Hospital Quality Standards for Wound Dressing Plasters: CE, ISO & Sterility Requirements Explained

Why Certification Matters When Choosing a Trusted Wound-Care Supplier

For hospitals, clinics, and professional distributors, wound dressing plasters are not simple consumer products—they areregulated medical devicesthat directly impact patient safety, wound healing speed, and infection control.

Procurement teams must ensure that every dressing plaster—whether PE, PVC, non-woven, elastic cloth, or long-roll dressing—is compliant with international medical standards, safe for use, and manufactured under strict quality control.

This guide explains the hospital-grade requirements, including CE, ISO, sterility levels, raw material safety, and batch testing, and how TICARE® ensures its wound dressing plasters meet or exceed these standards.

1. Why Certification Matters for Wound Dressing Plasters

Dressing plasters make direct contact with wounds or healing skin. Without proper certification:

• Adhesives may cause dermatitis or irritation
• Pads may fail to absorb properly
• Fabric may shed fibers into wounds
• Non-sterile product may increase infection risk
• Product lifespan & adhesion may be inconsistent

Certification is a hospital’s first layer of risk control.

High-compliance suppliers reduce the risk of:

✔ patient complaints
✔ dressing failure
✔ cross-contamination
✔ litigation or regulatory penalties
✔ product recalls

This is why top hospitals only source from CE/ISO-certified suppliers.

2. CE Certification for Wound Dressing Plasters (EU Standard)

CE certification is required for medical devices sold in the European Union.
Wound dressing plasters fall intoClass I Medical Device, sometimesClass Isif sterile.

What CE Certification Ensures

A CE-marked dressing plaster must:

• Usebiocompatible materials(adhesive, fabric, absorbent pad)
• Passcytotoxicity, irritation, and skin-sensitivity tests
• Provide clearlabeling,lot numbers, andexpiry dates
• FollowEN ISO 10993testing for patient-contact materials
• Meet EUMDR 2017/745regulations for safety and traceability

TICARE® Compliance

TICARE® wound dressing plasters pass:

✔ Biocompatibility
✔ Adhesive safety tests
✔ Absorbency performance
✔ Peel strength validation
✔ Product labeling and traceability requirements

3. ISO13485: The Global Standard for Medical Device Manufacturing

Hospitals and procurement teams increasingly treatISO13485as a mandatory benchmark.

Why ISO13485 Matters

It ensures the manufacturer:

• Has strictquality management systems
• Maintainsconsistent raw materials
• Performsbatch-level QC testing
• Tracks every lot viatraceability systems
• Follows standardizedproduction & documentation procedures

In other words, ISO13485 guaranteespredictablequality—which hospitals rely on.

TICARE® Manufacturing Advantages

TICARE® is ISO13485-certified and offers:

✔ Stable long-term adhesive formulas
✔ Consistent pad absorbency
✔ Controlled material thickness and flexibility
✔ Documented quality inspections at each stage
✔ Reliable long-term supply for hospitals & distributors

4. Sterility Requirements: Sterile vs Non-Sterile Plasters

Hospitals require two types of wound dressing plasters, depending on usage environment.

Sterile Dressing Plasters

Used for:

• post-surgical wounds
• catheter sites
• open or draining wounds
• ICU and high-risk areas

Sterile compliance includes:

• EO sterilization or gamma sterilization
• Medical-grade packaging
• Sterility assurance level (SAL) verification
• Lot-by-lot sterility testing

Non-Sterile Dressing Plasters

Used for:

• minor cuts
• general outpatient use
• emergency departments for non-open wounds
• first-aid applications

Requirements include:

• Clean-room manufacturing
• Low bacterial contamination levels
• Skin-safe adhesives
• Biocompatible materials

TICARE® supplies both sterile and non-sterile options depending on hospital application.

5. Adhesive Quality & Biocompatibility Requirements

Hospital-grade dressings requireadhesives that perform consistently:

Required Tests

• Skin sensitivity testing
• Peel adhesion strength
• Moisture resistance
• Long-wear comfort testing
• Migration & chemical safety analysis

Low-quality adhesives can cause:

✘ skin irritation
✘ premature peeling
✘ increased replacement frequency
✘ higher labor and material costs

TICARE® uses:

✔ medical-grade hot-melt adhesive
✔ breathable and hypoallergenic options
✔ long-wear optimized performance

6. Fabric & Material Standards: PE, PVC, Non-Woven, Elastic Cloth

Each fabric type has different regulatory expectations.

PE & PVC

• Must meet flexibility and tensile strength standards
• Require latex-free formulations
• Must maintain integrity during movement

Non-Woven

• Requires high breathability
• Must be skin-friendly
• Ideal for pediatric or sensitive-skin patients

Elastic Cloth

• Must maintain elasticity over wear time
• Must not fray or shed fibers
• Requires strong adhesion for joint areas

TICARE® maintains strict raw material audits to ensure consistency.

7. Labeling, Traceability & Lot Control

Hospitals prioritize suppliers that maintain excellent documentation.

CE & ISO compliance requires:

• Lot number
• Expiry date
• Sterilization method
• Storage conditions
• Manufacturer contact info
• SKU identification

TICARE® provides:

✔ traceable packaging labels
✔ compliance documentation
✔ MSDS, COA, and test reports
✔ OEM/private label customization

This supports hospital audits and tender processes.

8. Why Compliance Is a Competitive Advantage for Hospitals

Choosing certified products:

• reduces procurement risk
• lowers long-term cost due to fewer failures
• improves patient healing outcomes
• streamlines quality audits
• ensures legal and regulatory protection

This is whyhigh-compliance wound dressing plasters improve both patient care AND budget efficiency.

Why Hospitals & Distributors Trust TICARE®

• CE-marked wound dressing plasters
• ISO13485-certified factory
• Multiple materials: PE, PVC, Non-Woven, Elastic Cloth
• Sterile & non-sterile options available
• OEM/private label manufacturing
• Stable long-term supply chain
• Competitive B2B pricing for bulk orders

Request Samples or a Quotation

Email: enquiry@ticarehealth.com
Website: ticarehealth.com
Company: Xiamen TICARE Medical Supplies Co., Ltd.