Certification
6.1.4 FDA/CDRH
6.1.4
FDA/CDRH
This device meets the requirements of the following U.S. Food and Drug
Administration (FDA) standard:
• Title 21 Code of Federal Regulations (CFR) – Chapter I – Sub-chapter J –
Radiological Health
6.1.5
ISED
This device is declared by Siemens AG to meet the requirements of the following
ISED (Innovation Science and Economic Development Canada) standard:
• CAN ICES-3 (A)/NMB-3 (A)
6.1.6
ISO
This device was designed and manufactured using a certified ISO (International
Organization for Standardization) quality program that adheres to the following
standard:
•
ISO 9001:2015
Quality management systems – Requirements
6.1.7
ACMA
This device meets the requirements of the following Australian Communications and
Media Authority (ACMA) standards under certificate ABN 98 004 347 880:
• Radiocommunications (Compliance Labelling – Devices) Notice 2014 made
under Section 182 of the Radiocommunications Act 1992
• Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2008
made under Section 182 of the Radiocommunications Act 1992
• Radiocommunications (Compliance Labelling – Electromagnetic Radiation)
Notice 2003 made under Section 182 of the Radiocommunications Act 1992
• Telecommunications Labelling (Customer Equipment and Customer Cabling)
Notice 2001 made under Section 407 of the Telecommunication Act 1997
The device is marked with an RCM symbol to indicate compliance when sold in the
Australian region.
A copy of the Declaration of Conformity is available via Siemens Industry Online
Support at
https://support.industry.siemens.com/cs/ww/en/view/89855782
.
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