BIS Certification For Ethylene Oxide Sterilization [IS 5573:1984]

Bureau of Indian Standard Certification is essential for ensuring product or process safety and quality standards. If you are a manufacturer or importer, you must know the benefits and importance of obtaining BIS Certification. BIS Certification for Ethylene Oxide Sterilization means obtaining a BIS certificate for using Ethylene Oxide which is hazardous to sterilize medical devices, especially those sensitive to heat and moisture.

What Is Ethylene Oxide? 

Ethylene Oxide is a chemical that, despite being of hazardous nature, is used extensively in the Healthcare sector, Agriculture and chemical industries is broad. It is used in the production of chemicals like ethylene glycol, found in antifreeze and polyester. It also serves as an effective sterilizing agent for medical devices, surgical tools, and spices, because of its pathogens removing property.

Obtaining BIS certification for ethylene oxide is mandatory by the Indian Government as it ensures compliance with Indian safety and quality standards under IS 5573:1984. The Bureau of Indian Standards (BIS) grants the ISI Mark based on a thorough evaluation of the manufacturer’s quality control, production processes, testing, and infrastructure.

Also Read: What Is BIS

What Is The Objective Of Getting BIS Certification For Ethylene Oxide Sterilization? 

The various objectives of getting BIS Certification by the use of ISI Mark are discussed below:

• Ensures that the product is of good quality standard and safe for use as set by the Indian Government.
• Build customer’s trust by providing a safe product that meets the regulatory aspects
• Enhances brand reputation and market value of the product.
• Protect from legal consequences
• Compliance with this standard ensures that ethylene oxide sterilization effectively eliminates microbes while maintaining product integrity.

What Are The Benefits Of BIS Certification For Ethylene Oxide Sterilization? 

If you are a manufacturer or importer and want to gain customer trust for your product then having BIS certification for ethylene oxide sterilization is essential for you. Here we have listed down the benefits of BIS Certification:

• Build customer’s trust and confidence
• Ensure quality assurance of the product
• Safeguard consumer health by preventing any use of any harmful substance
• Helps in legally sell manufactured products as per Regulatory Compliance
• Increase opportunities for global marketing of the product as well as product credibility
• Boost market reputation of brand and product

List Of Documents Required For BIS Certification For Ethylene Oxide Sterilization 

For the hassle-free and smooth process of getting BIS Certification various documents must be submitted along with the application form, listed below:

1. Application form
2. Personal details of the applicant
3. Product Details
4. Proof of Manufacturing/business establishment
5. Manufacturing License
6. Product test reports from a certified laboratory
7. Site Layout
8. MSME/SSI Certificate
9. List of equipment or Instruments
10. Power of Attorney certificate if any
11. Other documents as per need or requirements

Also Read: Requirements For BIS Certification

Procedure To Obtain BIS Certification For Ethylene Oxide  Sterilization

The various steps to be followed for the seamless process of getting BIS Certification For Ethylene Oxide are as follows:

1. Fill out the application form and mention all the details carefully
2. Attach all the required documents along with the application form
3. Preliminary Inspection and Audit by BIS
4. Testing and Validation of product and Report
5. Surveillance process
6. Site visit and testing
7. Create performance Report
8. After successful review and verification License is granted
9. Audit by BIS conducted at regular intervals to ensure compliance

Validity Of BIS Certification For Ethylene Oxide  Sterilization

The validity of BIS Certification is one year from the date of issuance of the certificate. After this, the certificate can be renewed in the given time along with the fees. If the BIS Certificate does not get renewed in the given time or you renew after expiration then a late fee of Rs.5000 is submitted along with the application form and necessary documents.

What Are The Key BIS Standards For EO Sterilization?

Here we have mentioned the BIS standards for EO sterilization =

• The primary BIS standard for Ethylene Oxide (EO) sterilization is IS/ISO 11135, which outlines the safety, effectiveness, and sterility requirements for healthcare products sterilized using ethylene oxide.
• Other relevant standards may include IS 5573:1984, which covers ethylene oxide’s quality and safety requirements as a sterilizing agent.