{"id":4359,"date":"2026-10-29T11:19:35","date_gmt":"2026-10-29T11:19:35","guid":{"rendered":"https:\/\/qualitanceindia.com\/?p=4359"},"modified":"2026-10-29T11:19:35","modified_gmt":"2026-10-29T11:19:35","slug":"bis-certification-for-sanitary-napkins-is-54052019-requirements-testing-and-isi-mark-qualitance","status":"publish","type":"post","link":"https:\/\/qualitanceindia.com\/bis-certification-for-sanitary-napkins-is-54052019-requirements-testing-and-isi-mark-qualitance\/","title":{"rendered":"BIS Certification for Sanitary Napkins | IS 5405:2019 \u2014 Requirements, Testing and ISI Mark -Qualitance"},"content":{"rendered":"<h2>Important Update: IS 5405:2019 Has Been Superseded<\/h2>\n<p>This article explains the certification framework associated with IS 5405:2019. However, the BIS standards catalogue now lists <strong>IS 5405:2025 \u2014 Disposable Sanitary Napkin\/Panty Liner\/Maternity Pad\/Period Panty \u2014 Specification (Third Revision)<\/strong> and identifies it as mandatory certification. IS 5405:2025 supersedes IS 5405:2019.<\/p>\n<p>Manufacturers planning a new BIS application in 2026 should therefore confirm the applicable product manual, testing requirements, licence scope and implementation position for IS 5405:2025 before proceeding. The technical details below that specifically refer to the 2019 edition are identified as such and should not automatically be treated as the current requirements for the 2025 edition. &lt;Cite refs={[&#8220;turn614900search0&#8243;,&#8221;turn699036search17&#8221;]}\/&gt;<\/p>\n<h2>1. Introduction<\/h2>\n<p>Sanitary napkins are essential personal hygiene products designed to absorb menstrual fluid while providing comfort, leakage protection and hygienic use. They are manufactured using combinations of a top sheet, absorbent core, bottom sheet and other components selected to meet the product&#8217;s performance requirements.<\/p>\n<p>Because sanitary napkins come into prolonged contact with sensitive skin, manufacturers must pay attention to product safety, absorbency, hygiene, pH, construction, workmanship and other applicable quality parameters.<\/p>\n<p>In India, sanitary napkins are regulated under the Medical Textiles Quality Control framework. The earlier certification standard was <strong>IS 5405:2019 \u2014 Sanitary Napkins \u2014 Specification<\/strong>. The BIS catalogue now lists the revised <strong>IS 5405:2025<\/strong>, whose scope includes disposable sanitary napkins, panty liners, maternity pads and period panties. &lt;Cite refs={[&#8220;turn699036search6&#8243;,&#8221;turn614900search0&#8221;]}\/&gt;<\/p>\n<p>For manufacturers, importers and private-label brands, understanding the applicable standard and BIS licensing requirements is important before placing products on the Indian market.<\/p>\n<h2>2. What Is IS 5405?<\/h2>\n<p>IS 5405 is an Indian Standard addressing product requirements for sanitary napkins and, under its 2025 revision, additional disposable menstrual hygiene products.<\/p>\n<p>The 2019 edition was titled <em>Sanitary Napkins \u2014 Specification<\/em>. Its BIS product manual, issued under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018, identifies product classification, sampling, test equipment, inspection and testing, and licence-scope requirements. &lt;Cite refs={[&#8220;turn699036search17&#8243;,&#8221;turn614900view0&#8221;]}\/&gt;<\/p>\n<p>The 2025 revision is titled <em>Disposable Sanitary Napkin\/Panty Liner\/Maternity Pad\/Period Panty \u2014 Specification<\/em>. Manufacturers should review the complete current standard to establish the requirements for the product they intend to manufacture. &lt;Cite refs={[&#8220;turn614900search0&#8221;]}\/&gt;<\/p>\n<h3>Why is the standard important?<\/h3>\n<p>Compliance helps establish that the product meets the applicable specification for its intended use. Depending on the applicable edition and product category, the assessment may address:<\/p>\n<ul>\n<li>Product type, design and dimensions.