BIS Certification for Bed Sheet and Pillow Cover | IS 17630:2021 BIS Consultancy

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 – Medical Textiles – Bed Sheet and Pillow Cover – Specification 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.

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. The BIS Product Manual also provides requirements relating to raw materials, fabric, performance and testing.

Manufacturers supplying these products to the medical and institutional sector should understand the requirements of IS 17630:2021 before beginning the BIS certification process.

About Bed Sheet and Pillow Cover under IS 17630:2021

IS 17630:2021 deals with Medical Textiles – Bed Sheet and Pillow Cover.

These products are designed for applications where the textile needs to meet specified requirements beyond ordinary household bedding.

The products may be manufactured using:

Cotton fabric
Polyester fabric
Cotton-polyester blends
Woven fabric
Spunlace non-woven fabric
Spunbond non-woven fabric

The BIS Product Manual specifically identifies these material options for manufacturing bed sheet and pillow cover sets.

What is IS 17630:2021?

IS 17630:2021 is titled:

Medical Textiles – Bed Sheet and Pillow Cover – Specification

The standard provides requirements for the relevant medical textile bed sheet and pillow cover products.

The BIS Product Manual identifies two amendments to the standard in its August 2024 revision.

The standard is included within India's medical textile certification framework.

Scope of IS 17630:2021

IS 17630:2021 establishes requirements for bed sheet and pillow cover products used as medical textiles.

The requirements cover areas such as:

Workmanship and finish
Fabric characteristics
Colour fastness
Dimensional stability
Pilling resistance
Scouring loss where applicable
Tensile strength
Bursting strength
Seam strength
pH
Water-soluble substances
Microbial cleanliness

The current BIS LIMS listings show testing against these different clauses of IS 17630:2021.

Raw Materials

The BIS Product Manual states that the bed sheet and pillow cover shall be made from:

Spunlace non-woven fabric
Spunbond non-woven fabric
Woven fabric

The fabric may be made from:

Cotton
Polyester
Cotton and polyester blends

For reusable bed sheet and pillow cover sets, the fabric is required to meet the applicable requirements specified in the standard.

Raw-material conformity may be established through suitable supplier certificates or test reports from recognised/accredited laboratories, as permitted under the Product Manual.

Types of Products

Depending on the manufacturer's product range, the certification scope may cover:

Bed Sheets

Medical-use bed sheets manufactured according to the applicable requirements of IS 17630:2021.

Pillow Covers

Medical-use pillow covers manufactured according to the applicable requirements.

Bed Sheet and Pillow Cover Sets

Products supplied together as a set can also be considered according to the applicable requirements and grouping provisions.

Manufacturers should determine the exact licence scope before sample testing.

Material Options

Cotton

Cotton fabrics may be used for manufacturing covered products where they meet the applicable requirements.

Polyester

Polyester fabrics can also be used.

Cotton-Polyester Blend

Blended fabrics consisting of cotton and polyester are included within the raw-material provisions identified by the BIS Product Manual.

Non-Woven Fabric

Spunlace and spunbond non-woven fabrics are also identified as applicable material options.

Important Requirements

Workmanship and Finish

The finished bed sheet and pillow cover should have suitable workmanship and finish according to the requirements of the standard.

Colour Fastness

Colour fastness requirements include testing related to:

Rubbing
Perspiration
Washing
Light

Current BIS LIMS listings show these tests under the general requirements of IS 17630:2021.

Dimensional Stability

The dimensional stability of the fabric after washing is also evaluated.

Pilling Resistance

The fabric is evaluated for pilling resistance as applicable.

Tensile Strength

Tensile strength is one of the performance characteristics listed in the BIS laboratory scope.

Bursting Strength

Bursting strength is also included among the performance requirements.

Seam Strength

Seam strength is evaluated under dry and wet conditions according to the applicable requirements.

pH

The pH of the product is also tested.

Water-Soluble Substance

The applicable quantity of water-soluble substances is evaluated.

Microbial Cleanliness

Microbial cleanliness is an important requirement for these medical textile products, and BIS laboratory listings include microbial cleanliness testing.

Testing Requirements

Testing plays an important role in obtaining BIS certification for bed sheets and pillow covers.

