If you are looking for Certified Adult Diaper & Under Pad OEM Solutions for Nursing Home & Medical Care Institutions, you can find the answer at Changzhou Glory Healthcare CO.,Ltd. Reliable, hypoallergenic, and medically compliant disposable incontinence products are essential for daily elderly care in hospitals, rehabilitation centers, and long-term nursing facilities. Unlike retail-grade consumer products, institutional nursing supplies require stable safety standards, consistent batch quality, full regulatory documentation, and long-term bulk supply capability.
As a professional ISO13485 & CE certified OEM factory focusing exclusively on adult diapers and disposable underpads, we provide one-stop institutional-grade supply solutions for global nursing homes, medical groups, and elderly care organizations.
ISO 13485 & CE Specific Standards for Adult Diapers & Under Pads (For Overseas Nursing & Medical Institution Clients)
1. ISO 13485:2016 (Factory System Standard)
ISO 13485 is not a product testing standard, but a quality management system standard for medical devices. It is the top priority audit requirement for overseas hospitals and nursing homes.
Core Requirements for Adult Diapers & Under pads
1. Complete Quality Management System
Full traceability covering raw material incoming inspection, production, quality control, finished goods delivery and after-sales service. Production logs, QC reports and non-conforming product disposal records are retained for every batch.
2. Compliant Clean Production Environment
Controlled clean workshop with strict environmental microorganism management to eliminate risks of cross-infection, which is the top concern of nursing facilities.
3. Risk Control System
Risk assessment and control measures for skin irritation, liquid leakage, excessive microorganisms and contaminated raw materials.
4. Archivable & Auditable Documentation
All procedure documents, test reports and batch records can be stored long-term to satisfy annual internal reviews and official authority inspections of overseas medical institutions.
ISO 13485 certification verifies that our factory Changzhou Glory Healthcare Co.,Ltd operates under medical-grade formal production systems rather than ordinary daily goods workshops. Our products are fully qualified for hospital and nursing home use.
2. CE EU Market Access Standards (Core Product Compliance)
Adult diapers and nursing underpads are classified as Class I Medical Devices in the EU.
The mandatory product standard for CE certification is EN 14126:2003, the core document required by all nursing facility buyers, European importers and large Middle Eastern medical institutions.
Specific Test Items Under EN 14126 for Incontinence Care Products
1. Liquid Absorption Performance (Core Indicator)
Testing of total absorption capacity, absorption speed and rewet volume to keep elderly users dry and reduce bedsores and skin disorders.
2. Anti-Leakage Performance
Dynamic anti-leakage tests simulating elderly users turning over and lying in bed for long hours.
3. Physical Strength Standards
Tensile resistance of back film, waistband tension and durability of leak-proof barriers to avoid breakage and liquid leakage during use.
4. Sanitary & Microbial Standards
Strict limits on total bacterial and fungal count to meet medical anti-infection requirements.
5. Skin Safety
Non-irritating, non-sensitizing formulation with no residual harmful chemicals, suitable for long-term skin contact.
6. Compliant Raw Materials
Non-woven fabric, SAP, fluff pulp and adhesive all comply with EU safety standards for materials contacting human skin.
3. Supplementary CE Compliance Standards Fully Covered by Our Products
1. EN ISO 10993 Biocompatibility Test
Tests for skin irritation and skin sensitization, frequently requested by nursing home purchasers.
2. Microbial Limit Test
Critical mandatory standard for medical facility procurement to prevent cross-infection inside care premises.
Changzhou Glory Healthcare Co.,Ltd holds the full set of required certificates and compliance documents. All products fully meet the strict standards and procurement requirements of overseas hospitals, nursing homes and long-term care facilities.
Please check more details regarding our certifications through link below.
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