Bed sheets and pillow covers are widely used in hospitals, healthcare facilities, medical institutions and other environments where hygiene and controlled textile performance are important. For medical applications, these products are required to meet specific requirements relating to fabric quality, physical performance, cleanliness and other characteristics.<\/p>\n
IS 17630:2021 \u2013 Medical Textiles \u2013 Bed Sheet and Pillow Cover \u2013 Specification<\/strong> specifies requirements for bed sheet and pillow cover products intended for medical textile applications. BIS has issued a Product Manual for this standard, and certification is operated under Scheme-I of the BIS Conformity Assessment Regulations, 2018<\/strong>.<\/p>\n The standard covers bed sheets and pillow covers manufactured from spunlace and\/or spunbond non-woven fabric or woven fabric made from cotton, polyester or their blends<\/strong>. The BIS Product Manual also provides requirements relating to raw materials, fabric, performance and testing.<\/p>\n Manufacturers supplying these products to the medical and institutional sector should understand the requirements of IS 17630:2021 before beginning the BIS certification process.<\/p>\n IS 17630:2021 deals with Medical Textiles \u2013 Bed Sheet and Pillow Cover<\/strong>.<\/p>\n These products are designed for applications where the textile needs to meet specified requirements beyond ordinary household bedding.<\/p>\n The products may be manufactured using:<\/p>\n The BIS Product Manual specifically identifies these material options for manufacturing bed sheet and pillow cover sets.<\/p>\n IS 17630:2021<\/strong> is titled:<\/p>\n Medical Textiles \u2013 Bed Sheet and Pillow Cover \u2013 Specification<\/strong><\/p>\n The standard provides requirements for the relevant medical textile bed sheet and pillow cover products.<\/p>\n The BIS Product Manual identifies two amendments<\/strong> to the standard in its August 2024 revision.<\/p>\n The standard is included within India’s medical textile certification framework.<\/p>\n IS 17630:2021 establishes requirements for bed sheet and pillow cover products used as medical textiles.<\/p>\n The requirements cover areas such as:<\/p>\n The current BIS LIMS listings show testing against these different clauses of IS 17630:2021.<\/p>\n The BIS Product Manual states that the bed sheet and pillow cover shall be made from:<\/p>\n The fabric may be made from:<\/p>\n For reusable bed sheet and pillow cover sets, the fabric is required to meet the applicable requirements specified in the standard.<\/p>\n Raw-material conformity may be established through suitable supplier certificates or test reports from recognised\/accredited laboratories, as permitted under the Product Manual.<\/p>\n Depending on the manufacturer’s product range, the certification scope may cover:<\/p>\n Medical-use bed sheets manufactured according to the applicable requirements of IS 17630:2021.<\/p>\n Medical-use pillow covers manufactured according to the applicable requirements.<\/p>\n Products supplied together as a set can also be considered according to the applicable requirements and grouping provisions.<\/p>\n Manufacturers should determine the exact licence scope before sample testing.<\/p>\n Cotton fabrics may be used for manufacturing covered products where they meet the applicable requirements.<\/p>\n Polyester fabrics can also be used.<\/p>\n Blended fabrics consisting of cotton and polyester are included within the raw-material provisions identified by the BIS Product Manual.<\/p>\n Spunlace and spunbond non-woven fabrics are also identified as applicable material options.<\/p>\n The finished bed sheet and pillow cover should have suitable workmanship and finish according to the requirements of the standard.