MHD 06-Medical and Surgical Cardiology Equipment  Standards List


Aspect : Publication Date :


Total Standards :  89

Revised Standards    New Standards
S.No IS Number IS Title Amendment Reaffirmation Year Document Action
1 IS 10540 : 1991
Reviewed In : 2022

(First Revision)
Cardiovascular Surgery Instruments - Clamps, Atrial Appendage, Glover's Pattern - Shape and Dimensions 0 Apr, 2022 Download
2 IS 10541 : 1991
Reviewed In : 2022

(First Revision)
Cardiovascular surgery instruments - Clamps vena cava,satinsky pattern shape, sizes and dimensions (First Revision) 0 Apr, 2022 Download
3 IS 11566 : 2024


(First Revision)
Thoracic Surgery Instruments — Valve Retractors — Specification (First Revision) 0 ---- Buy
4 IS 11566 : 1986
Reviewed In : 2022

Specification for valve retractors 0 Sep, 2022 Download
5 IS/ISO 11658 : 2012

ISO 11658 : 2012
Cardiovascular Implants and Extracorporeal Organs Blood/Tissue Contact Surface Modifications for Extracorporeal Perfusion Systems 0 ---- Buy
6 IS/ISO 12417-1 : 2015

IS/ISO 12417-1:2015
Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements 0 ---- Buy
7 IS 13940 : 1994
Reviewed In : 2022

Cardiovascular surgery instruments - Clamps, bulldog, DeBakey,ring handle - Shape and dimensions 0 Apr, 2022 Download
8 IS/ISO 15674-2004 : 2016
Reviewed In : 2022
IS/ISO 15674 : 2016
(Second Revision)
Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision) 0 Feb, 2022 Buy
9 IS/ISO 15675 : 2016

IS/ISO 15675:2016
Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters 0 ---- Buy
10 IS/ISO 15676 : 2016
ISO 10555-6:2015

ISO 10555-6:2015
(First Revision)
Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation ECMO First revision 0 ---- Buy
11 IS 17646 (Part 1) : 2021
ISO 21091:2013

ISO 21091:2013
Preparation and quality management of fluids for haemodialysis and related therapies : Part 1 General requirements 0 ---- Buy
12 IS 17646 (Part 2) : 2021
ISO/TR 22696:2020

ISO/TR 22696:2020
Preparation and quality management of fluids for haemodialysis and related therapies Part 2 Water treatment equipment for haemodialysis applications and related therapies 0 ---- Buy
13 IS 17646 (Part 3) : 2021
ISO TS 21547:2010

ISO TS 21547:2010
Preparation and quality management of fluids for haemodialysis and related therapies Part 3 Water for haemodialysis and related therapies 0 ---- Buy
14 IS 17646 (Part 4) : 2021


Preparation and quality management of fluids for haemodialysis and related therapies Part 4 Concentrates for haemodialysis and related therapies 0 ---- Download
15 IS 17646 (Part 5) : 2021

19944 Part 1:2020
Preparation and quality management of fluids for haemodialysis and related therapies Part 5 Quality of dialysis fluid for haemodialysis and related therapies 0 ---- Buy
16 IS 17708 : 2021

ISO/TS 21569-6 : 2016
Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment 0 ---- Buy
17 IS 17709 : 2022


Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements 0 ---- Buy
18 IS 17710 : 2021
ISO 4037-1 : 2019

ISO 4037-1 : 2019
Cardiac rhythm management devices- Symbols to be used with cardiac rhythm management device labels and information to be supplied General requirements 0 ---- Buy
19 IS 17712 (Part 2) : 2021
IEC 60268-10:1991

IEC 60268-10:1991
Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads 0 ---- Buy
20 IS 17712 (Part 3) : 2021


Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors IS-1 for implantable pacemakers 0 ---- Download
21 IS 17745 : 2021
ISO 9008:1991

ISO 9008:1991
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices 0 ---- Buy
22 IS 17746 : 2021

