Puffco Product Safety Standards
Puffco Quality & Standards
At Puffco, 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:
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 62133, UL 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 15, ANSI C63.4, IEC 61000-3-2/3, EN 50663, EN 55032, EN 55035, EN 62368, EN 62479, RE 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-140-2019-002, 10 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 60086-2-32, IEC 61000-4-2, IEC 60529, ISO 3160, EIA-364-13/17C/26B/28F/31C/32F, ASTM D 3363, ASTM D 3359, ASTM F 2357, and MIL-STD-202-215.
Health and Environmental Testing 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 51, California 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.
Coated Glass Testing Standards
Whenever we introduce new materials or technologies to our devices, we assess any potential risk to the customer experience – including user safety, device performance, and product reliability.
The Indiglow Peak Pro was the first Puffco product to introduce glass coating technology. As such, we completed the following tests on the coating:
ISO 10993-5:2009 for In Vitro Cytotoxicity (intact skin/mucosal tissue contacting device with limited contact duration)
ISO 10993-10:2010 for Irritation and Skin Sensitization (intact skin/mucosal tissue contacting device with limited contact duration)
FDA 21CFR 175.300 for resinous and polymeric coatings
CEN/TS 15968:2010 - Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire fighting foams - Method for sampling, extraction and analysis by LC-qMS or LC-tandem/MS
US EPA 3540C:1996 & US EPA 8270E:2018 for detection of Hexabromocyclododecane (HBCDD), Short-Chain Chlorinated Paraffins (SCCPs), Polychlorinated biphenyls (PCBs), and Phenylpropionitrile (PCN)
AfPS GS 2014:01 PAK for detection of Polycyclic Aromatic Hydrocarbons (PAHs)
MIL-STD-202 - Resistance to Solvents
(i) Two hundred and five (205) substances in the Candidate List of Substances of Very High Concern (SVHC) for authorization published by European Chemicals Agency (ECHA) on and before Jan 16, 2020 regarding Regulation (EC) No 1907/2006 concerning the REACH
(ii) Five (5) substances in the Public Consultation List of potential Substances of Very High Concern (SVHC) published by European Chemicals Agency (ECHA) on Mar 3, 2020 regarding Regulation (EC) No 1907/2006 concerning the REACH
CA Prop 65 (Lead, Cadmium, and Phthalates)
When the units are manufactured, the glass coating is applied only to the surface (not in airpath) of the glass in a controlled environment and then fired at 180 °C (356 °F). The resulting effect is a colorful exterior that is chemically-resilient, food-safe, and non-toxic/biocompatible to medical device standards. The coating does not interact with the vapor being generated.
Finally, the units can withstand temperatures up to 200 °C (392 °F). Exposing units to environments that exceed 392 °F may void the warranty and could damage the unit.
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