11.040.10 (Anaesthetic, respiratory and reanimatio 标准查询与下载



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4.1 Purpose of Guide G88—The purpose of this guide is to furnish qualified technical personnel with pertinent information for use in designing oxygen systems or assessing the safety of oxygen systems. It emphasizes factors that cause ignition and enhance propagation throughout a system's service life so that the occurrence of these conditions may be avoided or minimized. It is not intended as a specification for the design of oxygen systems. 4.2 Role of Guide G88—ASTM Committee G04’s abstract standard is Guide G128, and it introduces the overall subject of oxygen compatibility and the body of related work and related resources including standards, research reports and a video3 G04 has developed and adopted for use in coping with oxygen hazards. The interrelationships among the standards are shown in Table 1. Guide G88 deals with oxygen system and hardware design principles, and it is supported by a regulator ignition test (see G175).Other standards cover: (1) the selection of materials (both metals and nonmetals) which are supported by a series of standards for testing materials of interest and for preparing materials for test; (2) the cleaning of oxygen hardware which is supported by a series of standards on cleaning procedures, cleanliness testing methods, and cleaning agent selection and evaluation; (3) the study of fire incidents in oxygen systems; and (4) related terminology.TABLE 1 Role of Guide G88 with Respect to Other ASTM G04 Standard Guides and Practices and their Supporting Test MethodsA, B G128 Guide to Control of Hazards and Risks in Oxygen-Enriched 8199;8199;8199;8199;Systems 8199;G88 Designing Systems for Oxygen Service 8199;8199;G175 Evaluating the Ignition Sensitivity and Fault Tolerance of 8199;8199;8199;8199;8199;8199;Oxygen Regulators   8199;G63 Evaluating Nonmetallic Materials 8199;8199;D2512 Compatibility of Materials With Liquid Oxygen 8199;8199;8199;8199;8199;8199;8199;(Mechanical Impact) 8199;8199;D2863 Measuring the Minimum Oxygen Concentration to Support 8199;8199;8199;8199;8199;8199;8199;Candle-Like Combustion (Oxygen Index) 8199;8199;D4809 Heat of Combustion of Liquid Hydrocarbon Fuels by 8199;8199;8199;8199;8199;8199;8199;Bomb Calorimeter (Precision Method)

Standard Guide for Designing Systems for Oxygen Service

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
2013
实施

4.1 This test method comprises two phases and is used to evaluate the ignition sensitivity and fault tolerance of oxygen pressure regulators used for medical and emergency applications. 4.2 Phase 1: Oxygen Pressure Shock Test—The objective of this test phase is to determine whether the heat or temperature from oxygen pressure shocks will result in burnout or visible heat damage to the internal parts of the pressure regulator. 4.2.1 The criteria for a valid test are specified in ISO 10524–1, Section 6.6 for oxygen pressure regulators and ISO 10524–3, Section 6.6 for oxygen VIPRs. 4.2.2 The pass/fail criteria for a pressure regulator are specified in ISO 10524–1, Section 6.6 for oxygen pressure regulators and ISO 10524–3, Section 6.6 for oxygen VIPRs. 4.3 Phase 2: Promoted Ignition Test— 4.3.1 Oxygen Pressure Regulator—The objective of this test phase is to determine if an ignition event upstream of the pressure regulator inlet filter will result in sustained combustion and burnout of the pressure regulator. 4.3.1.1 The criterion for a valid test is either, (1) failure of the pressure regulator, as defined in 4.3.1.2, or (2) if the pressure regulator does not fail, consumption of at least 908201;% of the ignition pill as determined by visual inspection or mass determination. 4.3.1.2 Failure of the pressure regulator is defined as the breach of the pressurized regulator component (burnout), which may include the CGA 870 seal ring, and ejection of molten or burning metal or any parts, including the gauge, from the pressure regulator. See Appendix X6 Testing Pressure Regulators and VIPRs with Gauges. However, momentary (less than 1 s) ejection of flame through normal vent paths, with sparks that look similar to those from metal applied to a grinding wheel, is acceptable and does not constitute a failure. 4.3.2 Oxygen VIPR—The objective of this test is to determine if an ignition event upstream of the shut-off valve or within the shut-off valve will result in sustained combustion and burnout of the VIPR, while the VIPR is flowing oxygen in the patient-use direction. 4.3.2.1 The criterion for a valid test is either, (1) failure of the VIPR as defined in 4.3.2.2, or (2) if the VIPR does not fail, consumption of at least 90 % of the ignition pill as determined by visual inspection or mass determination. Although the intent and desired result is to provide sufficient energy to ignite the shut-off valve seat, ignition of the shut-off valve seat is not required for a valid test. See Rationale in Appendix X7. 4.3.2.2 Failure of the VIPR is defined as the breach of the pressurized VIPR component (burnout) and ejection of molten or burning metal or any parts, including the gauge, from the VIPR. See Appendix X6 Testing Pressure Regulators and VIPRs with Gauges. However, mome......

Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
2013
实施

1.1 *This standard covers basic safety and essential performance requirements for fixation devices designed to be attached to the head, face, or mouth of the patient and equipped with a means to secure and stabilize a tracheal tube or other airway device in its intended position. Devices within the scope of this standard may be provided with a wide variety of patient attachment mechanisms and tube locking mechanisms. 1.2 *Devices intended to secure tracheostomy tubes are outside the scope of this standard. NOTE These requirements are addressed in ISO 5366-11 and 5366-32. 1.3 *Fixation devices intended to secure devices such as gastric tubes, feeding tubes and suction catheters are outside the scope of this standard. 1.4 Flammability of fixation devices, for example if used in the presence of certain flammable anesthetics, electrosurgical units, or lasers is a well-recognized hazard that is outside the scope of this standard. See Annex F for guidance.

Standard specification for fixation devices for tracheal tubes and other airway devices

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
P94
发布
2008
实施

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 G 63 and G 94 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 1The 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.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 and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Designing Systems for Oxygen Service

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C46
发布
2005
实施

This test method comprises two phases and is used to evaluate the ignition sensitivity and fault tolerance of oxygen regulators used for medical and emergency applications. Phase 1: Oxygen Pressure Shock Test8212;The objective of this test phase is to determine whether the heat from oxygen pressure shocks will result in burnout or visible heat damage to the internal parts of the regulator. Phase 1 is performed according to ISO 10524, Section 11.8.1. 4.2.1 The criteria for an acceptable test are specified in ISO 10524, Section 11.8.1. 4.2.2 The pass/fail criteria for a regulator are specified in ISO 10524, Section 11.8.1. Phase 2: Regulator Inlet Promoted Ignition Test8212;The objective of this test phase is to determine if an ignition event upstream of the regulator inlet filter will result in sustained combustion and burnout of the regulator. 4.3.1 The criterion for an acceptable test is either, (1) failure of the regulator, which is defined as the breach of the pressurized regulator component (burnout) and ejection of molten or burning metal or any internal parts from the regulator, or (2) if the regulator does not fail, consumption of at least 90 % of the ignition pill as determined by visual inspection or mass determination. Failure of the regulator at the seal ring does not constitute an acceptable test. 4.3.2 Momentary (less than 1 s) ejection of flame through normal vent paths, with sparks that look similar to those from metal applied to a grinding wheel, is acceptable.1.1 This standard describes a test method for evaluating the ignition sensitivity and fault tolerance of oxygen regulators used for medical and emergency applications.1.2 For the purpose of this standard, a pressure regulator is a device, also called a pressure-reducing valve, that is intended for medical or emergency purposes and 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)].1.3 This standard applies only to oxygen regulators used for medical and emergency applications that are designed and fitted with CGA 540 inlet connections or CGA 870 pin-index adapters (CGA V-1).1.4 This standard provides an evaluation tool for determining the fault tolerance of oxygen regulators used for medical and emergency applications. A fault tolerant regulator is defined as (1) having a low probability of ignition as evaluated by rapid pressurization testing, and (2) having a low consequence of ignition as evaluated by forced ignition testing.1.5 This standard is not a design standard; however, it can be used to aid designers in designing and evaluating the safe performance and fault tolerance capability of oxygen regulators used for medical and emergency applications (G 128).Note 18212;It is essential that a risk assessment be carried out on breathing gas systems, especially concerning oxygen compatibility (refer to ASTM G 63 and G 94) and toxic product formation due to ignition or decomposition of nonmetallic materials as weighed against the risk of flammability (refer to ISO 15001.2). See Appendix X1 and X2.1 for details.1.6 This standard is also used to aid those responsible for purchasing or using oxygen regulators used for medical and emergency applications in ensuring that selected regulators are tolerant of the ignition mechanisms that are normally active in oxygen systems.1.7 This standard does not purport to address the ignition sensitivity and fault tolerance of an oxygen regulator caused by contamination during field maintenance or use. Regulator designers and manufacturers should provi......

Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C47
发布
2003
实施

This clause of the GENERAL STANDARD applies with the following amendment: This specification presents particular requirements for an ANESTHESIA WORKSTATION when supplied as a complete unit, as well as particular requirements for individual devices which together make up a complete ANESTHESIA WORKSTATION. It is the intent of this specification that both complete ANESTHESIA WORKSTATIONS and the individual devices be commercially available to allow USERS to configure an ANESTHESIA WORKSTATION to meet the needs of their clinical practice in conformance with their national regulations or guidelines, or both. To this end the standard has been structured in such a way as to clearly identify particular requirements pertinent to specific devices currently available. Note 1Although this specification does not mandate the use of a single communication protocol, the purpose of digital data communication in this specification is to facilitate transfer of data between devices. Possible uses of data from multiple sources include integrated data display and alarm annunciation, and aiding DECISION SUPPORT SYSTEMS. Centralized display integration and functional integration are the hallmarks differentiating this specification from previous anesthesia gas machine standards. Digital communication makes possible integration among workstation devices that may be modular, or interact only through communication interfaces. Documentation and disclosure requirements vary because of expected variations in implementation permitted by the specified standards. Additional documentation requirements are imposed when interface methods not included in the specified DIGITAL INTERFACE standards are encountered. Equipment that can be used with flammable anesthetic agents, intermittent flow machines, that only deliver gas to the patient at varying rates in response to the patient's inspiratory efforts, and dental nitrous oxide - oxygen machines are not covered by this specification.

Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C31
发布
2000
实施

1.1 This specification establishes the requirements for two wall thickness schedules of specially cleaned, straight lengths of seamless copper tube, identified as Types K and L, suitable for medical gas systems. The tube shall be installed in conformance with the requirements of the National Fire Protection Association (NFPA) Standard 99, Gas and Vacuum Systems (NFPA) Standard 99C, Standard for Hypobaric Facilities (NFPA) Standard 99B, and Canadian Standards Association (CSA) Standard Z 305.1/Z 7396.1, Nonflammable Medical Gas Piping Systems. Note 1--Types K and L tube are defined in Specification B88.Note 2--Drawn temper tube is suitable for use with capillary (solder joint) fittings for brazing.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units, which are provided for information only and are not considered standard.1.3 The following safety hazard caveat pertains only to the test method portion of Section 12 of this specification. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Seamless Copper Tube for Medical Gas Systems

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
H62
发布
2000
实施

For purpose of determining compliance with the specified limits for requirements of the properties listed in Table 9, an observed value or calculated value shall be rounded as indicated in accordance with the rounding of Practice E29. TABLE 9 Rounding Units PropertyRounded Unit for Observed for Calculated Value Chemical compositionnearest unit in the last right-hand place figures of the specified limit Hardness valuesnearest unit in the last right-hand place figures of the specified limit Tensile strengthnearest ksi Expansionnearest 1 % Grain size: Up to 0.055 mm, inclnearest multiple of 0.005 mm1.1 This specification establishes the requirements for two wall thickness schedules of specially cleaned, straight lengths of seamless copper tube, identified as Types K and L, suitable for medical gas systems. The tube shall be installed in conformance with the requirements of the National Fire Protection Association (NFPA) Standard 99, Gas and Vacuum Systems (NFPA) Standard 99C, Standard for Hypobaric Facilities (NFPA) Standard 99B, and Canadian Standards Association (CSA) Standard Z 305.1/Z 7396.1, Nonflammable Medical Gas Piping Systems. Note 18212;Types K and L tube are defined in Specification B88. Note 28212;Drawn temper tube is suitable for use with capillary (solder joint) fittings for brazing. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units, which are provided for information only and are not considered standard. 1.3 The following safety hazard caveat pertains only to the test method portion of Section 12 of this specification. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Seamless Copper Tube for Medical Gas Systems

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
H62
发布
2000
实施

1.1 This specification establishes the requirements for two wall thickness schedules of specially cleaned, straight lengths of seamless copper tube, identified as Types K and L, suitable for medical gas systems. The tube shall be installed in conformance with the requirements of the National Fire Protection Association (NFPA) Standard 99, Gas and Vacuum Systems (NFPA) Standard 99C, Standard for Hypobaric Facilities (NFPA) Standard 99B, and Canadian Standards Association (CSA) Standard Z 305.1/Z 7396.1, Nonflammable Medical Gas Piping Systems. Note 1Types K and L tube are defined in Specification B 88.Note 2Drawn temper tube is suitable for use with capillary (solder joint) fittings for brazing.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units, which are provided for information only and are not considered standard.The following safety hazard caveat pertains only to the test method portion of Section of this specification. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Seamless Copper Tube for Medical Gas Systems

