Product Safety

At Sacred Healing Supply Company, we are committed to delivering the highest-quality wellness products to enhance your life. Our dedication to quality begins with rigorous testing processes that ensure the safety, effectiveness, and reliability of every item we offer.

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Requirements and Standards Conformity

  1. IEC 60601-1 - General Standard: Requirements for Basic Safety and Essential Performance.
  2. IEC 60601-1-2 - Collateral Standard: Electromagnetic Disturbances - Requirements.
  3. IEC 60601-1-6 - Collateral Standard: Usability.
  4. IEC 60601-1-11 - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
  5. IEC 60601-2-57 - Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use.
  6. IEC 60601-2-83 - Particular requirements for the basic safety and essential performance of home light therapy equipment.
  7. IEC 62471 - Photobiological safety for lamps or lamps and lamp systems.
  8. IEC 62304 - International Standard: Medical device software - software life cycle processes.

Risk Management

Conformity to ISO 14971 - Medical Devices - Application of risk management to medical devices.

Quality Management System:

Conformity to ISO 13485 - Medical Devices - Quality management systems - requirements for regulatory purposes.

These standards ensure our products meet stringent requirements for safety, performance, and quality. By adhering to these high standards, we guarantee that when you choose Sacred Healing Supply Company, you're choosing products of the highest caliber, designed to enhance your well-being and quality of life. Your satisfaction and trust are at the core of everything we do. Thank you for choosing us for your wellness journey.