BIS Certification for Clinical Thermometers – Part 1: Solid Stem Type – IS 3055 (Part 1):1994
BIS Certification for Clinical Thermometers – Part 1: Solid Stem Type – IS 3055 (Part 1):1994
Clinical thermometers are medical instruments used to measure human body temperature. They play an important role in healthcare facilities, hospitals, clinics, diagnostic centres and household medical applications. Since the accuracy and reliability of a clinical thermometer directly affect temperature measurement, its construction, graduation, accuracy and performance must comply with the applicable Indian Standard.
In India,
Clinical Thermometers – Solid Stem Type are covered under IS 3055 (Part 1):1994 – Clinical Thermometers: Part 1 Solid Stem Type – Specification (Second Revision).
This product is included in the Bureau of Indian Standards (BIS) compulsory certification list under Scheme-I and is covered by the
Clinical Thermometers (Quality Control) Order, 2001.
Manufacturers intending to manufacture and sell solid stem clinical thermometers covered under this requirement must obtain the applicable BIS licence and comply with the relevant Indian Standard before using the ISI Standard Mark.
This article explains the product scope, applicable standard, sample quantity, testing requirements, laboratory facilities, documents and BIS certification process for solid stem clinical thermometers.
1. Applicable Indian Standard – IS 3055 (Part 1):1994
The applicable Indian Standard is:
| Particular |
Details |
| Indian Standard |
IS 3055 (Part 1):1994 |
| Standard title |
Clinical Thermometers – Part 1 Solid Stem Type |
| Revision |
Second Revision |
| Number of amendments in BIS Product Manual |
5 |
| BIS Product Manual |
PM/IS 3055 (Part 1)/2/December 2018 |
| Certification scheme |
Scheme-I – ISI Mark Scheme |
| Product category |
Clinical thermometers – solid stem type |
| Certification authority |
Bureau of Indian Standards (BIS) |
| Quality Control Order |
Clinical Thermometers (Quality Control) Order, 2001 |
The standard specifies requirements and methods of sampling and testing for
solid-stem, mercury-in-glass clinical thermometers having a maximum indicating device.
The BIS Product Manual PM/IS 3055 (Part 1)/2/December 2018 is the product-specific reference for certification under Scheme-I. It identifies the applicable standard, sample size, grouping guidelines, testing equipment and Scheme of Inspection and Testing.
2. Is BIS Certification Mandatory for Solid Stem Clinical Thermometers?
<badge color="success">Mandatory BIS Certification</badge>
Yes. BIS includes IS 3055 (Part 1) in its compulsory certification list under Scheme-I.
The applicable regulation is the
Clinical Thermometers (Quality Control) Order, 2001, notified through G.S.R. 843(E), dated 9 November 2001.
The Quality Control Order identifies clinical thermometers as medical thermometers of the liquid-in-glass type, provided with a maximum indicating device for measuring human body temperature.
It specifically identifies two types:
- Solid stem type – solid-stem, mercury-in-glass clinical thermometers.
- Enclosed-scale type – enclosed-scale mercury-in-glass clinical thermometers.
The Order identifies IS 3055 (Part 1):1994 for solid stem type and IS 3055 (Part 2) for enclosed-scale type.
Manufacturers of products covered by the Order must comply with the applicable BIS certification requirements and obtain a valid licence before applying the ISI Standard Mark.
Important: IS 3055 (Part 1) and IS 3055 (Part 2) cover different thermometer constructions. A licence under Part 1 should not be assumed to cover enclosed-scale thermometers under Part 2.
3. Product Scope Covered Under IS 3055 (Part 1):1994
IS 3055 (Part 1):1994 covers solid-stem, mercury-in-glass clinical thermometers having a maximum indicating device.
The BIS Product Manual identifies the licence scope as follows:
| Scope parameter |
Details |
| Product name |
Clinical Thermometers |
| Product type |
Solid stem |
| Thermometer construction |
Mercury-in-glass |
| Intended type |
Oral / Rectal |
| Applicable standard |
IS 3055 (Part 1):1994 |
Key product characteristics
A solid-stem clinical thermometer generally consists of:
- A glass stem.
- A capillary tube.
- A bulb containing the thermometric liquid.
