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What regulatory standards and directives do Styku X2 body scanners comply with?

What regulatory standards and directives do Styku X2 body scanners comply with?

Overview

Styku, LLC has issued a Declaration of Conformity confirming that the Styku X2 family of 3D body scanners meets all applicable EU regulatory requirements. This document summarises the directives, standards, and scope of compliance.

Details

Manufacturer information

  • Manufacturer: Styku, LLC
  • Address: 5462 Jillson St., Los Angeles, CA, USA 90040
  • Signed by: Jason Delevan, Chief Operating Officer
  • Date of Issue: May 8, 2023

Product scope

  • Product type: 3D Body Scanner for measuring the human body
  • Covered models: Styku X2, X2 Hub, X2+, X2 MD

EU Measuring Instruments Directive The scanners satisfy all essential requirements in Annex I and Annex XI (Dimensional Measuring Instruments, MI-009) of Directive 2014/32/EU, in accordance with BS EN ISO/IEC 17050-1:2010.

Additional EU harmonisation legislation

Directive | Scope

2014/35/EU | Low-Voltage Directive

2014/30/EU | Electromagnetic Compatibility (EMC) Directive

2014/53/EU | Radio Equipment Directive (RTTE)

2011/65/EU | Restriction of Hazardous Substances (RoHS) Directive

Harmonised standards applied

Standard | Description

ISO 20685:2010 | 3D Scanning Methodologies for Internationally Compatible Anthropometric Databases

ISO 7250-1:2008 | Basic human body measurements for technological design — Body measurement definitions and landmarks

Notes

  • These scanners are not intended for the diagnosis, mitigation, treatment, or prevention of any disease, disorder, or abnormal physical state. Styku, LLC does not condone the use of these instruments for clinical medical applications.
  • This declaration covers the non-medical configuration of the listed models.
  • Compliance is declared under the manufacturer's sole responsibility.

If the problem persists, contact support and include: the specific model name and business location name or license key for your device, and the nature of your compliance or regulatory inquiry.

Applies to: Styku X2, X2 Hub, X2+, X2 MD (non-medical configuration)