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
Scope 1.1 This Standard applies to the use of medical devices and systems for the application of electrosurgical energy. It applies to all procedures in all health care settings where such medical devices and systems are used, including, but not limited to, the following: a) surgical facilities; b) dental clinics; c) medical offices; d) veterinary facilities; e) laboratories and other research facilities; f) cosmetic treatment facilities; g) teaching facilities; and h) professional exhibitions and trade shows. 1.2 This Standard provides requirements for the education, training, purchasing, installation, use, service, and maintenance of electrosurgical units (ESUs). 1.3 This Standard does not include requirements for a) aspects of laser safety (see CSA Z386); b) aspects of other energy-based medical device safety not utilizing electricity to deliver a therapeutic effect (e.g., ultrasonic scalpels); and c) surgical plume. 1.4 In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.
Safe use of electrosurgical medical devices and systems in health care
- ICS
- 11.040
- CCS
- 发布
- 2013-01-01
- 实施
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ICS
- 11.040
- CCS
- 发布
- 2012-08-20
- 实施
Disposable general medical mask
- ICS
- 11.040
- CCS
- C 47
- 发布
- 2012-03-12
- 实施
- 2012-11-01
Medical device software -- Software life cycle processes
- ICS
- 11.040
- CCS
- C37
- 发布
- 2012-03-01
- 实施
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- ICS
- 11.040
- CCS
- 发布
- 2012-01-31
- 实施
- 2012-01-31
Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
- ICS
- 11.040
- CCS
- 发布
- 2012-01-31
- 实施
- 2012-01-31
이 표준은 의료용으로 사용하는 뜸의 종류, 뜸을 뜨는 데 사용되는 재료 및 뜸을 뜨는 데
General requirement of moxibustion in oriental medicine
- ICS
- 11.040
- CCS
- C10
- 发布
- 2012-01-02
- 实施
- 2012-01-02
이 표준은 이후로는 ME 기기(MEDICAL ELECTRICAL EQUIPMENT)와 ME
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
- C37
- 发布
- 2012-01-02
- 实施
- 2012-01-02
이 표준은 의료용 전기기기나 의료용 전기 시스템이 비전문 운영자가 사용하기 위한 것인지 훈
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
- ICS
- 11.040
- CCS
- Y64
- 发布
- 2012-01-02
- 实施
- 2012-01-02
이 표준에서는 의료용 전기기기[이후로는 의료용 전기기기(ME 기기)라고 함.]의 기본안전
Medical electrical equipment-Part 1-6:General requirements for basic safety and essential performance-Collateral Standard:Usability
- ICS
- 11.040
- CCS
- C37
- 发布
- 2012-01-02
- 实施
- 2012-01-02
YY/T 0855的本部分适用于标称抗激光的一次性使用和重复性使用手术单和其他病人防护覆盖物所用非织造材料和织造材料。 YY/T 0855的本部分为手术单和(或)其他病人防护覆盖物对激光导致的危害提供了一个标准的试验和分类方法,并给出了相应的分类体系。YY/T 0855的本部分不包括一般性防火安全规范。本部分仅限于根据YY/T 0855.1分类的I1或I2级材料的次级点燃试验。 所有材料都能反射一部分光束,用户必须决定镜面反射是否会带来危害,但这在YY/T 0855的本部分中不涉及。 YY/T 0855的本部分的结果不适用于其他波长和时间格式。 YY/T 0855的本部分选择20W的CO2激光(连续波)作为试验激光。
Test method and classification for the laser resistance of surgical drapes and/or patient protective covers.Part 2:Secondary ignition
- ICS
- 11.040
- CCS
- C47
- 发布
- 2011-12-31
- 实施
- 2013-06-01
除下述内容外，通用标准的本章适用。 范围： 增加：本专用标准规定了对电热毯、电热垫和电热床垫的要求，电热床垫包括气垫和充气系统。定义见2.2.102、2.2.106和2.2.107. 加热设备是用于医疗和辅助医疗的设备。
Medical electrical equipment.Part 2-35:Particular requirements for the safety of blankets,pads and mattresses,intended for heating in medical use
- ICS
- 11.040
- CCS
- C42
- 发布
- 2011-12-31
- 实施
- 2013-06-01
이 표준은 비침습 자동 혈압계의 기본 안전 및 필수 성능(BASIC SAFETY and E
Medical electrical equipment－Part 2-30：Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ICS
- 11.040
- CCS
- C39
- 发布
- 2011-12-08
- 实施
- 2011-12-08
이 국제표준은 이후로는 ME 기기(MEDICAL ELECTRICAL EQUIPMENT)와
Medical electrical equipment-Part 1:General requirements for basic safety and essential performance
- ICS
- 11.040
- CCS
- C39
- 发布
- 2011-12-08
- 实施
- 2011-12-08
1.1 * Domaine d'application La présente Norme internationale spécifie un PROCESSUS destiné à un FABRICANT pour analyser, spécifier, concevoir, VÉRIFIER et VALIDER l'APTITUDE À L'UTILISATION, ayant trait à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ÉLECTROMÉDICAUX, désignés ci-après sous le terme d'APPAREILS EM. Ce PROCESSUS D'INGÉNIERIE DE L'APTITUDE À L'UTILISATION évalue et réduit les RISQUES provoqués par les problèmes D'APTITUDE À L'UTILISATION associés à une UTILISATION CORRECTE et à des ERREURS D'UTILISATION, c’est-à-dire une UTILISATION NORMALE. Il peut être utilisé pour identifier mais n'évalue pas et ne réduit pas les RISQUES associés à une UTILISATION ANORMALE. Si le PROCESSUS D'INGÉNIERIE DE L'APTITUDE À L'UTILISATION détaillé dans la présente norme collatérale a été satisfait et si les critères d’acceptation documentés dans le plan de VALIDATION DE L'APTITUDE À L'UTILISATION ont été satisfaits (voir le 5.9 de la CEI 62366:2007), les RISQUES RÉSIDUELS définis dans l’ISO 14971 associés à l’APTITUDE À L'UTILISATION d’un APPAREIL EM sont alors présumés acceptables, sauf s'il existe une PREUVE TANGIBLE du contraire (voir le 4.1.2 de la CEI 62366:2007).
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Fitness for use
- ICS
- 11.040
- CCS
- 发布
- 2011-12-01
- 实施
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability (Third Edition)
- ICS
- 11.040
- CCS
- 发布
- 2011-12-01
- 实施
1.1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. 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. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
- ICS
- 11.040
- CCS
- 发布
- 2011-12-01
- 实施
This National Standard of Canada is equivalent to International Standard IEC 60601-1-11:2010. 1.1 * Scope 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, which are intended by their MANUFACTURER for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. NOTE 1 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can also be intended for use in other environments, for example, in a professional healthcare facility. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use by emergency medical services or solely for use in professional healthcare facilities. NOTE 2 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.
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
- ICS
- 11.040
- CCS
- 发布
- 2011-07-01
- 实施
Medical electrical equipment -- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2009 + corrigendum Jan. 2010)
- ICS
- 11.040
- CCS
- 发布
- 2011-01-14
- 实施
- 2011-01-14
