BIS Certification for Orthotic Components (Stirrups) IS 9471 Part 2

BIS Certification of Orthotic Components (Stirrups) in the requirements of IS 9471 (Part 2) is mandatory so as to ascertain consistent quality and patient safety. This standard provides that orthotic stirrups are of high quality according to material, design, mechanical strength and performance, consequently making their use safe in medical and rehabilitation practice. 

What is a BIS License for manufacturers?

The national authority in India is the Bureau of Indian Standards (BIS) which is in charge of implementing quality and safety standards of products. The BIS certification ensures that orthotic parts are in line with IS 9471 (Part 2) that outlines specifications of Orthotic supports and aids.

Manufacturers authorized to use the BIS license have been qualified to use the ISI Mark, which indicates that the orthotic stirrups have been applied to rigorous testing and met the prescribed safety, performance and durability standards.

Requirement of ISI Mark Certification

Among the reasons why ISI mark is important to the orthotic components (stirrups) is the following:

1. Ensures Patient Safety : Certified orthotic stirrups help in minimizing the chances of failures of the device, wrong position, or painfulness when using it.
2. Guarantees Strength and Durability : Components that are BIS-certified are subject to severe mechanical tests in order to verify the load-bearing potential and durability.
3. Compliance with IS 9471 (Part 2) : The standard brings consistency in the design of the products, material quality and performance of all the certified products.
4. Improves Credibility of the Market : Orthopaedic professionals and hospitals also prefer the use of BIS-certified products with patients.
5. Legal and Commercial Support : Certification The certification of BIS is required to be sold in India, and it facilitates the involvement in government bids and institutional buying. 

What is IS 9471 (Part 2)

IS 9471 (Part 2) outlines the standards of orthotic components, specifically the stirrups, in Orthotic appliances. This standard addresses material specifications, dimensional accuracy, mechanical strength, surface finish, and corrosion resistance.

It also requires testing of different performance, durability and safety of repetitive use. The adherence to IS 9471 (Part 2) reduces the risk of component failure and also makes orthotic devices comfortable, stable, and effective. In general, the standard will ensure effective, safe and comfortable Orthotic solutions.

Essential Documents Required for Registration 

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

Procedure for ISI Certification of Products  

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. Factory Inspection with EVTL India Engineer : 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. 

Overall timeline for BIS License Approval Completion

The expected timeline for BIS license for Orthotic Components (Stirrups) under IS 9471 (Part 2) is:     

• For Indian Manufacturers (40-45 days is the standard timeframe)
• For International Manufacturers (180 days is the standard timeframe) 

Why trust EVTL India to complete your BIS Approval process?

EVTL India is a reputed BIS certification advisor that provides full-fledged services to Orthotic Components (Stirrups) BIS Certification as per the IS 9471 (Part 2).

EVTL India provides a hassle free certification process through analysis and documentation of gaps to laboratory testing coordination and assistance in audit.

We have a highly qualified staff to make sure that your orthotic components are of all BIS standards so that you can enter the market on time and be able to operate in full compliance with the regulations. 

Conclusion

BIS Certification of Orthotic Components (Stirrups) according to IS 9471 (Part 2) is not just a law requirement, but the responsibility to care about safety, the reliability and quality of the products.

The ISI mark shows adherence to the Indian standards and creates trust between the healthcare professionals, hospitals, and patients.

Manufacturers have the opportunity to be certified with minimal effort, build positive brand reputation in the market of Orthotic products with a professional BIS consultancy support. 

Frequently Asked Questions (FAQs)

1. What is the meaning of BIS Certification according to the IS 9471 (Part 2)?

It validates the fact that the orthotic stirrups are safe and meet the performance criteria in India.

2. What is the need of a BIS Certification of orthotic components?

It guarantees patient safety, durability, and Orthotic device quality uniformity. 

3. Does India have mandatory BIS Certification of orthotic stirrups?

Yes, there is BIS certification to manufacture and sell orthotic parts in India.

4. What is the meaning of the ISI mark on orthotic components?

The ISI mark demonstrates that the product has been tested, approved and meets the compliance of the IS 9471 (Part 2).

5. What is the role of BIS Certification in the hospital and patients?

It guarantees quality performance of Orthotic aids, safety, and its long-term sustainability.