{"id":4380,"date":"2026-10-30T11:41:29","date_gmt":"2026-10-30T11:41:29","guid":{"rendered":"https:\/\/qualitanceindia.com\/?p=4380"},"modified":"2026-10-30T11:41:29","modified_gmt":"2026-10-30T11:41:29","slug":"bis-certification-for-clinical-thermometers-part-1-solid-stem-type-is-3055-part-11994","status":"publish","type":"post","link":"https:\/\/qualitanceindia.com\/bis-certification-for-clinical-thermometers-part-1-solid-stem-type-is-3055-part-11994\/","title":{"rendered":"BIS Certification for Clinical Thermometers \u2013 Part 1: Solid Stem Type \u2013 IS 3055 (Part 1):1994"},"content":{"rendered":"

BIS Certification for Clinical Thermometers \u2013 Part 1: Solid Stem Type \u2013 IS 3055 (Part 1):1994<\/h3>\n

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.<\/p>\n

In India, Clinical Thermometers \u2013 Solid Stem Type are covered under IS 3055 (Part 1):1994 \u2013 Clinical Thermometers: Part 1 Solid Stem Type \u2013 Specification (Second Revision)<\/strong>.<\/p>\n

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<\/strong>.<\/p>\n

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.<\/p>\n

This article explains the product scope, applicable standard, sample quantity, testing requirements, laboratory facilities, documents and BIS certification process for solid stem clinical thermometers.<\/p>\n

1. Applicable Indian Standard \u2013 IS 3055 (Part 1):1994<\/h2>\n

The applicable Indian Standard is:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
Particular<\/th>\nDetails<\/th>\n<\/tr>\n
Indian Standard<\/td>\nIS 3055 (Part 1):1994<\/td>\n<\/tr>\n
Standard title<\/td>\nClinical Thermometers \u2013 Part 1 Solid Stem Type<\/td>\n<\/tr>\n
Revision<\/td>\nSecond Revision<\/td>\n<\/tr>\n
Number of amendments in BIS Product Manual<\/td>\n5<\/td>\n<\/tr>\n
BIS Product Manual<\/td>\nPM\/IS 3055 (Part 1)\/2\/December 2018<\/td>\n<\/tr>\n
Certification scheme<\/td>\nScheme-I \u2013 ISI Mark Scheme<\/td>\n<\/tr>\n
Product category<\/td>\nClinical thermometers \u2013 solid stem type<\/td>\n<\/tr>\n
Certification authority<\/td>\nBureau of Indian Standards (BIS)<\/td>\n<\/tr>\n
Quality Control Order<\/td>\nClinical Thermometers (Quality Control) Order, 2001<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

The standard specifies requirements and methods of sampling and testing for solid-stem, mercury-in-glass clinical thermometers having a maximum indicating device<\/strong>.<\/p>\n

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.<\/p>\n

2. Is BIS Certification Mandatory for Solid Stem Clinical Thermometers?<\/h2>\n

<badge color=”success”>Mandatory BIS Certification<\/badge><\/p>\n

Yes. BIS includes IS 3055 (Part 1) in its compulsory certification list under Scheme-I.<\/p>\n

The applicable regulation is the Clinical Thermometers (Quality Control) Order, 2001<\/strong>, notified through G.S.R. 843(E), dated 9 November 2001.<\/p>\n

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.<\/p>\n

It specifically identifies two types:<\/p>\n

    \n
  • Solid stem type \u2013 solid-stem, mercury-in-glass clinical thermometers.<\/li>\n
  • Enclosed-scale type \u2013 enclosed-scale mercury-in-glass clinical thermometers.<\/li>\n<\/ul>\n

    The Order identifies IS 3055 (Part 1):1994 for solid stem type and IS 3055 (Part 2) for enclosed-scale type.<\/p>\n

    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.<\/p>\n

    Important:<\/strong> 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.<\/p>\n

    3. Product Scope Covered Under IS 3055 (Part 1):1994<\/h2>\n

    IS 3055 (Part 1):1994 covers solid-stem, mercury-in-glass clinical thermometers having a maximum indicating device.<\/p>\n

