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BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

Programme of Work




MHD7 : Neurosurgery Instruments Implants and Accessories


  • Scope : To formulate Indian Standards for Neurosurgery instruments, implants and accessories (cranial & spinal) and monitoring devices
  • Liaison :
    ISO TC 150/WG 15 - Neurosurgical implants

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
 IS 10157 : 2023
Neurological Percussor (First Revision)
-
Indigenous
2.
 IS 10172 : 1982
Reviewed In : 2022
Specification for burs and perforators for drill brace
July, 2022
-
Indigenous
3.
 IS 10172 : 2023
Drill Brace - Burs and Perforators ( First Revision )
-
Identical under dual numbering
4.
 IS 10174 : 2023
Skull Traction Tongs - Crutchfield's Pattern (First Revision)
-
Indigenous
5.
 IS 10183 : 2024
Self- Retaining Retractor For Laminectomy (first revision)
-
Indigenous
6.
 IS 10183 : 1982
Reviewed In : 2022
Specification for retractor, deep, self - Retaining, laminectomy
July, 2022
-
Indigenous
7.
 IS 10676 : 2024
Brain Spatula — Olivecrona’s Pattern (First Revision)
-
Indigenous
8.
 IS 10676 : 1983
Reviewed In : 2022
Spatula, Brain, Double-ended Malleable, Olivecrona's Pattern
July, 2022
-
Indigenous
9.
 IS 10677 : 2024
Intervertebral Disc Rongeur (First Revision)
-
Indigenous
10.
 IS 10765 : 2024
Cushing�s Pattern Toothed and Bayonet Shaped Dissecting Forceps( First Revision )
-
Indigenous
11.
 IS 10765 : 1983
Reviewed In : 2022
Forceps, Dissecting, Toothed and Bayonet Shaped, Cushing's Pattern
July, 2022
-
Indigenous
12.
 IS 13141 : 2023
Leksell's Rongeur for Neurosurgery (First Revision)
-
Indigenous
13.
 IS 13175 : 1991
Reviewed In : 2022
Neurosurgical instruments - Needle holder - Shape and dimensions
April, 2022
-
Indigenous
14.
 IS 13180 : 2023
Neurosurgery - Scoville Trephine ( First Revision )
-
Indigenous
15.
 IS 14139 (Part 1) : 2024
ISO 9713 : 2022
Neurosurgical Implants Part 1 Self-Closing Intracranial Aneurysm Clips (Second Revision)
-
Identical under dual numbering
16.
 IS 14139 (Part 1) : 2008
ISO 9713
Reviewed In : 2023
Neurosurgical implants - Self - Closing intracranial aneurysm clips (First Revision)
January, 2023
-
Identical under dual numbering
17.
 IS 14679 : 1999
Reviewed In : 2021
Neurosurgical implants - Implantable peripheral nerve stimulators
January, 2021
-
Indigenous
18.
 IS/ISO 14708-1 : 2014
ISO 14708-1 : 2014
Reviewed In : 2023
Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision)
January, 2023
-
Identical under single numbering
19.
 IS/ISO 14708-3 : 2017
ISO 14708-3 : 2017
Reviewed In : 2024
Implants for surgery - Active implantable medical devices: Part 3 implantable neurostimulators (First Revision)
March, 2024
-
Identical under single numbering
20.
 IS 17744 : 2021
16054:2019
Implants for surgery Minimum data sets for surgical implants
-
Identical under dual numbering
21.
 IS/ISO 7197 : 2006
Reviewed In : 2024
Neurosurgical implants - Sterile, singleuse hydrocephalus shunts and components
July, 2024
-
Indigenous
22.
 IS 8174 : 1994
Reviewed In : 2022
Neurosurgical instruments - Forceps, artery, Dandy's pattern - Shape and dimensions - First Revision
April, 2022
-
Indigenous
23.
 IS 8175 : 1994
Reviewed In : 2022
Neurosurgical Instruments - Forceps, Artery, Straight and Curved on Flat, Hugh Cairn's Pattern - Shape and Dimensions (First Revision)
April, 2022
-
Indigenous
24.
 IS 8176 : 2023
Dissectors - Penfield's Pattern (First Revision)
-
Indigenous
25.
 IS 8334 : 1977
Reviewed In : 2022
Rongeur, Cranial, Dahlgren's Pattern
July, 2022
-
Indigenous
26.
 IS 8380 : 2023
Double Action Rongeur - Olivecrona's Pattern (First Revision)
-
Indigenous
27.
 IS 8695 : 1978
Reviewed In : 2022
Forceps, Dressing, Bayonet Shape, Cushing's Pattern
July, 2022
-
Indigenous
28.
 IS 8696 : 1978
Reviewed In : 2022
Guide, Saw, De Martel's Pattern
July, 2022
-
Indigenous
29.
 IS 8799 : 2023
Kerrison Rongeur (First Revision)
-
Indigenous
30.
 IS 9041 : 2023
Neurosurgery - Periosteal Elevator ( First Revision )
-
Indigenous
31.
 IS 9072 : 2023
Pituitary Rongeur (First Revision)
-
Indigenous
32.
 IS 9073 : 2023
Neuro-suction Tubes (First Revision)
-
Indigenous
33.
 IS 9074 : 2023
Raney Clips and Applicators (First Revision)
-
Indigenous
34.
 IS 9408 : 2024
Self-Retaining Retractor for Neurosurgery (second revision)
-
Indigenous
35.
 IS 9408 : 1986
Reviewed In : 2022
Specification for retractor, self retaining (First Revision)
August, 2022
-
Indigenous
36.
 IS 9410 (Part 1) : 2023
Silver Clip Sets Part 1 Clip Cutting and Forming Forceps (First Revision)
-
Indigenous
37.
 IS 9410 (Part 2) : 2023
Silver Clip Sets Part 2 Clip Applying Forceps (First Revision)
-
Indigenous
38.
 IS 9410 (Part 3) : 2023
Silver Clip Sets Part 3 Clip Racks (First Revision)
-
Indigenous
39.
 IS 9903 : 2023
Skull Brace (First Revision)
-
Indigenous
40.
 IS 9904 : 2023
Dural Hooks (First Revision)
-
Indigenous
41.
 IS 9911 : 1981
Reviewed In : 2022
Specification for cannula, brain
April, 2022
-
Indigenous
42.
 IS 9914 : 2023
Ice Tong Calipers - Cone's Pattern (First Revision)
-
Indigenous
43.
 IS 9933 : 2023
Brain Retractors (First Revision)
-
Indigenous

