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Significance and Use
5.1 This practice will be suitable to direct the preparation of test coupons with a known amount of contaminant on the surface. A standard test coupon is described and a list of contaminants that have typically been found in oxygen-enriched systems and components is provided.
5.2 These test coupons shall be used in the evaluation of cleaning agents for oxygen-enriched systems and components. This will permit direct comparison within and between test facilities.
5.3 Materials used in other fluid handling systems such as nitrogen, helium, hydrogen, gasoline, etc. may also be prepared for evaluation by this practice.
1.1 This practice describes the procedure for the preparation of single- and double-sided contaminated test coupons for the evaluation of cleaning agents. It is applicable for the evaluation of cleaning agents proposed for the cleaning of oxygen equipment, pharmaceutical manufacturing equipment, and medical devices (see Test Method and Guide ). It also is applicable to other systems where contamination is a concern.
1.2 Several classes of contaminants/residues most likely to be found in oxygen equipment, pharmaceutical manufacturing equipment, and medical devices are identified. However, if the user of this practice has identified contaminants not included in these classes, such identified contaminants may be substituted for the preparation of the test coupons if appropriate for this test method.
1.3 Solvent and cleaning agent compatibility with nonmetallic substrates should be verified prior to the preparation of the test coupons. Typical nonmetallic materials utilized in oxygen systems are contained in Guide .
1.4 This practice may involve hazardous materials, operations, and equipment. This practice does not purport to address all of the safety concerns associated with its use. It is the responsibility of whomever uses this practice to consult and establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D1193 Specification for Reagent Water
E1235 Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environmentally Controlled Areas for Spacecraft
E3106 Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
F303 Practices for Sampling for Particles in Aerospace Fluids and Components
F312 Test Methods for Microscopical Sizing and Counting Particles from Aerospace Fluids on Membrane Filters
F324 Test Method for Nonvolatile Residue of Volatile Cleaning Solvents Using the Solvent Purity Meter
F331 Test Method for Nonvolatile Residue of Solvent Extract from Aerospace Components (Using Flash Evaporator)
F3127 Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
G63 Guide for Evaluating Nonmetallic Materials for Oxygen Service
G94 Guide for Evaluating Metals for Oxygen Service
G122 Test Method for Evaluating the Effectiveness of Cleaning Agents
G127 Guide for the Selection of Cleaning Agents for Oxygen-Enriched Systems
ICS Number Code 71.100.40 (Surface active agents)
UNSPSC Code 47131800(Cleaning and disinfecting solutions)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM G121-18, Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top