PHS SAFETY


	Important Safety Notice (click here) Catalina Cylinders has issued a safety alert pertaining to Young-Do valves installed on their cylinders . If you have any questions you can contact Professional Healthcare Services -PHS @410-781-8500.




Off-The-Shelf Software Use in Medical Devices
General Principles of Software Validation
Medical Device Reporting for Manufacturers
Analytical Methods Validation Guidance
Container Closure System Guidance
FDA Open Dewar Letter
Formal Dispute Resolution Guidance
Marketing Un-Approved Drugs Guidance
Process Validation Guidance
Quality System Guidance
Stability Testing Guidance Document
Manufacturer's Technical Data Sheets:
ALAC Oxygen MSDS
DOT Documents:
DOT Oxygen Shipping Advisory
Forms:
Oxygen Duration Chart
Safety Alerts and Buletins:
o CGA Safety Alert SA-5 ALUMINUM CYLINDERS — EXPOSURE TO HIGH HEAT
o CGA Safety Alert SA-6 USE OF NITROGEN FOR SURGICAL AIR TOOLS
oCGA Safety Alert SA-11 POTENTIAL FOR HIDDEN CRYOGENIC LIQUID CYLINDER CONTAMINATION
CGA Safety Alert SA-12 BLENDED BREATHING AIR FATALITIES
CGA Safety Alert SA-14 HAZARDS OF COMPRESSED GAS CYLINDERS IN THEMAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENT
Mil Specs
MilSpec Helium MIL-PRF-27407B
MilSpec Nitrogen MIL-PRF 27401D
ABO specification AS8010C
NASA Oxygen Standard I
o 21 CFR part 210, 21 CFR part 211
FDA Medical Gas Guidelines
2003 Med Gas cGMP Guidance
o Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application