ISO/IEC 17629:2014
Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements 0 ---- Buy
23 IS 17750 (Part 5) : 2021

ISO/IEC 23736-6: 2020
Implants for surgery Active Implantable Medical Devices Part 5: Circulatory Support Devices 0 ---- Buy
24 IS 17750 (Part 6) : 2022
ISO/IEC 7942-3: 1999

ISO/IEC 7942-3: 1999
Implants for Surgery Active Implantable Medical Devices Part 6 Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia Including Implantable Defibrillators 0 ---- Buy
25 IS 17751 (Part 2) : 2024


(First Revision)
Cardiovascular Implants and Extracorporeal Systems � Vascular Device-Drug Combination Products Part 2 Local Regulatory Information ( First Revision ) 0 ---- Buy
26 IS 17751 : 2022
ISO 15190:2020

ISO 15190:2020
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 2: Local regulatory information 0 ---- Buy
27 IS 17840 (Part 1) : 2022
ISO 8362-1:2018

ISO 8362-1:2018
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements 0 ---- Buy
28 IS 17840 (Part 2) : 2022


Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute First Revision 0 ---- Download
29 IS 17840 (Part 3) : 2022
ISO 9276-3 :2008

ISO 9276-3 :2008
Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Transcatheter Techniques First Revision 0 ---- Buy
30 IS 17841 (Part 2) : 2022
ISO 14344:2010

ISO 14344:2010
Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision 0 ---- Buy
31 IS 17841 (Part 4) : 2023


Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices 0 ---- Buy
32 IS 17842 : 2022


Active Implantable Medical Devices Electromagnetic Compatibility EMC Test Protocols for Implantable Cardiac Pacemakers Implantable Cardioverter Defibrillators and Cardiac Resynchronization Devices 0 ---- Download
33 IS 17843 : 2022
ISO 12749-1 : 2020

ISO 12749-1 : 2020
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants 0 ---- Buy
34 IS 18207 : 2023


Evaluation of CPB Devices Relative to their Capabilities of Reducing the Transmission of Gaseous Microemboli GME to a Patient during Cardiopulmonary Bypass 0 ---- Buy
35 IS/ISO 18241 : 2016

IS/ISO 18241:2016
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps 0 ---- Buy
36 IS/ISO 18242 : 2016

IS/ISO 18242:2016
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps 0 ---- Buy
37 IS/ISO 25539-1 : 2017

ISO 25539 : Part 1
(First Revision)
Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) 0 ---- Buy
38 IS/ISO 25539-3 : 2011
Reviewed In : 2022
ISO 25539-3 : 2011
Cardiovascular implants - Endovascular devices: Part 3 vena cava filters 0 Feb, 2022 Buy
39 IS 6395 : 2024


(Second Revision)
Thoracic Surgery Instruments — Auricle Clamps, Crafoords Pattern — Specification (Second Revision) 0 ---- Buy
40 IS 6395 : 1989
Reviewed In : 2022

(First Revision)
Thoracic Surgery Instruments - Clamps, Auricle, Crafoord's Pattern 0 Sep, 2022 Download
41 IS 6436 : 1989
Reviewed In : 2022

(First Revision)
Thoracic Surgery Instruments - Rib Spreader, Finochietto's Pattern, Adult Size 0 Sep, 2022 Download
42 IS 6442 : 2024


(Second Revision)
Thoracic Surgery Instruments — Rib Shears, Tudor Edward’s Pattern — Specification (Second Revision) 0 ---- Buy
43 IS 6442 : 1989
Reviewed In : 2023

(First Revision)
Thoracic Surgery Instruments - Shears, Rib, Tudor Edward's Pattern for Posterior End of Ribs - Specification(First Revision) 0 Oct, 2023 Download
44 IS 6466 : 1989
Reviewed In : 2022

(First Revision)
Thoracic and cardiovascular surgery instruments - Needle holders - Specification (First Revision) 0 Sep, 2022 Download
45 IS 6466 : 2024


