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Certificates & Declarations of Conformity

Our certifications
at a glance

For the manufacture of your products, we set high standards within the Group in the area of quality management.

01

Certification in the Industrial Solutions area: ISO9001

ISO 9001 (International Organization for Standardization) is the most widely used standard for quality management (QM). This standard concerns internal company processes that comply with international QM standards. ISO 9001 is based on the principles of QM: customer orientation, leadership, involvement of people, process-oriented approach, improvement, fact-based decision-making and relationship management. Based on ISO 9001, the IATF 16949 technical specification applies to series production in the automotive industry. IATF 16949 Certification according to IATF 16949 (International Automotive Task Force) is an international quality management standard for the automotive industry that has been in existence since 2016. This standard was created specifically for the automotive industry and contains requirements for the quality management system in the interest of continuous improvement in the form of avoiding waste, nonconformities and errors in the supply chain.

02

Certification in the Medical area: DIN EN ISO 13485

ISO 13485 provides a benchmark for a comprehensive quality management system specifically for the manufacture of medical devices. In its scope and purpose, ISO 13485 is similar to ISO 9001. It just contains additional specific requirements for medical devices and rephrases some specifications of ISO 9001. Therefore, in most markets, certification to ISO 9001 is not an adequate substitute for certification in accordance with the requirements of ISO 13485.

EN 14683 Typ II R

This standard specifies the construction, design, performance requirements and test methods for medical face masks. Our surgical masks are all CE certified to Type II R and therefore meet the following requirements:

  • Bacterial filtration efficiency ≥ 98%
  • Pressure difference (Pa/cm²) < 60
  • Splash resistance pressure (kPA) ≥ 16.0
  • Microbial cleanliness (CFU/g) ≤ 30

This CE certification means that our surgical masks meet the requirements for use in medical facilities. In addition, our dual-use FFP2 masks also meet the requirements of EN 14683 Type II R and can therefore be used both as personal protective equipment and as surgical masks. This gives medical personnel a particularly high level of protection compared to conventional surgical masks.

UNI EN ISO 9001:2015

Zender Germany GmbH

IATF 16949:2016

Zender Germany GmbH

UNI EN ISO 9001:2015

Zender Italia S.R.L.

IATF 16949:2016

Zender Italia S.R.L.

UNI EN ISO 14001:2015

Zender Italia S.R.L.

ISO 13485:2016

Zender Italia S.R.L. & Zender Medical GmbH

Declarations of Conformity

Z2100

Zender Germany GmbH

Z2101

Zender Germany GmbH

Z2200

Zender Germany GmbH

Z2300

Zender Germany GmbH

Z2600

Zender Medical GmbH

Z3101

Zender Medical GmbH

Z3200

Zender Medical GmbH

You’ll find us here.

Zender GERMANY Gmbh

Wersener Landstr. 80
49076 Osnabrück, Germany

Phone: +49 541 – 201 934-0
Mail: info-os@zendergroup.com

Zender Medical Gmbh

Carl-Lüer-Straße 13
49084 Osnabrück, Germany

Phone: +49 541 – 201 934-0
Mail: medical@zendergroup.com

Zender Italia s.r.l.

Strada Traghete 74
30021 Caorle (VE), Italia

Phone: +39 421 – 212 480
Mail: info-it@zendergroup.com