<\/li>\n<li>Construction, workmanship and finish.<\/li>\n<li>pH value.<\/li>\n<li>Absorption-related performance.<\/li>\n<li>Hygiene and microbiological requirements.<\/li>\n<li>Applicable material and chemical-safety requirements.<\/li>\n<li>Any additional or optional requirements included in the applicable standard.<\/li>\n<\/ul>\n<p>The precise requirements and acceptance criteria must be verified against the current edition of IS 5405.<\/p>\n<h2>3. Is BIS Certification Mandatory for Sanitary Napkins?<\/h2>\n<p>Yes. Sanitary napkins are covered by the Medical Textiles Quality Control Order framework, which requires covered products to conform to the applicable Indian Standard and bear the BIS Standard Mark under a licence issued in accordance with Scheme-I, subject to the order&#8217;s provisions and exemptions. &lt;Cite refs={[&#8220;turn614900search7&#8243;,&#8221;turn614900search1&#8221;]}\/&gt;<\/p>\n<h3>Regulatory background<\/h3>\n<p>The Ministry of Textiles notified the Medical Textiles (Quality Control) Order, 2023 on 27 September 2023. The order was subsequently replaced or amended through further notifications, including the Medical Textiles (Quality Control) Order, 2024 and amendments issued in 2025. &lt;Cite refs={[&#8220;turn614900search7&#8243;,&#8221;turn699036search6&#8243;,&#8221;turn614900search5&#8243;,&#8221;turn614900search6&#8221;]}\/&gt;<\/p>\n<p>The original implementation schedule specified:<\/p>\n<ul>\n<li>General enterprises: 1 April 2024.<\/li>\n<li>Small and micro enterprises: 1 October 2024.<\/li>\n<\/ul>\n<p>Subsequent government notifications extended the compliance date for specified small and medium enterprises and provided for the clearance of certain declared legacy stock. Those transitional arrangements had defined conditions and deadlines; they should not be treated as a continuing general exemption. &lt;Cite refs={[&#8220;turn699036search3&#8243;,&#8221;turn614900search2&#8243;,&#8221;turn614900search6&#8221;]}\/&gt;<\/p>\n<h3>What should manufacturers do in 2026?<\/h3>\n<p>Before applying, manufacturers should:<\/p>\n<ol start=\"1\">\n<li>Confirm that their product falls within the current QCO scope.<\/li>\n<li>Check the current edition of IS 5405 and its product manual.<\/li>\n<li>Verify the applicable implementation provisions and any specific exemption.<\/li>\n<li>Establish whether the intended product and manufacturing unit are covered by the proposed licence.<\/li>\n<li>Ensure that the Standard Mark is used only in accordance with a valid BIS licence.<\/li>\n<\/ol>\n<p>The official BIS catalogue lists IS 5405:2025 as mandatory certification and confirms that it supersedes IS 5405:2019. &lt;Cite refs={[&#8220;turn614900search0&#8221;]}\/&gt;<\/p>\n<h2>4. Types of Sanitary Napkins and Product Classification<\/h2>\n<p>The BIS product manual for IS 5405:2019 identifies two principal types of sanitary napkins for licence grouping.<\/p>\n<h3>4.1 Thick sanitary napkins<\/h3>\n<p>These are classified as thick napkins under the 2019 product manual. Manufacturers intending to cover this category must declare the relevant product varieties and demonstrate conformity under the applicable certification requirements.<\/p>\n<h3>4.2 Thin sanitary napkins<\/h3>\n<p>Thin napkins form a separate group under the 2019 product manual. The grouping guidance specifies a sample from each of the thick and thin groups for the corresponding licensing assessment. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>4.3 Shape and design variations<\/h3>\n<p>The 2019 manual identifies the following design-related variations:<\/p>\n<ul>\n<li>With wings or without wings.<\/li>\n<li>With tab or tab-less.<\/li>\n<li>Other designs permitted by the standard.<\/li>\n<\/ul>\n<p>The manual also identifies size categories based on pad length, including Regular, Large, Extra-Large and XXL. These categories should be interpreted in accordance with the manual&#8217;s stated dimensions and the applicable standard. