Quality & Compliance

Buyers in healthcare need more than a description of a product: they need to be able to evidence it. This page sets out the certificates our systems hold, the test data behind our barrier fabric, and the controls we run during production.

Certifications

Our management systems are certified by BELCERT Uluslararası Belgelendirme, an accredited certification body in Istanbul; the validity of every certificate can be checked independently at belcert.com. Current certificates were issued on 14 November 2025 and are valid through 14 November 2026:

• ISO 13485:2016 — Medical devices quality management system. Scope: medical and industrial textile product production. Certificate no. A 1598089. Download the certificate (PDF)
• ISO 9001:2015 — Quality management system. Scope: medical and industrial textile product production. Certificate no. A 1598092. Download the certificate (PDF)
• ISO 14001:2015 — Environmental management system. Scope: medical and industrial textile product production. Certificate no. A 1598094. Download the certificate (PDF)
• ISO 10002:2018 — Customer satisfaction and complaints management. Scope: medical and industrial textile product production. Certificate no. A 1598093. Download the certificate (PDF)
• Respect for Nature certificate for environmental commitment in textile production. Certificate no. A 1598091. Download the certificate (PDF)
• CE Declaration of Conformity for the PU hospital bed cover, under the General Product Safety Directive 2001/95/EC, referencing TS EN ISO 9001:2015 and ISO 13485:2016. Certificate no. A 1598090. Download the declaration (PDF)

Certificates are re-issued annually after surveillance audits. When you evaluate a product we will send the current certificates together with the test reports that apply to your construction.

PU-coated barrier fabric — tested values

The polyurethane-coated polyester knit at the core of our hospital mattress covers is produced and tested against a written specification. The data sheet below covers the 150 g/m² construction; the fabric weight can vary per product, and the other technical values apply across the range. Download the fabric data sheet (PDF).

• Composition: 37 % polyurethane coating / 63 % polyester base knit
• Weight 150 g/m² ±15 (BS EN ISO 12127); thickness 0.30 mm ±0.1 (ISO 2286-3); widths 110–220 cm
• Tensile strength: warp ≥ 300 N, weft ≥ 210 N (ISO 1421); elongation at break: warp 62 %, weft 95 %
• Tear strength: warp ≥ 28 N, weft ≥ 27 N (ISO 4674-1); peel adhesion ≥ 35 N/50 mm (ISO 2411)
• Waterproofness: hydrostatic head ≥ 2 m water column (EN 20811)
• Breathability: water-vapour permeability ≥ 500 g/m²/24 h (ASTM E96)
• Antibacterial (ISO 22196) and antifungal (AATCC 30) finishes
• Flame retardancy passes BS 7175 Crib 5
• Withstands 20 autoclave cycles at 121 °C, 20 min, with no loss of performance (internal test method)
• Accelerated ageing — jungle test (ISO 1419): no loss of quality after three weeks
• OEKO-TEX® Standard 100, Class 1 (certificate no. 1506032, Centexbel); halogen-free

Controls during production

• Incoming fabric and coating are checked against the approved sample before cutting
• The approved sample is the reference for every subsequent production run
• Seams, closures and dimensions are inspected before packing
• A production record is kept per programme so a batch can be traced back

Laundering and service life

A protective textile fails at the wash cycle far more often than it fails in use. If the product will be laundered industrially, tell us the temperature, the chemistry and the frequency before we finalise a construction. The same cover specified for a 60 °C domestic cycle and a 90 °C hospital cycle is not the same product.

Regulatory scope

Where a product falls under a medical device framework, its classification depends on the product and the market it is placed on. We work with the buyer's regulatory requirements for the destination market rather than asserting a classification on their behalf. Tell us the market and the intended use and we will confirm what we can support.

Questions

For anything not covered here, the fastest route is to send the product and the requirement you have to satisfy. Vague questions get vague answers; a specific requirement gets a specific one.