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Medical Gases
ID
Ed.
Published
Title
Data pager
Data pager
1
27
items in
1
pages
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-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
3
26 Aug 2022
Guideline for Liquid Oxygen and Liquid Nitrogen Bulk Transport 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
2
23 Feb 2022
Standard for Food, Drug, and Medical Device Gas and Gas Equipment Manufacturers on Electronic Records and Signatures
M-17
2
23 Feb 2022
Standard for Automatic Trailer Fill Compliance to 21 CFR Part 11 and PIC/S Annex 11 Requirements
M-18
2
26 Aug 2022
Standard for the Change of Product and Change of Grade for High Pressure and Refrigerated Liquid Containers
M-19
2
10 Mar 2023
Standard for Biocompatibility of Materials for Medical Gas Equipment
M-2
3
29 Jun 2021
Standard for the Manufacture of Medical Gases Classified as Drugs
M-20
2
16 Dec 2020
Guideline for the Implementation of Unique Device Identification
M-21
2
06 Oct 2022
Guideline for Determining Pharmacovigilance Reporting Requirements in North America
M-22
1
12 Oct 2017
Standard for Medical Gas Quick Connect Adaptors (Formerly SB-43)
M-23
1
24 Sep 2019
Standard for Regulatory Classification of Medical Device Gases
M-24
2
23 Apr 2024
Standard for Mitigating Oxygen Hazards in the Health Care Environment
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-27
1
24 Aug 2021
Guideline for Complying with Data Integrity Regulatory Expectations
M-28
1
30 Mar 2022
Guideline for Assessment of Health Care Facility Medical Oxygen Systems
M-3
5
29 Jun 2021
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
6
13 Nov 2022
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