The BIS certificate for thoracic and cardiovascular surgery instruments is a trusted mark of assurance. This confirms that these devices meet stringent safety and performance standards that healthcare professionals and patients trust.
Under the BIS Act of 2016, obtaining this certification is crucial for manufacturers, importers, and distributors seeking to supply surgical instruments in the Indian market.
This article will cover all you need to know about obtaining BIS certificate for surgical instruments, emphasizing its significance and its role in enhancing the quality of surgical instruments across India.
What Is BIS Certificate For Thoracic And Cardiovascular Surgery Instruments?
A BIS Certification for Thoracic and Cardiovascular Surgery Instruments is an official certification required in India that ensures that these specialized medical instruments meet rigorous national standards for safety, quality, and performance.
The BIS certification is a mark of trust, confirming that these instruments have undergone thorough testing and validation, essential for their safe and effective use in critical surgeries.
What Are Thoracic And Cardiovascular Surgery Instruments?
Thoracic and cardiovascular surgery instruments are highly specialized tools for procedures involving the heart, lungs, chest cavity, and related blood vessels. These instruments support complex surgeries, such as open-heart operations, lung resections, and coronary artery bypass grafting (CABG).
Examples of Thoracic and cardiovascular surgery instruments are thoracic retractors, cardiovascular clamps, and suction cannulas. These instruments must meet rigorous standards for precision and safety.
Also Read: BIS Certificate For Ear, Nose, And Throat Surgical Instruments
Who Can Apply For BIS Certification For Thoracic And Cardiovascular Surgery Instruments?
The following entities are eligible to apply for a BIS Certificate for Thoracic and cardiovascular surgery instruments:
- Manufacturers who want to manufacture Thoracic and cardiovascular surgery instruments can apply for a BIS Certificate.
- Importers who intend to market and distribute Thoracic and cardiovascular surgery instruments in India are also eligible to apply.
- An authorized representative may submit a BIS certificate application on behalf of the manufacturer, importer, or foreign entity.
What Are The Benefits Of Obtaining BIS Certificate For Thoracic And Cardiovascular Surgery Instruments?
Obtaining a BIS Certification for Thoracic and cardiovascular surgery instruments offers several key benefits:
- Quality Assurance: BIS Certificate confirms that your products meet crucial Indian quality and safety standards, essential in the medical industry.
- Easy Market Access: A BIS certificate is required for certain medical instruments in India and streamlines the regulatory approval process.
- Enhance Reputation: Helps businesses build a solid reputation for producing high-quality products.
- Build Customer Trust: It shows customers that your products are safe, reliable, and of good quality, helping you gain their trust.
- Competitive Advantage: Certified products are often more appealing to buyers, providing a competitive edge.
- Global Reach: A BIS certificate can build the way to international markets, extending your business’s reach.
- Increased Transparency: The certificate encourages transparent manufacturing processes, which is particularly crucial for medical devices.
Also Read: BIS Certification for Medical Devices
Procedure For Obtaining BIS Certification For Thoracic And Cardiovascular Surgery Instruments
To obtain a BIS Certificate for Thoracic and cardiovascular surgery instruments follow these key steps:
- Identify Applicable Standards
- Prepare and Compile Required Documents
- Log into the BIS online portal.
- Fill out the BIS Certification Application form.
- Submit all required documents, including test reports from a BIS-approved lab, product specifications, and user manuals.
- Manufacturing site inspection by BIS officials.
- A thorough review of the application and supporting documents.
- Generation of a performance report by authorities.
- Upon successful review and verification, the BIS license is issued.
- Participate in regular BIS audits to maintain compliance.
Document Required For BIS Certificate For Thoracic And Cardiovascular Surgery Instruments
To ensure a seamless and efficient process for obtaining a BIS Certificate for Thoracic and cardiovascular surgery instruments, various essential documents must accompany the application form. These include:
- Completed application form
- Applicant’s details
- Detailed product information
- Proof of manufacturing or business establishment
- Valid manufacturing license
- Product test reports from a certified laboratory
- Site layout documentation
- Quality Management System (QMS) documentation
- Declaration of conformity (if applicable)
- MSME/SSI certification
- Comprehensive list of equipment or instruments
- Proof of fee payment
- Power of Attorney (if applicable)
- Additional documents as required for specific cases
Validity Of BIS Certificate For Thoracic And Cardiovascular Surgery Instruments
The BIS Certificate of Thoracic and Cardiovascular Surgery Instruments is valid for one year. Upon expiration, it must be renewed by submitting an updated application form along with any necessary documentation.
Timeline For Obtaining BIS Certification For Thoracic And Cardiovascular Surgery Instruments
The timeline for obtaining a BIS Certificate for Thoracic and cardiovascular surgery instruments typically requires 40-45 working days, though the timeline may vary depending on the product and application status.
