11.040.10 麻醉、呼吸和复苏设备 标准查询与下载
共找到 2037 条与 麻醉、呼吸和复苏设备 相关的标准，共 136 页
本文件规定了导气管和相关设备的通用要求。本文件适用于特定标准引用了本文件的那些设备。
General requirements for airways and related equipment in anesthesia and respiratory equipment
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2022-10-17
- 实施
- 2023-10-01
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy. This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-08-31
- 实施
- 2022-11-30
1 Scope This document specifies requirements for low-flow nasal cannulae , used in both home care and hospital environments for the administration of oxygen therapy . This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
Anaesthetic and respiratory equipment. Low-flow nasal cannulae for oxygen therapy
- ICS
- 11.040.10
- CCS
- 发布
- 2022-08-31
- 实施
- 2022-08-31
1 Scope This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes . These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document
Anaesthetic and respiratory equipment. Tracheobronchial tubes
- ICS
- 11.040.10
- CCS
- 发布
- 2022-07-31
- 实施
- 2022-07-31
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy. This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
Anaesthetic and respiratory equipment — Low-flow nasal cannulae for oxygen therapy
- ICS
- 11.040.10
- CCS
- 发布
- 2022-07-29
- 实施
This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-07-06
- 实施
- 2022-10-31
1 Scope This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices , such as supralaryngeal airways , tracheal tubes or tracheostomy tubes . This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.
Anaesthetic and respiratory equipment. Cuff pressure indication, control and regulation devices
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-30
- 实施
- 2022-06-30
1 Scope This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction . It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use . Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document. This document does not apply to mucus extractors.
Medical suction equipment. Manually powered suction equipment
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-30
- 实施
- 2022-06-30
201.1 Scope, object and related standards Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows: NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 201.1.1 * Scope Replacement: This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator . This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: — anaesthetic gas delivery system; — anaesthetic breathing system; — anaesthetic gas scavenging system (AGSS);
Medical electrical equipment. Particular requirements for basic safety and essential performance of an anaesthetic workstation
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-30
- 实施
- 2022-06-30
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and — intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system
Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-30
- 实施
1 Scope This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices . Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).
Anaesthetic and respiratory equipment. Air entrainment devices
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-30
- 实施
- 2022-06-30
1 Scope This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction . It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
Medical suction equipment. Suction equipment powered from a vacuum or positive pressure gas source
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-30
- 实施
- 2022-06-30
BS EN ISO 15002. Flow-metering devices for connection to terminal units of medical gas pipeline systems
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-28
- 实施
- 2022-06-28
This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document
Anaesthetic and respiratory equipment — Tracheobronchial tubes
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-16
- 实施
This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system (AGSS); anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1. An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard. NOTE 2 The applicability of this document is indicated in Table AA.2. This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components including accessories, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-15
- 实施
- 2022-09-30
This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.
Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-06-01
- 实施
- 2022-09-30
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-05-25
- 实施
- 2022-08-31
This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).
Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-05-25
- 实施
- 2022-08-31
This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document. This document does not apply to mucus extractors.
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-05-25
- 实施
- 2022-08-31
规格要求、工作条件、外观与结构、输出流量偏差、制氧机所产生气体的理化指标、气密性、出气口压力范围、最大氧产量及氧浓度、噪声、计时器、制氧机监控灯、断电报警、定时功能、连续工作时间、电气安全要求。
Mobile intelligent high pressure oxygen supply system
- ICS
- 11.040.10
- CCS
- C358
- 发布
- 2022-05-25
- 实施
- 2022-05-25