- A graduated temperature scale.
- A maximum indicating device.
- A suitable constriction or arrangement to retain the maximum temperature indication.
The maximum indicating device retains the highest temperature reached during measurement until the thermometer is reset.
The exact construction and dimensional requirements must comply with the relevant clauses of IS 3055 (Part 1):1994.
4. Understanding Solid Stem Clinical Thermometers
Solid-stem clinical thermometers are liquid-in-glass instruments designed for measuring human body temperature.
The thermometer uses a thermometric liquid contained in a glass bulb and capillary arrangement. As the temperature increases, the liquid expands and moves through the capillary tube.
The maximum indicating device helps retain the highest temperature reached during measurement, allowing the reading to be observed after the thermometer is removed.
Major components
| Component |
Function |
| Glass stem |
Main body of the thermometer |
| Bulb |
Holds the thermometric liquid |
| Capillary tube |
Allows movement of the thermometric liquid |
| Graduation |
Indicates the temperature reading |
| Maximum indicating device |
Retains the maximum temperature reading |
| Glass tubing |
Provides the thermometer's structural body |
The standard includes requirements relating to materials, construction, dimensions, graduation, numbering, appearance, ageing, accuracy and immersion-time effects.
5. Technical Requirements Under IS 3055 (Part 1):1994
The standard specifies requirements for the construction, materials and performance of solid-stem clinical thermometers.
Important technical areas include the following.
A. Materials
The materials used in the thermometer must comply with the applicable requirements of the standard.
The product manual identifies glass tubing conforming to
IS 4529:1968, except for the specified provisions relating to stability of the bulb tube and limit of alkalinity.
The standard also includes requirements relating to:
- Glass bulb.
- Hydrolytic resistance of glass.
- Thermometric liquid.
- Maximum indicating device.
B. Construction
The thermometer must comply with the prescribed construction requirements, including the arrangement of the bulb, capillary tube, stem and maximum indicating device.
C. Dimensions
The dimensions of the thermometer must comply with the requirements and dimensional provisions specified in the standard.
D. Graduation and numbering
The temperature scale and numbering must be clearly marked and comply with the applicable graduation requirements.
E. Appearance
The thermometer must meet the applicable appearance and workmanship requirements.
F. Ageing and accuracy
The thermometer must maintain the prescribed accuracy after the applicable ageing procedure.
G. Influence of immersion time
The thermometer is evaluated for the effect of immersion time on its temperature indication.
These requirements help ensure that the instrument provides reliable temperature measurements under the conditions specified by the standard.
6. BIS Testing Requirements for IS 3055 (Part 1):1994
Testing is a critical part of BIS certification. The thermometer must be evaluated against the applicable requirements of IS 3055 (Part 1):1994.
The BIS Product Manual identifies the following major tests and assessment parameters:
| Sr. No. |
Test / Parameter |
Relevant clause |
| 1 |
Materials – glass tubing |
Clause 7.2.1 |
| 2 |
Materials – bulb |
Clause 7.2.2 |
| 3 |
Hydrolytic resistance of glass |
Clause 7.2.3 |
| 4 |
Thermometric liquid |
Clause 7.2.4 |
| 5 |
Construction |
Clause 7.3 |
| 6 |
Hardness of maximum indicating device |
Clause 7.3.2.1 |
| 7 |
Dimensions |
Clause 7.4 |
| 8 |
Graduation and numbering |
Clause 7.5 |
| 9 |
Permanency of marking |
Clause 7.5.8 |
| 10 |
Appearance |
Clause 8.1 |
| 11 |
Ageing and accuracy |
Clause 8.2 |
| 12 |
Influence of immersion time |
Clause 8.3 |
The exact test methods, apparatus, conditioning requirements and acceptance criteria must be followed as specified in IS 3055 (Part 1):1994.
7. BIS Sample Quantity for IS 3055 (Part 1):1994
<badge color="success">10 pieces</badge>
According to the BIS Product Manual
PM/IS 3055 (Part 1)/2/December 2018, the specified sample size is:
10 pieces of solid stem clinical thermometers.
The product manual also states that the standard covers two patterns only.
The proposed samples should represent the thermometer type and pattern intended to be covered under the BIS licence.
