共找到 341 条与 医疗设备 相关的标准,共 23 页
NEW! IEC 80601-2-30:2018 is available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-30:2018 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. 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. 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. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015; b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12; c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series; d) added additional requirements for public self-use sphygmomanometers; e) added a list of primary operating functions.
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
本标准规定了血液酒精含量的顶空气相色谱检验方法。 本标准适用于道路交通执法活动中对人员血液中酒精的定性和定量分析。
Examination methods for ethanol concentration in blood
Electrically operated adjustable bed for home care
Manually operated adjustable bed for home care
Ophthalmic optical intraocular lenses Part 3: Mechanical properties and test methods
Functionality and compatibility testing methods for remote medical imaging equipment
Medical devices — Part 1:Application of usability engineering to medical devices
Medical devices — Part 1:Application of usability engineering to medical devices
The technology for gene expression analysis using DNA microarrays — General requirements and definitions
Medical electrical equipment-Part 1-6:General requirements for basic safety and essential performance-Collateral Standard:Usability
Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard:Requirements for medical electrical equipment and medical electrical sys
Medical electrical equipment-Part 1-6:General requirements for basic safety and essential performance-Collateral Standard:Usability
Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard:Requirements for medical electrical equipment and medical electrical sys
The technology for gene expression analysis using DNA microarrays — General requirements and definitions
Technical guidelines for peritoneal dialysis fluid packaging systems
Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT hereafter referred to as ME EQUIPMENT. 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. NOTE See also 4.2 of the general standard.
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
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
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
This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1: 2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME EQUIPMENT or ME SYSTEM is designed. This standard contains: – "general requirements", which contain clauses of general concern, and – "particular requirements", further clauses handling special types of ME EQUIPMENT or ME SYSTEMS and applying in connection with the "General requirements". NOTE At this stage, there are no particular requirements. This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME SYSTEMS. For assembling ME SYSTEMS see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for REPAIR, exchange of components and MODIFICATION of ME EQUIPMENT or ME SYSTEMS. All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after REPAIR. IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 requires that, as part of the RISK MANAGEMENT PROCESS, the MANUFACTURER considers how the safety of ME EQUIPMENT or an ME SYSTEM can be ensured during product lifetime. As part of the risk management process the MANUFACTURER may have identified MAINTENANCE procedures. This includes defining the respective tests for ME EQUIPMENT or for ME SYSTEM. The MANUFACTURER may have defined necessary measurement settings and methods including performance assurance tests in the instructions for use or other ACCOMPANYING DOCUMENTS. This standard provides consistent test procedures. This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals are not defined by the MANUFACTURER, Annex F can be used to help establish such intervals. Testing of the electrical installation, including the SUPPLY MAINS and associated wiring, in medical locations is excluded from this standard. Such tests are covered by IEC 60364-7-710 or national equivalents,
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
General requirement of moxibustion in oriental medicine
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