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Certifications

Full Experience of Medical Certifications

No need to worry about the problem of getting documents. With internal and external test laboratories, our experienced LAB engineers with more 10 years make sure your product certified.
Onyx can help you bring your market to USA, Europe and China quickly.

  • ISO 9001:2015

    Onyx meets specifies requirements of ISO 9001:2015 for a quality management system where an organization from 2011/08/02.

  • ISO 14001:2004

    Onyx meets specifies requirements of ISO 14001:2004 for Environmental requirements, where an organization from February 2016.
    Environmental Policy:
    Green Manufacturing, Environmental Innovation, Sustainable ,Development Continuous Improvement
     

  • ISO 13485:2003

    Onyx meets specifies requirements of ISO 13485:2003 for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services from 2011/08/02.

  • FCC

    All of onyx's products comply with FCC Part 18.

  • CE : EN 60601-1-2 : 2015 (V4.0) / EN60601-1 : 2006 / A1 : 2013 (V3.1)

    All of onyx"s products  comply with 93/42/EEC.

  • UL : ANSI / AAMI ES60601-1 : 2012 (V3.1)

    All of onyx's products have got the UL certificate.

  • CCC

    Some of Onyx products meets the CCC mark is required for both Chinese manufactured and foreign imported products.

  • Clorox Healthcare Compatibility Program

    Onyx Products Approved Clorox Healthcare Compatible™ for Safer Medical Environments

Onyx Healthcare is the first company with EMC 4.0 / Safe 3.1 ready products

In the European Union, the Date of Withdrawal (DoW) of EN 60601-1:2006 (Safety Edition 3.0) is published as Dec. 31st 2017 and DoW of EN 60601-1-2:2007(EMC Edition 3.0) is published as Dec. 31st 2018.
All devices manufactured and imported into the EU are required to comply with EN 60601-1:2006/A1:2013 (Safety Edition 3.1) after year 2018 and EN 60601-1-2:2015 (EMC Edition 4.0) after year 2019.
All Onyx products in mass production are compliant to Safety Edition 3.1 and EMC Edition 4.0 and please refer to the following product list.

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