11.040.10 麻醉、呼吸和复苏设备 标准查询与下载
共找到 2040 条与 麻醉、呼吸和复苏设备 相关的标准，共 136 页
IEC 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-20:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT. 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 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-20:2020 specifies safety requirements for INFANT TRANSPORT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50. IEC 60601-2-20:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
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- 11.040.10
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- 发布
- 2020-10-09
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- 2021-01-07 (7)
This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
Suction catheters for use in the respiratory tract (ISO 8836:2019)
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- 11.040.10
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- 发布
- 2020-10-07
- 实施
- 2021-01-31
This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name. NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.
Anaesthetic and respiratory equipment — User-applied labels for syringes containing drugs used during anaesthesia — Colours, design and performance
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- 11.040.10
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- 发布
- 2020-10-02
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What is ISO 7376 about? ISO 7376 discusses Laryngoscopes for tracheal intubation for anaesthetic and respiratory equipment. ISO 7376 outlines requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation. ISO 7376 also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook‐on fittings. Note: ISO 7376 does not apply to flexible laryngoscopes, laryngoscopes designed for surgery, laryngoscopes powered from the mains electricity supply, laryngoscopes connected by light‐transmitting cables to external light sources, video laryngoscopes designed to work with an external, integral, or attached video system. Who is ISO 7376 for?
Anaesthetic and respiratory equipment. Laryngoscopesfor tracheal intubation
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- 11.040.10
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- 发布
- 2020-09-30
- 实施
- 2020-09-30
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
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- 11.040.10
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- 发布
- 2020-09-29
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Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
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- 11.040.10
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- 发布
- 2020-09-29
- 实施
This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook‐on fittings. It is not applicable to the following: — flexible laryngoscopes; — laryngoscopes designed for surgery; — laryngoscopes powered from mains electricity supply; — laryngoscopes connected by light‐transmitting cables to external light sources; — video laryngoscopes designed to work with an external, integral or attached video system.
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)
- ICS
- 11.040.10
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- 发布
- 2020-09-23
- 实施
- 2020-12-31
Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical el
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- 11.040.10
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- 2020-09-23
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Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
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- 11.040.10
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- 2020-09-23
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Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers
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- 11.040.10
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- 2020-09-21
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Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical sy
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- 11.040.10
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- 发布
- 2020-09-21
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Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers
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- 11.040.10
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- 发布
- 2020-09-21
- 实施
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
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- 11.040.10
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- 发布
- 2020-09-16
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- 2020-12-31
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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- 11.040.10
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- 发布
- 2020-09-02
- 实施
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
- ICS
- 11.040.10
- CCS
- 发布
- 2020-09-02
- 实施
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
- ICS
- 11.040.10
- CCS
- 发布
- 2020-09-02
- 实施
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
- ICS
- 11.040.10
- CCS
- 发布
- 2020-09-02
- 实施
Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation
- ICS
- 11.040.10
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- 发布
- 2020-08-26
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Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
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- 11.040.10
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- 发布
- 2020-07-21
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What is ISO 9170 ‑ 1 about? ISO 9170 discusses terminal units for medical gas pipeline systems. ISO 9170 ‑ 1 is intended specially to ensure the gas-specific assembly, mechanical resistance, flow, leakage, and pressure drop of terminal units. To prevent their interchange between different gases and services. ISO 9170-1 applies to terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1 , used as pressure outlets on pressure regulators in accordance with ISO 10524-1 , used as pressure outlets on pressure regulators integrated with cylinder valves (VIPR) in accordance with ISO 10524-3 . ISO 9170-1 applies to terminal units for use with the following gases for administration to patients or for medical uses (A) oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixture, helium/oxygen mixtures, oxygen 93, gases delivered to medical devices or intended for medical purposes, gas mixtures classified as a medical device, gases, and gas mixtures for medicinal use not specified above. ISO 9170-1 also applies to terminal units for use with gases (B) is air for driving surgical tools and nitrogen for driving surgical tools. ISO 9170-1 also applies to terminal units for use with vacuum systems. Note 1: The requirements of ISO 9170 ‑ 1 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. Note 2: ISO 9170-1 does not specify the requirements for terminal units for anesthetic gas scavenging systems (AGSS), which are specifi...
Terminal units for medical gas pipeline systems - Terminal units for use with compressed medical gases and vacuum
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- 11.040.10
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- 发布
- 2020-06-30
- 实施
- 2020-06-30
