11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

DIN EN ISO 5361:2017 麻醉和呼吸设备.气管导管和连接器(ISO 5361-2016);德文版本EN ISO 5361-2016

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016); German version EN ISO 5361:2016

DIN EN ISO 5364:2017 麻醉和呼吸设备.口咽导气管(ISO 5364-2016);德文版本EN ISO 5364-2016

Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016); German version EN ISO 5364:2016

GSO ISO 11712:2016 ​麻醉和呼吸设备 喉上气道和连接器​

ISO 11712:2009 provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. ISO 11712:2009 specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this International Standard. ISO 11712:2009 requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be size-compatible.

​Anaesthetic and respiratory equipment -- Supralaryngeal airways and connectors​

GSO ISO 80601-2-55:2016 医用电气设备 第2-55部分：呼吸气体监测仪基本安全和基本性能的特殊要求

IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 * Scope Replacement: This International Standard specifies particular requirements for the basic safety and Essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient. This International Standard specifies requirements for — anaesthetic gas monitoring, — carbon dioxide monitoring, and — oxygen monitoring. NOTE 1 An rgm can be either standalone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. This International Standard is not applicable to an rgm intended for use with flammable anaesthetic agents. Environmental aspects are addressed in Annex BB. NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9. 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 standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1). NOTE 3 See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular basic safety and essential performance requirements for an rgm (as defined in 201.3.210) and its accessories. NOTE Accessories are included because the combination of the rgm and the accessories needs to be safe. Accessories can have a significant impact on the basic safety and essential performance of an rgm. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3 does not apply. 201.1.4 Particular standards Subclause 1.4 of the general standard is replaced by: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2:2007 collateral standard, 206.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-6:2010 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses or figures which are additional to those of the general standard are numbered starting from 201.101. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2:2007, 203 for IEC 60601-1-3:2008, etc. The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

GSO ISO 80601-2-69:2016 医用电气设备 第2-69部分：制氧机设备基本安全和基本性能的特殊要求

IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by: This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT OPERABLE use by a single PATIENT in various environments including any private and public transportation as well as in commercial aircraft. NOTE 1 Such an OXYGEN CONCENTRATOR can also be used in professional health care facilities. This particular standard is applicable to a TRANSIT‐OPERABLE and non‐TRANSIT‐OPERABLE OXYGEN CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used with other medical devices, ME EQUIPMENT or ME SYSTEMS. EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT [10] or humidifier [4]. EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand. EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases. [3] EXAMPLE 4 An OXYGEN CONCENTRATOR with an integrated liquid reservoir or gas cylinder filling system. This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR. This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083. 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE 2 See also 4.2 of the General Standard. This International Standard is a particular standard in the IEC 60601‐1 series of standards.

Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

GSO ISO 5356-2:2016 麻醉和呼吸设备 锥形连接器 第2部分：螺纹承重连接器

ISO 5356-2:2012 specifies dimensional requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators. Such connectors are intended for mounting heavy accessories. ISO 5356-2:2012 specifies requirements for the following screw-threaded, weight-bearing conical connectors: 22 mm connectors; 22/15 mm coaxial connectors.

Anaesthetic and respiratory equipment -- Conical connectors -- Part 2: Screw-threaded weight-bearing connectors

GSO ISO 5360:2016 麻醉蒸发器 药剂专用填充系统

This International Standard specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers. This International Standard does not specify construction materials. NOTE 1 For recommendations on materials, see Annex A. Because of the unique properties of desflurane, dimensions for this agent have not been specified in this International Standard. NOTE 2 Designs of connection systems, which only permit engagement of the agent-specific bottle adaptor to the bottle when the bottle collar is in place, are encouraged.

Anaesthetic vaporizers -- Agent-specific filling systems

GSO ISO 5364:2016 麻醉和呼吸设备 口咽气道

This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. This International Standard is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.

Anaesthetic and respiratory equipment -- Oropharyngeal airways

GSO ISO 18082:2016 麻醉和呼吸设备 用于医用气体的不可互换螺纹 (NIST) 低压连接器的尺寸

ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute. ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; use with vacuum.

Anaesthetic and respiratory equipment -- Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases

GSO ISO 23747:2016 麻醉和呼吸设备 用于评估自主呼吸人的肺功能的峰值呼气流量计

This International Standard specifies requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function device or as a stand-alone device. Planning and design of products applying to this International Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E. NOTE Additional aspects of environmental impact are addressed in ISO 14971.

Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

GSO ISO 26782:2016 麻醉和呼吸设备 用于测量人体用力呼气时间的肺量计

This International Standard specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg. This International Standard applies to a spirometer that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed. Devices intended for continuously monitoring patients are outside the scope of this International Standard.

Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans

GSO IEC 60601-2-4:2016 医用电气设备 第2-4部分：心脏除颤器基本安全和基本性能的特殊要求

IEC 60601-2-4:2010 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

GSO ISO 5359:2016 麻醉和呼吸设备 用于医用气体的低压软管组件

1.1 This International Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: — oxygen, — nitrous oxide, — medical air, — helium, — carbon dioxide, — xenon, — specified mixtures of the gases listed above, — oxygen-enriched air, — air for driving surgical tools, — nitrogen for driving surgical tools, and for use with vacuum. 1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. 1.3 This International Standard does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies. NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are specified in CGA V-5 [28]. NOTE 2 Specifications for the dimensions and allocation of sleeve indexed system (SIS) connectors are specified in AS 2896 [23]. NOTE 3 Dimensions and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in ISO 18082 [11]. NOTE 4 Terminal units designed for quick connectors are specified in ISO 9170-1. 1.4 This International Standard does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools. 1.5 This International Standard does not specify the intended uses of hose assemblies. NOTE Environmental aspects are dealt with in Annex B.

Anaesthetic and respiratory equipment -- Low-pressure hose assemblies for use with medical gases

GSO ISO 5367:2016 麻醉和呼吸设备 呼吸装置和连接器

ISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions. ISO 5367:2014 is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled. Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

Anaesthetic and respiratory equipment -- Breathing sets and connectors

GSO ISO 8185:2016 医用呼吸道加湿器 呼吸加湿系统的特殊要求

IEC 60601-1:1988, Clause 1, applies, except as follows: Amendment (add at the end of 1.1): This International Standard includes requirements for the basic safety and essential performance of humidification systems, as defined in 3.6. This International Standard also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes. NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1. * This International Standard also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This International Standard is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance. Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, this International Standard has been prepared as a Particular Standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. Where this International Standard specifies that a Clause of IEC 60601-1 applies, it means that the Clause applies only if the requirement is relevant to the humidification system under consideration. This International Standard is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. This International Standard is not applicable to nebulizers used for the delivery of drugs to patients. In the planning and design of products within the scope of this International Standard, it is advisable to give due consideration to the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex GG. NOTE Additional aspects of environmental impact are addressed in ISO 14971.

Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems

GSO ISO 18835:2016 吸入麻醉系统 抽吸麻醉系统

ISO 18835:2015 specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia. Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents. ISO 18835:2015 also includes requirements for a bellows-type manual ventilator. NOTE 1 Requirements for automatic anaesthetic ventilators are covered by ISO 80601‑2-13. NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651‑4. ISO 18835:2015 does not specify requirements for monitoring of the equipment or the patient.

Inhalational anaesthesia systems -- Draw-over anaesthetic systems

GSO ISO 9360-1:2016 麻醉和呼吸设备 用于加湿人体呼吸气体的热湿交换器（HME） 第1部分：用于最小潮气量 250 毫升的 HME

This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including those incorporating breathing system filters, intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, and describes test methods for their evaluation.

Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans -- Part 1: HMEs for use with minimum tidal volumes of 250 ml

GSO ISO 5362:2016 麻醉储液袋

This International Standard specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance. This International Standard includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of this International Standard for the recommended product life. This International Standard is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of this International Standard.

Anaesthetic reservoir bags

GSO ISO 21969:2016 用于医用气体系统的高压柔性连接

ISO 21969:2009 applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. ISO 21969:2009 applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1. ISO 21969:2009 applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1.

  High-pressure flexible connections for use with medical gas systems  

GSO ISO 15002:2016 用于连接医用气体管道系统终端单元的流量计量装置

1.1 This International Standard is applicable to: — flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases; — flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators. 1.2 This International Standard applies to: a) flow-metering devices intended to be used with the following medical gases: — oxygen; — nitrous oxide; — medical air; — carbon dioxide; — oxygen/nitrous oxide mixture [50 %/50 % (by volume)]; — specified mixtures of the gases listed above; b) flow-metering devices intended to be used with the following gases: — oxygen-enriched air; — helium; — xenon. NOTE Regional or national regulations might permit use of oxygen-specific connection points for oxygen-enriched air. 1.3 This International Standard does not apply to electrical or electronic flow-metering devices. 1.4 This International Standard does not apply to gases used for driving surgical tools.

Flow-metering devices for connection to terminal units of medical gas pipeline systems