BIS Certification for Orthotic Hip Joints – IS 9471 (Part 6) Compliance & Safety

These components are required to be of satisfying safety, strength, and performance standards, which is supported by BIS Certification for Orthotic Hip Joints according to IS 9471 (Part 6). The standard is designed to ensure that the orthotic hip joints offer correct alignment, smooth movement, durability as well as comfort, hence, are safe and dependable to use in the medical and rehabilitation field. 

What is an ISI Mark Certification for Manufacturers?

The national body that controls the standards of quality and safety of products in India is the Bureau of Indian Standards (BIS). BIS certification demonstrates that the orthotic hip joints are in line with the requirements of the IS 9471 (Part 6) which is the specification of the orthotic components of medical equipment.

The manufacturers that receive a BIS license are entitled to utilize the use of the ISI Mark, which certifies that the orthotic hip joints have gone through rigorous tests and that they have been bought in accordance with the stipulated quality, safety, and life span. 

Requirement for ISI Mark Certification

ISI Mark certification on orthotic hip joints is necessary because of the following reasons:

1. Ensures  Patient Safety : Certified orthotic hip joints limit the chances of mechanical breakdown, pain or joint movement misalignment when using them.
2. Ensures Strength and Durability : Hip joints which are certified by BIS are undergone through tough mechanical and fatigue tests to make sure that they will perform over time.
3. Compliance with IS 9471 (Part 6) : The standard guarantees consistency in the quality of material, design precision, and performance.
4. Improves the Credibility of Markets : Orthopaedic professionals, rehabilitation centres, and hospitals tend to use BIS-certified orthotic components.
5. Legal and Commercial Benefits: The sale in India and government tenders are mandatory to use BIS certification. 

An Overview of IS 9471 (Part 6) 

IS 9471 (Part 6) identifies the requirements in the Orthotic Hip Joints to Orthopaedic appliances. The standard addresses the material specifications, design characteristics, dimensional accuracy, mechanical strength, corrosion resistance, and surface finish.

It also involves performance testing that would allow to make sure that joints move correctly, are not weakened with repeated use, and are safe in general. Adherence to IS 9471 (Part 6) can reduce joint failure as well as provide stable, comfortable and effective orthotics to the patients.

List of Mandatory Registration Documents 

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

How to apply 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. 

Timeline for successful BIS License approval ?

The expected timeline for BIS license for Orthotic Hip Joints under IS 9471(Part 6):

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

Why EVTL India is the right choice for BIS Approval?

EVTL India is a reputable BIS certification consultancy that offers total support of BIS License for Orthotic Hip Joint in accordance with IS 9471(Part 6).

EVTL India takes care of the entire certification process without any stress or strain through gap analysis, documentation, and laboratory coordination, and audit support.

Our expert workers assist manufacturers to comply with all the BIS requirements in an efficient way to enter into the market faster and in a fully compliant state. 

Conclusion

The certification of Orthotic Hip Joints as per the IS 9471 (Part 6) with BIS is not only a legal requirement but also a promise of quality of products, safety and reliability.

The ISI mark builds confidence in the hospitals, medical practitioners, and patients because it ensures adherence to the Indian standards. Through the assistance of the experienced BIS consultants, manufacturers will gain certification relatively easily and will be able to reinforce their brands within the orthotic products market. 

Frequently Asked Questions (FAQs)

1. What is the BIS Certification according to IS 9471 (Part 6)?

It assures that the orthotic hip joints comply with the Indian safety and performance requirements.

2. What is the rationale of BIS Certification of orthotic hip joints?

It guarantees safety of patients, longevity, and uniform quality of products. 

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

BIS certification is required to produce and to market orthotic hip joints in India.

4. What is the ISI Mark for the orthotic hip joints?

It depicts that the product is tested, approved, and in accordance with the IS 9471 (Part 6).

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

It provides reliable and long lasting orthotic solutions in order to provide better patient care.