(Second Revision)
Thoracic Surgery Instruments — Needle Holder — Specification 0 ---- Buy
46 IS 6467 : 1989
Reviewed In : 2022

(First Revision)
Thoracic Surgery Instruments - Periosteotome, Rib, Alexander's Pattern 0 Sep, 2022 Download
47 IS 6467 : 2024


(Second Revision)
Thoracic Surgery Instruments — Rib Periosteotome, Alexander’s Pattern — Specification (Second Revision) 0 ---- Buy
48 IS 6468 : 1989
Reviewed In : 2022

(First Revision)
Thoracic Surgery Instruments - Trocar, Empyema, Nelson's Pattern 0 Sep, 2022 Download
49 IS 6468 : 2024


(Second Revision)
Thoracic Surgery Instruments — Empyema Trocar, Nelson’s Pattern — Specification (Second Revision) 0 ---- Buy
50 IS 6777 : 1989
Reviewed In : 2022

(First Revision)
Thoracic and cardiovascular surgery instruments - Forceps, dissecting, lung - Specification (First Revision) 0 Sep, 2022 Download
51 IS 6778 : 1989
Reviewed In : 2022

(First Revision)
Thoracic Surgery Instruments - Forceps, Lung, Duval's Pattern 0 Sep, 2022 Download
52 IS 6778 : 2024


(Second Revision)
Thoracic Surgery Instruments — Lung Forceps, Duval’s Pattern — Specification (Second Revision) 0 ---- Buy
53 IS 6779 : 1989
Reviewed In : 2020

(First Revision)
Thoracic Surgery Instruments - Forceps, Dissecting and Ligature, Mixter's Pattern - Specification (First Revision) 0 Dec, 2020 Download
54 IS 6780 : 1989
Reviewed In : 2022

(First Revision)
Thoracic Surgery Instruments - Forceps, Artery, Robert's Pattern, Curved on Flat 0 Sep, 2022 Download
55 IS 6780 : 2024


(Second Revision)
Thoracic Surgery Instruments — Artery Forceps, Robert’s Pattern — Specification (Second Revision) 0 ---- Buy
56 IS/ISO 7198 : 2016

IS/ISO 7198:2016
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches 0 ---- Buy
57 IS /ISO (Part 71991996) : 2016
Reviewed In : 2022
ISO 7199 : 2016
(Second Revision)
Cardiovascular implants and artificial organs - Blood - Gas exchangers (Oxygenators) (Second Revision) 0 Feb, 2022 Buy
58 IS 7345 : 1994
Reviewed In : 2022

(Second Revision)
Cardiovascular surgery instruments - Anastomosis forceps and clamps - Patterns, shapes and dimensions (Second Revision) 0 Apr, 2022 Download
59 IS 7346 : 2024


(Second Revision)
Thoracic Surgery Instruments — Rib Raspatories — Specification (Second Revision) 0 ---- Buy
60 IS 7346 : 1987
Reviewed In : 2022

(First Revision)
Raspatories, Rib, Semb's Pattern 1 Sep, 2022 Download
61 IS 7355 : 2024


(Second Revision)
Thoracic Surgery Instruments — Rib Spreader, Tuffier’s Pattern — Specification (Second Revision) 0 ---- Buy
62 IS 7355 : 1987
Reviewed In : 2022

(First Revision)
Spreader, Rib, Tuffier's Pattern, Adult Size 1 Sep, 2022 Download
63 IS 7367 : 1987
Reviewed In : 2022

(First Revision)
Clamps, Coarctation, Potts' Pattern, Straight and Angular 0 Sep, 2022 Download
64 IS 7379 : 2024


(Second Revision)
Thoracic Surgery Instruments — Straight and Angular Patent Ductus Clamps — Specification (Second Revision) 0 ---- Buy
65 IS 7379 : 1987
Reviewed In : 2022

(First Revision)
Clamps, Patent Ductus, Potts' Pattern, Straight and Angular 0 Sep, 2022 Download
66 IS 7382 : 2024


