Laboratory Glassware
Single Volume Pipettes
Strategic Recommendations for Laboratory Glassware – Single Volume Pipettes
- Begin BIS Certification Immediately
Manufacturers and importers should initiate the BIS certification process without delay to meet the 1 July 2024 compliance deadline. - Consult Compliance Professionals
Partner with the ERA Compliance Team for BIS application, product testing, and ISI mark labeling
Contact: 📧 cs@eraglobal.co.in | 📞 +91 9599296331 | 💬 WhatsApp - Track Exemptions & Deadlines
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Ensure export-only products are documented correctly to claim exemption. - Ensure Proper ISI Marking & Packaging
All Laboratory Glassware – Single-Volume Pipettes must bear the ISI mark. Non-marked products after the deadline will be seized. - Ensure Marking & Declarations
All single-volume pipette packs must carry the ISI mark, or be declared under exemption by the deadline.
| Section | Details |
|---|---|
| Product Name | Laboratory Glassware – Single Volume Pipettes |
| Applicable Indian Standard (IS) No. | IS 1117:2018 |
| Title of Indian Standard | Laboratory Glassware – Single Volume Pipettes – Specification |
| Quality Control Order | Laboratory Glassware (Quality Control) Order, 2023 |
| Notification & Amendments | Notified via S.O. 44(E), dated 1 January 2024. No amendments to IS 1117:2018 are published as of this QCO. |
| Final Enforcement Date | Notified via S.O. 44(E), dated 1 January 2024. No amendments to IS 1117:2018 are published as of this QCO. Large & Medium Enterprises: 1 July 2024 Small Enterprises: 1 October 2024 Micro Enterprises: 1 January 2025 |
| Objective & Scope | To ensure accuracy, durability, and safety of single-volume pipettes used in laboratories by enforcing conformity with IS 1117:2018. |
| Products Covered | Single-volume glass pipettes of different capacities used for accurate transfer of specific liquid volumes. |
| Exemptions | Goods manufactured domestically for export only are exempted. |
| Industries Impacted | Laboratory glassware manufacturers, chemical and pharmaceutical companies, research institutes, healthcare diagnostic labs, testing and calibration labs. |
| Mandatory Compliance | BIS licence under Scheme-I of BIS (Conformity Assessment) Regulations, 2018 is required. All pipettes must carry the ISI mark. |
| Next Steps for Stakeholders | Apply for BIS licence, submit samples for testing at BIS-recognized labs, obtain certification, affix ISI mark, and maintain compliance documentation. |
| Legal Framework Provision & Enforcement | Enforced under the BIS Act, 2016, with the Bureau of Indian Standards as the implementing authority. |
| Penalties for Non-Compliance | Non-compliance may lead to seizure of stock, suspension of licence, financial penalties, or imprisonment (up to 2 years, or both). |
| Conclusion | From enforcement dates, all single-volume pipettes in India must conform to IS 1117:2018 and display the ISI mark. |
| References / Annexures | QCO: S.O. 44(E), 1 Jan 2024; IS 1117:2018; BIS Act, 2016; BIS (Conformity Assessment) Regulations, 2018. |
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Notification
The product Single Volume Pipettes is covered under the Laboratory Glassware (Quality Control) Order, 2023, issued via S.O. 44(E), dated 1 January 2024 under the BIS Act, 2016. Compliance requires adherence to IS 1117:2018 and mandatory BIS certification.
Enforcement Timeline
The Order enforces compliance from 1 July 2024 for large & medium enterprises, 1 October 2024 for small enterprises, and 1 January 2025 for micro enterprises.
Overview
Single-volume pipettes are precision glassware used for transferring a defined volume of liquid with high accuracy in laboratories. Given their use in clinical diagnostics, pharmaceutical R&D, and chemical analysis, uniform quality standards are essential for accuracy and safety.
Objective & Scope
IS 1117:2018 specifies material requirements, dimensional accuracy, calibration, and permissible tolerances for pipettes to ensure reliability and consistency in laboratory operations.
Products Covered
Glass pipettes designed to measure and deliver a single fixed volume of liquid, used in chemical, biological, and analytical laboratories.
Exemptions Provided
Products manufactured solely for export purposes are exempted from domestic certification.
Industries Impacted
Manufacturers of laboratory glassware, pharmaceutical testing labs, chemical companies, clinical and diagnostic labs, and academic research institutions will be most impacted.
Mandatory Compliance Requirements
Manufacturers and importers must obtain BIS licence under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018. Each pipette must carry the ISI mark before being sold, imported, or distributed in India.
Next Steps for Stakeholders
Begin BIS application early, submit representative samples to BIS-approved labs, update packaging with ISI marking, and maintain compliance documentation.
Legal Provisions, Enforcement & Penalties
The Order is enforced under the BIS Act, 2016. Penalties for violations include seizure of goods, fines, imprisonment (up to 2 years), and licence cancellation.
Conclusion
From the notified enforcement dates, all single-volume pipettes sold in India must comply with IS 1117:2018 and bear BIS certification to remain legally marketable.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.