Programme of work


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
Reviewed In : 2022
Cardiovascular Surgery Instruments - Clamps, Atrial Appendage, Glover's Pattern - Shape and Dimensions
April, 2022
-
Indigenous
2.
IS 10541 : 1991
Reviewed In : 2022
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 11566 : 1986
Reviewed In : 2022
Specification for valve retractors
September, 2022
-
Indigenous
5.
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
6.
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
7.
IS 13940 : 1994
Reviewed In : 2022
Cardiovascular surgery instruments - Clamps, bulldog, DeBakey,ring handle - Shape and dimensions
April, 2022
-
Indigenous
8.
IS/ISO 15674-2004 : 2016
ISO 15674 : 2016
Reviewed In : 2022
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
9.
IS/ISO 15675 : 2016
ISO 15675 : 2016
Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters
-
Identical under single numbering
10.
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
11.
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
12.
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
13.
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
14.
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
15.
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
16.
IS 17708 : 2021
ISO/TS 23810:2018
Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment
-
Identical under single numbering
17.
IS 17709 : 2022
ISO 11318:2002
Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements
-
Identical under dual numbering
18.
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
19.
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
20.
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
21.
IS 17745 : 2021
ISO 5910:2018
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
-
Identical under dual numbering
22.
IS 17746 : 2021
Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements
-
Modified/Technically Equivalent
23.
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
24.
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
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 17751 : 2022
ISO/TR 12417-2:2017
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 2: Local regulatory information
-
Identical under dual numbering
27.
IS 17840 (Part 1) : 2022
5840-1:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements
-
Identical under dual numbering
28.
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
29.
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
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 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
32.
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
33.
IS 17843 : 2022
ISO/TS 17137:2021
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants
-
Identical under dual numbering
34.
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
35.
IS/ISO 18241 : 2016
ISO 18241 : 2016
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps
-
Identical under single numbering
36.
IS/ISO 18242 : 2016
ISO 18242 : 2016
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps
-
Identical under single numbering
37.
IS/ISO 25539-1 : 2017
ISO 25539-1 : 2017
Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)
-
Identical under single numbering
38.
IS/ISO 25539-3 : 2011
ISO 25539-3 : 2011
Reviewed In : 2022
Cardiovascular implants - Endovascular devices: Part 3 vena cava filters
February, 2022
-
Identical under single numbering
39.
IS 6395 : 2024
Thoracic Surgery Instruments — Auricle Clamps, Crafoords Pattern — Specification (Second Revision)
-
Indigenous
40.
IS 6395 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Clamps, Auricle, Crafoord's Pattern
September, 2022
-
Indigenous
41.
IS 6436 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Rib Spreader, Finochietto's Pattern, Adult Size
September, 2022
-
Indigenous
42.
IS 6442 : 2024
Thoracic Surgery Instruments — Rib Shears, Tudor Edward’s Pattern — Specification (Second Revision)
-
Indigenous
43.
IS 6442 : 1989
Reviewed In : 2023
Thoracic Surgery Instruments - Shears, Rib, Tudor Edward's Pattern for Posterior End of Ribs - Specification(First Revision)
October, 2023
-
Indigenous
44.
IS 6466 : 1989
Reviewed In : 2022
Thoracic and cardiovascular surgery instruments - Needle holders - Specification (First Revision)
September, 2022
-
Indigenous
45.
IS 6466 : 2024
Thoracic Surgery Instruments — Needle Holder — Specification
-
Indigenous
46.
