|   127 | IS/ISO 7176-26 : 2007         | Wheelchairs: Part 26 vocabulary                                                                                                      |
|   128 | IS 7373 : 2003                | Hip disarticulation joint unit for lower limb prosthetic fitments - Specification (Second Revision)                                  |
|   129 | IS 7419 : 1983                | Requirements for stairs for physical rehabilitation (First Revision)                                                                 |
|   130 | IS 7454 : 1991                | Rehabilitation equipment - Wheelchairs, folding, adult size - Specification (First Revision)                                         |
|   131 | IS 7454 : 2024                | Rehabilitation Equipment ' Wheelchairs, Folding, Adult Size" Specification (Second Revision)                                         |
|   132 | IS 7924 : 1976                | Specification for thigh blocks, wooden                                                                                               |
|   133 | IS 8086 : 1991                | Rehabilitation equipment - Wheelchairs, folding, junior size - Specification (First Revision)                                        |
|   134 | IS 8086 : 2024                | Rehabilitation Equipment - Wheelchairs, Folding, Junior Size - Specification (Second Revision)                                       |
|   135 | IS 8088 : 2019                | Tricycle, hand propelled - specification (First Revision)                                                                            |
|   136 | IS 8492 : 1985                | Specification for ankle blocks, wooden (First Revision)                                                                              |
|   137 | IS 8511 : 1985                | Specification for valves for suction socket for artificial limbs (First Revision)                                                    |
|   138 | IS/ISO 8669-2 : 1996          | Urine Collection Bags Part 2 Requirements and Test Methods                                                                           |
|   139 | IS 8798 : 1978                | Specification for wheel, multipurpose                                                                                                |
|   140 | IS 9471 (Part 1) : 1980       | Specification for modular lower limb orthotic components: Part 1 stirrups                                                            |
|   141 | IS 9471 (Part 2) : 1980       | Specification for modular lower limb orthotic components: Part 2 stirrups, split                                                     |
|   142 | IS 9471 (Part 3) : 2024       | Modular Lower Limb Orthotic Components' Specification Part 3 Stirrup Plates (First Revision)                                         |
|   143 | IS 9471 (Part 3) : 1980       | Specification for modular lower limb orthotic components: Part 3 stirrup plates                                                      |
|   144 | IS 9471 (Part 4) : 2024       | Modular Lower Limb Orthotic Components ' Specification Part 4 Joint Unit, Ankle (First Revision)                                     |
|   145 | IS 9471 (Part 4) : 1980       | Specification for modular lower limb orthotic components: Part 4 joint unit, ankle                                                   |
|   146 | IS 9471 (Part 5) : 1980       | Specification for modular lower limb orthotic components: Part 5 joint unit, knee                                                    |
|   147 | IS 9471 (Part 5/Sec 2) : 2019 | Specification for modular lower limb orthotic components: Part 5 joint unit section 2 standard knee                                  |
|   148 | IS 9471 (Part 6) : 2024       | Modular Lower Limb Orthotic Components - Specification Part 6 Orthotic Hip Joint (Joint Unit, Hip Drop Lock) (First Revision)        |
|   149 | IS 9471 (Part 6) : 2000       | Modular lower limb orthotic components part 6 orthotic hip joint (Joint Unit, Hip Drop Lock) - Specification                         |
|   150 | IS 9471 (Part 7) : 2024       | Modular Lower Limb Orthotic Components - Specification Part 7 Orthotic Joint Bars, Ankle and Knee (Upper and Lower) (First Revision) |
|   151 | IS 9471 (Part 7) : 2000       | Modular lower limb orthotic components - Specification: Part 7 orthotic joint bars, ankle and knee (Upper And Lower)                 |
|   152 | IS 9797 : 1981                | Specification for cycle, fret - Saw                                                                                                  |

ANNEXURE  REFERRED  TO  IN  REPLY  TO  PART  (b)  OF  LOK  SABHA  UNSTARRED QUESTION NUMBER NO.3754 FOR ANSWER ON 18.12.2024 REGARDING DEVELOPMENT OF STANDARDS FOR MEDICAL ASSISTIVE TECHNOLOGIES.

