11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

DIN EN IEC 60601-2-20:2021 医用电气设备-第2-20部分：婴儿运输保育箱基本安全和基本性能的特殊要求（IEC 60601-2-20:2020）；德文版 EN IEC 60601-2-20:2020

This Standard specifies the basic safety and essential performance of infant transport incubator equipment. This particular requirements amend und supplement DIN EN 60601-1 (VDE 0750-1).

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2020); German version EN IEC 60601-2-20:2020

ISO 80601-2-90:2021 医用电气设备.第2-90部分：呼吸高流量治疗设备的基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

EN ISO 10651-5:2021 医用肺通气机.基本安全和性能的特殊要求.第5部分:气体驱动急救人工呼吸器

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)

SN EN ISO 80601-2-74:2021 医用电气设备 第 2-74 部分：呼吸湿化设备基本安全和基本性能的特殊要求（ISO 80601-2-74:2021）

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)

prEN ISO 80601-2-12:2021 医用电气设备 第 2-12 部分：重症监护呼吸机基本安全和基本性能的特殊要求（ISO/DIS 80601-2-12:2021）

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/DIS 80601-2-12:2021)

DS/EN ISO 80601-2-74:2021 医用电气设备第2-74部分：呼吸湿化设备基本安全和基本性能的特殊要求（ISO 80601-2-74:2021）

Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021)

DS/ISO 80601-2-74:2021 《医用电气设备》第2-74部分：呼吸湿化设备基本安全和基本性能的特殊要求

Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

BS EN ISO 80601-2-74:2021 医疗电气设备 呼吸湿化设备基本安全和基本性能的特殊要求

Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory humidifying equipment

NF S95-186-2-74*NF EN ISO 80601-2-74:2021 医疗电气设备. 第2-74部分: 呼吸加湿器基本安全和基本性能的详细要求

Medical electrical equipment - Part 2-74 : particular requirements for basic safety and essential performance of respiratory humidifying equipment

DS/EN IEC 60601-2-19:2021 《医用电气设备》第2-19部分：婴儿保育箱基本安全和基本性能的特殊要求

Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

DS/EN IEC 60601-2-21:2021 《医用电气设备》第2-21部分：婴儿辐射取暖器基本安全和基本性能的特殊要求

Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

LST EN ISO 80601-2-87:2021 医用电气设备 第 2-87 部分：高频呼吸机基本安全和基本性能的特殊要求（ISO 80601-2-87:2021）

Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021)

ISO 80601-2-74:2021 医疗电气设备. 第2-74部分: 呼吸加湿器基本安全和基本性能的详细要求

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

GSO ISO 80601-2-74:2021 医用电气设备 第2-74部分：呼吸湿化设备基本安全和基本性能的特殊要求

ISO 80601-2-74:2017 applies to the basic safety and essential performance of a humidifier, also hereafter referred to as me equipment, in combination with its accessories, the combination also hereafter referred to as me system. ISO 80601-2-74:2017 is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or me equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE 1 Heated breathing tubes and their controllers are me equipment and are subject to the requirements of IEC 60601‑1. NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes. ISO 80601-2-74:2017 includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients. NOTE 3 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier. EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12[12] also applies. EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2-72[14] also applies. EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2-70[13] also applies. ISO 80601-2-74:2017 also includes requirements for an active hme (heat and moisture exchanger), me equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the hme to the patient. This document is not applicable to a passive hme, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture. NOTE 4 ISO 9360‑1[5] and ISO 9360‑2[6] specify the safety and performance requirements for a passive hme. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems 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 me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. ISO 80601-2-74:2017 does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789:?.[8] This document is not applicable to equipment commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. ISO 80601-2-74:2017 is not applicable to nebulizers used for the delivery of drugs to patients. NOTE 6 ISO 27427[10] specifies the safety and performance requirements for nebulizers. ISO 80601-2-74:2017 is a particular standard in the IEC 60601‑1 and the ISO/IEC 80601 series.

Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

GSO ISO 18562-2:2021 医疗保健应用中呼吸气体路径的生物相容性评估 第2部分：颗粒物排放测试

ISO 18562-2:2017 specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,2 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 µm in diameter. NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction. ISO 18562-2:2017 therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry. ISO 18562-2:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient. ISO 18562-2:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing. ISO 18562-2:2017 does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. ISO 18562-2:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts). NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter

GSO ISO 9170-1:2021 医用气体管道系统终端装置 第1部分：用于压缩医用气体和真空的终端装置

ISO 9170-1:2017 is intended especially to ensure the gas-specific assembly, mechanical resistance, flow, leakage and pressure drop of terminal units and to prevent their interchange between different gases and services and applies to terminal units: a) intended for use in medical gas pipeline systems in accordance with ISO 7396‑1; b) used as pressure outlets on pressure regulators in accordance with ISO 10524‑1; c) used as pressure outlets on pressure regulators integrated with cylinder valves (VIPR) in accordance with ISO 10524‑3. ISO 9170-1:2017 applies to terminal units for use with the following gases for administration to patients or for medical uses (A): - oxygen (A); - nitrous oxide (A); - medical air (A); - carbon dioxide (A); - oxygen/nitrous oxide mixture (A); - helium/oxygen mixtures (A); - oxygen 93 (A); - gases and gas mixtures classified as medical device (A); - gases delivered to medical devices or intended for medical purposes (A); - gases and gas mixtures for medicinal use not specified above (A). ISO 9170-1:2017 applies to terminal units for use with the following gases (B): - air for driving surgical tools (B); - nitrogen for driving surgical tools (B). This document applies to terminal units for use with vacuum systems (C). NOTE The requirements of this document can be used as guidelines for terminal units for other gases. These other gases will be considered for inclusion in this document when they come into general use. ISO 9170-1:2017 specifies requirements for terminal units for supply and disposal of nitrogen and air for driving surgical tools. ISO 9170-1:2017 specifies requirements for probes intended to be connected to the gas-specific connection point. ISO 9170-1:2017 does not specify the dimensions of probes or of the gas-specific connection points. NOTE Regional or national standards specifying dimensions of probes and gas-specific connection points are given in the Bibliography. Other connection systems in national use may be acceptable under this document. Dimensioning for such connections will be specified by their respective national standards. ISO 9170-1:2017 does not specify the requirements for terminal units for anaesthetic gas scavenging systems (AGSS), which are specified in ISO 9170‑2.

Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum

GSO ISO 80601-2-61:2021 医用电气设备 第2-61部分：脉搏血氧计设备基本安全和基本性能的特殊要求

ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.

Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

GSO ISO 80369-1:2021 医疗保健应用中用于液体和气体的小口径连接器 第1部分：一般要求

This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to: — breathing systems and driving gases; — enteral; — limb cuff inflation; — neuraxial; — intravascular or hypodermic. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series. This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered. NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur. NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

GSO ASTM F2726:2021 气管插管和其他气道装置固定装置的标准规范

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

GSO ISO 11197:2021 医疗供应单位

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

Medical supply units