IS 6467 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Periosteotome, Rib, Alexander's Pattern
September, 2022
-
Indigenous
47.
IS 6467 : 2024
Thoracic Surgery Instruments — Rib Periosteotome, Alexander’s Pattern — Specification (Second Revision)
-
Indigenous
48.
IS 6468 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Trocar, Empyema, Nelson's Pattern
September, 2022
-
Indigenous
49.
IS 6468 : 2024
Thoracic Surgery Instruments — Empyema Trocar, Nelson’s Pattern — Specification (Second Revision)
-
Indigenous
50.
IS 6777 : 1989
Reviewed In : 2022
Thoracic and cardiovascular surgery instruments - Forceps, dissecting, lung - Specification (First Revision)
September, 2022
-
Indigenous
51.
IS 6778 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Forceps, Lung, Duval's Pattern
September, 2022
-
Indigenous
52.
IS 6778 : 2024
Thoracic Surgery Instruments — Lung Forceps, Duval’s Pattern — Specification (Second Revision)
-
Indigenous
53.
IS 6779 : 1989
Reviewed In : 2020
Thoracic Surgery Instruments - Forceps, Dissecting and Ligature, Mixter's Pattern - Specification (First Revision)
December, 2020
-
Indigenous
54.
IS 6780 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Forceps, Artery, Robert's Pattern, Curved on Flat
September, 2022
-
Indigenous
55.
IS 6780 : 2024
Thoracic Surgery Instruments — Artery Forceps, Robert’s Pattern — Specification (Second Revision)
-
Indigenous
56.
IS/ISO 7198 : 2016
ISO 7198 : 2016
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
-
Identical under single numbering
57.
IS /ISO (Part 71991996) : 2016
ISO 7199 : 2016
Reviewed In : 2022
Cardiovascular implants and artificial organs - Blood - Gas exchangers (Oxygenators) (Second Revision)
February, 2022
-
Identical under single numbering
58.
IS 7345 : 1994
Reviewed In : 2022
Cardiovascular surgery instruments - Anastomosis forceps and clamps - Patterns, shapes and dimensions (Second Revision)
April, 2022
-
Indigenous
59.
IS 7346 : 2024
Thoracic Surgery Instruments — Rib Raspatories — Specification (Second Revision)
-
Indigenous
60.
IS 7346 : 1987
Reviewed In : 2022
Raspatories, Rib, Semb's Pattern
September, 2022
1
Indigenous
61.
IS 7355 : 2024
Thoracic Surgery Instruments — Rib Spreader, Tuffier’s Pattern — Specification (Second Revision)
-
Indigenous
62.
IS 7355 : 1987
Reviewed In : 2022
Spreader, Rib, Tuffier's Pattern, Adult Size
September, 2022
1
Indigenous
63.
IS 7367 : 1987
Reviewed In : 2022
Clamps, Coarctation, Potts' Pattern, Straight and Angular
September, 2022
-
Indigenous
64.
IS 7379 : 2024
Thoracic Surgery Instruments — Straight and Angular Patent Ductus Clamps — Specification (Second Revision)
-
Indigenous
65.
IS 7379 : 1987
Reviewed In : 2022
Clamps, Patent Ductus, Potts' Pattern, Straight and Angular
September, 2022
-
Indigenous
66.
IS 7382 : 2024
Thoracic Surgery Instruments — Rib Shears, Thomas Pattern — Specification (Second Revision)
-
Indigenous
67.
IS 7382 : 1987
Reviewed In : 2022
Shears, Rib, Price Thomas' Pattern
September, 2022
-
Indigenous
68.
IS 7399 : 1987
Reviewed In : 2022
Knife, Sternum, Lebsche's Pattern
September, 2022
1
Indigenous
69.
IS 7434 : 1987
Reviewed In : 2022
Retractor, Scapula, Tudor Edward's Pattern
September, 2022
-
Indigenous
70.
IS 7434 : 2024
Thoracic Surgery Instruments — Scapula Retractor — Specification (Second Revision)
-
Indigenous
71.
IS 7971 : 1987
Reviewed In : 2020
Tourniquet, Cardiovascular Rumel-Belmont's Pattern
January, 2020
-
Indigenous
72.
IS 7972 : 2024
Thoracic Surgery Instruments — Dissecting Scissors — Specification (Second Revision)
-
Indigenous
73.
IS 7972 : 1987
Reviewed In : 2022
Scissors, Dissecting, Metzenbaum's Pattern
September, 2022
1
Indigenous
74.
IS 8317 : 1991
Reviewed In : 2022
Cardiovascular surgery instruments - Clamps, vascular, angled at 45 - Shape and dimensions (First Revision)
April, 2022
-
Indigenous
75.
IS 8335 : 1991
Reviewed In : 2022
Cardiovascular Surgery Instruments - Clamps, Auricle, Satinsky Pattern - Sizes, Shape and Dimensions
April, 2022
-
Indigenous
76.
IS 8345 : 1994
Reviewed In : 2022
Cardiovascular surgery instruments - Clamps, bulldog, cross action type - Specification (First Revision)
September, 2022
-
Indigenous
77.
IS 8549 : 1991
Reviewed In : 2022
Cardiovascular surgery instruments - Angled scissors, potts smith pattern - Specification (First Revision)
September, 2022
-
Indigenous
78.
IS 8549 : 2024
Thoracic Surgery Instruments - Angled Scissors - Specification (Second Revision)
-
Indigenous
79.
IS/ISO 8637-1 : 2017

Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
-
Identical under single numbering
80.
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
81.
IS/ISO 8637-3 : 2018
ISO 5840-3 : 2018
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters
-
Identical under single numbering
82.
IS 8890 : 1991
Reviewed In : 2022
Thoracic surgery instruments - Clamps,bronchus - Types, shapes and dimensions (First Revision)
April, 2022
-
Indigenous
83.
IS 9928 : 1981
Reviewed In : 2022
Clamp, Aortic, DeBakey's Pattern (Spoon Shaped angled Jaw)
September, 2022
-
Indigenous
84.
IS 9950 : 2024
Thoracic Surgery Instruments — Vascular Clamp — Specification (First Revision)
-
Indigenous
85.
IS 9950 : 1981
Reviewed In : 2022
Specification for clamp, vascular, wister pattern
September, 2022
-
Indigenous
86.
IS 9951 : 2024
Thoracic Surgery Instruments — Blunt End Scissors — Specification (First Revision)
-
Indigenous
87.
IS 9951 : 1981
Reviewed In : 2022
Specification for scissors, blunt end, nelson pattern
September, 2022
-
Indigenous
88.
IS 9987 : 1981
Reviewed In : 2022
Clamps, Multipurpose, De-bakey's Pattern
September, 2022
-
Indigenous
89.
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
No Records Found