    The BIS Product Manual identifies the licence scope as follows:<\/p>\n\n\n\n\n\n\n\n\n
    Scope parameter<\/th>\nDetails<\/th>\n<\/tr>\n
    Product name<\/td>\nClinical Thermometers<\/td>\n<\/tr>\n
    Product type<\/td>\nSolid stem<\/td>\n<\/tr>\n
    Thermometer construction<\/td>\nMercury-in-glass<\/td>\n<\/tr>\n
    Intended type<\/td>\nOral \/ Rectal<\/td>\n<\/tr>\n
    Applicable standard<\/td>\nIS 3055 (Part 1):1994<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    Key product characteristics<\/h3>\n

    A solid-stem clinical thermometer generally consists of:<\/p>\n

      \n
    • A glass stem.<\/li>\n
    • A capillary tube.<\/li>\n
    • A bulb containing the thermometric liquid.<\/li>\n
    • A graduated temperature scale.<\/li>\n
    • A maximum indicating device.<\/li>\n
    • A suitable constriction or arrangement to retain the maximum temperature indication.<\/li>\n<\/ul>\n

      The maximum indicating device retains the highest temperature reached during measurement until the thermometer is reset.<\/p>\n

      The exact construction and dimensional requirements must comply with the relevant clauses of IS 3055 (Part 1):1994.<\/p>\n

      4. Understanding Solid Stem Clinical Thermometers<\/h2>\n

      Solid-stem clinical thermometers are liquid-in-glass instruments designed for measuring human body temperature.<\/p>\n

      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.<\/p>\n

      The maximum indicating device helps retain the highest temperature reached during measurement, allowing the reading to be observed after the thermometer is removed.<\/p>\n

      Major components<\/h3>\n\n\n\n\n\n\n\n\n\n
      Component<\/th>\nFunction<\/th>\n<\/tr>\n
      Glass stem<\/td>\nMain body of the thermometer<\/td>\n<\/tr>\n
      Bulb<\/td>\nHolds the thermometric liquid<\/td>\n<\/tr>\n
      Capillary tube<\/td>\nAllows movement of the thermometric liquid<\/td>\n<\/tr>\n
      Graduation<\/td>\nIndicates the temperature reading<\/td>\n<\/tr>\n
      Maximum indicating device<\/td>\nRetains the maximum temperature reading<\/td>\n<\/tr>\n
      Glass tubing<\/td>\nProvides the thermometer’s structural body<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      The standard includes requirements relating to materials, construction, dimensions, graduation, numbering, appearance, ageing, accuracy and immersion-time effects.<\/p>\n

      5. Technical Requirements Under IS 3055 (Part 1):1994<\/h2>\n

      The standard specifies requirements for the construction, materials and performance of solid-stem clinical thermometers.<\/p>\n

      Important technical areas include the following.<\/p>\n

      A. Materials<\/h3>\n

      The materials used in the thermometer must comply with the applicable requirements of the standard.<\/p>\n

      The product manual identifies glass tubing conforming to IS 4529:1968<\/strong>, except for the specified provisions relating to stability of the bulb tube and limit of alkalinity.<\/p>\n

      The standard also includes requirements relating to:<\/p>\n

        \n
      • Glass bulb.<\/li>\n
      • Hydrolytic resistance of glass.<\/li>\n
      • Thermometric liquid.<\/li>\n
      • Maximum indicating device.<\/li>\n<\/ul>\n

        B. Construction<\/h3>\n

        The thermometer must comply with the prescribed construction requirements, including the arrangement of the bulb, capillary tube, stem and maximum indicating device.<\/p>\n

        C. Dimensions<\/h3>\n

        The dimensions of the thermometer must comply with the requirements and dimensional provisions specified in the standard.<\/p>\n

        D. Graduation and numbering<\/h3>\n

        The temperature scale and numbering must be clearly marked and comply with the applicable graduation requirements.<\/p>\n

