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
Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems used in home care environments
- ICS
- 11.040
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Active implantable medical devices-Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
- ICS
- 11.040
- CCS
- C30/49
- 发布
- 2021-01-01
- 实施
General requirements for clinical laboratory automation system performance
- ICS
- 11.040
- CCS
- 发布
- 20201230
- 实施
- 20201230
General requirements for clinical laboratory automation system information
- ICS
- 11.040
- CCS
- 发布
- 20201230
- 实施
- 20201230
Medical device software — Software life cycle processes
- ICS
- 11.040
- CCS
- 发布
- 2020-12-30
- 实施
Medical device software — Software life cycle processes
- ICS
- 11.040
- CCS
- 发布
- 2020-12-30
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2020-12-30
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2020-12-30
- 实施
Graphical symbols for medical electrical equipment
- ICS
- 11.040
- CCS
- 发布
- 2020-12-30
- 实施
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
- ICS
- 11.040
- CCS
- 发布
- 2020-11-16
- 实施
- 2020-11-16
Measurement method of energy consumption of medical electrical equipment
- ICS
- 11.040
- CCS
- C30
- 发布
- 2020-09-27
- 实施
- 2021-09-01
Human Gene Single Nucleotide Polymorphism (SNP) Detection Kit
- ICS
- 11.040
- CCS
- C44
- 发布
- 2020-06-30
- 实施
- 2021-06-01
Iodine solution protective cap for peritoneal dialysis
- ICS
- 11.040
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-06-01
Disposable hemodialysis catheter
- ICS
- 11.040
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-06-01
Nucleic acid extraction kit (magnetic bead method)
- ICS
- 11.040
- CCS
- C44
- 发布
- 2020-03-31
- 实施
- 2021-04-01
Classification of medical electrical equipment using robotics
- ICS
- 11.040
- CCS
- C30
- 发布
- 2020-02-21
- 实施
- 2021-06-01
Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
- ICS
- 11.040
- CCS
- 发布
- 2019-11-25
- 实施
Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
- ICS
- 11.040
- CCS
- 发布
- 2019-11-25
- 实施
Surgical drapes, gowns and clean clothing for patients, medical staff and instruments - Part 8: Product-specific requirements
- ICS
- 11.040
- CCS
- C46
- 发布
- 2019-07-24
- 实施
- 2020-08-01
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
- ICS
- 11.040
- CCS
- 发布
- 2019-05-24
- 实施
- 2019-08-24 (7)
