BIS Certification Consultant for Laboratory Glassware – Single Volume Pipettes | IS 1117:2018 | Qualitance India
Introduction
Single volume pipettes are precision laboratory glassware used to transfer a specified volume of liquid accurately. They are commonly used in chemical analysis, pharmaceutical laboratories, research facilities, educational institutions, food testing laboratories and industrial quality control departments.
Accurate liquid transfer is essential for preparing standard solutions, carrying out chemical analyses and maintaining the reliability of laboratory test results. Manufacturers must therefore ensure that their pipettes meet applicable requirements for accuracy, material, dimensions, workmanship, graduation markings and delivery time.
In India,
IS 1117:2018 – Laboratory Glassware: Single-Volume Pipettes (Second Revision) specifies metrological and constructional requirements for volumetric pipettes intended for general laboratory use. The standard covers pipettes designed for total delivery and relevant configurations with one or two marks, as specified in the standard. <Cite refs={["turn567050search27","turn567050search26"]}/>
The standard is included in the Laboratory Glassware Quality Control Order framework. Manufacturers and businesses dealing with these products should verify the applicable BIS licensing requirements, amendments and exemptions before manufacturing, importing or selling covered products. <Cite refs={["turn936690search0","turn936690search12"]}/>
Qualitance India provides consultancy support for BIS product certification, technical documentation, product testing coordination and regulatory compliance.
What Is IS 1117:2018?
IS 1117:2018 is the Indian Standard for laboratory glassware – single-volume pipettes. It specifies requirements intended to help ensure that pipettes deliver the designated volume within the applicable permissible error limits.
A single-volume pipette is used when a defined volume of liquid must be transferred from one vessel to another. Depending on the design, the pipette may have a single calibration mark or two marks, as covered by the standard.
The requirements address important product characteristics, including:
- Classification and accuracy.
- Nominal volume.
- Measurement accuracy and permissible error.
- Glass material and resistance to water attack.
- Pipette pattern and construction.
- Dimensions and wall thickness.
- Graduation line and visibility.
- Delivery time.
- Product marking and identification.
The exact requirements and acceptance criteria must be checked against the current official version of IS 1117:2018 and its applicable provisions. <Cite refs={["turn567050search26","turn567050search27"]}/>
Types and Accuracy Classes of Single Volume Pipettes
The standard distinguishes between different classes of pipettes based on their applicable accuracy and delivery characteristics.
1. Class A pipettes
Class A pipettes are intended for applications requiring a higher level of volumetric accuracy within the tolerances specified by the standard.
They may be used in analytical laboratories, research facilities and quality control operations where controlled volume transfer is important.
2. Class B pipettes
Class B pipettes are subject to the permissible error limits specified for Class B under the standard. They may be appropriate for laboratory applications where the relevant Class B performance requirements are suitable.
3. Class AS pipettes
Class AS pipettes are associated with a specified waiting time of five seconds. Their delivery characteristics must comply with the applicable requirements of IS 1117:2018.
The applicable class must be clearly identified in the manufacturer's product specifications and proposed BIS licence scope. <Cite refs={["turn567050search27","turn567050search26"]}/>
Nominal Capacities Covered Under IS 1117:2018
The standard covers a series of nominal capacities for single-volume pipettes. The capacity series identified in the BIS technical reference includes:
- 0.5 ml
- 1 ml
- 2 ml
- 5 ml
- 10 ml
- 20 ml
- 25 ml
- 50 ml
- 100 ml
The actual product range proposed for certification should be checked against the official standard, relevant product manual and applicable BIS grouping requirements. <Cite refs={["turn567050search27","turn936690search1"]}/>
Manufacturers should prepare a capacity-wise list specifying the product class, pattern and applicable technical details. This helps ensure that the samples and testing plan represent the intended range.
Is BIS Certification Mandatory for Single Volume Pipettes?
IS 1117:2018 is listed under the Laboratory Glassware Quality Control Order, 2023, and appears in BIS's Scheme-I compulsory certification listing. Businesses must therefore review the applicable Quality Control Order, subsequent amendments and any relevant exemptions to establish their obligations for the products they manufacture or import. <Cite refs={["turn936690search0","turn936690search12"]}/>
Before placing covered products on the Indian market, manufacturers and importers should:
- Confirm that the product falls within the scope of IS 1117:2018.