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
H62
发布
2000
实施

1.1 This standard covers minimum requirements for primary medical oxygen delivery systems for EMS ground vehicles used in the following applications: 1.1.1 The transportation of the sick and injured to or from an appropriate medical facility while basic, advanced, or specialized life support services are being provided. 1.1.2 The delivery of interhospital critical transport care. 1.1.3 The delivery of nonemergency, medically required, transport services, and 1.1.4 The transportation and delivery of personnel and supplies essential for proper care of an emergent patient. 1.2 This standard establishes criteria to be considered in the he performance, specification, purchase, and acceptance testing of ground vehicles for EMS use. 1.3 This entire standard should be read before ordering an ambulance in order to be knowledgeable of the types of equipment that are available and their performance requirements. Due to the variety of ambulance equipment or features, some options may be incompatible with all chassis manufacturers' models. Detailed technical information is available from the chassis manufacturers. 1.4 The sections in this standard appear in the following sequence: Scope (1); Referenced Documents (2); Terminology (3); Significance and Use (4); Design Requirements (5); Performance Requirements (6); Installation Requirements (7); GOX System Design Requirements (8); GOX System Installation Requirements (9); GOX System Test Requirements (10); LOX System Design Requirements (11); LOX System Installation Requirements (12); LOX System Test Requirements (13); Keywords (14).

Standard Specification for Medical Oxygen Delivery Systems for EMS Ground Vehicles

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C47
发布
1999
实施

1.1 This standard covers minimum requirements for primary medical oxygen delivery systems for EMS ground vehicles used in the following applications: 1.1.1 The transportation of the sick and injured to or from an appropriate medical facility while basic, advanced, or specialized life support services are being provided. 1.1.2 The delivery of interhospital critical transport care. 1.1.3 The delivery of nonemergency, medically required, transport services, and 1.1.4 The transportation and delivery of personnel and supplies essential for proper care of an emergent patient. 1.2 This standard establishes criteria to be considered int he performance, specification, purchase, and acceptance testing of ground vehicles for EMS use. 1.3 This entire standard should be read before ordering an ambulance in order to be knowledgeable of the types of equipment that are available and their performance requirements. Due to the variety of ambulance equipment or features, some options may be incompatible with all chassis manufacturers' models. Detailed technical information is avalilable from the chassis manufacturers. 1.4 The sections in this standard appear in the following sequence: Scope (1); Referenced Documents (2); Terminology (3); Significance and Use (4); Design Requirements (5); Performance Requirements (6); Installation Requirements (7); GOX System Design Requirements (8); GOX System Installation Requirements (9); GOX System Test Requirements (10); LOX System Design Requirements (11); LOX System Installation Requirements (12); LOX System Test Requirements (13); Keywords (14).

Standard Specification for Medical Oxygen Delivery Systems for EMS Ground Vehicles

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C47
发布
1999
实施

1.1 This standard covers minimum requirements for primary medical oxygen delivery systems for EMS ground vehicles used in the following applications: 1.1.1 The transportation of the sick and injured to or from an appropriate medical facility while basic, advanced, or specialized life support services are being provided, 1.1.2 The delivery of interhospital critical transport care, 1.1.3 The delivery of nonemergency, medically required, transport services, and 1.1.4 The transportation and delivery of personnel and supplies essential for proper care of an emergent patient. 1.2 This standard establishes criteria to be considered in the performance, specification, purchase, and acceptance testing of ground vehicles for EMS use. 1.3 This entire standard should be read before ordering an ambulance in order to be knowledgeable of the types of equipment that are available and their performance requirements. Due to the variety of ambulance equipment or features, some options may be incompatible with all chassis manufacturers' models. Detailed technical information is available from the chassis manufacturers. 1.4 The sections in this standard appear in the following sequence:   Section Scope 1 Referenced Documents 2 Terminology 3 Significance and Use 4 Design Requirements 5 Performance Requirements 6 Installa......

