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 G122 and Guide G127). It also is applicable to other systems where contamination is a concern.
1.2 Several classes of contaminants/residue
s 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 G63.
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.
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 G122 and Guide G127). 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 G63.
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.
