Programme of work

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BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

Programme of Work




MHD6 : Medical and Surgical Cardiology Equipment


  • Scope : 1) To formulate Indian Standards for thoracic and cardiovascular surgery instruments, cardiology equipment, implants and accessories. 2) To coordinate with the work of: a) ISO/TC 150/ SC2 ‘Cardiovascular Implants & Extracorporeal System’: (P Member) b) ISO/TC 150/SC 6 ‘Active Implants’: (P Member) 3) To coordinate the work of sub-committees under this sectional committee (MHD-06): a) Cardiothoracic and Vascular Surgery Sub Committee b) Cardiology Sub Committee
  • Liaison :
    ISO/TC 150/SC 6 - Active implants - Participating (P)
    ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems - Participating (P)
    ISO TC 150/SC 2/WG 1 - Cardiac valves
    ISO TC 150/SC 2/WG 6 - Vascular device-drug combination products
    ISO/TC 150/SC 6/JWG 1 - Joint ISO/TC 150/SC 6 - IEC/SC 62D WG: Cardiac pacemakers and implantable defibrillators
    ISO/TC 150/SC 6/JWG 2 - JWG between ISO/TC 150/SC 6 and IEC/SC62B: Effects of magnetic resonance imaging on active implantable medical devices
    ISO TC 150/SC 6/WG 1 - Fundamental standards