<\/p>\n Colour fastness requirements include testing related to:<\/p>\n Current BIS LIMS listings show these tests under the general requirements of IS 17630:2021.<\/p>\n The dimensional stability of the fabric after washing is also evaluated.<\/p>\n The fabric is evaluated for pilling resistance as applicable.<\/p>\n Tensile strength is one of the performance characteristics listed in the BIS laboratory scope.<\/p>\n Bursting strength is also included among the performance requirements.<\/p>\n Seam strength is evaluated under dry and wet conditions according to the applicable requirements.<\/p>\n The pH of the product is also tested.<\/p>\n The applicable quantity of water-soluble substances is evaluated.<\/p>\n Microbial cleanliness is an important requirement for these medical textile products, and BIS laboratory listings include microbial cleanliness testing.<\/p>\n Testing plays an important role in obtaining BIS certification for bed sheets and pillow covers.<\/p>\n Current BIS LIMS listings identify testing under IS 17630:2021 for characteristics including:<\/p>\n \n The exact testing programme should be determined according to the current standard, applicable amendments, Product Manual and proposed product scope.<\/p>\n BIS LIMS currently lists laboratories having testing facilities for IS 17630:2021 Medical Textiles Bed Sheet and Pillow Cover Specification<\/strong>.<\/p>\n Laboratory charges vary according to the laboratory and testing scope.<\/p>\n For example, one current listing shows an overall listed testing charge of \u20b910,050 excluding taxes<\/strong>, with individual charges for different tests. Another listing shows \u20b98,550<\/strong> for its listed scope, while another laboratory listing shows a substantially higher charge where a broader testing scope is available.<\/p>\n Therefore, manufacturers should confirm the current testing scope and quotation with the selected laboratory before submitting samples.<\/p>\n The earlier BIS Product Manual specifies a sample size of:<\/p>\n 2 packs<\/strong><\/p>\n for IS 17630:2021.<\/p>\n However, the current revised Product Manual should be referred to before sample submission because BIS Product Manuals can be revised.<\/p>\n Manufacturers should ensure that samples represent the actual product proposed for certification.<\/p>\n Product grouping is important when a manufacturer produces different:<\/p>\n The BIS Product Manual provides grouping guidance under Annex A<\/strong>.<\/p>\n Before testing, manufacturers should identify the products that need to be covered under the proposed licence and determine the appropriate grouping and sample requirements.<\/p>\n The current BIS Product Manual states that the raw material is required to conform to applicable Biocompatibility Evaluation<\/strong> requirements and Moisture Vapour Transmission Rate<\/strong>, where applicable, under Clause 7.1.<\/p>\n This is particularly important because these products are classified as medical textiles.<\/p>\n Manufacturers should therefore maintain suitable raw-material information and supporting test documentation.<\/p>\n A typical manufacturing process may include:<\/p>\n Cotton, polyester, blended or applicable non-woven fabric is selected.<\/p>\n The fabric is checked against the applicable raw-material requirements.<\/p>\n The fabric is processed, cut and prepared according to the required product dimensions.<\/p>\n Fabric is cut according to bed sheet and pillow cover dimensions.<\/p>\n The components are stitched using appropriate methods.<\/p>\n Edges and seams are finished appropriately.<\/p>\n Where applicable, required finishing operations are performed.<\/p>\n Finished products are inspected for:<\/p>\n Samples are tested against applicable requirements of IS 17630:2021.<\/p>\n The finished products are packed and identified as required.<\/p>\n During BIS factory assessment, the manufacturing unit may be reviewed for:<\/p>\n Verification of fabric composition and supplier records.