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Details of Priority List-I (March 2025) are as under:-

|   Sr No. | Subject                                                                                                                |
|----------|------------------------------------------------------------------------------------------------------------------------|
|        1 | PDA closure device / Muscular VSD closure device/ASD closure device                                                    |
|        2 | Dental Intra oral camera                                                                                               |
|        3 | Dental motorised Suction Unit                                                                                          |
|        4 | Airway exchange catheter and bougie                                                                                    |
|        5 | Endotracheal tube - cuffed, microcuffed tube, laser double lumen and Reinforced tube                                   |
|        6 | Bain's circuit &JR circuit                                                                                             |
|        7 | HFNO with cannula                                                                                                      |
|        8 | NIV, NRB, Venturi Mask &Nebulizer Mask                                                                                 |
|        9 | HME Filters                                                                                                            |
|       10 | Oro + Nasopharyngeal airway                                                                                            |
|       11 | Supraglottic devices                                                                                                   |
|       12 | High Flow Nasal O2 therapy Unit                                                                                        |
|       13 | Closed suction catheter                                                                                                |
|       14 | Plasma Sterilizer                                                                                                      |
|       15 | Introducer sheath (Femoral, Radial/Brachial), Mullin sheath, Shuttle sheath                                            |
|       16 | Coronary Angiography diagnostic catheters                                                                              |
|       17 | Angiographic Guide Wire (all types)                                                                                    |
|       18 | Angiography catheter/ Angioplasty guiding catheter                                                                     |
|       19 | Radiofrequency ablation catheter and connectors                                                                        |
|       20 | steerable guidewires                                                                                                   |
|       21 | ENT treatment unit                                                                                                     |
|       22 | Navigation system                                                                                                      |
|       23 | Blood Gas Analyser                                                                                                     |
|       24 | Electrolyte Analyzer                                                                                                   |
|       25 | Chemiluminescence Analyser                                                                                             |
|       26 | Hydrogen breath testing device                                                                                         |
|       27 | Esophageal impedence manometry                                                                                         |
|       28 | Telescope                                                                                                              |
|       29 | OIU Set                                                                                                                |
|       30 | Monopolar /Bipolar TURP Set                                                                                            |
|       31 | Cannulated Battery Drill/Battery Operated Drill/Micromotor Drill/High Speed Pneumatic Drill/Oscillating Saw with Drill |
|       32 | Inflation device                                                                                                       |
|       33 | Y-connector                                                                                                            |
|       34 | Manifold                                                                                                               |

|   35 | Fully Electrically Operated Dental Chair                                                          |
|------|---------------------------------------------------------------------------------------------------|
|   36 | Cervical Traction unit                                                                            |
|   37 | Bicycle ergo meter                                                                                |
|   38 | Tilt table                                                                                        |
|   39 | UVR with stand (It is a medical device use for pressure ulcers &wound healing)                    |
|   40 | Infra red with stand (It is a medical device used for pain management )                           |
|   41 | Automatic Anaerobic Jar System                                                                    |
|   42 | CO2 Laser                                                                                         |
|   43 | Fluid warmer                                                                                      |
|   44 | X-Ray view box                                                                                    |
|   45 | Body Composition Monitor                                                                          |
|   46 | Portable Xray Machine                                                                             |
|   47 | HPLC HbA1c analyzer                                                                               |
|   48 | Electrophoresis system                                                                            |
|   49 | Western blot apparatus                                                                            |
|   50 | Automated Identification &Sensitivity system for bacteria &yeast Automated tb culture system-MGIT |
|   51 | Fully Automated Blood Culture System                                                              |
|   52 | Mannequin for skill based training                                                                |
|   53 | Ultrasonic energy devices                                                                         |
|   54 | Vessel sealing devices                                                                            |
|   55 | Fully Automated Chemiluminescence immunoassay analyser                                            |
|   56 | Urine Strip Analyzer                                                                              |

## ANNEXURE-III

ANNEXURE  REFERRED  TO  IN  REPLY  TO  PART  (b)  OF  LOK  SABHA  UNSTARRED QUESTION NUMBER NO.3754 FOR ANSWER ON 18.12.2024 REGARDING DEVELOPMENT OF STANDARDS FOR MEDICAL ASSISTIVE TECHNOLOGIES.