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
 IS 10540:1991
Cardiovascular Surgery Instruments - Clamps, Atrial Appendage, Glover's Pattern - Shape and Dimensions
April, 2022
-
Indigenous
2.
 IS 10541:1991
Cardiovascular surgery instruments - Clamps vena cava,satinsky pattern shape, sizes and dimensions (First Revision)
April, 2022
-
Indigenous
3.
 IS 11566:2024
Thoracic Surgery Instruments — Valve Retractors — Specification (First Revision)
-
Indigenous
4.
 IS/ISO 11658:2012
ISO 11658 : 2012
Cardiovascular Implants and Extracorporeal Organs Blood/Tissue Contact Surface Modifications for Extracorporeal Perfusion Systems
-
Identical under single numbering
5.
 IS/ISO 12417-1:2015
ISO 12417-1 : 2015
Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements
-
Identical under single numbering
6.
 IS 13940:1994
Cardiovascular surgery instruments - Clamps, bulldog, DeBakey,ring handle - Shape and dimensions
April, 2022
-
Indigenous
7.
 IS/ISO 15674-2004:2016
ISO 15674 : 2016
Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision)
February, 2022
-
Identical under single numbering
8.
 IS/ISO 15675:2016
ISO 15675 : 2016
Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters
-
Identical under single numbering
9.
 IS/ISO 15676:2016
ISO 15676 : 2016
Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation ECMO First revision
-
Identical under single numbering
10.
 IS 17646 (Part 1):2021
ISO 23500-1 : 2019
Preparation and quality management of fluids for haemodialysis and related therapies : Part 1 General requirements
-
Identical under dual numbering
11.
 IS 17646 (Part 2):2021
IS/ISO 23500-2 : 2019
Preparation and quality management of fluids for haemodialysis and related therapies Part 2 Water treatment equipment for haemodialysis applications and related therapies
-
Identical under dual numbering
12.
 IS 17646 (Part 3):2021
ISO 23500-3 : 2019
Preparation and quality management of fluids for haemodialysis and related therapies Part 3 Water for haemodialysis and related therapies
-
Identical under dual numbering
13.
 IS 17646 (Part 4):2021
ISO 23500-4 : 2019
Preparation and quality management of fluids for haemodialysis and related therapies Part 4 Concentrates for haemodialysis and related therapies
-
Identical under dual numbering
14.
 IS 17646 (Part 5):2021
ISO 23500-5 : 2019
Preparation and quality management of fluids for haemodialysis and related therapies Part 5 Quality of dialysis fluid for haemodialysis and related therapies
-
Identical under dual numbering
15.
 IS 17708:2021
ISO/TS 23810:2018
Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment
-
Identical under single numbering
16.
 IS 17709:2022
ISO 11318:2002
Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements
-
Identical under dual numbering
17.
 IS 17710:2021
ISO 27185:2012
Cardiac rhythm management devices- Symbols to be used with cardiac rhythm management device labels and information to be supplied General requirements
-
Identical under dual numbering
18.
 IS 17712 (Part 2):2021
ISO 5841-2:2014
Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
-
Identical under dual numbering
19.
 IS 17712 (Part 3):2021
ISO 5841-3:2013
Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors IS-1 for implantable pacemakers
-
Identical under dual numbering
20.
 IS 17745:2021
ISO 5910:2018
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
-
Identical under dual numbering
21.
 IS 17746:2021
Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements
-
Modified/Technically Equivalent
22.
 IS 17750 (Part 4):2025
Implants for surgery � Active implantable medical devices � Part 4: Implantable infusion pump systems (ISO 14708-4 : 2022, MOD)
-
Modified/Technically Equivalent
23.
 IS 17750 (Part 6):2022
ISO 14708-6:2019
Implants for Surgery Active Implantable Medical Devices Part 6 Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia Including Implantable Defibrillators
-
Identical under dual numbering
24.
 IS 17750 (Part 5):2021
ISO 14708-5:2020
Implants for surgery Active Implantable Medical Devices Part 5: Circulatory Support Devices
-
Identical under dual numbering
25.
 IS 17751 (Part 2):2024
ISO/TR 12417-2
Cardiovascular Implants and Extracorporeal Systems � Vascular Device-Drug Combination Products Part 2 Local Regulatory Information ( First Revision )
-
Identical under dual numbering
26.
 IS 17840 (Part 1):2022
5840-1:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements
-
Identical under dual numbering
27.
 IS 17840 (Part 2):2022
5840-2:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute First Revision
-
Identical under dual numbering
28.
 IS 17840 (Part 3):2022
ISO 5840-3:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Transcatheter Techniques First Revision
-
Identical under dual numbering
29.
 IS 17841 (Part 4):2023
ISO 25539-4:2021
Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices
-
Identical under dual numbering
30.
 IS 17841 (Part 2):2022
ISO 25539:2020
Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision
-
Identical under dual numbering
31.
 IS 17842:2022
ISO 14117:2019
Active Implantable Medical Devices Electromagnetic Compatibility EMC Test Protocols for Implantable Cardiac Pacemakers Implantable Cardioverter Defibrillators and Cardiac Resynchronization Devices
-
Identical under dual numbering
32.
 IS 17843:2022
ISO/TS 17137:2021
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants
-
Identical under dual numbering
33.