<\/p>\n Inspection of cutting, stitching and finishing equipment.<\/p>\n Review of the complete manufacturing process.<\/p>\n Checking incoming, in-process and finished-product inspection.<\/p>\n Verification of available testing and measuring equipment.<\/p>\n Review of calibration records for applicable equipment.<\/p>\n Checking product sizes, compositions and other relevant details.<\/p>\n Verification of production, inspection and test records.<\/p>\n Review of packaging and marking arrangements.<\/p>\n A manufacturer should maintain suitable controls for:<\/p>\n Good quality control helps manufacturers maintain consistent product quality between production batches.<\/p>\n Common documents may include:<\/p>\n The exact documentation depends on the manufacturer’s production setup and proposed licence scope.<\/p>\n The Medical Textiles (Quality Control) Order<\/strong> includes Bedsheet and Pillow Cover<\/strong> against IS 17630:2021 \u2013 Medical Textiles \u2013 Bed sheet and pillow cover \u2013 Specification<\/strong>.<\/p>\n The 2024 notification lists the implementation timeline for Bedsheet and Pillow Cover as \u201cNone\u201d<\/strong> in the schedule.<\/p>\n Because regulatory notifications can be amended, manufacturers should verify the latest applicable notification before relying on a specific compliance date.<\/p>\n Manufacturers involved in producing medical textile bed sheets and pillow covers covered by IS 17630:2021 may need to obtain BIS certification according to the applicable regulatory requirements.<\/p>\n This can include:<\/p>\n Importers should separately verify the current requirements applicable to imported products.<\/p>\n A manufacturer should generally have:<\/p>\n Manufacturers may face delays because of:<\/p>\n Proper preparation before applying can help reduce avoidable delays.<\/p>\n After successful grant of the BIS licence, the manufacturer can use the applicable BIS Standard Mark and licence number (CM\/L)<\/strong> according to BIS certification conditions.<\/p>\n The Standard Mark should only be used on products covered by the approved licence scope and according to the applicable marking requirements.<\/p>\n The total cost can depend on:<\/p>\n Laboratory charges vary significantly depending on the testing scope and laboratory. Current BIS LIMS listings demonstrate this variation.<\/p>\n The time required can depend on:<\/p>\n Manufacturers with multiple fabric compositions or product variants should plan their certification scope carefully before submitting samples.<\/p>\n Testing verifies important physical, chemical and performance characteristics.<\/p>\n Certification helps manufacturers demonstrate conformity with the applicable Indian Standard.<\/p>\n Hospitals and institutional buyers can have greater confidence in certified products.<\/p>\n BIS certification supports market access where the applicable regulatory framework requires certification.<\/p>\n Quality-control requirements encourage consistency across production batches.<\/p>\n The certification process encourages manufacturers to maintain proper production and quality records.<\/p>\n BIS certification can strengthen the credibility of manufacturers supplying medical and institutional textiles.<\/p>\n Qualitance India<\/strong> provides BIS certification consultancy for manufacturers across various product categories and Indian Standards.<\/p>\n For Bed Sheet and Pillow Cover as per IS 17630:2021<\/strong>, assistance can include:<\/p>\n Qualitance India<\/strong><\/p>\n Phone:<\/strong> +91-9310-615-170 Product Identification<\/strong> IS 17630:2021 is the Indian Standard titled Medical Textiles \u2013 Bed Sheet and Pillow Cover \u2013 Specification<\/strong>.<\/p>\n Yes, the standard specifically covers medical textile bed sheets and pillow covers.