Standard Specification for Medical Oxygen Delivery Systems for EMS Ground Vehicles

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
1999
实施

1.1 The requirements given in Clause 1 of the General Standard apply with the following additions and modifications: 1.1.1 Replace 1.1 with the following: 1.1.1.1 This specification includes requirements for the safety and performance of active vaporizing and nebulizing humidification systems, as defined in 3.6, suitable for inclusion in breathing systems (both intubated and nonintubated patients). 1.1.1.2 This specification also includes requirements for breathing tubes, including heated breathing tubes (heated-wire breathing circuits), and devices intended to control these heated breathing tubes, heated breathing tube controllers. 1.1.1.3 Heat and moisture exchangers (HMEs) are outside the scope of this specification. However, it is recognized that their safety and performance may affect that of humidification systems. Numerous studies have been published citing the benefits and risks of HMEs used in conjunction with humidification systems. It is advisable to review the instructions for use provided with the humidification systems and HMEs and the available literature for more details. 1.1.1.4 Devices commonly referred to as "room humidifiers," humidifiers used in heating, ventilation, and airconditioning systems and humidifiers used to condition the environment within infant incubators are outside the scope of this specification. 1.1.1.5 It has not been found possible to include guidance on the matter of droplet size in the case of nebulizing humidifiers. 1.1.1.6 Gas-powered nebulizers used for the delivery of drugs to patients through their respiratory system are outside the scope of this specification. 1.1.1.7 Appendices in this specification are not mandatory unless made so by an explicit statement in the main text. 1.2 The values stated in SI units are to be regarded as the standard.

Standard Specification for Humidifiers for Medical Use-Part 1 General Requirements for Active Humidification Systems

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C47
发布
1996
实施

1.1 This clause of the general standard applies except as follows (replacement): This particular specification specifies safety requirements for oxygen concentrators as defined in 3.1. This specification does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic or cleaning agents, or both. 1.2 The values stated in SI units are to be regarded as the standard.

Standard Specification for Oxygen Concentrators for Domiciliary Use

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
1993
实施

1.1 This clause of the General Standard applies except as follows:1.1.1 This specification applies to anesthetic gas monitors used with adults, children, and neonates.1.1.2 It does not apply to devices intended for use in laboratory research applications, nonhuman applications, or for calibration of anesthetic agent vaporizers.1.1.3 This specification does not apply to anesthetic gas monitors intended for use with flammable anesthetic mixtures.

Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
1992
实施

1.1 This specification covers the minimum performance and safety requirements to be used for systems for scavenging excess anesthetic gases from operating rooms. It applies to scavenging from breathing machines for medical use, extracorporeal oxygenators, and anesthetic breathing machines. It is not intended to apply to machines designed exclusively for dental use. Note 1-This standard supercedes ANSI Z79.11-1982.

Specification for Anesthetic Equipment-Scavenging Systems for Anesthetic Gases

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C46
发布
1991
实施

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 G 63 and G 94 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 1The 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.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 and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Designing Systems for Oxygen Service

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
1990
实施

4.1 This specification applies to rigid bronchoscopes, those endoscopic accessories through which rigid bronchoscopes are used, those accessories which are passed through rigid bronchoscopes in use, and those associated accessories which are inserted into the body. 1.1 This specification covers definitions and requirements for rigid bronchoscopes and certain bronchoscopic accessories used in the practice of medicine.

Standard Specification for Bronchoscopes 40;Rigid41;

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
1989
实施

1.1 This specification covers breathing systems and components employed with anesthesia gas machines for humans. This specification considers the circle system as a whole and some of its components individually. A particular emphasis is placed upon component arrangement in the circle absorber-type system, and submits a system of standard description and notation. Excluded are ventilators for use during anesthesia, Mapelson nonrebreathing type systems, as well as breathing systems and related components of dental analgesia machines. (For rationale, see Appendix X1.)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 and health practices and determine the applicability of regulatory limitations prior to use.1.3 This specification is arranged as follows:SectionScope1Referenced Documents2Terminology3System Classification4Graphic NotationsDiagramatic RulesFunctional Segments of the Circle SystemTest Procedures-General5Sterilization6Systems7Leakage of Breathing SystemResistance of Breathing SystemsVolume of Gas Not Delivered to Patient Due to Internal ComplianceMonitoring RequirementsAdjustable Pressure-Limiting (APL) Valves8Reservoir Bags9CO2 Absorbers10Unidirectional Valves11RequirementsTest ProcedureOptional Components12Breathing Tubes13Fresh Gas Inlet and Fresh Gas Supply Tube or Hose14Connectors15Pressure Gauges16Y-Piece and Breathing Tubes17Information in Labeling18RationaleAppendix X1

Standard Specification for Minimum Performance and Safety Requirements for Anesthesia Breathing Systems

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
发布
1989
实施

1.1 This specification covers definitions and requirements for rigid bronchoscopes and certain bronchoscopic accessories used in the practice of medicine.

Standard Specification for Bronchoscopes (Rigid)

ICS
11.040.10 (Anaesthetic, respiratory and reanimatio
CCS
C40
发布
1989
实施



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