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>4.4 Product scope under IS 5405:2025<\/h3>\n<p>The 2025 standard&#8217;s title expressly includes:<\/p>\n<ul>\n<li>Disposable sanitary napkins.<\/li>\n<li>Panty liners.<\/li>\n<li>Maternity pads.<\/li>\n<li>Period panties.<\/li>\n<\/ul>\n<p>Manufacturers should not assume that the grouping or sampling rules for sanitary napkins under the 2019 edition automatically apply to all products covered by the 2025 revision. The current standard and product manual must be consulted for each product category. &lt;Cite refs={[&#8220;turn614900search0&#8221;]}\/&gt;<\/p>\n<h2>5. Raw Material Requirements<\/h2>\n<p>Raw materials play an important role in sanitary napkin performance and product safety. Manufacturers should establish material specifications, supplier controls, incoming inspection and traceability for the components used in production.<\/p>\n<p>The 2019 product manual specifies that, if cotton gauze is used, it shall conform to IS 758. It also refers to requirements for the cover or top sheet, absorbent core and bottom sheet under the relevant clauses of IS 5405:2019. &lt;Cite refs={[&#8220;turn699036search17&#8243;,&#8221;turn699036search20&#8221;]}\/&gt;<\/p>\n<p>Depending on the applicable standard and product design, manufacturers may need to maintain information concerning:<\/p>\n<ul>\n<li>Top-sheet material.<\/li>\n<li>Absorbent-core materials.<\/li>\n<li>Bottom-sheet material.<\/li>\n<li>Adhesives and other construction materials.<\/li>\n<li>Supplier specifications and test certificates.<\/li>\n<li>Material batch identification and traceability.<\/li>\n<li>Any applicable chemical-safety or biocompatibility evidence.<\/li>\n<\/ul>\n<p>The current requirements for IS 5405:2025 must be checked directly. The 2019 material provisions should not be used as a substitute for the revised standard.<\/p>\n<h2>6. Testing Requirements for Sanitary Napkins<\/h2>\n<p>Testing is a central part of BIS product certification. The required tests depend on the applicable edition of IS 5405, the product type, the manufacturing process and the requirements applicable to the proposed licence scope.<\/p>\n<p>The BIS product manual for the 2019 edition identifies the following tests as possible to complete in one day:<\/p>\n<ul>\n<li>Type and shape.<\/li>\n<li>Size.<\/li>\n<li>Manufacture, workmanship and finish.<\/li>\n<li>pH value.<\/li>\n<li>Ability to withstand pressure after absorption. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/li>\n<\/ul>\n<p>The manual also identifies hygiene testing and biocompatibility-related requirements in its test-equipment section.<\/p>\n<h3>6.1 Type, shape and size<\/h3>\n<p>The product is checked against its declared type, shape and dimensions. The manufacturer&#8217;s declared varieties should be consistent with the proposed licence scope and actual production capability.<\/p>\n<h3>6.2 Manufacture, workmanship and finish<\/h3>\n<p>The product should meet the applicable construction and finish requirements. Manufacturing defects that affect the product&#8217;s intended use or conformity must be controlled through inspection and quality procedures.<\/p>\n<h3>6.3 pH value<\/h3>\n<p>The 2019 product manual specifies pH testing and identifies a pH meter, buffer solutions, distilled or deionised water and related laboratory equipment. The applicable method and acceptance limits must be taken from the standard. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>6.4 Ability to withstand pressure after absorption<\/h3>\n<p>The 2019 manual identifies this as a performance test and lists apparatus including a flat transparent surface, standard weight, weighing balance, thermometer, coloured distilled water and a controlled-flow burette unit. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>6.5 Hygiene and microbiological testing<\/h3>\n<p>The 2019 manual identifies bacterial and fungal bioburden testing and testing for the common skin pathogen <em>Staphylococcus aureus<\/em>. It also lists relevant microbiological laboratory equipment and media. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>6.6 Biocompatibility evaluation<\/h3>\n<p>The 2019 product manual addresses biocompatibility evaluation, including cytotoxicity, irritation and skin sensitisation. The manual identifies this as an optional requirement for the scope of the licence. If a manufacturer intends to include biocompatibility in that licence scope, the corresponding conformity requirements must be established. &lt;Cite refs={[&#8220;turn614900view0&#8243;,&#8221;turn699036search20&#8221;]}\/&gt;<\/p>\n<h3>6.7 Biodegradability and compostability<\/h3>\n<p>The 2019 product manual lists biodegradability and compostability as optional requirements. Manufacturers must verify whether and how these requirements apply to the product and claims they intend to make, and whether the current standard contains revised provisions. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<p><strong>Important:<\/strong> The list above describes the 2019 product manual. It is not a confirmed complete test matrix for IS 5405:2025. Applicants must obtain the current product manual and confirm the complete testing programme with BIS and the laboratory.<\/p>\n<h2>7. Sample Requirements and Grouping Guidelines<\/h2>\n<p>For the 2019 edition, the BIS product manual specifies a sample size of <strong>50 sanitary napkins<\/strong>. &lt;Cite refs={[&#8220;turn699036search17&#8243;,&#8221;turn614900view0&#8221;]}\/&gt;<\/p>\n<p>The manual divides sanitary napkins into two groups for licensing purposes:<\/p>\n<table>\n<tbody>\n<tr>\n<th>Group<\/th>\n<th>Product type<\/th>\n<th>Sampling guidance under the 2019 manual<\/th>\n<\/tr>\n<tr>\n<td>Group 1<\/td>\n<td>Thick napkins<\/td>\n<td>One sample of thick napkins, of any shape\/design and size<\/td>\n<\/tr>\n<tr>\n<td>Group 2<\/td>\n<td>Thin napkins<\/td>\n<td>One sample of thin napkins, of any shape\/design and size<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>The manual states that one sample from each group is to be tested to cover the varieties in that group. It also states that the licence scope is restricted by the manufacturer&#8217;s manufacturing and testing capabilities. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>Before sending samples<\/h3>\n<p>A manufacturer should confirm:<\/p>\n<ul>\n<li>The applicable standard edition.<\/li>\n<li>The required number and identification of samples.<\/li>\n<li>The product type and design.<\/li>\n<li>The product varieties to be included in the licence.<\/li>\n<li>The required laboratory and test programme.<\/li>\n<li>Any additional material or specimen requirements.<\/li>\n<\/ul>\n<p>The 50-piece sample quantity is specific to the 2019 product manual. Do not assume it remains the required sample quantity under IS 5405:2025 without checking the current manual.<\/p>\n<h2>8. Laboratory and Testing Equipment<\/h2>\n<p>The 2019 product manual identifies equipment for dimensional checks, pH testing, pressure-after-absorption testing, hygiene testing, biocompatibility evaluation and optional biodegradability testing. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<p>Depending on the test programme, the equipment may include:<\/p>\n<ul>\n<li>Vernier calipers and steel scales.<\/li>\n<li>pH meter, buffers and laboratory glassware.<\/li>\n<li>Weighing balance and temperature-control equipment.<\/li>\n<li>Apparatus for testing the ability to withstand pressure after absorption.<\/li>\n<li>Microbiological laboratory equipment, including incubators, autoclave, colony counter and laminar-flow facilities.<\/li>\n<li>Equipment required for the applicable biocompatibility tests.<\/li>\n<li>Equipment for optional biodegradability or compostability testing.<\/li>\n<\/ul>\n<p>The actual equipment and facility requirements must be checked against the applicable product manual and the tests required for the licence scope.