BIS Certification for Orthotic Stirrup Plates IS 9471 (Part 3)

The orthotic stirrup plates should be in accordance with IS 9471 (Part 3), whereby the components are up to the required performances on quality and material, design, strength, and durability. BIS Certification for Stirrup Plates ensures that they are safe and functional and therefore offer reliability and effectiveness in the medical profession. 

What is a BIS License for Manufacturers?

The Bureau of Indian Standards (BIS) is a national authority which provides safety and quality standards for products in India. BIS certification is done to make sure that a product, such as orthotic stirrup plates, has met the requirements of the IS 9471 (Part 3), which deals with the orthopaedic component standards incorporated into the medical equipment.

Manufacturers who receive BIS certification are allowed to attach the ISI mark to their product, which implies that the stirrup plates were thoroughly tested and can comply with all the required safety, durability, and performance standards. 

Reasons for obtaining ISI Certification

The ISI certification of the orthotic stirrup plates has been important due to a number of reasons:

1. Ensures  Patient Safety : The BIS-certified stirrup plates contain less risk of mechanical breakdowns, instability, and decomposition to be used safely in orthopaedic practices.
2. Assurance of Strength and Durability : The certified stirrup plates are being tested to determine the mechanical strength and fatigue resistance, which means they will have a long life operating.
3. Compliance with IS 9471 (Part 3) : IS 9471 (Part 3) standard provides quality uniformity in materials, design and performance which makes the product fit to be used in medical applications.
4. Raise credibility in the market : The ISI mark enhances the credibility of the orthotic stirrup plates, making them more believable to the hospitals, healthcare givers and patients.
5. Lawful and Business Benefits: In India, orthotic components have to be sold with BIS certification to sell them and can be useful in tenders and large-scale contracts provided by the government. 

Key Specifications of IS 9471 (Part 3) 

The technical specifications of orthotic components (orthopaedic appliances), including stirrup plates, are found in IS 9471 (Part 3). The standard encompasses the assumption of the materials, design, dimension, strength, and functional performance.

It consists of the criteria related to the testing of the durability and wear resistance of the components and their capability to sustain the structural stability and comfort in the course of repeated use. Adherence to this standard is of significance, as the stirrup plates are able to give patients stable, secure and effective support.

Necessary Documents for Obtaining BIS License  

The following documents are necessary for Domestic Manufacturers:

1. List of raw material
2. Layout plan of the factory premises
3. List of testing equipment as per the Indian standard
4. Quality Control (QC) Personnel Details (Education degree and Aadhaar card)
5. GST
6. Authorized Person Aadhar & Pan Card
7. MSME
8. Electricity Bill
9. Email Address & Permanent Contact Number
10. Office Address
11. Factory Address
12. Copy of Partnership Deed / MOA (for Private Limited Co.)
13. Premises document / Rent Agreement
14. List of Manufacturing Machinery  

The following documents are necessary for Foreign Manufacturers:

1. Checklist for Application
2. Copy of Swift Remittance
3. Duly Filled Application Form
4. Copy of Business License
5. List of Machinery
6. List of Raw Material
7. Test certificate of Raw Material
8. List of Testing Equipment
9. Calibration certificate of Test Equipment
10. Process Flowchart
11. Layout Plan
12. Location Plan (Route Map)
13. Details of Technical Personnel
14. Qualification of QC
15. Copy of Certification of Product and/ System
16. Factory Test Report  
17. Agreement with AIR
18. Aadhar Card of AIR
19. AIR Nomination Form
20. Educational Degree of AIR
21. Undertakings
22. Scope of License

Detailed Steps for obtaining ISI Certification   

There are two key procedures to get your BIS license: Simplified and Normal.