Current BIS LIMS listings identify testing under IS 17630:2021 for characteristics including:

Workmanship and finish
Fabric washing and tumble drying
Colour fastness to rubbing
Colour fastness to perspiration
Colour fastness to washing
Colour fastness to light
Dimensional stability
Pilling resistance
Scouring loss for cotton
Tensile strength
Bursting strength
Seam strength
pH
Water-soluble substances
Microbial cleanliness
Marking

The exact testing programme should be determined according to the current standard, applicable amendments, Product Manual and proposed product scope.

Laboratory Testing

BIS LIMS currently lists laboratories having testing facilities for IS 17630:2021 Medical Textiles Bed Sheet and Pillow Cover Specification.

Laboratory charges vary according to the laboratory and testing scope.

For example, one current listing shows an overall listed testing charge of ₹10,050 excluding taxes, with individual charges for different tests. Another listing shows ₹8,550 for its listed scope, while another laboratory listing shows a substantially higher charge where a broader testing scope is available.

Therefore, manufacturers should confirm the current testing scope and quotation with the selected laboratory before submitting samples.

Sample Requirements

The earlier BIS Product Manual specifies a sample size of:

2 packs

for IS 17630:2021.

However, the current revised Product Manual should be referred to before sample submission because BIS Product Manuals can be revised.

Manufacturers should ensure that samples represent the actual product proposed for certification.

Product Grouping

Product grouping is important when a manufacturer produces different:

Bed sheet sizes
Pillow cover sizes
Fabric compositions
Construction types
Product variants

The BIS Product Manual provides grouping guidance under Annex A.

Before testing, manufacturers should identify the products that need to be covered under the proposed licence and determine the appropriate grouping and sample requirements.

Biocompatibility Requirements

The current BIS Product Manual states that the raw material is required to conform to applicable Biocompatibility Evaluation requirements and Moisture Vapour Transmission Rate, where applicable, under Clause 7.1.

This is particularly important because these products are classified as medical textiles.

Manufacturers should therefore maintain suitable raw-material information and supporting test documentation.

Manufacturing Process

A typical manufacturing process may include:

1. Raw Material Selection

Cotton, polyester, blended or applicable non-woven fabric is selected.

2. Incoming Inspection

The fabric is checked against the applicable raw-material requirements.

3. Fabric Processing

The fabric is processed, cut and prepared according to the required product dimensions.

4. Cutting

Fabric is cut according to bed sheet and pillow cover dimensions.

5. Stitching

The components are stitched using appropriate methods.

6. Seam Finishing

Edges and seams are finished appropriately.

7. Washing/Finishing

Where applicable, required finishing operations are performed.

8. Inspection

Finished products are inspected for:

Dimensions
Workmanship
Stitching
Finish
Defects
Colour
General appearance

9. Laboratory Testing

Samples are tested against applicable requirements of IS 17630:2021.

10. Packing

The finished products are packed and identified as required.

Factory Inspection

During BIS factory assessment, the manufacturing unit may be reviewed for:

Raw Materials

Verification of fabric composition and supplier records.

Manufacturing Machinery

Inspection of cutting, stitching and finishing equipment.

Production Process

Review of the complete manufacturing process.

Quality Control

Checking incoming, in-process and finished-product inspection.

Testing Facilities

Verification of available testing and measuring equipment.

Calibration

Review of calibration records for applicable equipment.

Product Identification

Checking product sizes, compositions and other relevant details.

Records

Verification of production, inspection and test records.

Packing and Marking

Review of packaging and marking arrangements.

Quality Control

A manufacturer should maintain suitable controls for:

Fabric composition
Fabric GSM where applicable
Fabric quality
Dimensions
Stitching
Seam strength
Colour
Washing performance
pH
Finished-product appearance
Microbial cleanliness
Batch identification
Test records

Good quality control helps manufacturers maintain consistent product quality between production batches.

Documents Required

Common documents may include:

Company registration documents
Factory address proof
Factory layout
Manufacturing process flow
Machinery list
Product specifications
Product drawings/dimensions
Fabric composition details
Raw-material specifications
Supplier test certificates
Internal test reports
Laboratory test reports
Testing equipment list
Calibration certificates
Quality-control plan
Production records
Inspection records
Product photographs
Packing details
Product marking details
Authorized signatory documents
Trademark documents, where applicable

The exact documentation depends on the manufacturer's production setup and proposed licence scope.