(Second Revision)
Thoracic Surgery Instruments — Rib Shears, Thomas Pattern — Specification (Second Revision) 0 ---- Buy
67 IS 7382 : 1987
Reviewed In : 2022

(First Revision)
Shears, Rib, Price Thomas' Pattern 0 Sep, 2022 Download
68 IS 7399 : 1987
Reviewed In : 2022

(First Revision)
Knife, Sternum, Lebsche's Pattern 1 Sep, 2022 Download
69 IS 7434 : 1987
Reviewed In : 2022

(First Revision)
Retractor, Scapula, Tudor Edward's Pattern 0 Sep, 2022 Download
70 IS 7434 : 2024


(Second Revision)
Thoracic Surgery Instruments — Scapula Retractor — Specification (Second Revision) 0 ---- Buy
71 IS 7971 : 1987
Reviewed In : 2020

(First Revision)
Tourniquet, Cardiovascular Rumel-Belmont's Pattern 0 Jan, 2020 Download
72 IS 7972 : 2024


(Second Revision)
Thoracic Surgery Instruments — Dissecting Scissors — Specification (Second Revision) 0 ---- Buy
73 IS 7972 : 1987
Reviewed In : 2022

(First Revision)
Scissors, Dissecting, Metzenbaum's Pattern 1 Sep, 2022 Download
74 IS 8317 : 1991
Reviewed In : 2022

(First Revision)
Cardiovascular surgery instruments - Clamps, vascular, angled at 45 - Shape and dimensions (First Revision) 0 Apr, 2022 Download
75 IS 8335 : 1991
Reviewed In : 2022

(First Revision)
Cardiovascular Surgery Instruments - Clamps, Auricle, Satinsky Pattern - Sizes, Shape and Dimensions 0 Apr, 2022 Download
76 IS 8345 : 1994
Reviewed In : 2022

(First Revision)
Cardiovascular surgery instruments - Clamps, bulldog, cross action type - Specification (First Revision) 0 Sep, 2022 Download
77 IS 8549 : 1991
Reviewed In : 2022

(First Revision)
Cardiovascular surgery instruments - Angled scissors, potts smith pattern - Specification (First Revision) 0 Sep, 2022 Download
78 IS 8549 : 2024


(Second Revision)
Thoracic Surgery Instruments - Angled Scissors - Specification (Second Revision) 0 ---- Buy
79 IS/ISO 8637-1 : 2017

ISO 8637-1:2017
Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators 0 ---- Buy
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 0 ---- Buy
81 IS/ISO 8637-3 : 2018

ISO 8637-3:2018
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters 0 ---- Buy
82 IS 8890 : 1991
Reviewed In : 2022

(First Revision)
Thoracic surgery instruments - Clamps,bronchus - Types, shapes and dimensions (First Revision) 0 Apr, 2022 Download
83 IS 9928 : 1981
Reviewed In : 2022

Clamp, Aortic, DeBakey's Pattern (Spoon Shaped angled Jaw) 0 Sep, 2022 Download
84 IS 9950 : 2024


(First Revision)
Thoracic Surgery Instruments — Vascular Clamp — Specification (First Revision) 0 ---- Buy
85 IS 9950 : 1981
Reviewed In : 2022

Specification for clamp, vascular, wister pattern 0 Sep, 2022 Download
86 IS 9951 : 2024


(First Revision)
Thoracic Surgery Instruments — Blunt End Scissors — Specification (First Revision) 0 ---- Buy
87 IS 9951 : 1981
Reviewed In : 2022

Specification for scissors, blunt end, nelson pattern 0 Sep, 2022 Download
88 IS 9987 : 1981
Reviewed In : 2022

Clamps, Multipurpose, De-bakey's Pattern 0 Sep, 2022 Download
89 IS 9987 : 2024


(First Revision)
Thoracic Surgery Instruments —Multipurpose Clamps — Specification (First Revision) 0 ---- Buy