BIS Certification for Orthotic Ankle Joints IS 9471 (Part 4)

Orthotic ankle joints under IS 9471 (Part 4) must meet the demands of the Bureau of Indian Standards (BIS). BIS Certification for Orthotic Components (Ankle Joint) assures correct positioning, proper movement, resilience, longevity, and conformability of the components to the end user which makes them reliable and safe in the medical and rehabilitation practices.

What is BIS Certification?

Bureau of Indian Standards (BIS) is the national standard body that sets quality, safety and performance standards on products in India. ISI Mark certification is used to ensure that orthotic ankle joints meet the requirements of IS 9471 (Part 4) which defines standards in relation to orthotic components that are used in medical equipment.

The manufacturers that receive a BIS License have a right to apply the ISI Mark which means that the ankle joints are tested and inspected seriously and have passed all the requirements of quality, safety and durability.

Need for ISI Mark Certification

The ISI Mark certification of orthotic ankle joints is necessary because of the following reasons: 

1. Ensures  Patient Safety : Ankle joints certified by BIS minimize the chances of mechanical failure, instability, pain, or improper movement of the joint when using it.
2. Guarantees Strength and Durability : The certified ankle joints also go through mechanical, fatigue, and performance tests to give an accurate working experience in the long term.
3. Compliance with IS 9471 (Part 4) : The standard guarantees standardized quality of materials, dimension, design and functional performance.
4. Increases Market Credibility : Hospitals, rehabilitation facilities, orthopaedic specialists, and government facilities are more likely to use BIS-certified orthotics components.
5. Legal and Commercial advantages: In India, BIS certification is required to sell orthotic ankle joints as well as to contribute to government tenders. 

What does IS 9471 (Part 4) cover? 

The IS 9471 (Part 4) sets technical specifications of Orthotic Components -Ankle Joints that are employed in orthopaedic appliances. The standard includes material specifications, structural design, dimensional tolerance, mechanical strength, corrosion, surface finish and work functionality.

It also requires performance testing to ensure that there is a smooth movement, wear resistance, structural stability and safety during repeated usage. The joint failure is reduced under compliance with IS 9471 (Part 4) and stable, comfortable, and effective use of orthotic support to patients.

Required Documentation for BIS License Approval  

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

Stepwise procedure for 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. 

BIS License Approval Time Duration 

The expected time duration for obtaining BIS Certification for Orthotic Ankle Joints under IS 9471 (Part 4) is as follows:

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

Why EVTL India is the correct choice of getting BIS Approval?

EVTL India is a reliable BIS certification service provider which provides support in BIS Certification of Orthotic Components (Ankle Joint) in accordance with IS 9471 (Part 4).

EVTL India is efficient in the whole process of certification, starting with gap analysis and documentation, through laboratory coordination and audit support. Our qualified staff has made sure that there is no breach of BIS regulations and it assists manufacturers to make quicker entry into the market with confidence. 

Conclusion

BIS Certification for Orthotic Ankle Joints under IS 9471 (Part 4) is not merely a regulatory obligation, but it is also a load towards quality, safety and performance. The ISI Mark is a trust-established mark between the hospitals, orthopaedic specialists and patients by guaranteeing compliance to Indian Standards.

Manufacturers pursue certification easily with the professional help of BIS consultants and enhance their brand image in the market of orthotic components.

Frequently Asked Questions (FAQs)

1. What is the BIS Certification according to the IS 9471 (Part 4)?

It proves that orthotic ankle joints are in accordance with Indian safety and performance criteria.

2. BIS Certification is mandatory for orthotic ankle joints; why?

It assures the safety of the patient, quality and longevity of the product.

3. Are the orthotic ankle joints in India required to be BIS Certified?

Yes, there is BIS certification requirement on the manufacturing and sale of orthotic ankle joints in India. 

4. What does the ISI Mark of ankle joints mean?

It shows that the product has been tested, accepted and that it is in conformance with the IS 9471 (Part 4).

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

It provides stable, secure and durable orthotic remedies to better patient care.