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Keyword: medical gases
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M-23 1 24 Sep 2019 Standard for Regulatory Classification of Medical Device Gases
M-25 1 29 Jul 2020 ICH Q3D Risk Assessment Report Elemental Impurities in Medicinal Gases
SA-36 1 08 Apr 2020 Safety Alert, Cylinder and Cryogenic Container Issue Related to Cylinder Conversion and Filling During the COVID-19 Crisis
C-9 6 26 Sep 2019 Standard Color Marking of Compressed Gas Containers for Medical Use
E-7 5 19 Sep 2018 Standard for Medical Gas Pressure Regulators, Flowmeters, and Orifice Flow Selectors
E-10 5 10 Sep 2018 Guideline for the Maintenance of Medical Gas and Vacuum Systems in Health Care Facilities
E-18 3 04 Dec 2019 Standard for Medical Gas Valve Integrated Pressure Regulators
G-8.1 5 22 Oct 2013 Standard for Nitrous Oxide Systems at Customer Sites
G-8.2 7 18 May 2017 Commodity Specification for Nitrous Oxide
G-8.3 3 05 Nov 2019 Safe Practices for Storage and Handling of Nitrous Oxide
M-1 4 29 Jan 2018 Standard for Medical Gas Supply Systems at Health Care Facilities (an American National Standard)
M-1.1 1 21 Feb 2019 Guidance for Compressed Medical Gas Cryogenic Fluid Central Supply System Training
M-2 2 02 Jan 2013 General Guide for the Manufacture of Medical Gases Classified as Drugs
M-3 4 12 Aug 2015 Standard for the Manufacturer of Bulk Medical Gases
M-4 2 17 May 2019 Guideline for Validation of Medical Cylinder Filling Systems
M-6 3 07 Nov 2019 Standard for Analytical Method Validation
M-7 5 12 Oct 2017 Standard for Qualifying Suppliers Used by Medical Gas Manufacturers, Equipment Manufacturers, and Distributors
M-8 3 19 Jan 2018 Standard for the Manufacturer of Calibration Gas Standards Used to Analyze Medical and Food Gases
M-9 2 12 Aug 2015 Guideline for Maintaining Bulk Gas Supplier Fingerprint Analysis at Compressed Medical Gas Filling Facilities
M-11 3 15 Mar 2021 Guideline for Compliance with the Quality Systems Approach to Current Good Manufacturing Practices
M-12 3 30 Jun 2020 Guideline for Investigating Out-of-Specification Test Results for Food and Medical Gas Manufacturing
M-13 3 30 Jun 2020 Guideline for Qualifying Third-Party Testing Laboratories
M-14 2 12 Aug 2015 Guideline for Bulk Liquid Oxygen and Bulk Liquid Nitrogen Trailer Change of Grade
M-15 3 31 Jan 2018 Standard for Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211
M-16 1 30 Mar 2016 Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry
M-17 1 30 Mar 2016 Standard for Automatic Trailer Fill Compliance to 21 CFR Part 11 and PIC/S Annex 11 Requirements
M-18 1 06 Jul 2018 Standard for the Change of Product and Change of Grade for High Pressure and Refrigerated Liquid Containers
M-19 1 16 Feb 2017 Standard for Biocompatibility of Materials for Medical Gas Equipment
M-21 1 16 Nov 2017 Guideline for Determining Pharmacovigilance Reporting Requirements in North America (for the U.S. & Reference for Canada)
M-22 1 12 Oct 2017 Standard for Medical Gas Quick Connect Adaptors (Formerly SB-43)