<\/p>\n<h3>In-house or external testing<\/h3>\n<p>Manufacturers should verify the applicable BIS inspection and testing provisions and the acceptability of any proposed external laboratory before finalising the application. Not every test should be assumed to be subcontractable, and laboratory acceptance should be confirmed for the specific test and standard.<\/p>\n<h2>9. Documents Required for BIS Certification<\/h2>\n<p>The following is a practical document-preparation checklist. The official application requirements may differ depending on the current standard, the applicant and the manufacturing site.<\/p>\n<h3>A. Company and factory documents<\/h3>\n<ul>\n<li>Company registration or constitution documents.<\/li>\n<li>Manufacturing-unit address and contact details.<\/li>\n<li>Factory layout and manufacturing-process flow chart.<\/li>\n<li>Details of production machinery and manufacturing capacity.<\/li>\n<li>Details of technical and quality-control personnel.<\/li>\n<li>List of products and varieties proposed for certification.<\/li>\n<\/ul>\n<h3>B. Raw material documents<\/h3>\n<ul>\n<li>Raw material specifications.<\/li>\n<li>Supplier details.<\/li>\n<li>Supplier test certificates and relevant test reports.<\/li>\n<li>Incoming inspection records.<\/li>\n<li>Material batch identification and traceability records.<\/li>\n<li>Applicable evidence for material conformity and safety requirements.<\/li>\n<\/ul>\n<h3>C. Manufacturing and quality-control documents<\/h3>\n<ul>\n<li>Manufacturing procedures and process controls.<\/li>\n<li>In-process inspection records.<\/li>\n<li>Finished-product inspection formats.<\/li>\n<li>Test procedures and test records.<\/li>\n<li>Procedures for handling non-conforming products.<\/li>\n<li>Batch identification and traceability system.<\/li>\n<li>Product packaging and marking details.<\/li>\n<\/ul>\n<h3>D. Laboratory documents<\/h3>\n<ul>\n<li>List of testing equipment and facilities.<\/li>\n<li>Calibration records for applicable equipment.<\/li>\n<li>Test methods and work instructions.<\/li>\n<li>Laboratory personnel details and competency records.<\/li>\n<li>Relevant laboratory test reports.<\/li>\n<li>Details of proposed external testing, where applicable.<\/li>\n<\/ul>\n<h3>E. BIS application documents<\/h3>\n<ul>\n<li>Application and declarations required by BIS.<\/li>\n<li>Product details and proposed licence scope.<\/li>\n<li>Factory and manufacturing information.<\/li>\n<li>Relevant test reports and supporting evidence requested by BIS.<\/li>\n<li>Applicable fee and licence-related documents.<\/li>\n<li>Additional records requested during scrutiny or factory assessment.<\/li>\n<\/ul>\n<p><strong>Note:<\/strong> This checklist is for preparation and is not an exhaustive official BIS application checklist. Confirm the current document requirements before submitting an application.<\/p>\n<h2>10. BIS Certification Process for Sanitary Napkins<\/h2>\n<h3>Step 1: Confirm the applicable standard<\/h3>\n<p>Determine whether the application must be prepared under IS 5405:2025 and verify the applicable QCO provisions.<\/p>\n<h3>Step 2: Define the product scope<\/h3>\n<p>Prepare a product matrix listing the products to be manufactured, including relevant types, designs, dimensions and any additional product categories.<\/p>\n<h3>Step 3: Review factory readiness<\/h3>\n<p>Assess production machinery, raw material controls, manufacturing processes, testing facilities, calibration and quality-control records.<\/p>\n<h3>Step 4: Prepare the application<\/h3>\n<p>Compile the required company, factory, product and quality-system information and complete the applicable BIS application process.<\/p>\n<h3>Step 5: Confirm the sampling plan<\/h3>\n<p>Confirm the required sample quantity, product varieties, grouping provisions and laboratory test programme against the current product manual.<\/p>\n<h3>Step 6: Complete product testing<\/h3>\n<p>Arrange testing as required by BIS and the applicable standard. Resolve any test failures or observations.