Hot Air Sterilizers are commonly used in laboratories, hospitals, pharmaceutical companies and research institutions for conducting dry heat sterilization of glassware, metal utensils and other heat-resistant equipment. They use hot air currents to carry out the dry heat sterilization of the equipment without the employment of moisture. Proper temperature and air currents need to be maintained during the dry heat sterilization as a variation in either affects the efficiency of the sterilization procedure.
The BIS Certification for Hot Air Sterilizers in accordance with Indian Standard IS 3119:1978 ensures that the equipment meets the minimum requirements for proper functioning. The process of testing, evaluation and conformance testing ensures that the equipment gives reliable results in any condition of usage.
What is the Importance of IS 3119:1978
This standard establishes the construction and performance requirements for hot air sterilizers used in laboratories, healthcare facilities, and research institutions. It ensures that the equipment delivers effective sterilization while maintaining operational safety. As prescribed by BIS, hot air sterilizers are:
- Tested for temperature accuracy
- Evaluated for heating efficiency
- Checked for safety compliance
- Assessed for operational reliability
Testing and Inspection Requirements
To achieve efficient and safe operation of hot air sterilizers, the Bureau of Indian Standards outlines the minimum requirements under IS 3119:1978. This certification verifies that the equipment is manufactured in accordance with the specified construction, temperature control and performance criteria necessary for dependable sterilization.
The BIS testing parameters and quality checks for the Hot Air Sterilizers are listed below:
BIS Certification Process for Laboratory Hot Air Sterilizers India
The BIS Authorisation process ensures that the dry heat sterilizer meets the required standards for proper and efficient operation. This process is set by the Bureau of Indian Standards (BIS) and includes the following steps:
- Online Registration: Manufacturers register on the BIS Manak portal by submitting company, factory, and product details. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for temperature accuracy, chamber uniformity, thermal efficiency, insulation performance, safety controls and overall sterilization effectiveness.
- Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
- Factory Inspection: BIS officials visit the manufacturing facility to evaluate production processes, safety measures, and the quality control system.
- Grant of BIS License: After all compliance requirements are satisfactorily met, BIS grants the certification license under Scheme-I.
- Use of ISI Mark: Following approval, the manufacturer is authorized to use the ISI Mark on the product along with a valid CM/L number, confirming that the product meets BIS standards.
Required Documents for IS 3119:1978 Approval
| Document Category | Documents Required |
|---|
| Basic Details | GST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms) |
| Manufacturing Details | List of Machinery, Process Flow Chart, Factory Layout Plan |
| Raw Material Details | List of Raw Materials, Supplier Details, Raw Material Invoices, Raw Material Test Certificates |
| Testing & Quality Control | List of Testing Equipment, Calibration Certificates, QC/Lab In-charge Appointment Letter & Qualification |
| Production Details | Annual Installed Capacity, Last Year Production Value |
| Product & Packaging Details | Quantity per Package, Nature of Packing, Product Printing / Marking Details |
| Management Details | Top Management Details, BIS Communication Contact Person |
| Brand & Certification Documents | Trademark / Brand Certificate, Consent Letter from BIS Recognized Laboratory |
| Additional Documents | Weekly Off Details, Hygiene Document (if applicable), Relaxation Letter (if applicable), Any Other Relevant Document |
| Foreign Manufacturer Requirement | Appointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India |
The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and manages all compliance and regulatory requirements in India.
Marking Requirements & License Validity
Marking Requirements
After the manufacturer obtains a BIS license, the ISI Mark for a hot air oven sterilizer must be written clearly and permanently either on its packaging or on the product. The marking should also include key information, such as the manufacturer’s identification and licence number (CM/L). Additional details are provided below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 3119:1978 |
| CML Number | Certification Marks License (CML) number issued by BIS |
| Manufacturer Details | Name of manufacturer or registered trademark |
| Batch / Date | Batch number, heat number, or manufacturing date for traceability |
Note: Marking is typically applied using durable stamping, tagging, or permanent printing to ensure clear identification during handling, storage, and transportation, as per BIS marking requirements.
BIS Approval Validity for Manufacturers and Importers
| particulars | Details |
|---|
| Initial Validity | Typically 1 to 2 years, depending on BIS approval conditions |
| Renewal | Must be renewed before expiry by submitting the application along with the prescribed fee and updated documents |
| Surveillane | BIS may inspect factories and test samples periodically |
| Annual Fees | Annual license fee must be paid regularly |
| Compliance | Continuous compliance with BIS requirements is necessary |
| License Format | BIS is shifting towards a 10-digit license number format |
| Non-Compliance Risk | May lead to suspension or cancellation of license |
How Much Does BIS Certification Cost
The cost of BIS Approval for hot air sterilizers includes charges for application, inspection, license, testing, and marking. These fees are paid to BIS as per Scheme I guidelines.
| Charge Type | Indian Manufacturers | Foreign Manufacturers |
|---|
| Application Fee | INR 1,000 | USD 15 |
| Audit Charges | INR 7,000 | USD 3,200 – 5,900 |
| License Fee | INR 1,000 | USD 15 |
| Marking Fee | As applicable | As applicable |
| Testing Charges | As applicable | As applicable |
| EVTL India Consultancy Fee | As per actual | As per actual |
Note:
- Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
- Audit charges for foreign manufacturers vary based on country/location.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Testing charges are to be paid directly to BIS-recognised laboratories.
- Consultancy fees can vary depending on product type and factory location.
Conclusion
The BIS certificate guarantees that the hot air sterilizer always performs at a validated level, providing accuracy and safety of operations in all critical areas. Compliance with IS 3119:1978 increases the credibility of products in hospitals and laboratories, as sterilization processes there cannot be compromised under any circumstances.
Testing ensures performance throughout the lifetime of the hot air sterilizer. For producers, such certification means regulatory conformity, which facilitates market penetration. EVTL India offers professional services from documentation to testing and obtaining licenses from the Bureau of Indian Standards.