<\/p>\n The Product Manual identifies spunlace, spunbond non-woven or woven fabrics made from cotton, polyester or their blends.<\/p>\n Yes. Pillow covers are specifically included in the title and scope of the standard.<\/p>\n Tests can include colour fastness, dimensional stability, pilling, tensile strength, bursting strength, seam strength, pH, water-soluble substances and microbial cleanliness, among others.<\/p>\n Yes. Current BIS laboratory listings include microbial cleanliness testing under the standard.<\/p>\n Colour fastness to rubbing, perspiration, washing and light is included in the listed testing scope.<\/p>\n Yes. Tensile strength under dry and wet conditions is included among the performance requirements.<\/p>\n Yes. The BIS LIMS testing scope includes seam strength under dry and wet conditions.<\/p>\n Yes, pH is included among the performance requirements.<\/p>\n The earlier Product Manual specifies 2 packs<\/strong> as the sample size. The current revised Product Manual should be checked before sample submission.<\/p>\n Yes. Grouping guidelines are provided in the Product Manual under Annex A.<\/p>\n Factory assessment forms part of the applicable BIS certification process under Scheme-I.<\/p>\n Suitable testing and measuring arrangements are required according to the applicable certification requirements.<\/p>\n IS 17630:2021 specifically addresses Medical Textiles \u2013 Bed Sheet and Pillow Cover<\/strong>. Applicability to an ordinary household product should therefore be assessed based on the product’s intended use and the current regulatory requirements.<\/p>\n Bedsheet and Pillow Cover are listed under the Medical Textiles Quality Control Order against IS 17630:2021.<\/p>\n The 2024 Medical Textiles QCO schedule lists the timeline for Bedsheet and Pillow Cover as None<\/strong>.<\/p>\n Testing charges vary by laboratory and scope. Current BIS LIMS listings show examples such as \u20b910,050, \u20b98,550 and \u20b946,240 for different laboratory scopes.<\/p>\n Yes. Qualitance India can assist with product assessment, documentation, testing coordination, BIS application and factory inspection preparation.<\/p>\n You can begin by sharing the fabric type, fibre composition, product dimensions, manufacturing process, product variants and available testing facilities.<\/p>\n It is the certification process for bed sheets falling within the applicable scope of IS 17630:2021 and the relevant regulatory requirements.<\/p>\n IS 17630:2021 is the Indian Standard for Medical Textiles \u2013 Bed Sheet and Pillow Cover \u2013 Specification<\/strong>.<\/p>\n The applicable requirement depends on the current regulatory framework for medical textiles. Bedsheet and Pillow Cover are listed in the Medical Textiles Quality Control Order against IS 17630:2021.<\/p>\n The Product Manual identifies woven, spunlace and spunbond non-woven fabrics made from cotton, polyester or their blends.<\/p>\n Testing can include colour fastness, dimensional stability, pilling, tensile strength, bursting strength, seam strength, pH, water-soluble substances and microbial cleanliness.<\/p>\n It is conformity assessment of applicable medical bed sheet and pillow cover products against IS 17630:2021.<\/p>\n BED SHEET & PILLOW COVER<\/strong><\/p>\n IS 17630:2021<\/strong><\/p>\n BIS CERTIFICATION CONSULTANCY<\/strong><\/p>\n MEDICAL TEXTILES<\/strong><\/p>\n Qualitance India<\/strong><\/p>\n +91-9310-615-170<\/strong> If you manufacture Medical Textile Bed Sheets and Pillow Covers<\/strong> covered under IS 17630:2021<\/strong>, proper assessment of your fabric, fibre composition, product variants, testing facilities and quality-control system is important.<\/p>\n Qualitance India<\/strong> can assist manufacturers with product assessment, product grouping, documentation, laboratory coordination, BIS application and factory inspection preparation.