Know Your Standard Standards under Mandatory Certification Group Wise Classification Ministry/Department Wise Classification
Total Standards : 70
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/ISO 11658 : 2012 ISO 11658 : 2012 |
Cardiovascular Implants and Extracorporeal Organs Blood/Tissue Contact Surface Modifications for Extracorporeal Perfusion Systems | 0 | ---- | Buy | |
| 5 |
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 | |
| 6 |
IS 13940 : 1994 Reviewed In : 2022 |
Cardiovascular surgery instruments - Clamps, bulldog, DeBakey,ring handle - Shape and dimensions | 0 | Apr, 2022 | Download | |
| 7 |
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 | |
| 8 |
IS/ISO 15675 : 2016 IS/ISO 15675:2016 |
Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters | 0 | ---- | Buy | |
| 9 |
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 | |
| 10 |
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 | |
| 11 |
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 | |
| 12 |
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 | |
| 13 |
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 | |
| 14 |
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 | |
| 15 |
IS 17708 : 2021 ISO/TS 21569-6 : 2016 |
Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment | 0 | ---- | Buy | |
| 16 |
IS 17709 : 2022 |
Cardiac defibrillators Connector assembly DF-1 for implantable defibrillators Dimensions and test requirements | 0 | ---- | Buy | |
| 17 |
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 | |
| 18 |
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 | |
| 19 |
IS 17712 (Part 3) : 2021 |
Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors IS-1 for implantable pacemakers | 0 | ---- | Download | |
| 20 |
IS 17745 : 2021 ISO 9008:1991 ISO 9008:1991 |
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices | 0 | ---- | Buy | |
| 21 |
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 | |
| 22 |
IS 17750 (Part 5) : 2021 ISO/IEC 23736-6: 2020 |
Implants for surgery Active Implantable Medical Devices Part 5: Circulatory Support Devices | 0 | ---- | Buy | |
| 23 |
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 | |
| 24 |
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 | |
| 25 |
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 | |
| 26 |
IS 17840 (Part 1) : 2022 ISO 8362-1:2018 ISO 8362-1:2018 |
Cardiovascular Implants Cardiac Valve Prostheses Part 1 General Requirements | 0 | ---- | Buy | |
| 27 |
IS 17840 (Part 2) : 2022 |
Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitute First Revision | 0 | ---- | Download | |
| 28 |
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 | |
| 29 |
IS 17841 (Part 2) : 2022 ISO 14344:2010 ISO 14344:2010 |
Cardiovascular Implants Endovascular Devices Part 2 Vascular Stents First Revision | 0 | ---- | Buy | |
| 30 |
IS 17841 (Part 4) : 2023 |
Cardiovascular Implants Endovascular Devices Part 4 Application of ISO 17327-1 for Coated Endovascular Devices | 0 | ---- | Buy | |
| 31 |
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 | |
| 32 |
IS 17843 : 2022 ISO 12749-1 : 2020 ISO 12749-1 : 2020 |
Cardiovascular Implants and Extracorporeal Systems Cardiovascular Absorbable Implants | 0 | ---- | Buy | |
| 33 |
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 | |
| 34 |
IS/ISO 18241 : 2016 IS/ISO 18241:2016 |
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps | 0 | ---- | Buy | |
| 35 |
IS/ISO 18242 : 2016 IS/ISO 18242:2016 |
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps | 0 | ---- | Buy | |
| 36 |
IS 18927 : 2024 |
Cardiovascular implants � Transcatheter cardiac occluders (ISO 22679 : 2021, MOD) | 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 6436 : 1989 Reviewed In : 2022 (First Revision) |
Thoracic Surgery Instruments - Rib Spreader, Finochietto's Pattern, Adult Size | 0 | Sep, 2022 | Download | |
| 41 |
IS 6442 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Rib Shears, Tudor Edward’s Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 42 |