 IS 18207:2023
ISO/TR19024:2016
Evaluation of CPB Devices Relative to their Capabilities of Reducing the Transmission of Gaseous Microemboli GME to a Patient during Cardiopulmonary Bypass
-
Identical under dual numbering
34.
 IS/ISO 18241:2016
ISO 18241 : 2016
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps
-
Identical under single numbering
35.
 IS/ISO 18242:2016
ISO 18242 : 2016
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps
-
Identical under single numbering
36.
 IS 18903:2025
ISO/PAS 7020:2023
Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
-
Identical under dual numbering
37.
 IS 18927:2024
Cardiovascular implants � Transcatheter cardiac occluders (ISO 22679 : 2021, MOD)
-
Modified/Technically Equivalent
38.
 IS 18974:2025
Cardiovascular Implants and Artificial Organs � Cannulae for Extracorporeal Circulation (ISO 18193 : 2021, MOD)
-
Modified/Technically Equivalent
39.
 IS/ISO 25539-1:2017
ISO 25539-1 : 2017
Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)
-
Identical under single numbering
40.
 IS/ISO 25539-3:2011
ISO 25539-3 : 2011
Cardiovascular implants - Endovascular devices: Part 3 vena cava filters
February, 2022
-
Identical under single numbering
41.
 IS 6395:2024
Thoracic Surgery Instruments — Auricle Clamps, Crafoords Pattern — Specification (Second Revision)
-
Indigenous
42.
 IS 6436:1989
Thoracic Surgery Instruments - Rib Spreader, Finochietto's Pattern, Adult Size
September, 2022
-
Indigenous
43.
 IS 6442:2024
Thoracic Surgery Instruments — Rib Shears, Tudor Edward’s Pattern — Specification (Second Revision)
-
Indigenous
44.
 IS 6466:2024
Thoracic Surgery Instruments — Needle Holder — Specification
-
Indigenous
45.
 IS 6467:2024
Thoracic Surgery Instruments — Rib Periosteotome, Alexander’s Pattern — Specification (Second Revision)
-
Indigenous
46.
 IS 6468:2024
Thoracic Surgery Instruments — Empyema Trocar, Nelson’s Pattern — Specification (Second Revision)
-
Indigenous
47.
 IS 6777:1989
Thoracic and cardiovascular surgery instruments - Forceps, dissecting, lung - Specification (First Revision)
September, 2022
-
Indigenous
48.
 IS 6778:2024
Thoracic Surgery Instruments — Lung Forceps, Duval’s Pattern — Specification (Second Revision)
-
Indigenous
49.
 IS 6780:2024
Thoracic Surgery Instruments — Artery Forceps, Robert’s Pattern — Specification (Second Revision)
-
Indigenous
50.
 IS/ISO 7198:2016
ISO 7198 : 2016
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
-
Identical under single numbering
51.
 IS 7199 (Part 71991996):2016
ISO 7199 : 2016
Cardiovascular implants and artificial organs - Blood - Gas exchangers (Oxygenators) (Second Revision)
February, 2022
-
Identical under single numbering
52.
 IS 7345:1994
Cardiovascular surgery instruments - Anastomosis forceps and clamps - Patterns, shapes and dimensions (Second Revision)
April, 2022
-
Indigenous
53.
 IS 7346:2024
Thoracic Surgery Instruments — Rib Raspatories — Specification (Second Revision)
-
Indigenous
54.
 IS 7355:2024
Thoracic Surgery Instruments — Rib Spreader, Tuffier’s Pattern — Specification (Second Revision)
-
Indigenous
55.
 IS 7367:1987
Clamps, Coarctation, Potts' Pattern, Straight and Angular
September, 2022
-
Indigenous
56.
 IS 7379:2024
Thoracic Surgery Instruments — Straight and Angular Patent Ductus Clamps — Specification (Second Revision)
-
Indigenous
57.
 IS 7382:2024
Thoracic Surgery Instruments — Rib Shears, Thomas Pattern — Specification (Second Revision)
-
Indigenous
58.
 IS 7399:1987
Knife, Sternum, Lebsche's Pattern
September, 2022
1
Indigenous
59.
 IS 7434:2024
Thoracic Surgery Instruments — Scapula Retractor — Specification (Second Revision)
-
Indigenous
60.
 IS 7972:2024
Thoracic Surgery Instruments — Dissecting Scissors — Specification (Second Revision)
-
Indigenous
61.
 IS 8317:1991
Cardiovascular surgery instruments - Clamps, vascular, angled at 45 - Shape and dimensions (First Revision)
April, 2022
-
Indigenous
62.
 IS 8335:1991
Cardiovascular Surgery Instruments - Clamps, Auricle, Satinsky Pattern - Sizes, Shape and Dimensions
April, 2022
-
Indigenous
63.
 IS 8345:1994
Cardiovascular surgery instruments - Clamps, bulldog, cross action type - Specification (First Revision)
September, 2022
-
Indigenous
64.
 IS 8549:2024
Thoracic Surgery Instruments - Angled Scissors - Specification (Second Revision)
-
Indigenous
65.
 IS/ISO 8637-1:2017
Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
-
Identical under single numbering
66.
 IS/ISO 8637-2:2018
ISO 8637-2 : 2018
Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
-
Identical under single numbering
67.
 IS/ISO 8637-3:2018
ISO 5840-3 : 2018
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters
-
Identical under single numbering
68.
 IS 8890:1991
Thoracic surgery instruments - Clamps,bronchus - Types, shapes and dimensions (First Revision)
April, 2022
-
Indigenous
69.
 IS 9928:1981
Clamp, Aortic, DeBakey's Pattern (Spoon Shaped angled Jaw)
September, 2022
-
Indigenous
70.
 IS 9950:2024
Thoracic Surgery Instruments — Vascular Clamp — Specification (First Revision)
-
Indigenous
71.
 IS 9951:2024
Thoracic Surgery Instruments — Blunt End Scissors — Specification (First Revision)
-
Indigenous
72.
 IS 9987:2024
Thoracic Surgery Instruments —Multipurpose Clamps — Specification (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 6 (27693)
Medical Cardiology Instruments Intracardiac Sucker - Specifications
2
MHD 6 (28470)
Dialyzer Reprocessing Machines Specification

