11.040.10 麻醉、呼吸和复苏设备 标准查询与下载
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1.1 This guide applies to the design of systems for oxygen or oxygen-enriched service but is not a comprehensive document. Specifically, this guide addresses system factors that affect the avoidance of ignition and fire. It does not thoroughly address the selection of materials of construction for which Guides G63 and G94 are available, nor does it cover mechanical, economic or other design considerations for which well-known practices are available. This guide also does not address issues concerning the toxicity of nonmetals in breathing gas or medical gas systems. NOTE 1—The American Society for Testing and Materials takes no position respecting the validity of any evaluation methods asserted in connection with any item mentioned in this guide. Users of this guide are expressly advised that determination of the validity of any such evaluation methods and data and the risk of use of such evaluation methods and data are entirely their own responsibility. 1.2 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. 1.3 This standard guide is organized as follows: Section Title Section Referenced Documents 2 ASTM Standards 2.1 ASTM Adjuncts 2.2 ASTM Manuals 2.3 NFPA Documents 2.4 CGA Documents 2.5 EIGA Documents 2.6 Terminology 3 Significance and Use 4 Purpose of G88 4.1 Section Title Section Role of G88 4.2 Use of G88 4.3 Factors Affecting the Design for an Oxygen or OxygenEnriched System 5 General 5.1 Factors Recognized as Causing Fires 5.2 Temperature 5.2.1 Spontaneous Ignition 5.2.2 Pressure 5.2.3 Concentration 5.2.4 Contamination 5.2.5 Particle Impact 5.2.6 Heat of Compression 5.2.7 Friction and Galling 5.2.8 Resonance 5.2.9 Static Electric Discharge 5.2.10 Electrical Arc 5.2.11 Flow Friction 5.2.12 Mechanical Impact 5.2.13 Kindling Chain 5.2.14 Other Ignition Mechanisms 5.2.15 Test Methods 6 System Design Method 7 Overview 7.1 Final Design 7.2 Avoid Unnecessarily Elevated Temperatures 7.3 Avoid Unnecessarily Elevated Pressures 7.4 Design for System Cleanness 7.5 Avoid Particle Impacts 7.6 Minimize Heat of Compression 7.7 Avoid Friction and Galling 7.8 Avoid Corrosion 7.9 Avoid Resonance 7.10 Use Proven Hardware 7.11 Design to Manage Fires 7.12 Anticipate Indirect Oxygen Exposure 7.13 Minimize Available Fuel/Oxygen 7.14 Avoid Potentially Exothermic Material Combinations 7.15 Anticipate Common Failure Mechanism Consequences 7.16 Avoid High Surface-Area-to-Volume (S/V) Conditions where Practical 7.17 1 This guide 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 G04.02 on Recommended Practices. Current edition approved Oct. 1, 2021. Published November 2021. Originally approved in 1984. Last previous edition approved in 2013 as G88 – 13ε1 . DOI: 10.1520/G0088-21. 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 Section Title Section Avoid Unnecessarily-Elevated Oxygen Concentrations 7.18 Anticipate Permutations from Intended System Design 7.19 Avoid Designs and Failure Scenarios that can Introduce Potential Flow Friction Ignition Hazards 7.20 Use Only the Most Compatible of Practical Materials and Designs 7.21 Provide Thorough Safety Training for All Personnel Working with Oxygen or OxygenEnriched Components or Systems, including Design, Cleaning, Assembly, Operations, and Maintenance as Applicable to Personnel 7.22 Miscellaneous 7.23 Examples 8 Key Words 9 References 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.
Standard Guide for Designing Systems for Oxygen Service
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- 11.040.10
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- 2021-10-01
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Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
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- 11.040.10
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- 2021-10-00
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Medical suction equipment - Part 1: Electrically powered suction equipment (ISO/FDIS 10079-1:2021)
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- 11.040.10
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- 2021-10-00
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This document applies to the basic safety and essential performance of a high-frequency ventilator in combination with its accessories. These ventilators are intended for use in a professional healthcare facility for patients who need a specialized care and whose conditions can b
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021); German version EN ISO 80601-2-87:2021
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- 11.040.10
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- 2021-10-00
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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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- 2021-10-00
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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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- 2021-10-00
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Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2020)
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- 11.040.10
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- 2021-09-30
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- 2021-09-30
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020)
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- 11.040.10
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- 2021-09-30
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- 2021-09-30
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)
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- 11.040.10
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- 2021-09-30
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- 2021-09-30
Medical electrical equipment -- Part 2-85: Particular requirements for 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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- 2021-09-27
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- 2021-09-27
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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- 2021-09-27
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- 2021-09-27
Lung ventilators and related equipment -- Vocabulary and semantics (ISO 19223:2019)
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- 11.040.10
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- 2021-09-22
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- 2021-09-22
Cryogenic storage systems with automated nitrogen supply system - Design, installation and testing
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- 11.040.10
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- 2021-09-16
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- 2021-09-16
Small medical gas cylinders - Pin-index yoke-type valve connections
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- 11.040.10
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- 2021-09-16
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- 2021-09-16
Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2021)
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- 11.040.10
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- 2021-09-15
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- 2021-09-15
Medical suction equipment – Part 4: General requirements
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- 11.040.10
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- 2021-09-08
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- 2021-09-08
Medical electrical equipment – Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
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- 11.040.10
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- 发布
- 2021-09-08
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- 2021-09-08
本文件规定了医用分子筛制氧系统（以下简称制氧系统）的基本要求、使用条件、技术要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存、质量承诺。 本文件适用于使用变压吸附法（PSA）制取富氧空气（93 %氧）或医用氧，经医用气体管道系统向其它用氧医疗器械提供气源，并按其临床适用范围向患者供氧的医用分子筛制氧系统。
Medical molecular sieve oxygen generation system
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- 11.040.10
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- C358
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- 2021-09-08
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- 2021-09-29
Anesthesia and Respiratory Equipment Spirometer for measuring human time forced expiratory volume
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- 11.040.10
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- C46
- 发布
- 2021-09-06
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- 2023-05-01
Medical device sleep apnea treatment masks and application accessories
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- 11.040.10
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- C46
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- 2021-09-06
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- 2024-05-01