<\/p>\n<h3>Step 7: Facilitate factory assessment<\/h3>\n<p>Support the BIS assessment of manufacturing capability, product controls, laboratory facilities and records, as applicable.<\/p>\n<h3>Step 8: Address observations<\/h3>\n<p>Provide corrective actions, supporting records or additional testing evidence where requested.<\/p>\n<h3>Step 9: Licence grant and Standard Mark<\/h3>\n<p>After BIS confirms compliance and grants the licence, use the Standard Mark only for products covered by the licence and in accordance with its conditions.<\/p>\n<p>Submitting an application or obtaining an individual test report does not, by itself, authorise the manufacturer to use the BIS Standard Mark.<\/p>\n<h2>11. BIS Certification Fees and Testing Costs<\/h2>\n<p>The total cost depends on the applicable BIS fee schedule, laboratory testing, product scope, sampling, factory readiness and any professional assistance required.<\/p>\n<p>Cost components may include:<\/p>\n<ul>\n<li>Applicable BIS application and processing charges.<\/li>\n<li>Factory assessment and other certification charges.<\/li>\n<li>Product testing charges.<\/li>\n<li>Sample preparation and transportation.<\/li>\n<li>Laboratory setup or equipment calibration, if required.<\/li>\n<li>Quality-control documentation and system preparation.<\/li>\n<li>Consultancy charges, if the manufacturer engages a consultant.<\/li>\n<\/ul>\n<h3>How to verify testing charges<\/h3>\n<p>Testing charges can vary with the applicable standard, test programme and laboratory. Manufacturers should check the current listing and confirm the complete test scope with the laboratory before preparing a budget.<\/p>\n<p>Official resource: <a href=\"https:\/\/lims.bis.gov.in\/\">BIS Laboratory Information Management System<\/a>.<\/p>\n<p><strong>Important:<\/strong> A laboratory testing quote is not the same as the complete cost of BIS certification. A reliable estimate requires confirmation of the applicable edition, product category, required tests and current BIS fees.<\/p>\n<h2>12. How Long Does BIS Certification Take?<\/h2>\n<p>There is no single guaranteed timeline for every sanitary napkin application. The duration depends on application completeness, the applicable standard, sample preparation, testing, factory readiness, laboratory availability and resolution of any observations.<\/p>\n<p>Common causes of delay include:<\/p>\n<ul>\n<li>Applying under an outdated standard.<\/li>\n<li>Incomplete product details or proposed licence scope.<\/li>\n<li>Missing raw material specifications or test reports.<\/li>\n<li>Inadequate laboratory facilities or calibration records.<\/li>\n<li>Incorrect sample selection.<\/li>\n<li>Non-conformities requiring corrective action or retesting.<\/li>\n<li>Changes to the applicable product manual or regulatory requirements.<\/li>\n<\/ul>\n<p>Manufacturers should establish a realistic project schedule after reviewing their product range and confirming the current BIS requirements.<\/p>\n<h2>13. Common Mistakes Manufacturers Should Avoid<\/h2>\n<ol start=\"1\">\n<li>Preparing a new application under IS 5405:2019 without checking the superseding 2025 standard.<\/li>\n<li>Assuming the 2019 sample quantity and grouping rules automatically apply to the 2025 edition.<\/li>\n<li>Treating a supplier&#8217;s material certificate as proof of complete product conformity.<\/li>\n<li>Failing to maintain raw material and production-batch traceability.<\/li>\n<li>Overlooking hygiene or microbiological testing requirements.<\/li>\n<li>Making biocompatibility, biodegradability or compostability claims without confirming the applicable requirements and supporting evidence.<\/li>\n<li>Treating laboratory testing charges as the complete certification cost.<\/li>\n<li>Assuming that a test report alone authorises use of the BIS Standard Mark.<\/li>\n<li>Relying on expired legacy-stock transition arrangements as a continuing exemption.