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
1
MHD 6 (26591)
Revision of: IS 10540:1991
Thoracic Surgery Instruments - Atrial Appendage Clamps Glovers Pattern - Specification
2
MHD 6 (26592)
Revision of: IS 10541:1991
Thoracic Surgery Instruments - Vena cava Clamps Satinskys pattern - Specification
3
MHD 6 (26594)
Revision of: IS 7345:1994
Thoracic Surgery Instruments -Anastomosis forceps and Clamps - Specification
4
MHD 6 (26596)
Revision of: IS 8335:1991
Thoracic Surgery Instruments - Auricle Clamps - Specification
5
MHD 6 (26597)
Revision of: IS 8890:1991
Thoracic Surgery Instruments -Bronchus Clamps - Specification
6
MHD 6 (26608)
Revision of: IS 6777:1989
Thoracic Surgery Instruments - Dissecting Forceps for lungs - Specification
7
MHD 6 (26610)
Revision of: IS 7367:1987
Thoracic Surgery Instruments - Straight and Angular Coarctation Clamps Potts Pattern - Specification
8
MHD 6 (26611)
Revision of: IS 7399:1987
Thoracic Surgery Instruments - Sternum Knife Lebsches Pattern - Specification
9
MHD 6 (26612)
Revision of: IS 9928:1981
Thoracic Surgery Instruments - Aortic Clamp DeBakeys Pattern - Specification