Manufacturers should ensure that the submitted samples:
- Are manufactured using the intended production process.
- Have the declared thermometer construction.
- Include the applicable graduation and numbering.
- Have the required maximum indicating device.
- Represent the proposed product scope.
Important: The sample size of 10 pieces is the quantity identified in the product manual's sampling guidelines. Routine factory testing and surveillance sampling are governed separately by the Scheme of Inspection and Testing.
8. Product Grouping Guidelines Under IS 3055 (Part 1)
The BIS Product Manual states:
“Standard covers two patterns only.”
The licence scope identified in the product manual is for solid-stem, mercury-in-glass, oral/rectal clinical thermometers.
The manufacturer should declare the proposed product pattern and range when applying for certification.
The scope of the licence must clearly identify the product type and range approved by BIS.
Manufacturers should not assume that the licence automatically covers all thermometer designs or temperature ranges. Any additional variety or change in scope should be assessed against the standard and applicable BIS procedures.
9. Possible Tests That Can Be Completed in One Day
The BIS Product Manual identifies certain tests that can be carried out within one day.
These include:
| Sr. No. |
Test |
Standard reference |
| 1 |
Construction |
Clause 7.3 |
| 2 |
Dimensions |
Clause 7.4 |
| 3 |
Graduation and numbering |
Clause 7.5 |
| 4 |
Appearance |
Clause 8.1 |
| 5 |
Influence of immersion time |
Clause 8.3 |
These are the tests specifically identified as possible tests in a day in the product manual.
This does not mean that the complete certification testing programme can be completed in one day. Other tests, including ageing and accuracy and material-related assessments, may require separate testing arrangements and time.
10. Manufacturing Facility Requirements
Manufacturers applying for BIS certification should establish suitable manufacturing and quality-control arrangements.
The production process should have documented controls covering:
A. Glass tubing and material procurement
- Procurement of suitable glass tubing.
- Supplier approval and evaluation.
- Incoming material inspection.
- Verification of relevant material test certificates.
B. Bulb and capillary manufacturing
- Bulb formation.
- Capillary tube preparation.
- Dimensional control.
- Inspection of glass components.
C. Thermometric liquid filling
- Selection and control of the thermometric liquid.
- Filling operation.
- Sealing and inspection.
- Control of filling quality.
D. Scale and graduation
- Graduation and numbering.
- Scale alignment.
- Marking inspection.
- Permanency of marking checks.
E. Final inspection
- Construction inspection.
- Dimensional checks.
- Appearance inspection.
- Accuracy testing.
- Immersion-time testing.
- Product identification and traceability.
The manufacturer should prepare a manufacturing process flow chart identifying all major manufacturing and inspection stages.
11. In-House Laboratory Requirements
The BIS Product Manual requires the manufacturer to maintain a suitably equipped and staffed laboratory for carrying out the tests specified in the standard.
The manufacturer must also prepare a calibration plan for the testing equipment and maintain test records to establish product conformity.
The laboratory should have appropriate facilities for:
- Material testing.
- Bulb-related testing.
- Hydrolytic resistance testing of glass.
- Maximum indicating device testing.
- Dimensional measurement.
- Ageing and accuracy testing.
- Immersion-time testing.
The product manual's Annex-A provides an indicative list of major testing equipment.
Major testing equipment identified in the BIS Product Manual
| Sr. No. |
Equipment |
Purpose |
| 1 |
Special test thermometers |
Bulb and material-related testing |
| 2 |
Temperature-controlled test bath |
Temperature testing |
| 3 |
Ice bath |
Temperature reference and conditioning |
| 4 |
Standard laboratory chemicals and apparatus |
Hydrolytic resistance testing |
| 5 |
Ball mill |
Preparation of glass samples |
| 6 |
Sieving machine |
Preparation and grading of glass samples |
| 7 |
Ultrasonic cleaner |
Cleaning of glass samples |
| 8 |
Drying oven |
Drying of prepared samples |
| 9 |
Heating bath |
Glass-related testing |
| 10 |
Centrifuge |
Hardness of maximum indicating device |
| 11 |
Stopwatch |
Timing measurements |
| 12 |
Vernier calipers |
Dimensional inspection |
| 13 |
Micrometer |
Dimensional inspection |
| 14 |
Comparator water bath |
Ageing and accuracy testing |
| 15 |
Reference thermometer |
Temperature comparison |
The BIS Product Manual states that this equipment list is indicative and should not be treated as exhaustive.