        E. Appearance<\/h3>\n

        The thermometer must meet the applicable appearance and workmanship requirements.<\/p>\n

        F. Ageing and accuracy<\/h3>\n

        The thermometer must maintain the prescribed accuracy after the applicable ageing procedure.<\/p>\n

        G. Influence of immersion time<\/h3>\n

        The thermometer is evaluated for the effect of immersion time on its temperature indication.<\/p>\n

        These requirements help ensure that the instrument provides reliable temperature measurements under the conditions specified by the standard.<\/p>\n

        6. BIS Testing Requirements for IS 3055 (Part 1):1994<\/h2>\n

        Testing is a critical part of BIS certification. The thermometer must be evaluated against the applicable requirements of IS 3055 (Part 1):1994.<\/p>\n

        The BIS Product Manual identifies the following major tests and assessment parameters:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
        Sr. No.<\/th>\nTest \/ Parameter<\/th>\nRelevant clause<\/th>\n<\/tr>\n
        1<\/td>\nMaterials \u2013 glass tubing<\/td>\nClause 7.2.1<\/td>\n<\/tr>\n
        2<\/td>\nMaterials \u2013 bulb<\/td>\nClause 7.2.2<\/td>\n<\/tr>\n
        3<\/td>\nHydrolytic resistance of glass<\/td>\nClause 7.2.3<\/td>\n<\/tr>\n
        4<\/td>\nThermometric liquid<\/td>\nClause 7.2.4<\/td>\n<\/tr>\n
        5<\/td>\nConstruction<\/td>\nClause 7.3<\/td>\n<\/tr>\n
        6<\/td>\nHardness of maximum indicating device<\/td>\nClause 7.3.2.1<\/td>\n<\/tr>\n
        7<\/td>\nDimensions<\/td>\nClause 7.4<\/td>\n<\/tr>\n
        8<\/td>\nGraduation and numbering<\/td>\nClause 7.5<\/td>\n<\/tr>\n
        9<\/td>\nPermanency of marking<\/td>\nClause 7.5.8<\/td>\n<\/tr>\n
        10<\/td>\nAppearance<\/td>\nClause 8.1<\/td>\n<\/tr>\n
        11<\/td>\nAgeing and accuracy<\/td>\nClause 8.2<\/td>\n<\/tr>\n
        12<\/td>\nInfluence of immersion time<\/td>\nClause 8.3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

        The exact test methods, apparatus, conditioning requirements and acceptance criteria must be followed as specified in IS 3055 (Part 1):1994.<\/p>\n

        7. BIS Sample Quantity for IS 3055 (Part 1):1994<\/h2>\n

        <badge color=”success”>10 pieces<\/badge><\/p>\n

        According to the BIS Product Manual PM\/IS 3055 (Part 1)\/2\/December 2018<\/strong>, the specified sample size is:<\/p>\n

        10 pieces of solid stem clinical thermometers.<\/strong><\/p>\n

        The product manual also states that the standard covers two patterns only.<\/p>\n

        The proposed samples should represent the thermometer type and pattern intended to be covered under the BIS licence.<\/p>\n

        Manufacturers should ensure that the submitted samples:<\/p>\n

          \n
        • Are manufactured using the intended production process.<\/li>\n
        • Have the declared thermometer construction.<\/li>\n
        • Include the applicable graduation and numbering.<\/li>\n
        • Have the required maximum indicating device.<\/li>\n
        • Represent the proposed product scope.<\/li>\n<\/ul>\n

          Important:<\/strong> 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.<\/p>\n

          8. Product Grouping Guidelines Under IS 3055 (Part 1)<\/h2>\n

          The BIS Product Manual states:<\/p>\n

          \u201cStandard covers two patterns only.\u201d<\/strong><\/p>\n

          The licence scope identified in the product manual is for solid-stem, mercury-in-glass, oral\/rectal clinical thermometers.<\/p>\n

          The manufacturer should declare the proposed product pattern and range when applying for certification.<\/p>\n

          The scope of the licence must clearly identify the product type and range approved by BIS.<\/p>\n