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 6 (00211)
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION ECMO
2
MHD 6 (00213)

Revision of: IS 7199:2016
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS --- BLOOD-GAS EXCHANGERS OXYGENATORS First Revision
3
MHD 6 (00214)

Revision of: IS/ISO 8637:2010
Cardiovascular Implants and extracorporeal systems --- Haemodialysers Haemodiafilters Haemofilters and Haemoconcentrators First Revision
4
MHD 6 (00215)

Revision of: IS/ISO 8638:2010
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS -- EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS HAEMODIAFILTERS AND HAEMOFILTERS First Revision
5
MHD 6 (00217)

Revision of: IS/ISO 15674:2016
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY VENOUS RESERVOIR SYSTEMS WITH WITHOUT FILTER AND SOFT VENOUS RESERVOIR BAGS First Revision
6
MHD 6 (00216)

Revision of: IS/ISO 13960:2010
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - PLASMAFILTERS First Revision
7
MHD 6 (10382)
CARDIOVASCULAR IMPLANTS ---ENDOVASCULAR DEVICES PART 2 VASCULAR STENTS
8
MHD 6 (10383)
CARDIOVASCULAR IMPLANTS ---ENDOVASCULAR DEVICES PART 3 VENA CAVA FILTERS
9
MHD 6 (11596)

Revision of: IS 7199:2016
Cardiovascular implants and artificial organs Blood-gas exchangers oxygenators Second Revision
10
MHD 6 (11598)

Revision of: IS/ISO 15674:2016
Cardiovascular implants and artificial organs Hard-shell cardiotomyvenous reservoir systems withwithout filter and soft venous reservoir bags Second Revision
11
MHD 6 (12971)
Cardiovascular implants and artificial organs Bloodtissue contact surface modifications for extracorporeal perfusion system
12
MHD 6 (12972)
Concentrates for haemodialysis and related therapies
13
MHD 6 (12973)
Water for haemodialysis and related therapies
14
MHD 6 (12974)

Revision of: IS/ISO 15676:2005
Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation ECMO First revision
15
MHD 6 (12975)
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
16
MHD 6 (13122)
Cardiovascular implants and extracorporeal systems Vascular prostheses Tubular vascular grafts and vascular patches
17
MHD 6 (13124)
Cardiovascular implants and extracorporeal systems Vascular Device-drug combination products Part 1 General requirements
18
MHD 6 (13125)
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
19
MHD 6 (13126)
Cardiovascular implants and extracorporeal systems Cardiopulmonary bypass systems Venous bubble traps
20
MHD 6 (13127)
Cardiovascular implants and extracorporeal systems Centrifugal blood pumps
21
MHD 6 (13128)