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Details of Priority List-II (December 2025) are as under:-

| Sr No.   | Subject                                                                                           |
|----------|---------------------------------------------------------------------------------------------------|
| 1        | PCNL Set                                                                                          |
| 2        | Pneumatic Lithoclast                                                                              |
| 3        | Tissue Morcellator                                                                                |
| 4        | Extra Shock Wave Lithotripsy (ESWL)                                                               |
| 5        | Uro Flow Meter                                                                                    |
| 6        | Urodynamic Machine                                                                                |
| 7        | Operating Loupe                                                                                   |
| 8        | Hyfrecator                                                                                        |
| 9        | Phototherapy chamber                                                                              |
| 10       | Iontophoresis machine                                                                             |
| 11       | Arthroscopy Work Station                                                                          |
| 12       | Single/ Double Bundle ACL Reconstruction Set + PCL Reconstruction                                 |
| 13       | CTG Machine                                                                                       |
| 14       | Labor Table                                                                                       |
| 15       | Fetoscopy Set                                                                                     |
| 16       | Epilepsy Monitoring Equipment                                                                     |
| 17       | Transcranial Magnetic Stimulation (Diagnostic &Therapeutic)                                       |
| 18       | 3D Dental Printers                                                                                |
| 19       | Dental Lasers (including soft tissues)                                                            |
| 20       | CPM Upper Limb/Lower limb                                                                         |
| 21       | Gait Training Treadmill                                                                           |
| 22       | Cryotherapy Equipment                                                                             |
| 23       |                                                                                                   |
|          | Osmometer                                                                                         |
| 24       | Impulse oscillometry                                                                              |
| 25       | Pocket dosimeter                                                                                  |
| 26       | Water Phantom/slab phantom/Computed Tomography Phantom/Anthropomorphic radiation therapy phantoms |
| 27       | Microwave ablation generator with probes.                                                         |
| 28       | Cryoablation system                                                                               |
| 29 30    | Interferential therapy unit Thermoablation instrument                                             |
| 31       | Cartridge-Based Nucleic Acid Amplification Test                                                   |
| 32       | HPLC hemoglobinopathies analyser                                                                  |

|   33 | Automated ESR Analyser                                                                                                                            |
|------|---------------------------------------------------------------------------------------------------------------------------------------------------|
|   34 | Platelet Aggregometer                                                                                                                             |
|   35 | Automated semen Analyser                                                                                                                          |
|   36 | Automated Urine and fluid Analyser                                                                                                                |
|   37 | Tissue embedding station/Automated Rotary microtome                                                                                               |
|   38 | Automatic Tissue Processor                                                                                                                        |
|   39 | Cryomicrotome                                                                                                                                     |
|   40 | Body bags                                                                                                                                         |
|   41 | Grossing station with imaging and documentation                                                                                                   |
|   42 | Cryosurgical equipment, cryotherapy unit                                                                                                          |
|   43 | Biopsy punches                                                                                                                                    |
|   44 | Dermatoscope                                                                                                                                      |
|   45 | Phototherapy machine                                                                                                                              |
|   46 | Wood's lamp                                                                                                                                       |
|   47 | ERCP processor and Endoscopy system                                                                                                               |
|   48 | Endoscopy Reprocessor                                                                                                                             |
|   49 | Endoscopy storage and pH metry system                                                                                                             |
|   50 | pHmetry system                                                                                                                                    |
|   51 | Laparoscopic set with HD camera, Monitor light Source &CO2 Insufflators                                                                           |
|   52 | Meniscal repair Set                                                                                                                               |
|   53 | Bankart repair Set                                                                                                                                |
|   54 | Rotator Cuff repair Set                                                                                                                           |
|   55 | Hysteroscope set with Hysteromat &office hysteroscope                                                                                             |
|   56 | Colposcope                                                                                                                                        |
|   57 | Micro debrider                                                                                                                                    |
|   58 | Nasal Endoscopes                                                                                                                                  |
|   59 | Plasma Ablation System (Coblation System)                                                                                                         |
|   60 | LED head light                                                                                                                                    |
|   61 | Flexible Video-Rhino-Laryngoscope (FOL)                                                                                                           |
|   62 | Camera monitor system for endoscopic sinus surgery                                                                                                |
|   63 | Otoendoscopes                                                                                                                                     |
|   64 | Microlaryngoscope                                                                                                                                 |
|   65 | Pure Tone Audiometer with Speech audiometers                                                                                                      |
|   66 | Tympanometer                                                                                                                                      |
|   67 | Automated otoacoustic emission recorder                                                                                                           |
|   68 | Automated auditory brain stem recorder                                                                                                            |
|   69 | Videonystagmography system                                                                                                                        |
|   70 | Evoked Potential system (for Brain Stem Evoked Response audiometry and Auditory steady state responses and vestibular evoked myogenic potentials) |
|   71 | Stroboscope                                                                                                                                       |
|   72 | Flexible Fibre optic bronchoscope                                                                                                                 |
|   73 | Manometer (in-line for venious pressure measurement)                                                                                              |