          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.<\/p>\n

          9. Possible Tests That Can Be Completed in One Day<\/h2>\n

          The BIS Product Manual identifies certain tests that can be carried out within one day.<\/p>\n

          These include:<\/p>\n\n\n\n\n\n\n\n\n
          Sr. No.<\/th>\nTest<\/th>\nStandard reference<\/th>\n<\/tr>\n
          1<\/td>\nConstruction<\/td>\nClause 7.3<\/td>\n<\/tr>\n
          2<\/td>\nDimensions<\/td>\nClause 7.4<\/td>\n<\/tr>\n
          3<\/td>\nGraduation and numbering<\/td>\nClause 7.5<\/td>\n<\/tr>\n
          4<\/td>\nAppearance<\/td>\nClause 8.1<\/td>\n<\/tr>\n
          5<\/td>\nInfluence of immersion time<\/td>\nClause 8.3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

          These are the tests specifically identified as possible tests in a day in the product manual.<\/p>\n

          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.<\/p>\n

          10. Manufacturing Facility Requirements<\/h2>\n

          Manufacturers applying for BIS certification should establish suitable manufacturing and quality-control arrangements.<\/p>\n

          The production process should have documented controls covering:<\/p>\n

          A. Glass tubing and material procurement<\/h3>\n
            \n
          • Procurement of suitable glass tubing.<\/li>\n
          • Supplier approval and evaluation.<\/li>\n
          • Incoming material inspection.<\/li>\n
          • Verification of relevant material test certificates.<\/li>\n<\/ul>\n

            B. Bulb and capillary manufacturing<\/h3>\n
              \n
            • Bulb formation.<\/li>\n
            • Capillary tube preparation.<\/li>\n
            • Dimensional control.<\/li>\n
            • Inspection of glass components.<\/li>\n<\/ul>\n

              C. Thermometric liquid filling<\/h3>\n
                \n
              • Selection and control of the thermometric liquid.<\/li>\n
              • Filling operation.<\/li>\n
              • Sealing and inspection.<\/li>\n
              • Control of filling quality.<\/li>\n<\/ul>\n

                D. Scale and graduation<\/h3>\n
                  \n
                • Graduation and numbering.<\/li>\n
                • Scale alignment.<\/li>\n
                • Marking inspection.<\/li>\n
                • Permanency of marking checks.<\/li>\n<\/ul>\n

                  E. Final inspection<\/h3>\n
                    \n
                  • Construction inspection.<\/li>\n
                  • Dimensional checks.<\/li>\n
                  • Appearance inspection.<\/li>\n
                  • Accuracy testing.<\/li>\n
                  • Immersion-time testing.<\/li>\n
                  • Product identification and traceability.<\/li>\n<\/ul>\n

                    The manufacturer should prepare a manufacturing process flow chart identifying all major manufacturing and inspection stages.<\/p>\n

                    11. In-House Laboratory Requirements<\/h2>\n

                    The BIS Product Manual requires the manufacturer to maintain a suitably equipped and staffed laboratory for carrying out the tests specified in the standard.<\/p>\n

                    The manufacturer must also prepare a calibration plan for the testing equipment and maintain test records to establish product conformity.<\/p>\n

                    The laboratory should have appropriate facilities for:<\/p>\n

                      \n
                    • Material testing.<\/li>\n
                    • Bulb-related testing.<\/li>\n
                    • Hydrolytic resistance testing of glass.<\/li>\n
                    • Maximum indicating device testing.<\/li>\n
                    • Dimensional measurement.<\/li>\n
                    • Ageing and accuracy testing.<\/li>\n
                    • Immersion-time testing.<\/li>\n<\/ul>\n

                      The product manual’s Annex-A provides an indicative list of major testing equipment.<\/p>\n