The manufacturer should review Annex-A and the complete standard before establishing the final laboratory equipment list.
12. Scheme of Inspection and Testing (SIT)
The BIS Product Manual includes a Scheme of Inspection and Testing (SIT) in Annex-B.
The manufacturer must maintain a laboratory that is suitably equipped and staffed to carry out the required tests.
12.1 Control unit
The product manual defines the control unit as:
All clinical thermometers of the same pattern manufactured in a day shall constitute one control unit.
This definition is important for determining the frequency and number of samples for routine factory testing.
12.2 Routine testing and inspection
The following table summarises the testing requirements and levels of control identified in the product manual.
| Test / Requirement |
Testing frequency / sample requirement |
| Glass tubing |
Every consignment received |
| Bulb |
Every consignment received |
| Hydrolytic resistance of glass |
One from every batch of glass used for maximum device, capillary tube and bulb received |
| Thermometric liquid |
Test certificate from supplier |
| Construction |
Each thermometer |
| Dimensions |
Each thermometer |
| Graduation and numbering |
Each thermometer |
| Permanency of marking |
1% with minimum 5 thermometers from each control unit |
| Appearance |
Each thermometer |
| Ageing and accuracy |
1% with minimum 5 thermometers from each control unit |
| Influence of immersion time |
1% with minimum 5 thermometers from each control unit |
The product manual also specifies:
- Subcontracting of specified material tests is permitted to a laboratory recognised by BIS or a Government laboratory empanelled by BIS.
- No further testing of a consignment or batch is required for the specified material checks where it is accompanied by a supplier's test certificate, as indicated in the manual.
- Rejected glass thermometers may be scrapped after recovering the mercury.
The control unit and levels of control specified by BIS are obligatory for the licensee.
13. Documents Required for BIS Certification
The following documents are generally required for a BIS Scheme-I application for solid stem clinical thermometers.
A. Company and legal documents
- Company registration certificate or proprietorship proof.
- GST registration certificate, where applicable.
- PAN card of the company/proprietor.
- Authorised signatory details.
- Identity and address proof of the authorised signatory.
- Factory address proof.
- Factory ownership document or rent/lease agreement.
B. Manufacturing facility documents
- Factory layout plan.
- Manufacturing process flow chart.
- List of manufacturing machinery.
- List of testing equipment.
- Production capacity details.
- Organisation chart.
- Details of production and quality-control personnel.
C. Product-related documents
- Product specifications.
- Technical drawings, where applicable.
- Thermometer pattern details.
- Temperature range details.
- Graduation and numbering details.
- Glass tubing specifications.
- Bulb and capillary details.
- Thermometric liquid details.
- Maximum indicating device details.
- Product marking and packaging details.
D. Quality-control and laboratory documents
- Quality Assurance Plan.
- In-house laboratory details.
- Testing equipment list.
- Calibration plan and records.
- Testing procedures.
- Internal test records.
- Supplier test certificates.
- Raw material inspection records.
- Routine inspection and testing records.
- Rejection and corrective action records.
The final document checklist should be prepared according to the manufacturer's factory arrangement and the applicable BIS application requirements.
14. BIS Certification Process for Solid Stem Clinical Thermometers
The general BIS certification process under Scheme-I involves the following stages.
Step 1 – Product applicability assessment
Confirm that the proposed product is a solid-stem, mercury-in-glass clinical thermometer covered under IS 3055 (Part 1):1994.
Step 2 – Technical review
Review the standard's requirements for materials, construction, dimensions, graduation, appearance, ageing, accuracy and immersion-time influence.
Step 3 – Factory readiness assessment
Review the manufacturing process, production machinery, quality-control system and testing laboratory.
Step 4 – Documentation preparation
Prepare the company, factory, product and laboratory documents required for the application.
Step 5 – Online BIS application
Submit the application through the BIS Manak Online portal under Scheme-I and pay the applicable government charges.
Step 6 – Factory inspection
BIS may conduct a factory inspection to assess the manufacturer's production capability, quality-control arrangements and testing facilities.
