11.040.10 麻醉、呼吸和复苏设备 标准查询与下载
共找到 2038 条与 麻醉、呼吸和复苏设备 相关的标准，共 136 页
Aerosol drug delivery device design verification —Requirements and test methods
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- 11.040.10
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- 2021-12-28
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Medical electrical equipment —Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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- 11.040.10
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- 2021-12-28
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Medical electrical equipment —Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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- 11.040.10
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- 2021-12-28
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Medical electrical equipment —Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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- 11.040.10
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- 发布
- 2021-12-28
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Medical electrical equipment —Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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- 11.040.10
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- 2021-12-28
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Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
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- 11.040.10
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- 发布
- 2021-12-28
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Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
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- 11.040.10
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- 发布
- 2021-12-28
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1.1 For the purpose of this standard, a pressure regulator, also called a pressure-reducing valve, is a device intended for medical or emergency purposes that is used to convert a medical or emergency gas pressure from a high, variable pressure to a lower, more constant working pressure [21 CFR 868.2700 (a)]. Some of these oxygen pressure regulators are a combination of a pressure regulator and cylinder valve. These devices are often referred to as valve integrated pressure regulators, or VIPRs. 1.2 This standard provides an evaluation tool for determining the ignition sensitivity and fault tolerance of oxygen pressure regulators and VIPRs used for medical and emergency applications. An ignition-sensitive pressure regulator or VIPR is defined as having a high probability of ignition as evaluated by rapid pressurization testing (Phase 1). A fault-tolerant pressure regulator or VIPR is defined as having a low consequence of ignition as evaluated by forced ignition testing (Phase 2). NOTE 1—It is essential that a risk assessment be carried out on breathing gas systems, especially concerning toxic product formation due to ignition or decomposition of nonmetallic materials as weighed against the risk of flammability (refer to Guide G63 and ISO 15001.2). See Appendix X1 and Appendix X2 for details. 1.3 This standard applies only to: 1.3.1 Oxygen pressure regulators used for medical and emergency applications that are designed and fitted with CGA 540 inlet connections, CGA 870 pin-index adapters (CGAV-1), or EN ISO 407 pin-index adapters. 1.3.2 Oxygen VIPRs used for medical and emergency applications that are designed to be permanently fitted to a medical gas cylinder. 1.4 This standard is a test standard not a design standard; This test standard is not intended as a substitute for traditional design requirements for oxygen cylinder valves, pressure regulators and VIPRs. A well-designed pressure regulator or VIPR should consider the practices and materials in standards such as Guides G63, G88, G94, and G128, Practice G93, CGA E-18, CGA E-7, ISO 15001, ISO 10524-1 and ISO 10524-3. NOTE 2—Medical applications include, but are not limited to, oxygen gas delivery in hospitals and home healthcare, and emergency applications including, but not limited to, oxygen gas delivery by emergency personnel. 1.5 This standard is also intended to aid those responsible for purchasing or using oxygen pressure regulators and VIPRs used for medical and emergency applications by ensuring that selected pressure regulators are tolerant of the ignition mechanisms that are normally active in oxygen systems. 1.6 This standard does not purport to address the ignition sensitivity and fault tolerance of an oxygen regulator or VIPR caused by contamination during field maintenance or use. Pressure regulator and VIPR designers and manufacturers should provide design safeguards to minimize the potential for contamination or its consequences (see Guide G88). NOTE 3—Experience has shown that the use of bi-direction flow filters in components can lead to accumulation and re-release of contaminants (refer to Guide G88-05 Section 7.5.3.8 and EIGA Info 21/08). 1.7 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.8 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. 1.9 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 This test method is under the jurisdiction of ASTM Committee G04 on Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres and is the direct responsibility of Subcommittee G04.01 on Test Methods. Current edition approved Dec. 1, 2021. Published December 2021. Originally published as PS 127 – 00. Last published in 2013 as G175 – 13. DOI: 10.1520/ G0175-13R21. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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 8QLYHUVLW\RI7RURQWR 8QLYHUVLW\RI7RURQWR SXUVXDQWWR/LFHQVH$JUHHPHQW1RIXUWKHUUHSURGXFWLRQVDXWKRUL]HG 'RZQORDGHGSULQWHGE\ &RS\ULJKWE\$670,QW O DOOULJKWVUHVHUYHG 0RQ'HF *07 2. Referenced Documents
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
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- 11.040.10
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- 2021-12-01
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DIN EN ISO 10651-5:2021 医用肺呼吸机 基本安全和基本性能的特殊要求 第5部分：气动紧急复苏器（ISO 10651-5:2006）；德文版 EN ISO 10651-5:2021
This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006); German version EN ISO 10651-5:2021
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- 11.040.10
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- 发布
- 2021-11-00
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Medical suction equipment – Part 4: General requirements (ISO 10079-4:2021)
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- 11.040.10
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- 2021-10-29
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- 2021-10-29
BS ISO 11712. Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
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- 11.040.10
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- 2021-10-25
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- 2021-10-25
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
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- 11.040.10
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- 发布
- 2021-10-21
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- 2021-10-21
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
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- 11.040.10
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- 2021-10-21
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- 2021-10-21
Medical suction equipment. General requirements
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- 11.040.10
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- 发布
- 2021-10-20
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- 2021-10-20
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
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- 11.040.10
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- 发布
- 2021-10-15
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- 2021-10-15
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
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- 11.040.10
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- 发布
- 2021-10-15
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- 2021-10-15
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021)
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- 11.040.10
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- 发布
- 2021-10-15
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- 2021-10-15
Medical electrical equipment – Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021)
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- 11.040.10
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- 发布
- 2021-10-13
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- 2021-10-13
Medical supply units (ISO 11197:2019)
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- 11.040.10
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- 发布
- 2021-10-07
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- 2021-10-07
