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 2-30：Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
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
- 2017-09-29
- 实施
U-healthcare ─ glucose meter ─ Particular requirements for the basic safety and performance
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
U-healthcare ─ gateway ─ Particular requirements for the basic safety and performance
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
U-healthcare ─ glucose meter ─ Particular requirements for the basic safety and performance
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
U-healthcare ─ electrocardiograph ─ Particular requirements for the basic safety and performance
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
U-healthcare ─ gateway ─ Particular requirements for the basic safety and performance
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
U-healthcare ─ electrocardiograph ─ Particular requirements for the basic safety and performance
- ICS
- 11.040
- CCS
- 发布
- 2017-09-29
- 实施
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- ICS
- 11.040
- CCS
- C39
- 发布
- 2017-03-01
- 实施
YY/T 0506的本部分规定了手术单、手术衣和洁净服的性能要求。
Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment.Part 2:Performance requirements and performance levels
- ICS
- 11.040
- CCS
- C46
- 发布
- 2017-01-01
- 实施
- 2017-01-01
本标准规定了儿童验光配镜技术服务规范的术语和定义、验光配镜要求、验光配镜技术规则、验光配镜流程、定配眼镜标志、包装要求和售后服务规范。 本标准适用于从事儿童验光配镜的经营性企业。设有儿童验光配镜的医疗机构可参照本标准。 本标准仅适用于7～14岁儿童的验光配镜。
Technical service specification for children's optometry
- ICS
- 11.040
- CCS
- C30
- 发布
- 2016-12-30
- 实施
- 2017-03-01
本标准规定了药品阴凉箱(以下简称阴凉箱)的术语和定义、技术要求和试验方法。 本标准适用于箱内温度范围为8 ℃～20 ℃、相对湿度范围为35%～75%的电机驱动压缩式全封闭型制冷系统的立式药品阴凉箱。
Technical requirements and test methods of pharmaceutical cool refrigerator
- ICS
- 11.040
- CCS
- C47
- 发布
- 2016-10-24
- 实施
- 2017-01-01
Disposable Biopsy Needles Part 4: Motorized Integrated
- ICS
- 11.040
- CCS
- C31
- 发布
- 2016-07-29
- 实施
- 2017-06-01
Technical requirements for inspection of imported medical devices Part 1: Medical electrical equipment
- ICS
- 11.040
- CCS
- C30
- 发布
- 2016-03-09
- 实施
- 2016-10-01
Application of medical device usability engineering to medical devices
- ICS
- 11.040
- CCS
- C30
- 发布
- 2016-01-26
- 实施
- 2017-01-01
Pedoman untuk petugas penatalaksanaan dan paramedis yang berhubungan dengan keselamatan penggunaan peralatan elektromedik dan sistem elektromedik
- ICS
- 11.040
- CCS
- 发布
- 2016
- 实施
Peralatan anestesi dan respirasi - Sistem nebulasi dan komponennya
- ICS
- 11.040
- CCS
- 发布
- 2016
- 实施
Scope is not provided for this standard
Medical devices - Part 1: Application of usability engineering to medical devices
- ICS
- 11.040
- CCS
- 发布
- 2015-12-21
- 实施
IEC 60601-1-6:2010+A1:2013 specifies a process for a manufacturer toanalyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical 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). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. This consolidated version consists of the third edition (2010) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ICS
- 11.040
- CCS
- 发布
- 2015-12-21
- 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 systems used in the home healthcare environment (IEC 6060
- ICS
- 11.040
- CCS
- 发布
- 2015-11-16
- 实施
