Programme of work

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 :

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 single numbering
4.	IS 10174 : 2023	Skull Traction Tongs - Crutchfield's Pattern (First Revision)		-	Indigenous
5.	IS 10174 : 1982 Reviewed In : 2022	Tongs, skull Traction, Crutchfield's Pattern	August, 2022	-	Indigenous
6.	IS 10183 : 1982 Reviewed In : 2022	Specification for retractor, deep, self - Retaining, laminectomy	July, 2022	-	Indigenous
7.	IS 10676 : 1983 Reviewed In : 2022	Spatula, Brain, Double-ended Malleable, Olivecrona's Pattern	July, 2022	-	Indigenous
8.	IS 10677 : 2024	Intervertebral Disc Rongeur (First Revision)		-	Indigenous
9.	IS 10677 : 1983 Reviewed In : 2022	Specification for rongeur, intervertebral disk	July, 2022	-	Indigenous
10.	IS 10765 : 1983 Reviewed In : 2022	Forceps, Dissecting, Toothed and Bayonet Shaped, Cushing's Pattern	July, 2022	-	Indigenous
11.	IS 13141 : 1991 Reviewed In : 2022	Neurosurgical Instruments-Leksell's Rongeur	August, 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 : 2008 ISO 9713 Reviewed In : 2023	Neurosurgical implants - Self - Closing intracranial aneurysm clips (First Revision)	January, 2023	-	Identical under dual numbering
16.	IS 14679 : 1999 Reviewed In : 2021	Neurosurgical implants - Implantable peripheral nerve stimulators	January, 2021	-	Indigenous
17.	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
18.	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
19.	IS 17744 : 2021 16054:2019	Implants for surgery Minimum data sets for surgical implants		-	Identical under dual numbering
20.	IS/ISO 7197 : 2006 Reviewed In : 2024	Neurosurgical implants - Sterile, singleuse hydrocephalus shunts and components	July, 2024	-	Indigenous
21.	IS 8174 : 1994 Reviewed In : 2022	Neurosurgical instruments - Forceps, artery, Dandy's pattern - Shape and dimensions - First Revision	April, 2022	-	Indigenous
22.	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
23.	IS 8176 : 2023	Dissectors - Penfield's Pattern (First Revision)		-	Indigenous
24.	IS 8334 : 1977 Reviewed In : 2022	Rongeur, Cranial, Dahlgren's Pattern	July, 2022	-	Indigenous
25.	IS 8380 : 2023	Double Action Rongeur - Olivecrona's Pattern (First Revision)		-	Indigenous
26.	IS 8695 : 1978 Reviewed In : 2022	Forceps, Dressing, Bayonet Shape, Cushing's Pattern	July, 2022	-	Indigenous
27.	IS 8696 : 1978 Reviewed In : 2022	Guide, Saw, De Martel's Pattern	July, 2022	-	Indigenous
28.	IS 8799 : 2023	Kerrison Rongeur (First Revision)		-	Indigenous
29.	IS 9041 : 2023	Neurosurgery - Periosteal Elevator ( First Revision )		-	Indigenous
30.	IS 9072 : 2023	Pituitary Rongeur (First Revision)		-	Indigenous
31.	IS 9073 : 2023	Neuro-suction Tubes (First Revision)		-	Indigenous
32.	IS 9073 : 1979 Reviewed In : 2022	Specification for neuro - Suction tubes	August, 2022	-	Indigenous
33.	IS 9074 : 2023	Raney Clips and Applicators (First Revision)		-	Indigenous
34.	IS 9408 : 1986 Reviewed In : 2022	Specification for retractor, self retaining (First Revision)	August, 2022	-	Indigenous
35.	IS 9410 (Part 1) : 2023	Silver Clip Sets Part 1 Clip Cutting and Forming Forceps (First Revision)		-	Indigenous
36.	IS 9410 (Part 2) : 2023	Silver Clip Sets Part 2 Clip Applying Forceps (First Revision)		-	Indigenous
37.	IS 9410 (Part 3) : 2023	Silver Clip Sets Part 3 Clip Racks (First Revision)		-	Indigenous
38.	IS 9903 : 2023	Skull Brace (First Revision)		-	Indigenous
39.	IS 9904 : 2023	Dural Hooks (First Revision)		-	Indigenous
40.	IS 9911 : 1981 Reviewed In : 2022	Specification for cannula, brain	April, 2022	-	Indigenous
41.	IS 9914 : 2023	Ice Tong Calipers - Cone's Pattern (First Revision)		-	Indigenous
42.	IS 9914 : 1981 Reviewed In : 2022	Calipers, Ice Tong, Cone's Pattern	August, 2022	-	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
No Records Found

Drafts Standards in WC Stage

SI. No.	Doc No	TITLE
1	MHD 7 (25834) Revision of: IS 8174:1994	Neurosurgical Instruments- Forceps Artery Dandys Pattern-Shape and Dimensions
2	MHD 7 (25835) Revision of: IS 8175:1994	Neurosurgical Instruments -Forceps Artery Straight and Curved on Flat Hugh Cairns Pattern - Shape and Dimensions
3	MHD 7 (25836) Revision of: IS 13175:1991	Neurosurgical Instruments - Needle Holder - Shape and Dimensions
4	MHD 7 (25864) Revision of: IS 8334:1977	Specification For Rongeur Cranial Dahlgrens Pattern
5	MHD 7 (25865) Revision of: IS 8695:1978	Specification For Forceps Dressing Bayonet Shape Gushings Pattern
6	MHD 7 (25866) Revision of: IS 8696:1978	Specification For Guide Saw De Martels Pattern
7	MHD 7 (25867) Revision of: IS 9911:1981	Specification For Cannula Brain
8	MHD 7 (25977)	Neurosurgical Implants Self Closing Intracranial Aneurysm Clips

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 (20220) Revision of: IS 10183:1982	Self- Retaining Retractor For Laminectomy
2	MHD 7 (20221) Revision of: IS 10676:1983	Brain Spatula Olivecrona s Pattern First Revision
3	MHD 7 (20223) Revision of: IS 10765:1983	Cushing s Pattern Toothed and Bayonet Shaped Dissecting Forceps First Revision
4	MHD 7 (20236) Revision of: IS 9408:1986	Self-Retaining Retractor for Neurosurgery
5	MHD 7 (21710) Revision of: IS 14139:2008	Neurosurgical Implants Part 1 Self Closing Intracranial Aneurysm Clips Second Revision

Total Published Standards:37 Total Standards Under development : 13

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

Total :38

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 : 1982 Reviewed In : 2022	Specification for retractor deep self - Retaining laminectomy
5.	IS 10676 : 1983 Reviewed In : 2022	Spatula Brain Double-ended Malleable Olivecrona s Pattern
6.	IS 10677 : 2024	Intervertebral Disc Rongeur First Revision
7.	IS 10765 : 1983 Reviewed In : 2022	Forceps Dissecting Toothed and Bayonet Shaped Cushing s Pattern
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 : 2008 ISO 9713 Reviewed In : 2023	Neurosurgical implants - Self - Closing intracranial aneurysm clips First 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 : 1986 Reviewed In : 2022	Specification for retractor self retaining First 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