List Of Indian Standards Of BIS For Thoracic And Cardiovascular Surgery Instruments
Below, we present the Indian Standards applicable for obtaining a BIS certificate for Veterinary hospital planning and surgical instruments. Explore them here:
| SI. No. | IS No. | TITLE |
|---|---|---|
| 1 | IS 10540: 1991 | Cardiovascular Surgery Instruments – Clamps, Atrial Appendage, Glover’s Pattern – Shape and Dimensions |
| (1 Revision) | ||
| 2 | IS 10541: 1991 | Cardiovascular surgery instruments – Clamps vena cava, satinsky pattern shape, sizes and dimensions (First Revision) |
| (1 Revision) | ||
| 3 | IS 11566: 1986 | Specification for valve retractors |
| 4 | IS 13940: 1994 | Cardiovascular surgery instruments – Clamps, bulldog, DeBakey, ring handle – Shape and dimensions |
| 5 | IS 17646: Part 1: 2021/ISO 23500-1: 2019 | Preparation and quality management of fluids for haemodialysis and related therapies: Part 1 General requirements |
| 6 | 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 |
| 7 | 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 |
| 8 | IS 17646: Part 4: 2021/ISO 23500-4: 2019 | Preparation and quality management of fluids for haemodialysis and related therapies Part 4 Concentrates on haemodialysis and related therapies |
| 9 | 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 |
| 10 | IS 17708: 2021/ISO/TS 23810:2018 | Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment |
| 11 | 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 |
| 12 | 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 |
| 13 | IS 17712: Part 3: 2021/ISO 5841-3:2013 | Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors IS-1 for implantable pacemakers |
| 14 | IS 17745: 2021/ISO 5910:2018 | Cardiovascular implants and extracorporeal systems Cardiac valve repair devices |
| 15 | IS 17746: 2021 | Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements |
| 16 | IS 17750: Part 5: 2021/ISO 14708-5:2020 | Implants for surgery Active Implantable Medical Devices Part 5: Circulatory Support Devices |
| 17 | IS 6395: 1989 | Thoracic Surgery Instruments – Clamps, Auricle, Crafoord’s Pattern |
| (1 Revision) | ||
| 18 | IS 6436: 1989 | Thoracic Surgery Instruments – Rib Spreader, Finochietto’s Pattern, Adult Size |
| (1 Revision) | ||
| 19 | IS 6442: 1989 | Code of practice for construction of floors and roofs using precast doubly – Curved shell units (First Revision) |
| (1 Revision) | ||
| 20 | IS 6466: 1989 | Thoracic and cardiovascular surgery instruments – Needle holders – Specification (First Revision) |
| (1 Revision) | ||
| 21 | IS 6467: 1989 | Thoracic Surgery Instruments – Periosteotome, Rib, Alexander’s Pattern |
| (1 Revision) | ||
| 22 | IS 6468: 1989 | Thoracic Surgery Instruments – Trocar, Empyema, Nelson’s Pattern |
| (1 Revision) | ||
| 23 | IS 6777: 1989 | Thoracic and cardiovascular surgery instruments – Forceps, dissecting, lung – Specification (First Revision) |
| (1 Revision) | ||
| 24 | IS 6778: 1989 | Thoracic Surgery Instruments – Forceps, Lung, Duval’s Pattern |
| (1 Revision) | ||
| 25 | IS 6779: 1989 | Thoracic Surgery Instruments – Forceps, Dissecting and |
| (1 Revision) | Ligature, Mixter’s Pattern – Specification (First Revision) | |
| 26 | IS 6780: 1989 | Thoracic Surgery Instruments – Forceps, Artery, Robert’s Pattern, Curved on Flat |
| (1 Revision) | ||
| 27 | IS 7345: 1994 | Cardiovascular surgery instruments – Anastomosis forceps and clamps – Patterns, shapes and dimensions (Second Revision) |
| (2 Revision) | ||
| 28 | IS 7346: 1987 | Raspatories, Rib, Semb’s Pattern |
| (1 Revision) | ||
| 29 | IS 7355: 1987 | Spreader, Rib, Tuffier’s Pattern, Adult Size |
| (1 Revision) | ||
| 30 | IS 7367: 1987 | Clamps, Coarctation, Potts’ Pattern, Straight and Angular |
| (1 Revision) | ||
| 31 | IS 7379: 1987 | Clamps, Patent Ductus, Potts’ Pattern, Straight and Angular |
| (1 Revision) | ||
| 32 | IS 7382: 1987 | Shears, Rib, Price Thomas’ Pattern |
| (1 Revision) | ||
| 33 | IS 7399 : 1987 | Knife, Sternum, Lebsche’s Pattern |
| (1 Revision) | ||
| 34 | IS 7434: 1987 | Retractor, Scapula, Tudor Edward’s Pattern |
| (1 Revision) | ||
| 35 | IS 7971: 1987 | Tourniquet, Cardiovascular Rumel-Belmont’s Pattern |
| (1 Revision) | ||
| 36 | IS 7972: 1987 | Scissors, Dissecting, Metzenbaum’s Pattern |
| (1 Revision) | ||