Standards Under Develpoment

Projects Approved

SI. No.
Doc No
TITLE
No Records Found

Preliminary Draft Standards

SI. No.
Doc No
TITLE
1
MHD 7 (26388)
SPECIFICATION FOR ALGOMETER
2
MHD 7 (26390)
Specification for Intracranial Pressure Monitors
3
MHD 7 (26391)
Specification for Electroconvulsive Therapy Machine
4
MHD 7 (26392)
Specification for Single Channel Physiological Recorder

Drafts Standards in WC Stage

SI. No.
Doc No
TITLE
No Records Found

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 7 (25834)

Revision of: IS 8174:1994
Neurosurgical Instruments- Forceps Artery Dandys Pattern-Shape and Dimensions Second Revision
2
MHD 7 (25835)

Revision of: IS 8175:1994
Neurosurgical Instruments -Forceps Artery Straight and Curved on Flat Hugh Cairns Pattern - Shape and Dimensions Second Revision
3
MHD 7 (25836)

Revision of: IS 13175:1991
Neurosurgical Instruments Needle Holder Shape and Dimensions First Revision
4
MHD 7 (25864)

Revision of: IS 8334:1977
Rongeur Cranial Dahlgren s Pattern Specification First Revision
5
MHD 7 (25865)

Revision of: IS 8695:1978
Specification For Forceps Dressing Bayonet Shape Gushings Pattern First Revision
6
MHD 7 (25866)

Revision of: IS 8696:1978
Guide Saw De Martel s Pattern Specification First Revision
7
MHD 7 (25867)

Revision of: IS 9911:1981
Brain Cannula - Specification First Revision


Aspect Wise Report

 
 Product:   35
 Code of Practices :    1
 Methods of Test :   0
 Terminology :   0
 Dimensions :   1
 System Standard :   0
 Safety Standard :   1
 Others :    0
 Service Specification :    0
 Process Specification :    0
 Unclassified :    0
 


Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.
IS No.
Title
1.
 IS 14219 : 2001
Reviewed In : 2006
Neurosurgical Implants - Sterile Single-Use Hydrocephalus Shunts and Components
2.
 IS/ISO 14708-7 : 2013
ISO 14708-7 : 2013
Implants for surgery - Active implantable medical devices Part 7 particular requirements for cochlear implant systems
3.
 IS 14921 : 2001
ISO 10310
Reviewed In : 2011
Neurosurgical Implants Marking and Packaging of Implantable Neural Stimulators


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
1.
 IS 10157 : 2023
Neurological Percussor First Revision
2.
 IS 10172 : 1982
Reviewed In : 2022
Specification for burs and perforators for drill brace
3.
 IS 10174 : 2023
Skull Traction Tongs - Crutchfield 39 s Pattern First Revision
4.
 IS 10183 : 2024
Self- Retaining Retractor For Laminectomy first revision
5.
 IS 10676 : 2024
Brain Spatula Olivecrona s Pattern First Revision
6.
 IS 10677 : 2024
Intervertebral Disc Rongeur First Revision
7.
 IS 10765 : 2024
Cushing s Pattern Toothed and Bayonet Shaped Dissecting Forceps First Revision
8.
 IS 13141 : 2023
Leksell 39 s Rongeur for Neurosurgery First Revision
9.
 IS 13175 : 1991
Reviewed In : 2022
Neurosurgical instruments - Needle holder - Shape and dimensions
10.
 IS 13180 : 2023
Neurosurgery - Scoville Trephine First Revision
11.
 IS 14139 (Part 1) : 2024
ISO 9713 : 2022
Neurosurgical Implants Part 1 Self-Closing Intracranial Aneurysm Clips Second Revision
12.
 IS 14679 : 1999
Reviewed In : 2021
Neurosurgical implants - Implantable peripheral nerve stimulators
13.
 IS/ISO 14708-3 : 2017
ISO 14708-3 : 2017
Reviewed In : 2024
Implants for surgery - Active implantable medical devices Part 3 implantable neurostimulators First Revision
14.
 IS/ISO 7197 : 2006
Reviewed In : 2024
Neurosurgical implants - Sterile singleuse hydrocephalus shunts and components
15.
 IS 8174 : 1994
Reviewed In : 2022
Neurosurgical instruments - Forceps artery Dandy 39 s pattern - Shape and dimensions - First Revision
16.
 IS 8175 : 1994
Reviewed In : 2022
Neurosurgical Instruments - Forceps Artery Straight and Curved on Flat Hugh Cairn 39 s Pattern - Shape and Dimensions First Revision
17.
 IS 8176 : 2023
Dissectors - Penfield 39 s Pattern First Revision
18.
 IS 8334 : 1977
Reviewed In : 2022
Rongeur Cranial Dahlgren s Pattern
19.
 IS 8380 : 2023
Double Action Rongeur - Olivecrona 39 s Pattern First Revision
20.
 IS 8695 : 1978
Reviewed In : 2022
Forceps Dressing Bayonet Shape Cushing s Pattern
21.
 IS 8696 : 1978
Reviewed In : 2022
Guide Saw De Martel s Pattern
22.
 IS 8799 : 2023
Kerrison Rongeur First Revision
23.
 IS 9041 : 2023
Neurosurgery - Periosteal Elevator First Revision
24.
 IS 9072 : 2023
Pituitary Rongeur First Revision
25.
 IS 9073 : 2023
Neuro-suction Tubes First Revision
26.
 IS 9074 : 2023
Raney Clips and Applicators First Revision
27.
 IS 9408 : 2024
Self-Retaining Retractor for Neurosurgery second revision
28.
 IS 9410 (Part 1) : 2023
Silver Clip Sets Part 1 Clip Cutting and Forming Forceps First Revision
29.
 IS 9410 (Part 2) : 2023
Silver Clip Sets Part 2 Clip Applying Forceps First Revision
30.
 IS 9410 (Part 3) : 2023
Silver Clip Sets Part 3 Clip Racks First Revision
31.
 IS 9903 : 2023
Skull Brace First Revision
32.
 IS 9904 : 2023
Dural Hooks First Revision
33.
 IS 9911 : 1981
Reviewed In : 2022
Specification for cannula brain
34.
 IS 9914 : 2023
Ice Tong Calipers - Cone 39 s Pattern First Revision
35.
 IS 9933 : 2023
Brain Retractors First Revision