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
1
MHD 6 (24992)
Sizing parameters of surgical valve prostheses Requirements regarding the application of ISO 5840-2
2
MHD 6 (24999)
Cardiovascular implants and artificial organs Cannulae for extracorporeal circulation
3
MHD 6 (25000)
Cardiovascular implants Transcatheter cardiac occluders
4
MHD 6 (25002)
Implants for surgery Active implantable medical devices Part 4 Implantable infusion pump systems

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
No Records Found


Aspect Wise Report

 
 Product:   59
 Code of Practices :    8
 Methods of Test :   3
 Terminology :   0
 Dimensions :   0
 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
Reviewed In : 2022
Cardiovascular implants - Endovascular devices Part 2 vascular stents
10.
IS/ISO 5840 : 2005
ISO 5840
Reviewed In : 2016
Cardiovascular implants - Cardiac valve prostheses
11.
IS/ISO 5840-2 : 2015

Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes
12.
IS/ISO 5840-3 : 2013
ISO 5840-3 : 2013 ‘
Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques
13.
IS 8409 : 1991
Reviewed In : 2021
Cardiovascular Surgery Instruments - Dilator Valve Tubb s Mitral Pattern
14.
IS 8550 : 1977
Reviewed In : 2001
Scissors angled on flat Potts Smith pattern
15.
IS/ISO 8637-2004 : 2010
ISO 8637:2010
Cardiovascular implants and extracorporeal systems - Haemodialysers haemodiafilters haemofilters and haemoconcentrators First Revision
16.
IS/ISO 8638-2004 : 2010
ISO 8638 : 2010
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers haemodiafilters and haemofilters First Revision
17.
IS 8898 : 1978
Clamp anastomosis Cooley s pattern
18.
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
Reviewed In : 2022
Cardiovascular Surgery Instruments - Clamps Atrial Appendage Glover s Pattern - Shape and Dimensions
2.
IS 10541 : 1991
Reviewed In : 2022
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
Reviewed In : 2022
Cardiovascular surgery instruments - Clamps bulldog DeBakey ring handle - Shape and dimensions
6.
IS/ISO 15674-2004 : 2016
ISO 15674 : 2016
Reviewed In : 2022
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 17709 : 2022
ISO 11318:2002
Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements
10.
IS 17712 (Part 3) : 2021
ISO 5841-3:2013
Implants for surgery Cardiac pacemakers Part 3 Low-profile connectors IS-1 for implantable pacemakers
11.
IS 17745 : 2021
ISO 5910:2018
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
12.
IS 17746 : 2021
Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements
13.
IS 17750 (Part 5) : 2021
ISO 14708-5:2020
Implants for surgery Active Implantable Medical Devices Part 5 Circulatory Support Devices
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 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
16.
IS 17840 (Part 1) : 2022
5840-1:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements
17.
IS 17840 (Part 2) : 2022
5840-2:2021
Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute 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 17841 (Part 2) : 2022
ISO 25539:2020
Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision
20.
IS 17841 (Part 4) : 2023
ISO 25539-4:2021
Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices
21.
IS 17843 : 2022
ISO/TS 17137:2021
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants
22.
IS/ISO 18241 : 2016
ISO 18241 : 2016
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps
23.
IS/ISO 18242 : 2016
ISO 18242 : 2016
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps
24.
IS/ISO 25539-1 : 2017
ISO 25539-1 : 2017
Cardiovascular implants - Endovascular devices Part 1 endovascular prostheses First Revision
25.
IS/ISO 25539-3 : 2011
ISO 25539-3 : 2011
Reviewed In : 2022
Cardiovascular implants - Endovascular devices Part 3 vena cava filters
26.
IS 6395 : 2024
Thoracic Surgery Instruments Auricle Clamps Crafoords Pattern Specification Second Revision
27.
IS 6436 : 1989
Reviewed In : 2022
Thoracic Surgery Instruments - Rib Spreader Finochietto s Pattern Adult Size
28.
IS 6442 : 2024
Thoracic Surgery Instruments Rib Shears Tudor Edward s Pattern Specification Second Revision
29.
IS 6466 : 2024
Thoracic Surgery Instruments Needle Holder Specification
30.
IS 6467 : 2024
Thoracic Surgery Instruments Rib Periosteotome Alexander s Pattern Specification Second Revision
31.
IS 6468 : 2024
Thoracic Surgery Instruments Empyema Trocar Nelson s Pattern Specification Second Revision
32.
IS 6777 : 1989
Reviewed In : 2022
Thoracic and cardiovascular surgery instruments - Forceps dissecting lung - Specification First Revision
33.
IS 6778 : 2024
Thoracic Surgery Instruments Lung Forceps Duval s Pattern Specification Second Revision
34.
IS 6779 : 1989
Reviewed In : 2020
Thoracic Surgery Instruments - Forceps Dissecting and Ligature Mixter 39 s Pattern - Specification First Revision
35.
IS 6780 : 2024
Thoracic Surgery Instruments Artery Forceps Robert s Pattern Specification Second Revision
36.
IS/ISO 7198 : 2016
ISO 7198 : 2016
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
37.
IS /ISO (Part 71991996) : 2016
ISO 7199 : 2016
Reviewed In : 2022
Cardiovascular implants and artificial organs - Blood - Gas exchangers Oxygenators Second Revision
38.
IS 7345 : 1994
Reviewed In : 2022
Cardiovascular surgery instruments - Anastomosis forceps and clamps - Patterns shapes and dimensions Second Revision
39.
IS 7346 : 2024
Thoracic Surgery Instruments Rib Raspatories Specification Second Revision
40.
IS 7355 : 2024
Thoracic Surgery Instruments Rib Spreader Tuffier s Pattern Specification Second Revision
41.
IS 7367 : 1987
Reviewed In : 2022
Clamps Coarctation Potts Pattern Straight and Angular
42.
IS 7379 : 2024
Thoracic Surgery Instruments Straight and Angular Patent Ductus Clamps Specification Second Revision
43.
IS 7382 : 2024
Thoracic Surgery Instruments Rib Shears Thomas Pattern Specification Second Revision
44.
IS 7399 : 1987
Reviewed In : 2022
Knife Sternum Lebsche s Pattern
45.
IS 7434 : 2024
Thoracic Surgery Instruments Scapula Retractor Specification Second Revision
46.
IS 7971 : 1987
Reviewed In : 2020
Tourniquet Cardiovascular Rumel-Belmont s Pattern
47.
IS 7972 : 2024
Thoracic Surgery Instruments Dissecting Scissors Specification Second Revision
48.
IS 8317 : 1991
Reviewed In : 2022
Cardiovascular surgery instruments - Clamps vascular angled at 45 - Shape and dimensions First Revision
49.
IS 8335 : 1991
Reviewed In : 2022
Cardiovascular Surgery Instruments - Clamps Auricle Satinsky Pattern - Sizes Shape and Dimensions
50.
IS 8345 : 1994
Reviewed In : 2022
Cardiovascular surgery instruments - Clamps bulldog cross action type - Specification First Revision
51.
IS 8549 : 2024
Thoracic Surgery Instruments - Angled Scissors - Specification Second Revision
52.
IS/ISO 8637-1 : 2017

Extracorporeal Systems for Blood Purification Part 1 Haemodialysers Haemodiafilters Haemofilters and Haemoconcentrators
53.
IS/ISO 8637-2 : 2018
ISO 8637-2 : 2018
Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers Haemodiafilters and Haemofilters
54.
IS/ISO 8637-3 : 2018
ISO 5840-3 : 2018
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters
55.
IS 8890 : 1991
Reviewed In : 2022
Thoracic surgery instruments - Clamps bronchus - Types shapes and dimensions First Revision
56.
IS 9928 : 1981
Reviewed In : 2022
Clamp Aortic DeBakey s Pattern Spoon Shaped angled Jaw
57.
IS 9950 : 2024
Thoracic Surgery Instruments Vascular Clamp Specification First Revision
58.
IS 9951 : 2024
Thoracic Surgery Instruments Blunt End Scissors Specification First Revision
59.
IS 9987 : 2024
Thoracic Surgery Instruments Multipurpose Clamps Specification First Revision