Accurate measurement is an important aspect of analytical chemistry, drug development, teaching laboratories and industry quality control operations. BIS Certification of Laboratory Glassware (IS 1997:2008) is a vital factor in achieving the precise volume measurements, consistent dimensions and reliable performance of the laboratory glassware. The use of lab glass containers that meet specified standards is important in ensuring scientific precision and operational credibility in laboratory work.
Certification is not only about meeting quality standards but also acts as a way of ensuring compliance with technical standards. Testing, documentation review, production controls and the certification process can ensure that glassware complies with standards regarding allowable error limits, design attributes and leakage prevention.
What is IS 1997:2008
This is the Indian Standard for laboratory glassware used in scientific laboratories, educational institutions, research facilities, healthcare laboratories, and industrial testing environments. It specifies the quality, dimensional accuracy, material requirements, and performance standards to ensure reliable and safe laboratory operations. As per the BIS (Bureau of Indian Standards), laboratory glassware is:
- Evaluated for thermal resistance
- Assessed for mechanical strength
- Verified for material quality
- Checked for dimensional accuracy
- Tested for chemical durability
Who Needs a BIS License for Laboratory Glassware Burettes
BIS authorisation under IS 1997:2008 is required for businesses involved in manufacturing, importing, or supplying Laboratory Glass Equipment in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if lab glass containers are covered under QCO.
- Foreign Manufacturers - Need certification to export the scientific glassware burettes to India.
- Importers/Brand Owners - Must ensure that products are BIS-certified before sale.
- Sellers/Distributors - Should only sell certified laboratory glass instruments.
BIS Testing Requirements for Laboratory Glassware Burettes
To maintain consistency regarding the quality and safety of glassware used in laboratories for research purposes, the IS 1997:2008 standards set out the basic guidelines. The Bureau of Indian Standards certifies all manufacturers to ensure that they manufacture glassware that meets certain standards in terms of precision, heat resistance, and chemical resistance.
The BIS testing parameters and quality checks for the laboratory glassware are listed below:
Laboratory Glassware Burettes BIS License Application Process
The BIS Authorisation process ensures that Laboratory Glassware Burettes complies with IS 1997:2008 for accuracy and chemical resistance. The process is regulated 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: Samples are tested for thermal resistance, dimensional accuracy, chemical durability, transparency and strength.
- 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: The officials of the BIS visit the manufacturing plant to assess the processes of manufacture, safety and quality control.
- Grant of BIS License: Upon satisfactory fulfillment of all criteria, the license is issued under Scheme-I by BIS.
- Use of ISI Mark: The use of the ISI mark with CM/L number is permitted after the successful grant of the license.
BIS Registration Documents for Laboratory Burettes Glassware
| 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 appoint an Authorized Indian Representative (AIR). This person acts as the local liaison between the manufacturer and the BIS in handling all regulations within the country.
BIS Marking Requirements for Laboratory Glassware Burettes
Once the BIS certification is obtained, it is mandatory to mark the ISI mark on the laboratory glassware properly, either on the product itself or its packaging. It must have information that includes the name of the manufacturer and the CM/L Number. These additional marking guidelines are listed below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 1997:2008 |
| 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.
How long is a Laboratory Glassware Burettes BIS License Valid
| 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 |
Cost Breakdown of BIS Certification under IS 1997:2008
The overall cost of BIS certification for laboratory glassware burettes includes charges for application processing, product testing, inspection, licensing, and marking. These fees are levied by BIS under 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 accuracy of laboratory results is dependent on the quality of measurement instruments used by labs. IS 1997:2008 will enable manufacturers of laboratory glassware to ensure that the glass equipment meets the set standards of precision, durability, dimension and consistency. BIS Certification of Laboratory Glassware Burettes (IS 1997:2008) helps boost the confidence of laboratories, research organizations, pharmaceutical firms and industries. Certification of Lab Glassware (IS 1997:2008) through
BIS could help facilitate market entry. It also shows the manufacturer’s dedication towards maintaining quality standards. Companies looking for help regarding technical documentation, laboratory testing coordination, certification process and AIR representation for overseas manufacturers can contact EVTL India.