<\/li>\n<li>Failing to check the current QCO and product manual before manufacturing or importing covered products.<\/li>\n<\/ol>\n<h2>14. Frequently Asked Questions (FAQs)<\/h2>\n<h3>Q1. Is BIS certification mandatory for sanitary napkins in India?<\/h3>\n<p>Yes. Sanitary napkins are covered by the Medical Textiles Quality Control framework, which requires the Standard Mark under a BIS licence for covered products, subject to the order&#8217;s provisions and exemptions. &lt;Cite refs={[&#8220;turn614900search7&#8243;,&#8221;turn614900search1&#8221;]}\/&gt;<\/p>\n<h3>Q2. Is IS 5405:2019 still the latest standard?<\/h3>\n<p>No. The BIS standards catalogue lists IS 5405:2025, titled <em>Disposable Sanitary Napkin\/Panty Liner\/Maternity Pad\/Period Panty \u2014 Specification<\/em>, and identifies it as superseding IS 5405:2019. &lt;Cite refs={[&#8220;turn614900search0&#8221;]}\/&gt;<\/p>\n<h3>Q3. What products are covered by IS 5405:2025?<\/h3>\n<p>The title of the 2025 standard includes disposable sanitary napkins, panty liners, maternity pads and period panties. Check the full standard for the exact product requirements and scope. &lt;Cite refs={[&#8220;turn614900search0&#8221;]}\/&gt;<\/p>\n<h3>Q4. How many samples were required under IS 5405:2019?<\/h3>\n<p>The 2019 BIS product manual specified 50 sanitary napkins. Confirm the sample quantity for the applicable 2025 standard before sending samples. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>Q5. Which tests were identified in the 2019 product manual?<\/h3>\n<p>The manual identifies type and shape, size, manufacture\/workmanship\/finish, pH value and ability to withstand pressure after absorption as tests possible to complete in one day. It also covers hygiene testing and biocompatibility-related requirements in its equipment section. &lt;Cite refs={[&#8220;turn614900view0&#8221;]}\/&gt;<\/p>\n<h3>Q6. Is biocompatibility testing mandatory?<\/h3>\n<p>The 2019 product manual describes biocompatibility evaluation as optional for the licence scope. If the manufacturer wants biocompatibility included, conformity must be established under the applicable requirements. Check the 2025 standard and current product manual before relying on the older provision. &lt;Cite refs={[&#8220;turn614900view0&#8243;,&#8221;turn699036search20&#8221;]}\/&gt;<\/p>\n<h3>Q7. Can one BIS licence cover multiple sanitary napkin varieties?<\/h3>\n<p>The 2019 manual contains grouping provisions for thick and thin sanitary napkins, but the approved scope depends on the manufacturer&#8217;s manufacturing and testing capabilities. For new applications, confirm the grouping provisions under the current 2025 standard. &lt;Cite refs={[&#8220;turn614900view0&#8243;,&#8221;turn614900search0&#8221;]}\/&gt;<\/p>\n<h3>Q8. How much does BIS certification cost?<\/h3>\n<p>The total varies with the applicable BIS fees, product scope, laboratory tests, sample requirements and factory readiness. Verify current charges through BIS and the relevant laboratory.<\/p>\n<h3>Q9. How long does certification take?<\/h3>\n<p>The timeline depends on application completeness, product testing, inspection, laboratory availability and any corrective actions. A product-specific assessment is needed for a reliable estimate.<\/p>\n<h3>Q10. Can a manufacturer use the ISI Mark after submitting an application?<\/h3>\n<p>No. The Standard Mark may be used only after the applicable BIS licence has been granted and in accordance with the approved licence scope and conditions.<\/p>\n<h3>Q11. Are there exemptions under the Medical Textiles QCO?<\/h3>\n<p>The original order includes provisions concerning goods meant for export and specified products manufactured by eligible Self-Help Groups. Manufacturers should verify the exact current order, amendments and applicability before relying on an exemption. &lt;Cite refs={[&#8220;turn614900search7&#8243;,&#8221;turn614900search5&#8243;,&#8221;turn614900search6&#8221;]}\/&gt;<\/p>\n<h2>15. BIS Certification Consultancy for Sanitary Napkins<\/h2>\n<p>BIS certification requires careful planning of the product scope, raw materials, manufacturing processes, testing programme and regulatory documentation. The transition from IS 5405:2019 to IS 5405:2025 makes it particularly important for manufacturers to verify the current requirements before applying.