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
IEC 60601-2-76:2018 applies to the basic safety and essential performance of low energy ionized gas haemostasis 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. This particular standard amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
- ICS
- 11.040
- CCS
- 发布
- 2019-05-24
- 实施
- 2019-08-24 (7)
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
- ICS
- 11.040
- CCS
- R86
- 发布
- 2019-04-19
- 实施
- 2019-05-01
Manually operated adjustable bed for home care
- ICS
- 11.040
- CCS
- 发布
- 2019-01-04
- 实施
Electrically operated adjustable bed for home care
- ICS
- 11.040
- CCS
- 发布
- 2019-01-04
- 实施
Ophthalmic optical intraocular lenses Part 3: Mechanical properties and test methods
- ICS
- 11.040
- CCS
- C40
- 发布
- 2018-12-20
- 实施
- 2020-06-01
Functionality and compatibility testing methods for remote medical imaging equipment
- ICS
- 11.040
- CCS
- C30
- 发布
- 2018-12-20
- 实施
- 2020-01-01
Medical devices — Part 1:Application of usability engineering to medical devices
- ICS
- 11.040
- CCS
- 发布
- 2018-11-05
- 实施
Medical devices — Part 1:Application of usability engineering to medical devices
- ICS
- 11.040
- CCS
- 发布
- 2018-11-05
- 实施
Medical electrical equipment－Part 1-6：General requirements for basic safety and essential performance－Collateral Standard：Usability
- ICS
- 11.040
- CCS
- 发布
- 2018-08-22
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment－Part 1-6：General requirements for basic safety and essential performance－Collateral Standard：Usability
- ICS
- 11.040
- CCS
- 发布
- 2018-08-22
- 实施
The technology for gene expression analysis using DNA microarrays — General requirements and definitions
- ICS
- 11.040
- CCS
- 发布
- 2018-08-22
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2018-08-22
- 实施
The technology for gene expression analysis using DNA microarrays — General requirements and definitions
- ICS
- 11.040
- CCS
- 发布
- 2018-08-22
- 实施
Technical guidelines for peritoneal dialysis fluid packaging systems
- ICS
- 11.040
- CCS
- J00/09
- 发布
- 2018-07-20
- 实施
- 2018-07-20
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
- ICS
- 11.040
- CCS
- 发布
- 2018-04-10
- 实施
- 2018-04-13
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
- ICS
- 11.040
- CCS
- 发布
- 2017-12-29
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2017-12-29
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2017-10-03
- 实施
General requirement of moxibustion in oriental medicine
- ICS
- 11.040
- CCS
- 发布
- 20170929
- 实施
- 20170929