Simplified Procedure

The steps involved in the simplified procedure are:

1. Document Collection : All the necessary KYC and technical documents are collected in order to start the BIS application without problems.
2. BIS Portal Registration : The license application is processed by the manufacturer being registered on the official portal of BIS.
3. Pre-Testing of Samples : Before submission, product samples are tested in a BIS authorized laboratory.
4. In-House Lab Requirement : Depending on the product, an internal laboratory facility might be necessary according to the BIS requirements.
5. BIS Review & Clarifications : BIS analyzes the documents and test reports provided and can seek clarifications.
6. BIS Audit at Factory : Audit of the product samples carried out by the BIS inspectors is done at the factory. 
7. Timely Audit Completion : The audit, inspection and sample collection are conducted within 17 days of the application submission along with the EVTL India engineer.
8. EVTL India Engineer- Factory Inspection : The BIS auditor and an engineer at EVTL India undertake a proper inspection at the factory.
9. Independent Collection of Samples : The BIS auditor draws samples to be tested by the post-audit.
10. Sample Testing at BIS Lab : BIS sealed samples are sent to BIS laboratories, and the BIS department pays the price of testing.
11. Grant of BIS License : Upon satisfactory document inspection, testing and audit, ISI license is issued. 

Normal Procedure

The steps involved in the normal procedure are:

1. Submit Documents : Firstly, it is required to submit all the KYC and technical documentation to start the BIS application.
2.  Plan In-House Laboratory and Technical Proposal : Prepare an internal lab in case necessary and prepare all technical documentation.
3. Ready Factory Test Report (FTR) : Carry out in-house tests and document the FTR to demonstrate that the product is to the standards.
4. Submit Application & Fees : Includes your BIS application and the amount of fees necessary by the government.
5. BIS Audit : An audit of documents and processes at a BIS takes place within 3 weeks.
6. EVTL India Engineer Factory Inspection : BIS auditor inspects the factory with an EVTL India engineer to make sure that everything is in order. 
7. Sample Collection & Sealing : The BIS auditor picks samples randomly, puts them into a sealed sample and forward the sample to a BIS authorized lab to be tested.
8. License Approval : After the lab tests of the sample are passed-on, BIS issues the ISI license, and your product is certified and market-ready. 

Duration for obtaining BIS License 

The expected time duration for obtaining BIS Certification for Orthotic Stirrup Plates under IS 9471 (Part 3) is:

• For Indian Manufacturers : 40-45 days
• For International Manufacturers : Approximately 180 days  

Why EVTL India is the best option for obtaining BIS Approval?

EVTL India is a reliable BIS certification consultancy firm that offers full services of acquiring a BIS certification of orthotic components, such as stirrup plates. Our team will provide services in terms of document preparation, coordination of the laboratory, audit support, and compliance management so that the certification process will be smooth.

We give manufacturers a new path to follow and ensure that they pass the BIS certification process within a very short time frame and in a cost-effective manner, which enhances brand recognition and market acceptance. 

Conclusion

BIS Certification of Orthotic Stirrup Plates with IS 9471 (Part 3) is not only used to meet the regulatory requirements but also high-quality standards, safety and performance standards. The ISI mark illustrates that the product meets the Indian standards, which creates confidence in the minds of the healthcare professionals, hospitals, and patients.

BIS certification through EVTL India enables the manufacturers to be certain to tap into the market, enhance their brand reputation and offer superior quality orthotic remedies.

Frequently Asked Questions (FAQs)

1. What is the BIS Certification as per IS 9471 (Part 3)?

It can ensure that the orthotic stirrup plates meet the Indian requirements in safety, performance and lifespan.

2. Why do we have to have BIS certification of orthotic stirrup plates?

It also does not compromise the safety or functionality of the product, hence making it reliable to be used by the patients. 

3. Should orthotic stirrup plates be BIS Certified in India?

Yes, like orthotic stirrup plates in India, BIS certification is needed in both manufacturing and sale. 

4. What is the ISI Mark of stirrup plates?

It means that the product has been tested and passed in accordance with the IS 9471 (Part 3). 

5. What are the advantages of BIS Certification to hospitals and patients?

It offers long-lasting, secure and efficient orthopaedic care, thus delivering higher quality patient care and comfort.