Step 7 – Sample drawal and testing
Samples are drawn and tested according to the applicable certification procedure and requirements of IS 3055 (Part 1):1994.
Step 8 – Closure of observations
If any non-conformities or observations are raised during inspection or testing, the manufacturer must take corrective action and submit the required evidence.
Step 9 – Grant of BIS licence
After satisfactory completion of the applicable assessment and testing requirements, BIS may grant the licence to use the ISI Standard Mark for the approved product scope.
Step 10 – Post-certification compliance
The licensee must maintain product conformity, conduct routine testing, maintain records, comply with the SIT and meet BIS surveillance requirements.
15. BIS Certification Fees and Testing Costs
The total cost of BIS certification depends on the manufacturer's production facility, testing arrangements, laboratory requirements and applicable BIS fee schedule.
The major cost components generally include:
| Cost component |
Details |
| BIS application fee |
Applicable application charges |
| Factory inspection charges |
Applicable inspection and related charges |
| Sample testing charges |
Laboratory testing charges |
| Licence fee |
Applicable BIS licence charges |
| Annual marking fee |
As per applicable BIS fee schedule |
| Consultancy charges |
Professional assistance for documentation, laboratory readiness and application coordination |
Important fee clarification
The BIS Product Manual PM/IS 3055 (Part 1)/2/December 2018 does not specify a fixed total certification cost.
Manufacturers should verify the current BIS fee schedule and obtain a laboratory quotation based on the required test programme before preparing the certification budget.
16. Timeline for BIS Certification
The overall timeline depends on:
- Completeness of application documents.
- Manufacturing facility readiness.
- Availability of the required laboratory equipment.
- Calibration status of testing equipment.
- Availability of representative samples.
- Laboratory testing duration.
- Factory inspection scheduling.
- Closure of any non-conformities.
- BIS processing and approval.
BIS provides different certification procedures under Scheme-I, subject to the applicable eligibility and documentation requirements.
Manufacturers should confirm the applicable procedure and expected timeline with BIS before committing to a commercial launch date.
17. Common Challenges Faced by Clinical Thermometer Manufacturers
Manufacturers may face the following challenges while obtaining BIS certification under IS 3055 (Part 1):1994.
1. Glass quality and material conformity
The quality of glass tubing, bulb and capillary components is important for reliable thermometer performance.
2. Accuracy-related non-conformities
The thermometer must comply with the applicable ageing and accuracy requirements.
3. Graduation and numbering defects
Incorrect graduation, scale alignment or numbering may result in non-conformity.
4. Maximum indicating device issues
The maximum indicating device must meet the construction and hardness requirements specified in the standard.
5. Inadequate laboratory facilities
The manufacturer must maintain appropriate facilities for temperature-controlled testing, dimensional measurement and accuracy evaluation.
6. Incomplete calibration records
The BIS Product Manual requires a calibration plan for testing equipment. Manufacturers should maintain suitable calibration and equipment records.
7. Failure to maintain control-unit records
All thermometers of the same pattern manufactured in a day constitute a control unit under the product manual. Routine inspection and testing records should be maintained accordingly.
8. Confusion between Part 1 and Part 2
Solid-stem and enclosed-scale clinical thermometers are covered under different parts of IS 3055. The correct standard must be identified before applying.
18. Difference Between IS 3055 (Part 1) and IS 3055 (Part 2)
The IS 3055 series covers two types of clinical thermometers.
| Particular |
IS 3055 (Part 1) |
IS 3055 (Part 2) |
| Product |
Clinical thermometers – solid stem type |
Clinical thermometers – enclosed scale type |
| Construction |
Solid stem |
Enclosed scale |
| Thermometric liquid |
Mercury-in-glass, as specified |
Mercury-in-glass, as specified |
| Applicable standard |
IS 3055 (Part 1):1994 |
IS 3055 (Part 2):2004 |
| Product type |
Solid-stem clinical thermometer |
Enclosed-scale clinical thermometer |
These are separate product standards. Manufacturers must apply under the correct part based on the construction and design of the thermometer.
19. How Qualitance India Can Help
Qualitance India provides professional assistance to manufacturers seeking BIS certification for medical and other regulated products.