- Review the current Quality Control Order and subsequent amendments.
- Check applicable implementation provisions and exemptions.
- Determine the required BIS licensing and marking arrangements.
- Ensure that the product and its declared capacity and class match the applicable requirements.
The Quality Control Order has provisions addressing specified categories of enterprises and certain imports, including goods imported for research and development under stated conditions. Such provisions are subject to specific eligibility criteria and restrictions; they should not be treated as blanket exemptions. <Cite refs={["turn936690search12"]}/>
A product test report alone does not authorize the use of the ISI Mark. Where a BIS licence is required, the manufacturer must obtain the applicable authorization and follow its conditions.
BIS Certification Process for Single Volume Pipettes
Manufacturers seeking BIS certification should plan the process around the product range, technical documentation, testing arrangements and factory quality control system.
Step 1: Confirm product applicability and scope
Identify the products intended to be covered by the application.
The preliminary review should include:
- Nominal capacities.
- Class A, Class AS or Class B designation, as applicable.
- Pipette pattern and configuration.
- Material specifications.
- Manufacturing facility details.
- Applicable standard and Quality Control Order provisions.
The proposed scope should reflect the products that the manufacturer actually intends to produce and supply.
Step 2: Review manufacturing facilities
The manufacturer should assess its production and inspection processes to ensure that the pipettes can consistently meet the applicable requirements.
The review may cover glass forming, finishing, calibration-mark application, dimensional inspection, delivery-time control and product marking.
Suitable inspection and testing arrangements should be established in accordance with the applicable BIS product manual and scheme requirements.
Step 3: Prepare the application documents
The manufacturer should prepare the documents required under the current BIS application procedure and product manual.
These may include:
- Company registration and legal entity documents.
- Factory address and manufacturing details.
- Authorized signatory information.
- Product specifications and capacity-wise range.
- Manufacturing process flow chart.
- Machinery and equipment list.
- Quality control personnel details.
- Inspection and testing equipment details.
- Calibration plans and records, where applicable.
- Raw material specifications and supplier documents.
- Internal quality control procedures and records.
- Proposed product marking and packaging details.
- Applicable declarations, undertakings and test reports.
The final document checklist should be prepared according to the manufacturer's circumstances and current BIS requirements.
Step 4: Arrange product testing
Samples should be tested against the applicable requirements of IS 1117:2018.
Testing should cover the relevant nominal capacities, classes and patterns within the proposed product range. The sample selection, testing scope and acceptance criteria must be confirmed from the current product manual and applicable BIS procedure.
Step 5: Complete BIS assessment
BIS evaluates the application and supporting records under the applicable conformity assessment procedure. Depending on the case, the process may include factory assessment, review of quality control arrangements and evaluation of product test results.
The manufacturer should address any technical observations or deficiencies raised during the process.
Step 6: Obtain the licence and follow marking requirements
After the applicable requirements are met, BIS may grant a licence with an approved product scope.
The manufacturer must follow the licence conditions, required inspection and testing procedures, and applicable marking and packaging requirements.
The Standard Mark must not be applied merely because a sample has passed testing or an application has been submitted. Its use is subject to valid BIS authorization.
Product Testing Requirements Under IS 1117:2018
Testing is a key part of assessing the conformity of single-volume pipettes. BIS's Laboratory Information Management System lists testing parameters for IS 1117:2018, including nominal capacity, accuracy, material, construction, dimensions, graduation lines and delivery time. <Cite refs={["turn567050search0","turn936690search1"]}/>
The following table provides a general overview of important testing areas.
| Testing area |
Purpose |
| Classification and accuracy class |
To verify the declared class and relevant requirements |
| Nominal capacity |
To confirm the specified volume |
| Accuracy and permissible error |
To evaluate whether the delivered volume meets the applicable limits |
| Material |
To assess the relevant glass material requirements |
| Limit of alkalinity |
To check conformity with the applicable material test |
| Pipette pattern |
To verify the product configuration |
| Workmanship and finish |
To assess the finish and construction of the pipette |
| Dimensions and wall thickness |
To verify specified dimensional requirements |
| Graduation line and visibility |
To assess the calibration mark and its visibility |
| Delivery time |
To verify compliance with the applicable delivery-time requirements |
| Marking |
To check product identification and required marking |
The exact test methods, tolerances and acceptance criteria must be taken from the current official standard and applicable product manual. This overview is not a replacement for the complete test schedule.
