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Medical Gases
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M-23 1 24 Sep 2019 Standard for Regulatory Classification of Medical Device Gases
M-24 1 27 Jan 2020 Standard for Mitigating Oxygen Hazards in the Health Care Environment (Formerly SB-31)
M-25 1 29 Jul 2020 ICH Q3D Risk Assessment Report Elemental Impurities in Medicinal Gases
M-26 1 16 Dec 2020 Guideline for Mitigating Oxygen Fires in Personal Use
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 2 14 Jul 2014 Guideline for Compliance with the Quality Systems Approach to Pharmaceutical CGMPs
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-14.1 1 11 Dec 2013 Bulk Trailer Change of Grade Validation Protocol
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-20 2 16 Dec 2020 Guideline for the Implementation of Unique Device Identification
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)