Regulatory Compliance
SAFE-TEC CLINICAL PRODUCTS LLC. is a registered FDA medical device establishment. Our Quality System is certified under ISO 13485:2003 and is periodically inspected by outside auditors to verify conformity with these standards and regulations, further assuring high quality products and service. SAFE-TEC CLINICAL PRODUCTS LLC. also maintains a Medical Device Establishment License in Canada and CE Mark in the European Union and other regulatory approvals and registrations as necessary in various countries.
Government Documents about Blood Handling Hazards:
Reduction of Blood-Borne Exposure to HBV and HIV by the Use of Self-Sealing Capillary Tubes —
At the hearing on proposed OHSA Standards regulating occupational exposure to blood-borne pathogens.
Proposed OSHA Safety Standards — Exposure to Blood-Borne Pathogens.
Glass Capillary Tubes: Joint Safety Advisory About Potential Risks
FDA Joint Safety Advisory — Glass Capillary Tube Usage Risks
For further reference, please visit the following links:
CDRH — Safety Alerts, Public Health Advisories, and Notices From CDRH
NIOSH — Blood-Borne Infectious Diseases HIV/AIDS, Hepatitis B Virus, and Hepatitis C Virus