QCO and Regulatory Requirement

The Medical Textiles (Quality Control) Order includes Bedsheet and Pillow Cover against IS 17630:2021 – Medical Textiles – Bed sheet and pillow cover – Specification.

The 2024 notification lists the implementation timeline for Bedsheet and Pillow Cover as “None” in the schedule.

Because regulatory notifications can be amended, manufacturers should verify the latest applicable notification before relying on a specific compliance date.

Who Needs BIS Certification?

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.

This can include:

Medical textile manufacturers
Hospital linen manufacturers
Bed sheet manufacturers for medical applications
Pillow cover manufacturers
Healthcare textile suppliers
Hospital linen suppliers
Institutional textile manufacturers
Non-woven medical textile manufacturers
Cotton medical textile manufacturers
Polyester medical textile manufacturers

Importers should separately verify the current requirements applicable to imported products.

Eligibility Requirements

A manufacturer should generally have:

Suitable manufacturing premises
Fabric sourcing arrangements
Cutting facilities
Stitching facilities
Finishing facilities
Inspection arrangements
Testing facilities or permitted testing arrangements
Quality-control procedures
Calibration arrangements
Production records
Batch traceability
Competent technical personnel

Common Reasons for Certification Delays

Manufacturers may face delays because of:

Incorrect product classification
Incorrect fabric composition
Incomplete raw-material records
Inadequate product specifications
Dimension failures
Colour-fastness failures
Tensile-strength failures
Seam-strength failures
pH non-conformity
Microbial cleanliness failure
Missing calibration certificates
Incomplete quality-control records
Incorrect samples
Factory not ready for inspection
Incomplete documentation
Incorrect marking

Proper preparation before applying can help reduce avoidable delays.

BIS Marking

After successful grant of the BIS licence, the manufacturer can use the applicable BIS Standard Mark and licence number (CM/L) according to BIS certification conditions.

The Standard Mark should only be used on products covered by the approved licence scope and according to the applicable marking requirements.

Cost of BIS Certification

The total cost can depend on:

BIS application charges
Laboratory testing
Number of product variants
Fabric compositions
Product grouping
Sample preparation
Factory inspection
Testing equipment
Calibration
Retesting
Documentation
Consultancy charges

Laboratory charges vary significantly depending on the testing scope and laboratory. Current BIS LIMS listings demonstrate this variation.

Certification Timeline

The time required can depend on:

Product scope
Documentation readiness
Sample availability
Laboratory availability
Testing results
BIS application processing
Factory readiness
Factory assessment
Closure of observations

Manufacturers with multiple fabric compositions or product variants should plan their certification scope carefully before submitting samples.

Benefits of BIS Certification

Product Quality

Testing verifies important physical, chemical and performance characteristics.

Medical Textile Compliance

Certification helps manufacturers demonstrate conformity with the applicable Indian Standard.

Customer Confidence

Hospitals and institutional buyers can have greater confidence in certified products.

Market Acceptance

BIS certification supports market access where the applicable regulatory framework requires certification.

Consistent Manufacturing

Quality-control requirements encourage consistency across production batches.

Better Documentation

The certification process encourages manufacturers to maintain proper production and quality records.

Business Credibility

BIS certification can strengthen the credibility of manufacturers supplying medical and institutional textiles.

Why Choose Qualitance India?

Qualitance India provides BIS certification consultancy for manufacturers across various product categories and Indian Standards.

For Bed Sheet and Pillow Cover as per IS 17630:2021, assistance can include:

Product applicability assessment
Product scope review
Fabric and raw-material assessment
Product grouping guidance
Documentation support
Testing requirement review
Laboratory coordination
Sample preparation guidance
BIS application assistance
Factory inspection preparation
Quality-control documentation
Test report coordination
Observation closure assistance
BIS licence support

Qualitance India

Phone: +91-9310-615-170
Email: info@qualitanceindia.com
Website: https://qualitanceindia.com/

BIS Certification Process

Product Identification
↓
IS 17630:2021 Requirement Review
↓
Fabric & Raw Material Assessment
↓
Product Scope & Grouping Review
↓
Factory & Testing Facility Assessment
↓
Documentation Preparation
↓
Sample Preparation
↓
Laboratory Testing
↓
BIS Application
↓
BIS Scrutiny
↓
Factory Assessment
↓
Test Report Evaluation
↓
Observation Closure
↓
BIS Licence Grant
↓
BIS Standard Mark

Frequently Asked Questions

1. What is IS 17630:2021?

IS 17630:2021 is the Indian Standard titled Medical Textiles – Bed Sheet and Pillow Cover – Specification.

