BIS Certification for Hot Air Sterilizers IS 3119

The BIS Certification for hot air sterilizers is under the control of the IS 3119 which indicates the safety, level of performance, construction, and temperature control. The BIS licensing also makes sure that the hot air sterilizers are safe, provide even heat and produce successful sterilization under specified circumstances. 

What is an ISI Mark Certification?

The ISI Mark Certification, which is awarded by the Bureau of Indian Standards (BIS), attests that some product meets the relevant Indian Standard. In the case of Hot Air Sterilizers, the ISI mark that is established under the IS 3119 means that the device has gone through type testing, factory inspection and on-going monitoring.

BIS uses a regular inspection of certified units to maintain consistency of quality in manufacturing, electrical safety and performance reliability. Hot air sterilizers that are ISI-marked are accepted by a lot of medical institutes, laboratories and government programs in procurement. 

How ISI Mark Compliance supports market trust

The major advantages that shows how ISI mark compliance supports market trust through ISI Mark Certification for Hot Air sterilizers are: 

1. Operational Safety : Assures electrical, thermal and mechanical safety to use.
2. Effective Sterilization : Assures even distribution of temperature and sterilizing efficacy.
3. Regulatory Compliance : Legally manufacturers, sellers, and suppliers in India.
4. Market Acceptance : Favored by government buyers, laboratories and hospitals.
5. Performance Reliability : Guarantees steady temperature regulation and extended life. 

Key specifications of IS 3119

IS 3119 provides the necessary technical and safety provisions on hot air sterilizers to provide a reliable sterilization. Key parameters include:

• Quality of construction and material of the chamber.
• Since the chamber has a wide range of temperatures, it should be uniform.
• Precision of thermostat and temperature controller.
• Efficiency and recovery time in heating.
• Insulation performance and heat insulation.
• Electrical safety, earthing and insulation resistance.
• Interlock systems and door sealing.
• Performance with regard to sterilization at required temperature time cycles.
• Labeling, user instructions, and marking. 

Products that meet these parameters only can be BIS certified and ISI marked. 

Required documentation for BIS 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

BIS Certification Procedure for manufacturers

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 examines the submissions of documents and test reports and may request clarification.
6. BIS Audit at Factory : The 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. 

Estimated Timeline for BIS Licensing approval

According to IS 3119, a BIS license for Hot Air sterilizers is expected to take:

For Simplified Procedure (Indian manufacturers)

Average 40-45 days

For Normal procedure  

• For Indian Manufacturers : 50-60 days
• For International Manufacturers : Approximately 180 days  

Why EVTL India is the smart choice for BIS Certification?

EVTL India is the Reliable BIS Consultant for Hot Air sterilizers whom manufacturers can rely on to support its entire certification process. The staff is involved in documentation and filing in the BIS portal and liaising with BIS-recognized laboratories.

EVTL India also provides professional technical services of establishing quality control and preparing factory audits. They have regulatory expertise that enables manufacturers to obtain faster approvals and have low compliance risk. 

Conclusion

To achieve the safety and sterilization effectiveness and conformity of Hot Air sterilization equipment in India the manufacturers of the equipment must be certified with BIS Certification under IS 3119. Certification bolsters product reliability, acceptability in the market and institutional trust.

Manufacturers will be able to simplify the BIS licensing procedures through professional assistance of EVTL India and to be sure of the delivery of ISI-marked hot air sterilizers to the medical, laboratory, and industrial markets.

Frequently Asked Questions (FAQs)

1. Were Hot Air Sterilizers in India required to have BIS Certification?

Yes, BIS certification according to IS 3119 is obligatory according to the rules. 

2. Who is eligible to BIS registration under IS 3119?

The Indian manufacturers and the foreign manufacturers via an Authorized Indian Representative (AIR).

3. Which tests are implemented under IS 3119?

Tests involve temperature consistency, thermostat correctness, efficiency of heating, electrical security and sterilization capability.

4. Is it possible for foreign manufacturers to get BIS Registration for Hot Air Sterilizers?

Yes, foreign manufacturers may make applications under BIS by nomination of AIR

5. Is ISI marking mandatory post-certification?

Yes, the equipment and packaging have to be marked with ISI after being accepted by the BIS license.