Product Approvals
Quality is key to all aspects of RDT’s products, services and business philosophy. This is demonstrated by our ongoing adherence to meeting the most stringent international quality systems standards such as EN ISO 9001:2008, EN ISO 13485:2003.
Tempus and its battery have been designed to comply with the particular requirements for use in aviation applications. Consequently, the requirements of the US FAA, EU EASA and international JAA have been taken into consideration in the design of the product.
Therefore, in order that the requirements of the FAA (AC91.21-1A) and the CAA (AIL0176 and AWN 12 appendix 39) can be met by operators using Tempus on their aircraft, RDT have:
- Tested Tempus to ensure that it complies with all the relevant sections of RTCA DO-160 E as well as those for electromagnetic compatibility (EMC).
- Documented all the information relevant to the design, construction and testing of Tempus and its battery in a Declaration of Design and Performance (DDP). The DDP is provided to client’s technical representatives to enable them to easily ensure the aircraft carrying Tempus continues to meet its operational regulations.
Delivery Documentation
Tempus is provided with a Certificate of Conformity which declares that it conforms to the specifications laid down in an associated DDP. The DDP is provided to the client’s relevant technical/engineering contact.
US Regulatory Compliance
RDT’s products have been cleared to market (510k) in the
European Regulatory Compliance
Tempus is CE marked under the European Medical Devices Directive (MDD - Directive 93/42/EEC).
RDT and its products have been independently certified to meet the requirements of the Directive under Annex II - Full Quality Assurance. Consequently, RDT’s design and manufacturing facility is certified under the internationally recognised quality assurance standards ISO9001:2008 and ISO 13485:2003.
Canadian Regulatory Compliance
Tempus is licensed under the Canadian Medcical Devices Regulations, Section 36.
Australian Regulatory Compliance
Tempus is listed by the Australian Therapeutic Goods Administration (TGA).
Safety
RDT’s products are certified to the relevant international safety standards such as IEC60601-1 for the General Requirements for Safety of Medical Electrical Equipment, IEC60601-1-1 for
the Requirements for Medical Electrical Systems - Medical Electrical Equipment, IEC60950 for the Safety of Informational Technology Equipment.
EMC
RDT’s products are certified to the relevant international standards for general electromagnetic compatibility (EMC) such as IEC60601-1-2:2001 for the EMC requirements for Electromedical Equipment, CISPR 11 and the US 47 CFR Part 15 (FCC).
Environmental
In addition to meeting the rigorous testing requirements for use in an aircraft cabin, Tempus also meets the water ingress test of IEC529 IPX6 (power hose).
Communications
Satellite - There are no specific regulatory or conformance requirements for products using satcoms networks. However, please note that Tempus has been designed to transmit voice and data communications using all types of satellite channels.
GSM/WiFi - The GSM and WiFi interfaces used in Tempus are certified for compliance with the requirements of all major market places e.g. the US FCC (US 47 CFR Parts 15C and 24) and the EU RTTE Directive. The interfaces also meet the following standards:
- GSM - 3GPP TS 51.010-1, ETSI EN 301 489-1, ETSI EN 301 489-7, ETSI EN 301 511.
- WiFi - ANSI C63.4:2001, ETSI EN 300 328, ETSI EN 301 489-1 and ETSI EN 301 489-17.
Data Security
RDT’s products comply with the requirements of the US Health Insurance and Portability Act (HIPAA) and include proprietary hardware-based encryption technology in addition to the 128bit software-based security encryption required by the US Centres for Medicare and Medicaid Services.
Furthermore at all stages where patient data is handled i.e. from collection and transmission through to display, storage and retransmission to the client’s own physician over the web, RDT’s technology ensures issues of access, authenticity and security are never compromised.
In addition, RDT’s products meet the requirements of the UK Data Protections Act.
