BIS Certification for Sterilizer, Shallow IS 3831

BIS Certification for Sterilizer, Shallow under IS 3831, and fulfills requirements include the construction, safety, and performance requirements. BIS licensing is done to ensure that the operation of shallow sterilizers is safe, uniform in temperature, and sterilization performance is reliable. 

ISI Mark Certification explained

The ISI Mark Certification given by the Bureau of Indian Standards (BIS) is an indicator of adherence to relevant Indian Standards. In the case of Shallow Sterilizers, the ISI mark in the standards of IS 3831 ensures that the equipment has successfully gone through laboratory testing, factory check and continuous quality monitoring.

BIS periodically audits its manufacturing process to guarantee uniformity in the quality of the manufactured goods, choice of material, and safety of operations. Shallow sterilizers with ISI-mark are common in the government hospitals, medical colleges, and institutional procurement programs. 

Commercial benefits of ISI Mark Certification

The commercial benefits of ISI mark certification for Sterilizer, Shallow IS 3831 are stated as below:

1. Medical Safety Assurance : Provides effective sterilization of the medical equipment, minimizing the possibility of infection and cross-infection.
2. Operational Reliability : Ensures that it has stable temperature control and predictable sterilization operation.
3. Regulatory Compliance : Authorizes legal production and sale by complying with the requirements of the known BIS notified standards.
4. Market Acceptance : Vastly accepted by hospitals, clinics, and government healthcare facilities as acceptable to procure.
5. Credibility of the Brand : Establishes credibility and trust with the medical and health professionals. 

An overview of Indian standard IS 3831

IS 3831 provides that shallow sterilizers must be made of corrosion resistant medical grade materials. The equipment should also have a uniform temperature distribution and good access to steam or moist heat throughout the sterilizing chamber.

Thermostatic control and safety valve requirements, and pressure regulation requirements, provide safe operation. The standard also provides capacity, performance testing, marking, and labeling requirements of traceability. 

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 application process

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. 

BIS Licensing approval schedule

According to IS 3831, a BIS license for Sterilizer, Shallow 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 partner with EVTL India?

EVTL India is a reliable BIS consultant that offers full certification support to Shallow Sterilizers on the basis of IS 3831. Their specialists deal with documents, filing of BIS portal and communication with BIS-certified labs.

EVTL India provides technical advice on quality control system and factory audit preparedness. Having a solid regulatory background, they assist manufacturers to get greater approvals at a low compliance risk. 

Conclusion

The company that manufactures shallow sterilizers needs to have BIS Certification according to IS 3831 to be sure that there is safety, effective sterilization, and as well as compliance with regulation in India. The certification enhances the market and institutional confidence in the healthcare sector.

Manufacturers with the help of professional services provided by EVTL India are able to simplify the BIS licensing process and be sure to provide ISI-marked shallow sterilizers to hospitals and medical institutions. 

Frequently Asked Questions (FAQs)

1. In India, is BIS Certification required to Shallow Sterilizers?

Yes, IS 3831 BIS certification is a requirement according to quality requirements. 

2. Who may seek registration under BIS under IS 3831?

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

3. What are the tests done in IS 3831?

Temperature uniformity, sterilization effectiveness, functioning of the safety valve and material quality are all tests.

4. Is Shallow sterilizers BIS certified by a foreign manufacturer?

Yes, the foreign manufacturers may apply under BIS by appointing an AIR.

5. Is ISI marking mandatory following certification?

The equipment and packaging must be marked with ISIs upon approval of the BIS license.