                      Major testing equipment identified in the BIS Product Manual<\/h3>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                      Sr. No.<\/th>\nEquipment<\/th>\nPurpose<\/th>\n<\/tr>\n
                      1<\/td>\nSpecial test thermometers<\/td>\nBulb and material-related testing<\/td>\n<\/tr>\n
                      2<\/td>\nTemperature-controlled test bath<\/td>\nTemperature testing<\/td>\n<\/tr>\n
                      3<\/td>\nIce bath<\/td>\nTemperature reference and conditioning<\/td>\n<\/tr>\n
                      4<\/td>\nStandard laboratory chemicals and apparatus<\/td>\nHydrolytic resistance testing<\/td>\n<\/tr>\n
                      5<\/td>\nBall mill<\/td>\nPreparation of glass samples<\/td>\n<\/tr>\n
                      6<\/td>\nSieving machine<\/td>\nPreparation and grading of glass samples<\/td>\n<\/tr>\n
                      7<\/td>\nUltrasonic cleaner<\/td>\nCleaning of glass samples<\/td>\n<\/tr>\n
                      8<\/td>\nDrying oven<\/td>\nDrying of prepared samples<\/td>\n<\/tr>\n
                      9<\/td>\nHeating bath<\/td>\nGlass-related testing<\/td>\n<\/tr>\n
                      10<\/td>\nCentrifuge<\/td>\nHardness of maximum indicating device<\/td>\n<\/tr>\n
                      11<\/td>\nStopwatch<\/td>\nTiming measurements<\/td>\n<\/tr>\n
                      12<\/td>\nVernier calipers<\/td>\nDimensional inspection<\/td>\n<\/tr>\n
                      13<\/td>\nMicrometer<\/td>\nDimensional inspection<\/td>\n<\/tr>\n
                      14<\/td>\nComparator water bath<\/td>\nAgeing and accuracy testing<\/td>\n<\/tr>\n
                      15<\/td>\nReference thermometer<\/td>\nTemperature comparison<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                      The BIS Product Manual states that this equipment list is indicative and should not be treated as exhaustive.<\/p>\n

                      The manufacturer should review Annex-A and the complete standard before establishing the final laboratory equipment list.<\/p>\n

                      12. Scheme of Inspection and Testing (SIT)<\/h2>\n

                      The BIS Product Manual includes a Scheme of Inspection and Testing (SIT) in Annex-B.<\/p>\n

                      The manufacturer must maintain a laboratory that is suitably equipped and staffed to carry out the required tests.<\/p>\n

                      12.1 Control unit<\/h3>\n

                      The product manual defines the control unit as:<\/p>\n

                      All clinical thermometers of the same pattern manufactured in a day shall constitute one control unit.<\/strong><\/p>\n

                      This definition is important for determining the frequency and number of samples for routine factory testing.<\/p>\n

                      12.2 Routine testing and inspection<\/h3>\n

                      The following table summarises the testing requirements and levels of control identified in the product manual.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                      Test \/ Requirement<\/th>\nTesting frequency \/ sample requirement<\/th>\n<\/tr>\n
                      Glass tubing<\/td>\nEvery consignment received<\/td>\n<\/tr>\n
                      Bulb<\/td>\nEvery consignment received<\/td>\n<\/tr>\n
                      Hydrolytic resistance of glass<\/td>\nOne from every batch of glass used for maximum device, capillary tube and bulb received<\/td>\n<\/tr>\n
                      Thermometric liquid<\/td>\nTest certificate from supplier<\/td>\n<\/tr>\n
                      Construction<\/td>\nEach thermometer<\/td>\n<\/tr>\n
                      Dimensions<\/td>\nEach thermometer<\/td>\n<\/tr>\n
                      Graduation and numbering<\/td>\nEach thermometer<\/td>\n<\/tr>\n
                      Permanency of marking<\/td>\n1% with minimum 5 thermometers from each control unit<\/td>\n<\/tr>\n
                      Appearance<\/td>\nEach thermometer<\/td>\n<\/tr>\n
                      Ageing and accuracy<\/td>\n1% with minimum 5 thermometers from each control unit<\/td>\n<\/tr>\n
                      Influence of immersion time<\/td>\n1% with minimum 5 thermometers from each control unit<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                      The product manual also specifies:<\/p>\n