Revision of: IS/ISO 25539:2017
Cardiovascular implants - Endovascular devices - Part 1 Endovascular prostheses
22
MHD 6 (13462)
Cardiovascular implants -- Cardiac valve prostheses -- Part 2 Surgically implanted heart valve substitutes
23
MHD 6 (13463)
Cardiovascular implants Cardiac valve prostheses Part 3 Heart valve substitutes implanted by Trans-catheter techniques
24
MHD 6 (14326)
Extracorporeal systems for blood purification - Part 1 Haemodialysers haemodiafilters haemofilters and haemoconcentrators
25
MHD 6 (14327)
Extracorporeal systems for blood purification - Part 2 Extracorporeal blood circuit for haemodialysers haemodiafilters and haemofilters
26
MHD 6 (14328)
Extracorporeal systems for blood purification - Part 3 Plasmafilters
27
MHD 6 (15598)
Preparation and quality management of fluids for haemodialysis and related therapies Part 1 General requirements
28
MHD 6 (15599)
Preparation and quality management of fluids for haemodialysis and related therapies Part 2 Water treatment equipment for haemodialysis applications and related therapies
29
MHD 6 (15600)
Preparation and quality management of fluids for haemodialysis and related therapies Part 3 Water for haemodialysis and related therapies
30
MHD 6 (15601)
Preparation and quality management of fluids for haemodialysis and related therapies Part 4 Concentrates for haemodialysis and related therapies
31
MHD 6 (15602)
Preparation and quality management of fluids for haemodialysis and related therapies Part 5 Quality of dialysis fluid for haemodialysis and related therapies
32
MHD 6 (15780)
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
33
MHD 6 (17400)
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 2 Local regulatory information
34
MHD 6 (17401)
Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment
35
MHD 6 (17403)
Implants for surgery Cardiac pacemakers Part 2 Reporting of clinical performance of populations of pulse generators or leads
36
MHD 6 (17404)
Implants for surgery Cardiac pacemakers Part 3 Low-profile connectors IS-1 for implantable pacemakers
37
MHD 6 (17406)
Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements
38
MHD 6 (17407)
Cardiac rhythm management devices- Symbols to be used with cardiac rhythm management device labels and information to be supplied General requirements
39
MHD 6 (17409)
Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements
40
MHD 6 (17438)
Implants for surgery Active Implantable Medical Devices Part 5 Circulatory Support Devices
41
MHD 6 (18158)
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements
42
MHD 6 (18159)

Revision of: IS/ISO 5840:2015
Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute First Revision
43
MHD 6 (18160)

Revision of: IS/ISO 5840:2013
Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Transcatheter Techniques First Revision
44
MHD 6 (18161)

Revision of: IS/ISO 25539:2012
Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision
45
MHD 6 (18162)
Evaluation of CPB Devices Relative to their Capabilities of Reducing the Transmission of Gaseous Microemboli GME to a Patient during Cardiopulmonary Bypass
46
MHD 6 (18163)
Active Implantable Medical Devices Electromagnetic Compatibility EMC Test Protocols for Implantable Cardiac Pacemakers Implantable Cardioverter Defibrillators and Cardiac Resynchronization Devices
47
MHD 6 (18164)
Implants for Surgery Active Implantable Medical Devices Part 6 Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia Including Implantable Defibrillators
48
MHD 6 (18165)
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants
49
MHD 6 (20911)

Revision of: IS 7346:1987
Thoracic Surgery Instruments - Rib Raspatories - Specification
50
MHD 6 (20912)

Revision of: IS 6395:1989
Thoracic Surgery Instruments - Auricle Clamps - Crafoords Pattern - Specification Second Revision
51
MHD 6 (20914)

Revision of: IS 6442:1989
Thoracic Surgery Instruments - Rib Shears Tudor Edward s pattern - Specification Second Revision
52
MHD 6 (20915)

Revision of: IS 6466:1989
Thoracic Surgery Instruments - Needle Holder - Specification Second Revision
53
MHD 6 (20916)

Revision of: IS 6467:1989
Thoracic Surgery Instruments Periosteotome Rib Alexanders Pattern Specification Second Revision
54
MHD 6 (20917)

Revision of: IS 6468:1989
Thoracic Surgery Instruments - Empyema Trocar Nelson s Pattern - Specification Second Revision
55
MHD 6 (20920)

Revision of: IS 6778:1989
Thoracic Surgery Instruments - Lung Forceps Duval s Pattern - Specification Second Revision
56
MHD 6 (20921)

Revision of: IS 6780:1989
Thoracic Surgery Instruments - Artery Forceps Robert s Pattern - Specification Second Revision
57
MHD 6 (20922)

