Quality and ISO certificates

Living quality

Because our offerings are applied in healthcare, quality is much more
than a department. It’s embedded in everything we do.

The Spacelabs quality management system is certified to ISO 13485.
You’ll find copies of our certificates below:

Spacelabs Healthcare, Inc., Snoqualmie, WA USA
ISO 13485 Certificate (PDF)
Current EC Certificate (PDF)
MDSAP Certificate (PDF)

Spacelabs Healthcare Ltd, Hertford, UK
UKCA Certificate
EU Quality Management System Certificate (MDR)
ISO 13485 Certificate (PDF)
MDSAP Certificate (PDF)

Environmental

⚠️ California Proposition 65 Warning

Spacelabs Healthcare products may contain chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm. These chemicals may include, but are not limited to:

  • Lead (a carcinogen),
  • Plasticizers and plastics (reproductive toxicants),
  • Tetrabromobisphenol A (TBBPA) used in printed circuit boards (a carcinogen).

This warning is provided in accordance with California’s Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986.

For more information about specific chemicals or product details, please contact Spacelabs Healthcare directly.