BIS Certification for Orthotic Joint Bars IS 9471 (Part 7)

The Orthotic Joint Bars are certified as BIS Certified to Part 7 of the ISO 9471 standard requirements so that they are safe and of the necessary quality. The certification will ensure the product meets Indian standards of design, quality of materials, strength, durability, and functionality. 

What to know about BIS Certification?

In India, product quality is established and implemented by the Bureau of Indian Standards (BIS). The BIS license of orthotic joint bars under IS 9471 (Part 7) assures the product to be within the safety, durability and performance standards.

Manufacturers holding BIS certification are allowed to use the ISI mark, indicating that their product is in compliance with the Indian regulations. This certification gives confidence among the healthcare professionals, manufacturers and patients. It ensures that the orthotic joint bars are secure, dependable and practical to use. 

Why is BIS License Essential?

BIS certification for non-plastic flushing cisterns plays an important role for the following reasons:

1. Ensures Safe Usage : To avoid any leakage, cracking or malfunction during normal operations, certified cisterns are tested.
2. Maintains Quality and Performance : Cisterns that are certified under IS 774 are guaranteed to possess good flushing, water efficiency and durability.
3. Confirms Compliance with IS 774: The standard outlines the material strength, dimensions, flushing efficiency and wear resistance.
4. Builds Trust in the Market : The ISI mark increases confidence among consumers, contractors, and infrastructure developers.
5. Supports Legal and Business Requirements : BIS licensing assists the manufacturers to adhere to the regulatory norms and enhances acceptance in government projects and bulk supply contracts. 

What is IS 9471 (Part 7) Cover?

The Indian Standard IS 9471(Part 7) describes the criteria of orthotic joint bars in medical devices. The standard stipulates the required material strength, sizes, and longevity to make sure that the bars work best and are not lost during the use.

The joint bars are safe to be used in orthotic equipment since they are in compliance with the requirements of IS 9471 (Part 7) to guarantee sufficient support and functionality to the wearer.

Required Documents for obtaining BIS 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

Complete Process to obtain ISI Mark 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. 

What is the expected Timeline for BIS License approval ?

The timeline required to achieve BIS License for Orthotic Joint Bars is as per the IS 9471 (Part 7):

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

Why EVTL India is a reliable partner for BIS Licensing?

EVTL India is a reputable BIS consultancy which specialises in assisting manufacturers to obtain BIS certification on orthotic joint bars in accordance with IS 9471 (Part 7).

Our services are end-to-end, including factory testing and record keeping, lab coordination, application, audit services, and compliance management. With our team of experts, we will make the process of certification hassle-free. 

Conclusion

The BIS Certification of orthotic joint bars according to the IS 9471 (Part 7) provides the quality of products, their safety, and adherence to Indian standards. The ISI mark leaves the consumer, health care provider and businesses confident about how effective and lasting the product is.

Partnering with EVTL India ensures a smooth and stable process of certification, which increases the trust of the brands and acceptance of the products in the market. 

Frequently Asked Questions (FAQs)

1. What is the BIS Certification of orthotic joint bars in IS 9471 (Part 7)?

It certifies that the joint bars are of the right safety, performance and durability requirements.

2. Why should orthotic joint bars have a BIS License?

It ensures good quality, safety, and functionality of the product, making it reliable in the long term.

3. What is the need for a BIS Certification for orthotic joint bars?

The manufacturers of the orthotic joint bars are supposed to be BIS certified in order to sell the same in India. 

4. What is the ISI Mark for the orthotic joint bars?

It implies that the product is in conformity with IS 9471 (Part 7) and has undergone quality and safety tests.

5. What are the advantages of BIS Certification to businesses?

It builds consumer confidence and provides product security and market acceptance. It is the same content reflected and is organised in a way that ensures that it is clear and flows well to BIS Certification.