<\/p>\n Qualitance India<\/strong> Contact Qualitance India for assistance with BIS Certification for Bed Sheet and Pillow Cover as per IS 17630:2021.<\/strong><\/p>\n IS 17630:2021 \u2013 Medical Textiles \u2013 Bed Sheet and Pillow Cover \u2013 Specification<\/strong> provides requirements for bed sheets and pillow covers intended for medical textile applications. The standard covers products made from woven, spunlace or spunbond non-woven fabrics using cotton, polyester or their blends.<\/p>\n The certification process involves assessment of the product and raw materials, applicable testing, documentation, factory assessment and conformity evaluation. Important performance characteristics include colour fastness, dimensional stability, tensile strength, bursting strength, seam strength, pH and microbial cleanliness.<\/p>\n Bedsheet and Pillow Cover are also listed under the Medical Textiles Quality Control Order against IS 17630:2021<\/strong>, making it important for manufacturers to verify the latest applicable regulatory requirements before placing products in the market.<\/p>\n With proper preparation of technical documents, samples, testing arrangements and factory records, manufacturers can make the certification process more systematic.<\/p>\n Qualitance India<\/strong> can assist manufacturers with the BIS certification process for Bed Sheet and Pillow Cover as per IS 17630:2021<\/strong>, from initial product assessment through testing, documentation and factory inspection preparation.<\/p>\n","protected":false},"excerpt":{"rendered":" Introduction Bed sheets and pillow covers are widely used in hospitals, healthcare facilities, medical institutions and other environments where hygiene and controlled textile performance are important. For medical applications, these products are required to meet specific requirements relating to fabric quality, physical performance, cleanliness and other characteristics. IS 17630:2021 \u2013 Medical Textiles \u2013 Bed Sheet […]<\/p>\n","protected":false},"author":1,"featured_media":3482,"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 Bed Sheet and Pillow Cover | IS 17630:2021 BIS Consultancy - Qualitance India","description":"Introduction Bed sheets and pillow covers are widely used in hospitals, healthcare facilities, medical institutions and other environments where hygiene and con"},"_slim_seo_primary_term_category":0,"_slim_seo_primary_term_post_tag":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3481","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/posts\/3481","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/comments?post=3481"}],"version-history":[{"count":1,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/posts\/3481\/revisions"}],"predecessor-version":[{"id":3483,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/posts\/3481\/revisions\/3483"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/media\/3482"}],"wp:attachment":[{"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/media?parent=3481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/categories?post=3481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/qualitanceindia.com\/wp-json\/wp\/v2\/tags?post=3481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nAbout Bed Sheet and Pillow Cover under IS 17630:2021<\/h1>\n
\n
\nWhat is IS 17630:2021?<\/h1>\n
\nScope of IS 17630:2021<\/h1>\n
\n
\nRaw Materials<\/h1>\n
\n
\n
\nTypes of Products<\/h1>\n
Bed Sheets<\/h3>\n
Pillow Covers<\/h3>\n
Bed Sheet and Pillow Cover Sets<\/h3>\n
\nMaterial Options<\/h1>\n
Cotton<\/h2>\n
Polyester<\/h2>\n
Cotton-Polyester Blend<\/h2>\n
Non-Woven Fabric<\/h2>\n
\nImportant Requirements<\/h1>\n
Workmanship and Finish<\/h2>\n
Colour Fastness<\/h2>\n
\n
Dimensional Stability<\/h2>\n
Pilling Resistance<\/h2>\n
Tensile Strength<\/h2>\n
Bursting Strength<\/h2>\n
Seam Strength<\/h2>\n
