OUR DOCUMENTATION – Quality assurance – Certificates – Tests
Oppenhejm & Jansson sets high standards of quality assurance (QA) and quality control (QC) through the production process to final delivery.
For all medical devices our QC includes 100% in-line inspection using running cards and a numbering system as well as 100% final inspection.
All our products are needle inspected through metal detectors.
RFX+Care os inspected on an on-going basis by auditors and holds:
• ISO14001: 2004 certification
• ISO13485: 2012 certification
We constantly test our materials in accordance with the European Chemicals Agency according to directive EC/1907/2006.
Our products are certified by TÜV, SP, FDA medical ISO standardization.
All our products comply with and even exceed current international CE standards and regulations. Above you see a few examples. All datasheets, test reports and certificates are available on request.
MORE CERTIFICATE DETAILS………
CE regulations for personal safety accessories and Hi-Vis garments
Standards and certification
European standards (EN) are defined by the European Committee for Standardization (CEN) under mandates from the Commission of the European Union and the European Free Trade Association. Implementation of these standards is mandatory within EU member states. All products complying with these standards must be marked with both the CE mark and the relevant standard number.
The standard covers three types of accessories:
Type 1 Free hanging accessories (Oppenhejm & Jansson hangers)
Type 2 Removable accessories (including Oppenhejm & Jansson slap wraps and soft bands)
Type 3 Mounted accessories (including Oppenhejm & Jansson high-strength adhesive stickers)
Accessories are required to meet both surface area and reflective requirements of the standard. When mounting the reflector on a garment the surface area of the accessory shall be such that the reflective value requirements are met. The surface area for type 1 accessories shall be between 15cm2 and 50 cm2 per side. If a type 1 accessory is reflective on two sides the thickness shall be maximum of 10mm. Each type 2 and type 3 accessory is required to have a surface area exceeding 15 cm2.
The EN13356 standard specifies the optical performance requirements for accessories that are worn, attached to
or carried by persons and that are designed for non-professional use. Visibility accessories complying with this standard are intended to signal the user’s presence visually when illuminated by vehicles on darks roads. This standard is not applicable to garments.
All Oppenhejm & Jansson slap wraps and soft bands
Type 3 products comply with and even exceed current international CE regulations.
All our certificates are available upon request. You can write to email@example.com for further information