|   75 | Physiological pressure transducer                                                                                                                    |
|------|------------------------------------------------------------------------------------------------------------------------------------------------------|
|   76 | Radiolucent ECG electrodes.                                                                                                                          |
|   77 | Embolization coils                                                                                                                                   |
|   78 | Microcoil delivery system                                                                                                                            |
|   79 | Reusable pressure transducer plate                                                                                                                   |
|   80 | Disposable ACT tubes                                                                                                                                 |
|   81 | Balloon flotation temporary pacemaker lead                                                                                                           |
|   82 | Mitral Valvuloplasty Single/Double lumen PTMC balloon with/without vent tube                                                                         |
|   83 | Rotational atherectomy catheter                                                                                                                      |
|   84 | Intracoronary intravascular Ultrasound catheter                                                                                                      |
|   85 | Coronary stent PTFE Graft                                                                                                                            |
|   86 | His bundle pacing system                                                                                                                             |
|   87 | CVP line                                                                                                                                             |
|   88 | DVT Pumps with sleeves                                                                                                                               |
|   89 | ACT monitoring machine.                                                                                                                              |
|   90 | Angiojet thrombectomy system.                                                                                                                        |
|   91 | Dialyzer Reprocessing Machine                                                                                                                        |
|   92 | Intra Operative Neuro Monitoring System                                                                                                              |
|   93 | TMS systems                                                                                                                                          |
|   94 | Electronic Balance(it is a medical device used for the patients with neurological balance disorders. )                                               |
|   95 | Dental Piezo - Ultrasonic Scaler                                                                                                                     |
|   96 | Dental sand blasting Machine                                                                                                                         |
|   97 | Orthodontic welder                                                                                                                                   |
|   98 | Dental Casting Machine                                                                                                                               |
|   99 | Dental Lathe                                                                                                                                         |
|  100 | Dental Ceramic furnace                                                                                                                               |
|  101 | Glass Bead Sterilizer                                                                                                                                |
|  102 | Piezo surgical unit                                                                                                                                  |
|  103 | Oscillating saws (with all hand piece )                                                                                                              |
|  104 | Robotic Hand Trainer                                                                                                                                 |
|  105 | Dynamic Stair Trainer                                                                                                                                |
|  106 | Active passive trainer                                                                                                                               |
|  107 | Robotic gait trainer                                                                                                                                 |
|  108 | Pressure mapping systems (it is a medical device used for the patients with Gait balance disorders. Evaluates pressure distribution and magnitude. ) |
|  109 | Motion capture systems for gait analysis and movement assessment                                                                                     |
|  110 | Fully automated Liquid based cytology system                                                                                                         |
|  111 | Semenology incubator                                                                                                                                 |
|  112 | PCR/Thermal Cycler/Real time PCR/ Digital PCR/Real time quantitative PCR                                                                             |
|  113 | PM Line                                                                                                                                              |
|  114 | 3-way stop cock                                                                                                                                      |