Revision of: IS 7355:1987
Specification for Spreader Rib Tuffiers Pattern Adult Size Second Revision
58
MHD 6 (20924)

Revision of: IS 7379:1987
Thoracic Surgery Instruments - Straight and Angular Patent Ductus Clamps - Specification Second Revision
59
MHD 6 (20925)

Revision of: IS 7382:1987
Thoracic Surgery Instruments - Rib Shears Thomas Pattern - Specification Second Revision
60
MHD 6 (20927)

Revision of: IS 7434:1987
Thoracic Surgery Instruments - Scapula Retractor - Specification Second Revision
61
MHD 6 (20928)

Revision of: IS 7972:1987
Thoracic Surgery Instruments - Dissecting Scissors - Specification Second Revision
62
MHD 6 (20930)

Revision of: IS 8549:1991
Thoracic Surgery Instruments - Angled Scissors - Specification Second Revision
63
MHD 6 (20932)

Revision of: IS 9950:1981
Thoracic Surgery Instruments - Vascular Clamp - Specification First Revision
64
MHD 6 (20933)

Revision of: IS 9951:1981
Thoracic Surgery Instruments - Blunt End Scissors - Specification First Revision
65
MHD 6 (20934)

Revision of: IS 9987:1981
Thoracic Surgery Instruments - Multipurpose Clamps - Specification First Revision
66
MHD 6 (20935)

Revision of: IS 11566:1986
Specification for Valve Retractors First Revision
67
MHD 6 (21272)
Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices
68
MHD 6 (23653)

Revision of: IS 17751:2022
Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 2 Local Regulatory Information First Revision
69
MHD 6 (24992)
Sizing parameters of surgical valve prostheses Requirements regarding the application of ISO 5840-2
70
MHD 6 (24999)
Cardiovascular Implants and Artificial Organs Cannulae for Extracorporeal Circulation ISO 18193 2021 MOD
71
MHD 6 (25000)
Cardiovascular implants Transcatheter cardiac occluders ISO 22679 2021 MOD
72
MHD 6 (25002)
Implants for surgery Active implantable medical devices Part 4 Implantable infusion pump systems ISO 14708-4 2022 MOD
73
MHD 6 (26577)

Revision of: IS 8345:1994
Thoracic Surgery Instruments Bulldog Clamps Specification
74
MHD 6 (26588)

Revision of: IS 6436:1989
Thoracic Surgery Instruments Rib Spreader Finochietto s Pattern Adult Size Specification
75
MHD 6 (26593)

Revision of: IS 13940:1994
Cardiovascular Surgery Instruments Bulldog Clamp DeBakey Pattern Specification First Revision
76
MHD 6 (26595)

Revision of: IS 8317:1991
Cardiovascular Surgery Instruments Angled Vascular Clamps Specification


Aspect Wise Report

 
 Product:   61
 Code of Practices :    7
 Methods of Test :   3
 Terminology :   0
 Dimensions :   1
 System Standard :   0
 Safety Standard :   0
 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 13878:1993
ISO 8638
Reviewed In : 2010
Extra Corporeal Circuit For Haemodialysers Haemofilters And Haemoconcentrators
2.
 IS 13890:1994
ISO 8637
Reviewed In : 2010
Haemodialysers Haemofilters and Haemoconcentrators
3.
 IS 13924:1994
ISO 5840
Reviewed In : 2010
Cardiovascular Implants - Cardiac Valve - Prostheses
4.
 IS/ISO 13958:2014
ISO 13958 : 2014
Concentrates for Haemodialysis and Related Therapies
5.
 IS/ISO 13959:2014
ISO 13959 : 2014
Water for haemodialysis and related therapies
6.
 IS/ISO 13960:2010
ISO 13960 : 2010
Cardiovascular implants and extracorporeal systems - Plasmafilters First Revision
7.
 IS/ISO/TS 15539:2000
ISO/TS 15539:2000
Reviewed In : 2017
Cardiovascular Implants -- EndovascuLar Prostheses
8.
 IS/ISO 23500:2014
ISO 23500 : 2014
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
9.
 IS/ISO 25539-2:2012
ISO 25539-2 : 2012
Cardiovascular implants - Endovascular devices Part 2 vascular stents
10.
 IS/ISO 5840-3:2013
ISO 5840-3 : 2013 ‘
Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques
11.
 IS/ISO 5840:2005
ISO 5840
Reviewed In : 2016
Cardiovascular implants - Cardiac valve prostheses
12.
 IS/ISO 5840-2:2015
Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes
13.
 IS 6779:1989
Thoracic Surgery Instruments - Forceps Dissecting and Ligature Mixter 39 s Pattern - Specification First Revision
14.
 IS 7971:1987
Tourniquet Cardiovascular Rumel-Belmont s Pattern
15.
 IS 8409:1991
Reviewed In : 2021
Cardiovascular Surgery Instruments - Dilator Valve Tubb s Mitral Pattern
16.
 IS 8550:1977
Reviewed In : 2001
Scissors angled on flat Potts Smith pattern
17.
 IS/ISO 8637-2004:2010
ISO 8637:2010
Cardiovascular implants and extracorporeal systems - Haemodialysers haemodiafilters haemofilters and haemoconcentrators First Revision
18.
 IS/ISO 8638-2004:2010
ISO 8638 : 2010
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers haemodiafilters and haemofilters First Revision
19.
 IS 8898:1978
Clamp anastomosis Cooley s pattern
20.
 IS 9927:1981
Clamp anastomosis dale-femoral Popliteal s pattern