Material and Construction Requirements
The material and construction of a single-volume pipette influence its volumetric performance and suitability for laboratory use.
The BIS technical reference for IS 1117:2018 identifies glass with hydrolytic resistance of class HGB 3 and specifies requirements relating to shape, dimensions and delivery characteristics. Manufacturers should verify the exact applicable clauses and test methods in the official standard. <Cite refs={["turn567050search27"]}/>
Quality control arrangements should address:
- Material specifications and supporting supplier documentation.
- Dimensional consistency across the declared product range.
- Proper formation and finishing of the pipette.
- Calibration-mark placement and visibility.
- Delivery-time performance.
- Product identification and marking.
Manufacturers should retain appropriate inspection and testing records to demonstrate ongoing conformity.
BIS Product Manual and Factory Testing Arrangements
The official BIS product manual for IS 1117:2018 includes a Scheme of Inspection and Testing. It requires a suitably equipped and staffed laboratory for the tests specified in the scheme and a calibration plan for test equipment. Manufacturers must also maintain test records to establish conformity. <Cite refs={["turn567050search26"]}/>
The manual further states that pipettes of the same class and nominal capacity produced in one day constitute a control unit for the purpose of the scheme. Conformity decisions for the control unit are based on the applicable test results.
The manufacturer should review the complete product manual to understand the applicable test frequency, levels of control, equipment and recordkeeping obligations.
Selection of a Testing Laboratory
Manufacturers should identify a laboratory whose listed scope covers the relevant pipette class, nominal capacity and required test parameters.
The BIS Laboratory Information Management System allows users to search by Indian Standard number and review available testing facilities. Listings for IS 1117:2018 include facilities with stated ranges and classes, but the scope differs between laboratories. <Cite refs={["turn567050search0","turn936690search1","turn936690search5"]}/>
Before sending samples, confirm:
- Whether the laboratory covers the required capacity range.
- Whether Class A, AS and B products are included in its scope.
- Whether the required accuracy test is available.
- Which parameters are included or excluded.
- Sample quantity and submission requirements.
- Testing charges, taxes and expected turnaround time.
Do not assume that every laboratory listed against the standard can perform every test for every capacity and class. Verify the current scope directly before arranging testing.
Documents Required for BIS Certification
A preliminary document checklist for single-volume pipettes may include:
- Company registration and legal entity documents.
- Manufacturing facility details and address.
- Authorized signatory authorization.
- Product specifications and capacity-wise product range.
- Product class and pattern details.
- Manufacturing process flow chart.
- Manufacturing machinery and equipment list.
- Quality control personnel details.
- Inspection and testing equipment list.
- Calibration plans and records, where applicable.
- Raw material specifications and supplier documents.
- Internal quality control procedures and test records.
- Proposed product markings and packaging details.
- Relevant product test reports, where applicable.
- Applicable declarations and undertakings.
- Other documents required under the current BIS application procedure and product manual.
The final checklist should be tailored to the applicant and checked against the latest BIS requirements.
Common Challenges During BIS Certification
Manufacturers may encounter delays when product specifications, testing arrangements or quality control documentation are incomplete.
Common challenges include:
- Incorrect identification of the applicable product class.
- Incomplete capacity-wise product specifications.
- Inconsistent product details across the application and test samples.
- Missing material documentation.
- Inadequate calibration and inspection records.
- Failure to verify laboratory scope before sample submission.
- Non-conformity in accuracy, dimensions or delivery time.
- Incomplete marking and packaging information.
- Failure to address observations raised during application scrutiny or assessment.
A technical review before application submission can help identify potential gaps and prepare the manufacturer for the applicable certification process.
How Qualitance India Can Help
Qualitance India provides consultancy support for BIS product certification and regulatory compliance. For manufacturers of single-volume pipettes, our services may include:
BIS applicability review: Initial review of the product, capacity range, class and relevant Indian Standard.
Documentation support: Assistance in preparing and reviewing applicable application documents and technical records.
Product testing coordination: Guidance on laboratory selection, sample planning and understanding the required test scope.
Factory-readiness guidance: Support in reviewing quality control procedures, calibration arrangements and inspection records.
Application support: Assistance in preparing application information and responding to technical observations.