2. Is IS 17630 applicable to medical bed sheets?

Yes, the standard specifically covers medical textile bed sheets and pillow covers.

3. What materials can be used?

The Product Manual identifies spunlace, spunbond non-woven or woven fabrics made from cotton, polyester or their blends.

4. Are pillow covers covered under IS 17630?

Yes. Pillow covers are specifically included in the title and scope of the standard.

5. What tests are performed?

Tests can include colour fastness, dimensional stability, pilling, tensile strength, bursting strength, seam strength, pH, water-soluble substances and microbial cleanliness, among others.

6. Is microbial cleanliness tested?

Yes. Current BIS laboratory listings include microbial cleanliness testing under the standard.

7. Is colour-fastness testing required?

Colour fastness to rubbing, perspiration, washing and light is included in the listed testing scope.

8. Is tensile strength tested?

Yes. Tensile strength under dry and wet conditions is included among the performance requirements.

9. Is seam strength tested?

Yes. The BIS LIMS testing scope includes seam strength under dry and wet conditions.

10. Is pH tested?

Yes, pH is included among the performance requirements.

11. What is the sample requirement?

The earlier Product Manual specifies 2 packs as the sample size. The current revised Product Manual should be checked before sample submission.

12. Is product grouping applicable?

Yes. Grouping guidelines are provided in the Product Manual under Annex A.

13. Is factory inspection required?

Factory assessment forms part of the applicable BIS certification process under Scheme-I.

14. Does the manufacturer need testing facilities?

Suitable testing and measuring arrangements are required according to the applicable certification requirements.

15. Is BIS certification applicable to ordinary household bed sheets?

IS 17630:2021 specifically addresses Medical Textiles – Bed Sheet and Pillow Cover. Applicability to an ordinary household product should therefore be assessed based on the product's intended use and the current regulatory requirements.

16. Is there a QCO for these products?

Bedsheet and Pillow Cover are listed under the Medical Textiles Quality Control Order against IS 17630:2021.

17. What is the implementation date?

The 2024 Medical Textiles QCO schedule lists the timeline for Bedsheet and Pillow Cover as None.

18. What is the BIS testing cost?

Testing charges vary by laboratory and scope. Current BIS LIMS listings show examples such as ₹10,050, ₹8,550 and ₹46,240 for different laboratory scopes.

19. Can Qualitance India help with IS 17630 certification?

Yes. Qualitance India can assist with product assessment, documentation, testing coordination, BIS application and factory inspection preparation.

20. How can I start BIS certification for medical bed sheets?

You can begin by sharing the fabric type, fibre composition, product dimensions, manufacturing process, product variants and available testing facilities.

Website Image Text

BED SHEET & PILLOW COVER

IS 17630:2021

BIS CERTIFICATION CONSULTANCY

MEDICAL TEXTILES

Qualitance India

+91-9310-615-170
info@qualitanceindia.com
qualitanceindia.com

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Need BIS Certification for Bed Sheet and Pillow Cover?

If you manufacture Medical Textile Bed Sheets and Pillow Covers covered under IS 17630:2021, proper assessment of your fabric, fibre composition, product variants, testing facilities and quality-control system is important.

Qualitance India can assist manufacturers with product assessment, product grouping, documentation, laboratory coordination, BIS application and factory inspection preparation.

Qualitance India
Phone: +91-9310-615-170
Email: info@qualitanceindia.com
Website: https://qualitanceindia.com/

Contact Qualitance India for assistance with BIS Certification for Bed Sheet and Pillow Cover as per IS 17630:2021.

Conclusion

IS 17630:2021 – Medical Textiles – Bed Sheet and Pillow Cover – Specification 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.

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.

Bedsheet and Pillow Cover are also listed under the Medical Textiles Quality Control Order against IS 17630:2021, making it important for manufacturers to verify the latest applicable regulatory requirements before placing products in the market.

With proper preparation of technical documents, samples, testing arrangements and factory records, manufacturers can make the certification process more systematic.

Qualitance India can assist manufacturers with the BIS certification process for Bed Sheet and Pillow Cover as per IS 17630:2021, from initial product assessment through testing, documentation and factory inspection preparation.