SAFETY - TECHNICAL INFORMATION

Important Safety Notice (click here)

Catalina Cylinders has issued a safety alert pertaining to Young-Do valves nstalled ontheir cylinders .

If you have any questions you can contact Atmospheric Products and Services -APS @ 410.833.7170.

• 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 THE MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENT

Mil Specs

• MilSpec Helium MIL-PRF-27407B

• MilSpec Nitrogen MIL-PRF 27401D

• MilSpec Oxygen Propellant MIL PRF-25508F

• 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