Regulatory compliance guidance: Support in understanding applicable licensing, inspection, testing and marking requirements.
The scope of consultancy depends on the product range, manufacturing arrangement and services agreed with the client. BIS retains authority over the certification decision.
Frequently Asked Questions (FAQs)
1. Which Indian Standard applies to single-volume pipettes?
The applicable standard is
IS 1117:2018 – Laboratory Glassware: Single-Volume Pipettes (Second Revision). It specifies metrological and constructional requirements for covered volumetric pipettes. <Cite refs={["turn567050search26"]}/>
2. Is BIS certification required for single-volume pipettes?
IS 1117:2018 is listed under the Laboratory Glassware Quality Control Order framework and BIS Scheme-I listing. Businesses should check the latest order, amendments, implementation provisions and any applicable exemptions for their specific circumstances. <Cite refs={["turn936690search0","turn936690search12"]}/>
3. Which nominal capacities are covered?
The standard's capacity series includes 0.5 ml, 1 ml, 2 ml, 5 ml, 10 ml, 20 ml, 25 ml, 50 ml and 100 ml. The proposed licence scope should be confirmed against the official standard and applicable BIS requirements. <Cite refs={["turn567050search27"]}/>
4. What is the difference between Class A, Class AS and Class B pipettes?
These designations relate to the applicable accuracy and delivery characteristics specified by the standard. Class AS includes a specified five-second waiting time. The relevant requirements should be checked against IS 1117:2018 before declaring a product class. <Cite refs={["turn567050search27"]}/>
5. What tests are required under IS 1117:2018?
Testing areas may include accuracy, nominal capacity, material, limit of alkalinity, pipette pattern, workmanship, dimensions, wall thickness, graduation line, visibility, delivery time and marking. The exact test schedule depends on the applicable requirements and product configuration.
6. Can a manufacturer apply for multiple capacities?
The proposed capacity range should be clearly identified in the application. The scope that can be covered depends on the applicable BIS requirements, test evidence and the licence granted by BIS.
7. Does a test report authorize the use of the ISI Mark?
No. A test report records test results. Where certification is compulsory, the manufacturer must complete the applicable BIS conformity assessment process and obtain the required licence before using the Standard Mark.
8. How can I find a testing laboratory for IS 1117:2018?
Use the official BIS Laboratory Information Management System and search for IS 1117:2018. Verify the listed scope, capacity range, class and available test parameters directly with the laboratory.
Official portal:
https://lims.bis.gov.in/home/search_is_number/
9. How can Qualitance India assist with BIS certification?
Qualitance India can provide consultancy support for applicability review, documentation, testing coordination, factory-readiness guidance and application-related compliance support.
Official References
For the latest technical and regulatory information, consult these official resources:
- BIS Product Manual – IS 1117:2018, Laboratory Glassware: Single-Volume Pipettes:
https://www.bis.gov.in/wp-content/uploads/2021/06/PM-IS-1117.pdf
- BIS Scheme-I – Products under Compulsory Certification:
https://www.bis.gov.in/products-under-compulsory-certification/scheme-1/?lang=en
- BIS Laboratory Information Management System:
https://lims.bis.gov.in/home/search_is_number/
- Laboratory Glassware Quality Control Amendment Order, 2024:
https://bis.gov.in/wp-content/uploads/2024/12/Laboratory-Glassware-Quality-Control-Amendment-Order-2024.pdf
- BIS Product-Specific Guidelines:
https://www.bis.gov.in/product-certification/product-specific-guidelines/?lang=ml
Review subsequent amendments and notifications before making a final compliance decision.
Conclusion: Get BIS Certification Support for Single Volume Pipettes
IS 1117:2018 specifies requirements for single-volume pipettes used in laboratory applications where accurate liquid transfer is essential. Manufacturers should pay close attention to product class, nominal capacity, material, construction, accuracy, dimensions, graduation lines and delivery time.
Businesses should also verify the current Laboratory Glassware Quality Control Order and applicable amendments to determine their BIS licensing obligations and marking requirements.
Qualitance India supports manufacturers with BIS certification consultancy, technical documentation, product testing coordination and regulatory compliance guidance.
Qualitance India – Improving Quality & Competence
For consultancy support for single-volume pipettes under IS 1117:2018:
Contact Qualitance India to discuss your product range, testing requirements and BIS certification needs.