For solid stem clinical thermometers under IS 3055 (Part 1):1994, our support may include:
- Product applicability assessment.
- Review of IS 3055 (Part 1):1994 requirements.
- Technical documentation review.
- Manufacturing process assessment.
- Factory readiness assessment.
- Laboratory equipment and calibration review.
- Quality Assurance Plan preparation.
- BIS application assistance.
- Coordination for sample testing.
- Support during BIS factory inspection.
- Assistance in closing inspection and testing observations.
- Guidance on licence scope and post-certification compliance.
Our objective is to help manufacturers understand the applicable requirements and prepare their manufacturing and quality-control systems for BIS certification.
20. Frequently Asked Questions (FAQs)
Q1. Is BIS certification mandatory for solid stem clinical thermometers?
Yes. IS 3055 (Part 1) is included in the BIS Scheme-I compulsory certification list under the Clinical Thermometers (Quality Control) Order, 2001.
Q2. Which Indian Standard applies to solid stem clinical thermometers?
The applicable standard is IS 3055 (Part 1):1994 – Clinical Thermometers: Part 1 Solid Stem Type – Specification.
Q3. What type of thermometer is covered under IS 3055 (Part 1)?
The standard covers solid-stem, mercury-in-glass clinical thermometers having a maximum indicating device.
Q4. What is the sample quantity required for BIS certification under IS 3055 (Part 1)?
The BIS Product Manual PM/IS 3055 (Part 1)/2/December 2018 specifies a sample size of 10 pieces.
Q5. How many product patterns are covered under the standard?
The BIS Product Manual states that the standard covers two patterns only.
Q6. Is an in-house laboratory required?
Yes. The product manual requires the manufacturer to maintain a suitably equipped and staffed laboratory for the tests specified in the standard.
Q7. What are the important tests for solid stem clinical thermometers?
Important tests include construction, dimensions, graduation and numbering, permanency of marking, appearance, ageing and accuracy, and influence of immersion time.
Q8. Which glass tubing standard is referred to in the product manual?
The product manual identifies glass tubing conforming to IS 4529:1968, subject to the exceptions stated for stability of the bulb tube and limit of alkalinity.
Q9. What is the control unit under the Scheme of Inspection and Testing?
All clinical thermometers of the same pattern manufactured in a day constitute one control unit.
Q10. Can material testing be subcontracted?
The product manual permits subcontracting of specified material tests to a laboratory recognised by BIS or a Government laboratory empanelled by BIS.
Q11. Is IS 3055 (Part 1) the same as IS 3055 (Part 2)?
No. Part 1 covers solid stem clinical thermometers, while Part 2 covers enclosed-scale clinical thermometers. Separate certification requirements apply.
Q12. Can Qualitance India assist with BIS certification under IS 3055 (Part 1)?
Yes. Qualitance India can assist with applicability review, technical documentation, factory and laboratory readiness, sample planning, application coordination and certification-related compliance support.
21. Contact Qualitance India for BIS Certification Assistance
Planning to manufacture or market solid stem clinical thermometers in India?
Before applying for BIS certification, ensure that your product construction, glass materials, graduation, accuracy, manufacturing process and testing arrangements comply with the requirements of IS 3055 (Part 1):1994.
Qualitance India – BIS Certification & Regulatory Compliance Consultancy
Improving Quality & Competence
Contact Qualitance India for professional assistance with BIS ISI Mark certification for clinical thermometers and other medical products.
Official References
- Bureau of Indian Standards – Products under Compulsory Certification, Scheme-I
- BIS – Product Manual PM/IS 3055 (Part 1)/2/December 2018
- BIS – Product-Specific Guidelines and Product Manuals
- Government of India – Clinical Thermometers (Quality Control) Order, 2001
- BIS – IS 3055 (Part 1):1994 Standard Document
- BIS – Product Certification FAQs
Regulatory note: This article is prepared with reference to the BIS Product Manual PM/IS 3055 (Part 1)/2/December 2018, the published Indian Standard information and the Clinical Thermometers (Quality Control) Order, 2001. The product manual identifies five amendments to the 1994 standard. Manufacturers should verify the current standard, all applicable amendments, BIS directions, fee schedule and certification instructions before submitting an application.
