11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

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 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 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 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

BS EN ISO 5366:2016 麻醉和呼吸设备 气管切开插管和连接器

Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors

ISO 18190:2016 麻醉和呼吸设备.气道和相关设备的一般要求

Anaesthetic and respiratory equipment - General requirements for airways and related equipment

BS EN ISO 5364:2016 麻醉和呼吸设备 口咽气道

Anaesthetic and respiratory equipment. Oropharyngeal airways

BS ISO 18190:2016 麻醉和呼吸器. 气道和相关设备的通用要求

Anaesthetic and respiratory equipment. General requirements for airways and related equipment

BS EN ISO 5361:2016 麻醉和呼吸器. 气管导管和连接件

Anaesthetic and respiratory equipment. Tracheal tubes and connectors

EN ISO 5366:2016 麻醉和呼吸设备-气管导管和连接器(ISO 5366:2016)

Der Anwendungsbereich wurde um sogenannte Spezial-TRACHEOTOMIETUBEN ergänzt, da diese zahlreiche Anforderungen gemeinsam haben. A.4 Allgemeine Anforderungen an TRACHEOTOMIETUBEN und Verbindungsstücke Dieser Abschnitt wurde überarbeitet und umfasst nun die wesentliche Leistung und Grundsätze des Risikomanagements im Zusammenhang mit Produkten für das Atemwegssystem und verwandte Geräte. In ISO 18190 wird die Erfordernis einer Risikomanagementakte sowie eines anerkannten Prozesses beschrieben, nach dem der Hersteller eines Medizinprodukts die mit dem Medizinprodukt verbundenen Gefährdungen identifizieren, die mit diesen Gefährdungen im Zusammenhang stehenden Risiken abschätzen und beurteilen, diese Risiken kontrollieren und die Wirksamkeit der Kontrolle überwachen kann. Um die Angemessenheit der Kontrollen zu bestätigen, kann auch eine klinische Bewertung erforderlich sein (siehe ISO 18190 für weitere Informationen). Sicherheitsbezogene Beispiele für den vorgesehenen Verwendungszweck, die von der derzeit anerkannten medizinischen Praxis abweichen können, können wie folgt sein (ohne darauf beschränkt zu sein):- spezifische Empfehlungen bezüglich der Patientengrundgesamtheit für den vorgesehenen Verwendungszweck; - eine Anforderung dahingehend, dass der CUFF-Druck begrenzt sein sollte; - eine Empfehlung dahingehend, dass der CUFF in vivo nicht vollständig entleert sein sollte; - eine Empfehlung dahingehend, dass der TRACHEOTOMIETUBUS nicht für den Einsatz bei einer spezifischen Patientengrundgesamtheit vorgesehen ist, beispielsweise frühgeborene Säuglinge sowie Säuglinge und Kinder, die klein für ihr Alter sind. A.5 Werkstoffe Obwohl die Bioverträglichkeit der Werkstoffe bei allen Trachealtuben und weiteren Atemwegsprodukten eine große Rolle spielt, wurde dieses Merkmal bei TRACHEOTOMIETUBEN, die möglicherweise über mehrere Wochen in situ verbleiben können, als besonders wichtig angesehen. A.6.2.1 Bezeichnete Größe Die zuvor in dieser Internationalen Norm verwendete Benennung "Durchmesser" wurde in Größe bzw. Maß geändert, da einige TRACHEOTOMIETUBEN oval sind. Die angegebene Größe ist die bezeichnete Größe und stellt das engste Maß über das gesamte Lumen des Tubus dar. Dies stellt die angemessene Auswahl eines INNENTUBUS bzw. Zubehörs sicher, das in den Tubus passt. Es identifiziert auch die größte Einengung, die Atemwiderstand hervorrufen kann.

Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors

ISO 5366:2016 麻醉和呼吸设备.气管造口插管和连接器

Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors

EN ISO 5364:2016 麻醉剂和呼吸设备-口咽导气管(ISO 5364:2016)

Diese Internationale Norm legt Anforderungen an Oropharyngealtuben aus Kunststoff und/oder Gummi, mit oder ohne Verstärkungseinsatz aus Kunststoff und/oder Metall, fest. Diese Internationale Norm gilt nicht für Oropharyngealtuben aus Metall und enthält keine Anforderungen an die Entflammbarkeit von Oropharyngealtuben. Die Entflammbarkeit von Oropharyngealtuben, z. B. bei Anwendung von entflammbaren Anästhesiemitteln, elektrochirurgischen Geräten oder Lasern, stellt eine bekannte Gefährdung dar. Sie wird durch entsprechendes klinisches Management berücksichtigt, das jedoch nicht Gegenstand dieser Internationalen Norm ist. Diese Internationale Norm gilt nicht für supralaryngeale Tuben ohne einen internen, integrierten Abdichtmechanismus.

Anaesthetic and respiratory equipment - Oropharyngeal airways

DIN EN ISO 7396-1:2016 医用气体管道系统.第1部分:压缩医疗气体和真空用管道系统(ISO 7396-1-2016).德文版本EN ISO 7396-1-2016

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016); German version EN ISO 7396-1:2016

EN ISO 5361:2016 麻醉和呼吸设备-气管导管和连接器第二版(ISO 5361:2016)

Diese Internationale Norm enthält die grundlegenden Leistungs- und Sicherheitsanforderungen an Orotracheal- und Nasotrachealtuben und an Verbindungsstücke für Trachealtuben. Trachealtuben mit durch Metall oder Nylon verstärkter Wand, Trachealtuben mit Schultern, konische Trachealtuben, Trachealtuben mit Möglichkeiten zum Absaugen, zum Überwachen oder zur Zufuhr von Medikamenten oder sonstigen Gasen und die zahlreichen anderen Arten von Trachealtuben für Spezialanwendungen wurden in diese Internationale Norm aufgenommen, da zahlreiche Spezial-Trachealtuben heutzutage häufig verwendet werden und für alle ähnliche grundlegende Anforderungen entsprechend dieser Internationalen Norm gelten. Endobronchialtuben (einschließlich Tracheobronchialtuben), Tracheostomietuben und supralaryngeale Atemwegsvorrichtungen sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen. Trachealtuben, die für die Anwendung mit brennbaren Anästhesiegasen oder -mitteln sowie Laser oder elektrochirurgischen Geräten bestimmt sind, sind nicht durch diese Internationale Norm abgedeckt.

Anaesthetic and respiratory equipment - Tracheal tubes and connectors

ISO 5361:2016 麻醉和呼吸设备.气管导管和连接件

Anaesthetic and respiratory equipment - Tracheal tubes and connectors

ISO 5364:2016 麻醉和呼吸设备.口咽导气管

Anaesthetic and respiratory equipment - Oropharyngeal airways

DIN EN ISO 5360:2016 麻醉蒸发器.专用试剂灌充装置(ISO 5360-2016).德文版本EN ISO 5360-2016

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016); German version EN ISO 5360:2016

DIN EN ISO 14408:2016 激光手术用气管导管.标记和伴随信息的要求(ISO 14408-2016);德文版本EN ISO 14408-2016

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016); German version EN ISO 14408:2016

NF S95-155-1*NF EN ISO 7396-1:2016 医疗用气体管道系统.第1部分:压缩的医疗气体管道系统和真空管道系统

Medical gas pipeline systems - Part 1 : pipeline systems for compressed medical gases and vacuum

FD S90-155-2016 压缩医用气体和真空管道 设计和交付验收的附加要素

Pipeline for compressed medical gases and vacuum - Additional elements for design and delivery acceptance