| 37 | IS 8317: 1991 | Cardiovascular surgery instruments – Clamps, vascular, angled at 45 – Shape and dimensions (First Revision) |
| (1 Revision) | ||
| 38 | IS 8335: 1991 | Cardiovascular Surgery Instruments – Clamps, Auricle, Satinsky Pattern – Sizes, Shape and Dimensions |
| (1 Revision) | ||
| 39 | IS 8345: 1994 | Cardiovascular surgery instruments – Clamps, bulldog, cross action type – Specification (First Revision) |
| (1 Revision) | ||
| 40 | IS 8409: 1991 | Cardiovascular Surgery Instruments – Dilator, Valve, Tubb’s Mitral Pattern |
| (1 Revision) | ||
| 41 | IS 8549: 1991 | Cardiovascular surgery instruments – Angled scissors, Potts Smith pattern – Specification (First Revision) |
| (1 Revision) | ||
| 42 | IS 8890: 1991 | Thoracic surgery instruments – Clamps, bronchus – Types, shapes and dimensions (First Revision) |
| (1 Revision) | ||
| 43 | IS 9928: 1981 | Clamp, Aortic, DeBakey’s Pattern (Spoon Shaped angled Jaw) |
| 44 | IS 9950: 1981 | Specification for clamp, vascular, wister pattern |
| 45 | IS 9951: 1981 | Specification for scissors, blunt end, nelson pattern |
| 46 | IS 9987: 1981 | Clamps, Multipurpose, De-bakey’s Pattern |
| 47 | IS/ISO 11658: 2012/ISO 11658 :2012 | Cardiovascular Implants and Extracorporeal Organs Blood/Tissue Contact Surface Modifications for Extracorporeal Perfusion Systems |
| 48 | IS/ISO 12417: Part 1 :2015/IS/ISO 12417-1:2015 | Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements |
| 49 | IS/ISO 15674: 2016/IS/ISO 15674: 2016 | Cardiovascular implants and artificial organs – Hard – Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision) |
| (2 Revision) | ||
| 50 | IS/ISO 15675: 2016/IS/ISO 15675:2016 | Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters |
| 51 | IS/ISO 15676: 2005/ISO 15676:2005 | Cardiovascular Implants and Artificial Organs – Requirements for Single-Use Tubing Packs for Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO) |
| 52 | IS/ISO 18241: 2016/IS/ISO 18241:2016 | Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps |
| 53 | IS/ISO 18242: 2016/IS/ISO 18242:2016 | Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps |
| 54 | IS/ISO 25539: Part 1: 2017/ISO 25539: Part 1 | Cardiovascular implants – Endovascular devices: Part 1 Endovascular prostheses (First Revision) |
| (1 Revision) | ||
| 55 | IS/ISO 25539: Part 2: 2012/25539 | Cardiovascular implants – Endovascular devices: Part 2 vascular stents |
| 56 | IS/ISO 25539: Part 3: 2011/ISO 25539-3: 2011 | Cardiovascular implants – Endovascular devices: Part 3 vena cava filters |
| 57 | IS/ISO 5840: Part 2: 2015/ISO 5840-2: 2015 | Cardiovascular Implants Cardiac Valve Prostheses Part 2 Surgically Implanted Heart Valve Substitutes |
| 58 | IS/ISO 5840: Part 3: 2013/ISO 5840-3: 2013 | Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques |
| 59 | IS/ISO 7198: 2016/IS/ISO 7198:2016 | Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches |
| 60 | IS/ISO 7199: 2016/ISO 7199 :2016 | Cardiovascular implants and artificial organs – Blood – Gas exchangers (Oxygenators) (Second Revision) |
| (2 Revision) | ||
| 61 | IS/ISO 8637: Part 1: 2017/ISO 8637-1:2017 | Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators |
| 62 | IS/ISO 8637 : Part 2 : 2018/ISO 8637-2:2018 | Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters |
| 63 | IS/ISO 8637: Part 3: 2018/ISO 8637-3:2018 | Extracorporeal Systems for Blood Purification Part 3 Plasmafilters |
How Will ELT Corporate Assist You With BIS Certificate For Thoracic And Cardiovascular Surgery Instruments?
ELT Corporate provides end-to-end support for obtaining BIS certificate for thoracic and cardiovascular surgery instruments. We will guide you through the application, assist with documentation, coordinate with BIS for inspections, and confirm ongoing compliance with BIS standards. From initial certification to renewals, we help you maintain uninterrupted certification.
What Are The Penalties For Non-Compliance With BIS Certificate?
Failure to comply with BIS standards can result in penalties such as fines, legal action, and damage to your reputation. It is crucial to adhere to BIS guidelines to avoid these consequences and ensure smooth operations.
Can BIS Certification Be Transferred?
Yes, BIS Certification can be transferred. However, if there are changes in the location or business structure, a new application must be submitted to reflect the update.