<\/p>\n<p><strong>Qualitance India<\/strong> supports manufacturers with BIS product certification and regulatory compliance consultancy.<\/p>\n<p>Our assistance may include:<\/p>\n<ul>\n<li>Preliminary review of the applicable Indian Standard and QCO.<\/li>\n<li>Product-scope planning and documentation preparation.<\/li>\n<li>Raw material and quality-control document review.<\/li>\n<li>Sample planning and laboratory coordination.<\/li>\n<li>Factory-readiness assessment.<\/li>\n<li>Application coordination and support in responding to observations.<\/li>\n<\/ul>\n<p>The final certification requirements, testing programme, fee schedule and timeline must be confirmed for the specific product and manufacturing unit.<\/p>\n<h3>Contact Qualitance India<\/h3>\n<p><strong>Qualitance India \u2014 Improving Quality &amp; Competence<\/strong><\/p>\n<ul>\n<li><strong>Call \/ WhatsApp:<\/strong> +91 93106 15170<\/li>\n<li><strong>Email:<\/strong> <a href=\"mailto:info@qualitanceindia.com\">info@qualitanceindia.com<\/a><\/li>\n<li><strong>Website:<\/strong> <a href=\"https:\/\/qualitanceindia.com\/\">https:\/\/qualitanceindia.com<\/a><\/li>\n<\/ul>\n<p>Contact us to discuss your sanitary napkin product range and the applicable BIS certification requirements.<\/p>\n<h2>Official References<\/h2>\n<ol start=\"1\">\n<li><a href=\"https:\/\/standards.bis.gov.in\/website\/standard-details\">BIS Standard Details \u2014 IS 5405:2025<\/a><\/li>\n<li><a href=\"https:\/\/www.bis.gov.in\/wp-content\/uploads\/2020\/09\/Revised-PM-IS-5405.pdf\">BIS Product Manual \u2014 Sanitary Napkins, IS 5405:2019<\/a><\/li>\n<li><a href=\"https:\/\/www.bis.gov.in\/wp-content\/uploads\/2023\/10\/Medical-Textiles-QCO-2023.pdf\">Medical Textiles (Quality Control) Order, 2023<\/a><\/li>\n<li><a href=\"https:\/\/texmin.gov.in\/\">Ministry of Textiles \u2014 Medical Textiles QCO information<\/a><\/li>\n<li><a href=\"https:\/\/www.bis.gov.in\/wp-content\/uploads\/2025\/07\/MEDICAL-TEXTILES-QUALITY-CONTROL-SECOND-AMENDMENT-ORDER-2025.pdf\">Medical Textiles QCO Second Amendment Order, 2025<\/a><\/li>\n<li><a href=\"https:\/\/www.bis.gov.in\/product-certification\/products-under-compulsory-certification\/\">BIS Products Under Compulsory Certification<\/a><\/li>\n<li><a href=\"https:\/\/lims.bis.gov.in\/\">BIS Laboratory Information Management System<\/a><\/li>\n<\/ol>\n<p><strong>Disclaimer:<\/strong> This article is for general information and preliminary compliance planning. IS 5405:2025 supersedes IS 5405:2019 in the BIS catalogue. Before applying, verify the current standard, product manual, Quality Control Order, amendments, exemptions, sampling requirements and fee schedule with the official sources.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Important Update: IS 5405:2019 Has Been Superseded This article explains the certification framework associated with IS 5405:2019. However, the BIS standards catalogue now lists IS 5405:2025 \u2014 Disposable Sanitary Napkin\/Panty Liner\/Maternity Pad\/Period Panty \u2014 Specification (Third Revision) and identifies it as mandatory certification. IS 5405:2025 supersedes IS 5405:2019. Manufacturers planning a new BIS application in [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4360,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"inline_featured_image":false,"slim_seo":{"title":"BIS Certification for Sanitary Napkins | IS 5405:2019 \u2014 Requirements, Testing and ISI Mark -Qualitance - Qualitance India","description":"Important Update: IS 5405:2019 Has Been Superseded This article explains the certification framework associated with IS 5405:2019. 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