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Quality

Quality

  • Tuesday, 03 September 2024
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We take the quality of our products seriously to deliver the best experience to our customers. We design our products with compliance in mind, consulting US-based compliance professionals, testing throughout the development process, and continuing to test once products go into production.

We hold our devices and technology to high category standards:

Device Standards

BATTERY STANDARDS

We test for reliability and operational consistency in both individual battery packs and at the larger systems level, including impact and drop testing as well as forced failure, all of which meet federal or international safety standards, such as IEC 62133UL 1642, and UL 2054.

ELECTROMAGNETIC COMPATIBILITY AND SAFETY STANDARDS

We test for and meet federal and international electromagnetic compatibility and safety standards and directives, like FCC Part 15ANSI C63.4IEC 61000-3-2/3EN 50663EN 55032EN 55035EN 62368EN 62479RE Directive 2014/53/EU, and ICES-003.

ENERGY EFFICIENCY STANDARDS

We test for and meet federal and international energy efficiency standards and regulations, like CEC-140-2019-00210 CFR Section 430.23, and NRCan: Amendment 14 to the Energy Efficiency Regulations for Battery chargers in the Canada Gazette, Part II.

HARDWARE RELIABILITY STANDARDS

We routinely conduct hardware tests for reliability in real-world scenarios, such as drop testing, IP testing, and environmental testing.

Wherever feasible, we adhere to industry and internationally recognized standards like IEC 60086-2-32IEC 61000-4-2IEC 60529ISO 3160EIA-364-13/17C/26B/28F/31C/32FASTM D 3363ASTM D 3359ASTM F 2357, and MIL-STD-202-215.

TRANSPORTATION STANDARDS

We adhere to voluntary and mandatory transportation testing to ensure our products arrive safely to our customers. Transportation standards we routinely test to include ISTA 2A and UN 38.3.

Health and Environmental Testing Standards

BIOCOMPATIBILITY STANDARDS

Our customers’ safety is of the utmost importance to us.  As such, we voluntarily test to medical device biocompatibility standards like ISO 10993-5:2009 for In Vitro Cytotoxicity, ISO 10993-10:2010 for Irritation and Skin Sensitization, and ISO 18562:2017-Biocompatibility evaluation of breathing gas pathways in healthcare applications including Part 1: Evaluation and testing within a risk management process, Part 2: Tests for Emissions of Particulate Matter, Part 3: Tests for Emissions of Volatile Organic Compounds, and Part 4: Tests for Leachables in Condensate.

HARDWARE SAFETY AND ENVIRONMENTAL STANDARDS

We also test to general hardware safety standards like National Sanitation Foundation NSF/ANSI 51California Proposition 65, the European Union’s RoHS (Restriction of Hazardous Substances) regarding the use of hazardous substances in electrical and electronic equipment, the European Union’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals for substances of very high concern (SVHC), and the European Union’s WEEE (Waste from Electrical and Electronic Equipment).

Supplier Controls Through Supply Chain

We maintain agreements with our suppliers requiring strict and precise testing of the component products they supply to our manufacturing partners.

We manage a program of supplier visits and recurring audits of their factories, including systems and practices in place for maintaining quality.

We maintain an approved vendor list to ensure only those companies that meet our quality standards are allowed to enter our supply chain system.

We maintain agreements with our finished-goods suppliers requiring strict adherence to our standards of quality.

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