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

Inhalational anaesthesia systems -- Part 3: Anaesthetic reservoir bags

ICS
11.040.10
CCS
C46
发布
2018-03-01
实施

Breathing system filters for anaesthetic and respiratory use -- Non-filtration aspects

ICS
11.040.10
CCS
C46
发布
2018-03-01
实施

Clause 1 of the general standard2 applies@ except as follows: Replacement: This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS@ hereafter referred to as ME EQUIPMENT@ which by means of an inflatable CUFF@ are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES@ including the requirements for the accuracy of a DETERMINATION. This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent@ indirect estimation of the BLOOD PRESSURE without arterial puncture@ including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2]. 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 201.11 and 201.105.3.3@ as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. 2 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012@ Medical electrical equipment ?C Part 1: General requirements for basic safety and essential performance.

Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers

ICS
11.040.10
CCS
C38
发布
2018-03-01
实施
2018-03-24

Standard Specification for Seamless Copper Tube for Medical Gas Systems

ICS
11.040.10
CCS
发布
2018-03-01
实施

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

ICS
11.040.10
CCS
发布
2018-02-28
实施

Medical electrical equipment -- Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ICS
11.040.10
CCS
发布
2018-02-01
实施

This document specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. This document applies to pressure regulators: a) intended to be connected to cylinders by the operator; b) with integral flow-metering devices intended to be connected to cylinders by the operator; c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators). A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set. pressure regulators are intended to be fitted to refillable cylinders with a working pressure up to 30000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.

Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices

ICS
11.040.10
CCS
发布
2018-02-01
实施
0000-00-00

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators; Amendment 1

ICS
11.040.10
CCS
C46
发布
2018-02-01
实施
2018-03-02

Object 20 Object Collateral Standards 20 Collateral standards Particular Standards 20 Particular standards

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

ICS
11.040.10
CCS
C46
发布
2018-02-01
实施

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

ICS
11.040.10
CCS
C46
发布
2018-02-01
实施

Anesthesia and Respiratory Equipment Medical Oxygen Humidifiers

ICS
11.040.10
CCS
C46
发布
2018-01-19
实施
2019-01-01

Flow-metering devices for connection to terminal units of medical gas pipeline systems — Amendment 1

ICS
11.040.10
CCS
发布
2018-01-03
实施

This document specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use. This document does not apply to: a) blocks of flowmeters with separate controls for the flow of each gas; c) stand-alone gas mixers with more than two different gas inlets; b) stand-alone gas mixers which mix oxygen with ambient air; d) stand-alone gas mixers connected to an oxygen concentrator.

Gas mixers for medical use - Stand-alone gas mixers

ICS
11.040.10
CCS
C46
发布
2018-01-01
实施

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators

ICS
11.040.10
CCS
C47
发布
2018-01-00
实施

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

ICS
11.040.10
CCS
发布
2017-12-29
实施

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

ICS
11.040.10
CCS
发布
2017-12-29
实施

Medical suction equipment — Part 1:Electrically powered suction equipment

ICS
11.040.10
CCS
发布
2017-12-29
实施

Medical suction equipment — Part 1:Electrically powered suction equipment

ICS
11.040.10
CCS
发布
2017-12-29
实施

Anaesthetic and respiratory equipment-Tracheal tubes and connectors

ICS
11.040.10
CCS
发布
2017-12-29
实施

Anaesthetic and respiratory equipment-Tracheal tubes and connectors

ICS
11.040.10
CCS
发布
2017-12-29
实施



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