ASTM D8419-21 - Standard Specification for Anesthesia Reservoir Bags
Standard Specification for Anesthesia Reservoir Bags
Standard number: | ASTM D8419-21 |
Released: | 01.11.2021 |
Status: | Active |
Pages: | 4 |
Section: | 09.02 |
Keywords: | anesthesia; compliance; pressure testing—medical equipment; pressure volume relationship (compliance); water test; |
1.1 This specification covers anesthesia reservoir bags for use with anesthesia breathing systems. For purposes of this specification, the reservoir bag includes the neck, body, and neck bushing, if provided. Special-purpose bags, for example, bellows, evacuation, and self-expanding bags are excluded from the scope of this specification.
1.2 The following subjects are covered: material, construction, neck, size, compliance (pressure-volume relationship), electrical conductivity, marking and labeling, and test methods to substantiate compliance with the requirements. Alternative test methods may be employed provided they can be shown to be equivalent or better. (A rationale is given in Appendix X1.)
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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.