11.040 医疗设备 标准查询与下载
共找到 341 条与 医疗设备 相关的标准，共 23 页
This technical report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. This technical report is primarily intended to be used by: – manufacturers of MEDICAL ELECTRICAL EQUIPMENT; – test houses and others responsible for assessment of compliance with IEC 60601-1:1988, and – those developing subsequent editions of IEC 60601-1. The recommendations in the first edition of IEC/TR 62296 were considered in preparing the third edition of IEC 60601-1. As the third edition of IEC 60601-1 has been published, some of the recommendations in the second edition of IEC/TR 62296 have been changed to align with requirements in IEC 60601-1:2005. Seven additional recommendations have been developed by IEC/SC 62A/WG 14 and are included in this edition of IEC/TR 62296. They are recommendations 57 through 63.
Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
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- 11.040
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- 2015-09-03
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for the development (analysis, design,VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE. NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard does not specify: _ additional mechanical requirements; or _ additional electrical requirements. This collateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE. A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard.
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
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- 2015-09-03
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General requirements for clinical laboratory automation system information
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- 11.040
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- C50
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- 2015-07-31
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General requirements for clinical laboratory automation system performance
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- 11.040
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- C49
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- 2015-07-31
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General requirements for clinical laboratory automation system performance
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- 11.040
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- 发布
- 2015-07-31
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General requirements for clinical laboratory automation system information
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- 11.040
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- 发布
- 2015-07-31
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Medical device software - Software life cycle processes
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- 11.040
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- 发布
- 2015-06-26
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Medical device software - Software life cycle processes
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- 11.040
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- 发布
- 2015-06-26
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Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES@ ACTIVITIES@ and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.
Medical device software - Software life cycle processes
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- 11.040
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- 发布
- 2015-06-01
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- 2015-07-02
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
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- 11.040
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- 2015-05-29
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Medical electrical equipment. Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
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- 11.040
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- 发布
- 2015-04-30
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- 2015-04-30
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014)
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- 11.040
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- 发布
- 2015-01-30
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- 2015-01-30
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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- 11.040
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- 发布
- 2015-01-16
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- 2015-01-16
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Third Edition)
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- 11.040
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- 2015-01-01
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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 systems used in the home healthcare environment (Second E
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- 11.040
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- 2015-01-01
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Implants for surgery. Calcium phosphates. Part 3. Hydroxyapatite and beta-tricalcium phosphate bone substitutes
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- 11.040
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- 发布
- 2015
- 实施
- 2016-03-01
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.
Medical devices - Application of usability engineering to medical devices
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- 11.040
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- 发布
- 2014-12-25
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This technical report applies to MEDICAL ELECTRICAL EQUIPMENT (as defined in Subclauses 3.63 of IEC 60601-1:2005 and 2.2.15 of IEC 60601-1:1988), hereinafter referred to as ME EQUIPMENT. The object of this technical report is to provide guidance on general testing PROCEDURES according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
General testing procedures for medical electrical equipment
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- 11.040
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- 2014-12-25
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This technical report applies only to those aspects of the installation ensuring the safety of the PATIENT, the OPERATOR and other persons during the RADIOTHERAPY EQUIPMENT use. General construction requirements are not addressed in this technical report. The installations considered in this technical report are those in which are located RADIOTHERAPY EQUIPMENT delivering IONIZING RADIATION used for therapeutic purpose, such as MEDICAL ELECTRON ACCELERATORS, GAMMA BEAM THERAPY EQUIPMENT AND GAMMA-RAY AFTERLOADING EQUIPMENT. RADIOTHERAPY SIMULATOR installations are not included in this technical report. A particular RADIOTHERAPY EQUIPMENT installation may generally consist of several rooms, such as: – the TREATMENT ROOM in which the RADIATION BEAM is emitted and in which the PATIENT is located during the IRRADIATION, including all enclosed spaces where a person could remain inadvertently during the IRRADIATION; – the control room in which the TREATMENT CONTROL PANEL is located and from which the OPERATOR controls the IRRADIATION and other functions of the RADIOTHERAPY EQUIPMENT; – other rooms which may contain other parts of the RADIOTHERAPY EQUIPMENT, but where IRRADIATION is not carried out.
Guidelines for radiotherapy treatment rooms design
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- 11.040
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- 2014-12-25
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IEC/TR 61258, which is a technical report, outlines a generic process for developing materials for education and training of OPERATORS of medical electrical equipment or a medical electrical system, hereafter referred to collectively as equipment. It can be used by standards organizations, manufacturers, health care facility managers, clinical engineers, physician and nurse educators, and others involved directly or indirectly in education and training of OPERATORS. In particular, manufacturers might find this process useful in preparing the necessary markings, ACCOMPANYING DOCUMENTS and other EDUCATIONAL MATERIALS which will provide necessary information to OPERATORS of the equipment and encourage them to employ safe and effective practices. This technical report is not intended to be used for regulatory purposes.
Guidelines for the development and use of medical electrical equipment educational materials
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- 11.040
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- 发布
- 2014-12-25
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