pH<\/h2>\n
Water-Soluble Substance<\/h2>\n
Microbial Cleanliness<\/h2>\n
\nTesting Requirements<\/h1>\n
\n
\nLaboratory Testing<\/h1>\n
\nSample Requirements<\/h1>\n
\nProduct Grouping<\/h1>\n
\n
\nBiocompatibility Requirements<\/h1>\n
\nManufacturing Process<\/h1>\n
1. Raw Material Selection<\/h3>\n
2. Incoming Inspection<\/h3>\n
3. Fabric Processing<\/h3>\n
4. Cutting<\/h3>\n
5. Stitching<\/h3>\n
6. Seam Finishing<\/h3>\n
7. Washing\/Finishing<\/h3>\n
8. Inspection<\/h3>\n
\n
9. Laboratory Testing<\/h3>\n
10. Packing<\/h3>\n
\nFactory Inspection<\/h1>\n
Raw Materials<\/h3>\n
Manufacturing Machinery<\/h3>\n
Production Process<\/h3>\n
Quality Control<\/h3>\n
Testing Facilities<\/h3>\n
Calibration<\/h3>\n
Product Identification<\/h3>\n
Records<\/h3>\n
Packing and Marking<\/h3>\n
\nQuality Control<\/h1>\n
\n
\nDocuments Required<\/h1>\n
\n
\nQCO and Regulatory Requirement<\/h1>\n
\nWho Needs BIS Certification?<\/h1>\n
\n
\nEligibility Requirements<\/h1>\n
\n
\nCommon Reasons for Certification Delays<\/h1>\n
\n
\nBIS Marking<\/h1>\n
\nCost of BIS Certification<\/h1>\n
\n
\nCertification Timeline<\/h1>\n
\n
\nBenefits of BIS Certification<\/h1>\n
Product Quality<\/h3>\n
Medical Textile Compliance<\/h3>\n
Customer Confidence<\/h3>\n
Market Acceptance<\/h3>\n
Consistent Manufacturing<\/h3>\n
Better Documentation<\/h3>\n
Business Credibility<\/h3>\n
\nWhy Choose Qualitance India?<\/h1>\n
\n
Email:<\/strong> info@qualitanceindia.com<\/a>
Website:<\/strong> https:\/\/qualitanceindia.com\/<\/a><\/p>\n
\nBIS Certification Process<\/h1>\n
\u2193
IS 17630:2021 Requirement Review<\/strong>
\u2193
Fabric & Raw Material Assessment<\/strong>
\u2193
Product Scope & Grouping Review<\/strong>
\u2193
Factory & Testing Facility Assessment<\/strong>
\u2193
Documentation Preparation<\/strong>
\u2193
Sample Preparation<\/strong>
\u2193
Laboratory Testing<\/strong>
\u2193
BIS Application<\/strong>
\u2193
BIS Scrutiny<\/strong>
\u2193
Factory Assessment<\/strong>
\u2193
Test Report Evaluation<\/strong>
\u2193
Observation Closure<\/strong>
\u2193
BIS Licence Grant<\/strong>
\u2193
BIS Standard Mark<\/strong><\/p>\n
\nFrequently Asked Questions<\/h1>\n
1. What is IS 17630:2021?<\/h3>\n
2. Is IS 17630 applicable to medical bed sheets?<\/h3>\n
3. What materials can be used?<\/h3>\n
4. Are pillow covers covered under IS 17630?<\/h3>\n
5. What tests are performed?<\/h3>\n
6. Is microbial cleanliness tested?<\/h3>\n
7. Is colour-fastness testing required?<\/h3>\n
8. Is tensile strength tested?<\/h3>\n
9. Is seam strength tested?<\/h3>\n
10. Is pH tested?<\/h3>\n
11. What is the sample requirement?<\/h3>\n
12. Is product grouping applicable?<\/h3>\n
13. Is factory inspection required?<\/h3>\n
14. Does the manufacturer need testing facilities?<\/h3>\n
15. Is BIS certification applicable to ordinary household bed sheets?<\/h3>\n
16. Is there a QCO for these products?<\/h3>\n
17. What is the implementation date?<\/h3>\n
18. What is the BIS testing cost?<\/h3>\n
19. Can Qualitance India help with IS 17630 certification?<\/h3>\n
20. How can I start BIS certification for medical bed sheets?<\/h3>\n
\nPeople Also Ask<\/h1>\n
What is BIS certification for bed sheets?<\/h3>\n
What is IS 17630?<\/h3>\n
Is BIS certification mandatory for medical bed sheets?<\/h3>\n
What fabric is used for medical bed sheets?<\/h3>\n
What tests are required for medical bed sheets?<\/h3>\n
What is medical textile bed sheet certification?<\/h3>\n
\nWebsite Image Text<\/h1>\n
info@qualitanceindia.com<\/a><\/strong>
qualitanceindia.com<\/strong><\/p>\n
\nImage Text Suggestions<\/h1>\n
\n
\nRelated Services<\/h1>\n
\n
\nRelated Topics for Your Website<\/h1>\n
\n
\nNeed BIS Certification for Bed Sheet and Pillow Cover?<\/h1>\n
Phone:<\/strong> +91-9310-615-170
Email:<\/strong> info@qualitanceindia.com<\/a>
Website:<\/strong> https:\/\/qualitanceindia.com\/<\/a><\/p>\n
\nConclusion<\/h1>\n