|   116 | coronary microcatheter                                                                                                                                                                                                                                                                             |
|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   117 | E.P. Catheters (multipolar and uni directional and bi-directional)                                                                                                                                                                                                                                 |
|   118 | Mother and child catheter assembly                                                                                                                                                                                                                                                                 |
|   119 | CSE Set                                                                                                                                                                                                                                                                                            |
|   120 | Epidural Set (Adult and Paediatric)                                                                                                                                                                                                                                                                |
|   121 | Spinal Needle (Adult and Paediatric)                                                                                                                                                                                                                                                               |
|   122 | ETO sterilisation system                                                                                                                                                                                                                                                                           |
|   123 | Physiodispenser                                                                                                                                                                                                                                                                                    |
|   124 | Dialysis Chair                                                                                                                                                                                                                                                                                     |
|   125 | Cell Separator (Apheresis machine)                                                                                                                                                                                                                                                                 |
|   126 | Goggles                                                                                                                                                                                                                                                                                            |
|   127 | Face shield                                                                                                                                                                                                                                                                                        |
|   128 | Hydraulic Bed                                                                                                                                                                                                                                                                                      |
|   129 | Anti- shock garment                                                                                                                                                                                                                                                                                |
|   130 | PMO lines and PICC line (PICC- it is a medical device called as Peripherally inserted central catheters-Central venous line for giving fluids/taking blood samples. PMO- Pressure Monitoring line , It is a medical device acts as an intermediatory device between syringe pump and iv cannulae ) |
|   131 | Angiography Machine: Monoplane / Bi-plane Digital Substraction Angiography Machine                                                                                                                                                                                                                 |
|   132 | TEG machine (Thromboelastography - method of testing the efficiency of blood coagulation. It is a medical device.)                                                                                                                                                                                 |
|   133 | Continuous Renal Replacement Therapy machine                                                                                                                                                                                                                                                       |
|   134 | Poly somnography machine                                                                                                                                                                                                                                                                           |
|   135 | Cobalt 60 Teletherapy Machine                                                                                                                                                                                                                                                                      |
|   136 | Tomotherapy                                                                                                                                                                                                                                                                                        |
|   137 | Robotic DSA system.                                                                                                                                                                                                                                                                                |
|   138 | CO2 angiography system.                                                                                                                                                                                                                                                                            |
|   139 | Xenon inhalation system for CBF                                                                                                                                                                                                                                                                    |
|   140 | Laser Scanning unit (Used in Pain management can be called as scanning laser therapy equipment)                                                                                                                                                                                                    |
|   141 | Continuous Renal Teplacement Therapy (CRRT) Machine                                                                                                                                                                                                                                                |
|   142 | Lase alignment tool                                                                                                                                                                                                                                                                                |
|   143 | Winston lutz test tool for SRS and SBRT                                                                                                                                                                                                                                                            |
|   144 | Radiation Field alignment test tools with radiopaque markers                                                                                                                                                                                                                                       |
|   145 | Polysomnography                                                                                                                                                                                                                                                                                    |
|   146 | Radiovisiography Machine (RVG)                                                                                                                                                                                                                                                                     |
|   147 | Orthopantomogram Machine (OPG)                                                                                                                                                                                                                                                                     |
|   148 | Tissue microarray System                                                                                                                                                                                                                                                                           |
|   149 | Fully Automated ImmunoAssay Analyser (IIF based) for ANA Screening                                                                                                                                                                                                                                 |
|   150 | Fully Automated Immunostainer                                                                                                                                                                                                                                                                      |
|   151 | Platelet function testing system                                                                                                                                                                                                                                                                   |

|   153 | Automated Hematology Analyser                                    |
|-------|------------------------------------------------------------------|
|   154 | Automated coagulation analyser (Fully automated &semi automated) |
|   155 | Microarray/ similar technology for rapid syndrome management     |
|   156 | Quick cool histology                                             |
|   157 | Fully Automated high risk HPV DNA detection &genotyping system   |
|   158 | DNA sequencer system                                             |

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