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
1.
 IS 10540:1991
Cardiovascular Surgery Instruments - Clamps Atrial Appendage Glover s Pattern - Shape and Dimensions
2.
 IS 10541:1991
Cardiovascular surgery instruments - Clamps vena cava satinsky pattern shape sizes and dimensions First Revision
3.
 IS 11566:2024
Thoracic Surgery Instruments Valve Retractors Specification First Revision
4.
 IS/ISO 12417-1:2015
ISO 12417-1 : 2015
Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements
5.
 IS 13940:1994
Cardiovascular surgery instruments - Clamps bulldog DeBakey ring handle - Shape and dimensions
6.
 IS/ISO 15674-2004:2016
ISO 15674 : 2016
Cardiovascular implants and artificial organs - Hard - Shell cardiotomy venous reservoir systems With without Filter and soft venous reservoir bags Second Revision
7.
 IS/ISO 15675:2016
ISO 15675 : 2016
Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters
8.
 IS/ISO 15676:2016
ISO 15676 : 2016
Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation ECMO First revision
9.
 IS 17646 (Part 2):2021
IS/ISO 23500-2 : 2019
Preparation and quality management of fluids for haemodialysis and related therapies Part 2 Water treatment equipment for haemodialysis applications and related therapies
10.
 IS 17709:2022
ISO 11318:2002
Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements
11.
 IS 17712 (Part 3):2021
ISO 5841-3:2013
Implants for surgery Cardiac pacemakers Part 3 Low-profile connectors IS-1 for implantable pacemakers
12.
 IS 17745:2021
ISO 5910:2018
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
13.
 IS 17746:2021
Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements
14.
 IS 17750 (Part 6):2022
ISO 14708-6:2019
Implants for Surgery Active Implantable Medical Devices Part 6 Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia Including Implantable Defibrillators
15.
 IS 17750 (Part 5):2021
ISO 14708-5:2020
Implants for surgery Active Implantable Medical Devices Part 5 Circulatory Support Devices
16.
 IS 17750 (Part 4):2025
Implants for surgery Active implantable medical devices Part 4 Implantable infusion pump systems ISO 14708-4 2022 MOD
17.
 IS 17751 (Part 2):2024
ISO/TR 12417-2
Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 2 Local Regulatory Information First Revision
18.
 IS 17840 (Part 3):2022
ISO 5840-3:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Transcatheter Techniques First Revision
19.
 IS 17840 (Part 1):2022
5840-1:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements
20.
 IS 17840 (Part 2):2022
5840-2:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute First Revision
21.
 IS 17841 (Part 2):2022
ISO 25539:2020
Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision
22.
 IS 17841 (Part 4):2023
ISO 25539-4:2021
Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices
23.
 IS 17843:2022
ISO/TS 17137:2021
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants
24.
 IS/ISO 18241:2016
ISO 18241 : 2016
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps
25.
 IS/ISO 18242:2016
ISO 18242 : 2016
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps
26.
 IS 18927:2024
Cardiovascular implants Transcatheter cardiac occluders ISO 22679 2021 MOD
27.
 IS 18974:2025
Cardiovascular Implants and Artificial Organs Cannulae for Extracorporeal Circulation ISO 18193 2021 MOD
28.
 IS/ISO 25539-3:2011
ISO 25539-3 : 2011
Cardiovascular implants - Endovascular devices Part 3 vena cava filters
29.
 IS/ISO 25539-1:2017
ISO 25539-1 : 2017
Cardiovascular implants - Endovascular devices Part 1 endovascular prostheses First Revision
30.
 IS 6395:2024
Thoracic Surgery Instruments Auricle Clamps Crafoords Pattern Specification Second Revision
31.
 IS 6436:1989
Thoracic Surgery Instruments - Rib Spreader Finochietto s Pattern Adult Size
32.
 IS 6442:2024
Thoracic Surgery Instruments Rib Shears Tudor Edward s Pattern Specification Second Revision
33.
 IS 6466:2024
Thoracic Surgery Instruments Needle Holder Specification
34.
 IS 6467:2024
Thoracic Surgery Instruments Rib Periosteotome Alexander s Pattern Specification Second Revision
35.
 IS 6468:2024
Thoracic Surgery Instruments Empyema Trocar Nelson s Pattern Specification Second Revision
36.
 IS 6777:1989
Thoracic and cardiovascular surgery instruments - Forceps dissecting lung - Specification First Revision
37.
 IS 6778:2024
Thoracic Surgery Instruments Lung Forceps Duval s Pattern Specification Second Revision
38.
 IS 6780:2024
Thoracic Surgery Instruments Artery Forceps Robert s Pattern Specification Second Revision
39.
 IS/ISO 7198:2016
ISO 7198 : 2016
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
40.
 IS 7199 (Part 71991996):2016
ISO 7199 : 2016
Cardiovascular implants and artificial organs - Blood - Gas exchangers Oxygenators Second Revision
41.
 IS 7345:1994
Cardiovascular surgery instruments - Anastomosis forceps and clamps - Patterns shapes and dimensions Second Revision
42.
 IS 7346:2024
Thoracic Surgery Instruments Rib Raspatories Specification Second Revision
43.
 IS 7355:2024
Thoracic Surgery Instruments Rib Spreader Tuffier s Pattern Specification Second Revision
44.
 IS 7367:1987
Clamps Coarctation Potts Pattern Straight and Angular
45.
 IS 7379:2024
Thoracic Surgery Instruments Straight and Angular Patent Ductus Clamps Specification Second Revision
46.
 IS 7382:2024
Thoracic Surgery Instruments Rib Shears Thomas Pattern Specification Second Revision
47.
 IS 7399:1987
Knife Sternum Lebsche s Pattern
48.
 IS 7434:2024
Thoracic Surgery Instruments Scapula Retractor Specification Second Revision
49.
 IS 7972:2024
Thoracic Surgery Instruments Dissecting Scissors Specification Second Revision
50.
 IS 8317:1991
Cardiovascular surgery instruments - Clamps vascular angled at 45 - Shape and dimensions First Revision
51.
 IS 8335:1991
Cardiovascular Surgery Instruments - Clamps Auricle Satinsky Pattern - Sizes Shape and Dimensions
52.
 IS 8345:1994
Cardiovascular surgery instruments - Clamps bulldog cross action type - Specification First Revision
53.
 IS 8549:2024
Thoracic Surgery Instruments - Angled Scissors - Specification Second Revision
54.
 IS/ISO 8637-1:2017
Extracorporeal Systems for Blood Purification Part 1 Haemodialysers Haemodiafilters Haemofilters and Haemoconcentrators
55.
 IS/ISO 8637-2:2018
ISO 8637-2 : 2018
Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers Haemodiafilters and Haemofilters
56.
 IS/ISO 8637-3:2018
ISO 5840-3 : 2018
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters
57.
 IS 8890:1991
Thoracic surgery instruments - Clamps bronchus - Types shapes and dimensions First Revision
58.
 IS 9928:1981
Clamp Aortic DeBakey s Pattern Spoon Shaped angled Jaw
59.
 IS 9950:2024
Thoracic Surgery Instruments Vascular Clamp Specification First Revision
60.
 IS 9951:2024
Thoracic Surgery Instruments Blunt End Scissors Specification First Revision
61.
 IS 9987:2024
Thoracic Surgery Instruments Multipurpose Clamps Specification First Revision