IS 6466 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Needle Holder — Specification | 0 | ---- | Buy | |
| 43 |
IS 6467 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Rib Periosteotome, Alexander’s Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 44 |
IS 6468 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Empyema Trocar, Nelson’s Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 45 |
IS 6777 : 1989 Reviewed In : 2022 (First Revision) |
Thoracic and cardiovascular surgery instruments - Forceps, dissecting, lung - Specification (First Revision) | 0 | Sep, 2022 | Download | |
| 46 |
IS 6778 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Lung Forceps, Duval’s Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 47 |
IS 6780 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Artery Forceps, Robert’s Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 48 |
IS/ISO 7198 : 2016 IS/ISO 7198:2016 |
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches | 0 | ---- | Buy | |
| 49 |
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 | |
| 50 |
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 | |
| 51 |
IS 7346 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Rib Raspatories — Specification (Second Revision) | 0 | ---- | Buy | |
| 52 |
IS 7355 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Rib Spreader, Tuffier’s Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 53 |
IS 7367 : 1987 Reviewed In : 2022 (First Revision) |
Clamps, Coarctation, Potts' Pattern, Straight and Angular | 0 | Sep, 2022 | Download | |
| 54 |
IS 7379 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Straight and Angular Patent Ductus Clamps — Specification (Second Revision) | 0 | ---- | Buy | |
| 55 |
IS 7382 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Rib Shears, Thomas Pattern — Specification (Second Revision) | 0 | ---- | Buy | |
| 56 |
IS 7399 : 1987 Reviewed In : 2022 (First Revision) |
Knife, Sternum, Lebsche's Pattern | 1 | Sep, 2022 | Download | |
| 57 |
IS 7434 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Scapula Retractor — Specification (Second Revision) | 0 | ---- | Buy | |
| 58 |
IS 7972 : 2024 (Second Revision) |
Thoracic Surgery Instruments — Dissecting Scissors — Specification (Second Revision) | 0 | ---- | Buy | |
| 59 |
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 | |
| 60 |
IS 8335 : 1991 Reviewed In : 2022 (First Revision) |
Cardiovascular Surgery Instruments - Clamps, Auricle, Satinsky Pattern - Sizes, Shape and Dimensions | 0 | Apr, 2022 | Download | |
| 61 |
IS 8345 : 1994 Reviewed In : 2022 (First Revision) |
Cardiovascular surgery instruments - Clamps, bulldog, cross action type - Specification (First Revision) | 0 | Sep, 2022 | Download | |
| 62 |
IS 8549 : 2024 (Second Revision) |
Thoracic Surgery Instruments - Angled Scissors - Specification (Second Revision) | 0 | ---- | Buy | |
| 63 |
IS/ISO 8637-1 : 2017 ISO 8637-1:2017 |
Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators | 0 | ---- | Buy | |
| 64 |
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 | |
| 65 |
IS/ISO 8637-3 : 2018 ISO 8637-3:2018 |
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters | 0 | ---- | Buy | |
| 66 |
IS 8890 : 1991 Reviewed In : 2022 (First Revision) |
Thoracic surgery instruments - Clamps,bronchus - Types, shapes and dimensions (First Revision) | 0 | Apr, 2022 | Download | |
| 67 |
IS 9928 : 1981 Reviewed In : 2022 |
Clamp, Aortic, DeBakey's Pattern (Spoon Shaped angled Jaw) | 0 | Sep, 2022 | Download | |
| 68 |
IS 9950 : 2024 (First Revision) |
Thoracic Surgery Instruments — Vascular Clamp — Specification (First Revision) | 0 | ---- | Buy | |
| 69 |
IS 9951 : 2024 (First Revision) |
Thoracic Surgery Instruments — Blunt End Scissors — Specification (First Revision) | 0 | ---- | Buy | |
| 70 |
IS 9987 : 2024 (First Revision) |
Thoracic Surgery Instruments —Multipurpose Clamps — Specification (First Revision) | 0 | ---- | Buy |