11.140 医院设备 标准查询与下载

PD CEN/TR 16953:2017 一次性使用医用手套 选择指南

Medical gloves for single use - Guidance for selection

EN 50637:2017 医用电气设备 儿童医用床基本安全和基本性能的特殊要求

Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children

DIN EN 80601-2-35:2017 医疗电气设备.第2-35部分:利用毯、衬垫和床垫的加温设备和医用加温设备的基本安全性和必要性能要求(IEC 80601-2-35-2009+Cor.-2012+Cor.-2015+A1-2016);德文版本EN 80601-2-35-2009+A11-2011+AC-2015+A1-2016

This standard of DIN EN 80601-2-35/A1 (VDE 0750-2-35/A1) is the alignment of the amendment of DIN N 60601-1:2013 and the related collateral standards of DIN EN 60601-1-x series. By the introduction of undated references, if no technical change is needed in this standard, the simplification of further alignment will be provided in the DIN EN 60601-2-series. Additional technical changes may be also included for the alignment of IEC 60601-1-2(electromagnetic phenomena), IEC 60601-1-11(home use) and IEC 60601-1-12(emergency use).

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 (IEC 80601-2-35:2009 + Cor.:2012 + Cor.:2015 +

ASTM F1670/F1670M-17a 防护服用于合成血液穿透的材料抗性的标准试验方法

1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration. 1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood. 1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671. 1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application. 1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.40 on Biological. Current edition approved Oct. 25, 2017. Published October 2017. Originally approved in 1995. Last previous edition approved in 2017 as F1670/F1670M – 17. DOI: 10.1520/F1670_F1670M-17A. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 Copyright ASTM International --`,,`,,,,,,,`,,`,,``,``,,,,`,`-`-`,,`,,`,`,,`--

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

T/ZGCMITT 002-2017 磁共振引导微创手术室配置要求

本标准规定了磁共振引导微创手术室的组成及设备配置要求。本标准适用于磁共振引导的微创手术室的构建。

Configuration for MRI-guided minimally invasive therapy suite

T/ZGCMITT 001-2017 CT引导微创手术室配置要求

本标准规定了CT（computed tomography 电子计算机断层扫描）引导微创手术室的组成及设备配置要求。本标准适用于CT引导的微创手术室的构建。

Configuration for CT-guided minimally invasive therapy suite

IEC TR 60601-4-1:2017 医疗电气设备 - 第4-1部分:指导和解释 - 使用一定程度自主权的医疗电气设备和医疗电气系统

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy

IEC/TR 60601-4-1:2017 医疗电气设备 - 第4-1部分:指导和解释 - 使用一定程度自主权的医疗电气设备和医疗电气系统

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy

ASTM F1670/F1670M-17 防护服用于合成血液穿透的材料抗性的标准试验方法

1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration. 1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood. 1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671. 1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application. 1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.40 on Biological. Current edition approved July 1, 2017. Published July 2017. Originally approved in 1995. Last previous edition approved in 2014 as F1670/F1670M – 08 (2014)ɛ1 . DOI: 10.1520/F1670_F1670M-17. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

ASTM D7102-17 无菌医用手套内毒素测定标准指南

1.1 This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate. 1.2 As bacteria may continue to grow on non-sterile gloves, reportable endotoxin levels are only appropriate for gloves labeled as sterile. Because most environments contain endotoxin, once a box of gloves is opened and the gloves are manipulated, endotoxin levels will increase making it inappropriate to report endotoxin levels on boxed gloves (ex. examination gloves). This is true even if the box had undergone sterilization prior to distribution. 1.3 This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations. 1.4 This guide is not applicable to the determination of pyrogens other than bacterial endotoxins. 1.5 The sample preparation method described must be used regardless of the test method selected. This method does not describe laboratory test method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed. 1.6 The safe and proper use of medical gloves is beyond the scope of this guide. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

IEC TR 60601-4-1:2017 医用电气设备 第 4-1 部分：指导和解释 采用一定程度自主性的医用电气设备和医用电气系统

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy

BS ISO 22882:2016 脚轮和轮子. 医院用床脚轮要求

Castors and wheels. Requirements for castors for hospital beds

ISO 22882:2016 脚轮和轮子. 医院用床脚轮要求

This document specifies the technical requirements, the appropriate dimensions and the requirements for the testing of swivel castors for hospital beds with a wheel diameter of 100 mm or more and which have a central locking device. Swivel castors may be used with the main principal dimensions.

Castors and wheels - Requirements for castors for hospital beds

WS 488-2016 医院中央空调系统运行管理

本标准规定了医院中央空调系统竣工验收合格并交付使用后，医院中央空调系统运行管理的基本要求和中央空调系统从业人员在主要设备运行操作、维护保养、应急处理等方面的行为准则。 本标准适用于各级各类医院的中央空调系统运行管理，有类似空调系统的其他医疗机构可参照执行。 本标准不适用于洁净室及相关受控环境。

Operational management of central air conditioning systems for hospitals

JIS T 9205:2016 医院用床

Hospital beds

IEC 60601-2-46:2016 医用电气设备第2-46部分:手术台基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

IEC 60601-2-46:2016 RLV 医用电气设备第2-46部分:手术台基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

YY/T 0506.4-2016 病人、医护人员和器械用手术单、手术衣和洁净服 第4部分:干态落絮试验方法

YY/T 0506的本部分规定了干态条件下测量手术单、手术衣和洁净服及材料落絮的试验方法。该方法也适合于其他医用纺织材料。

Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment.Part 4: Test method for linting in the dry state

YY/T 1497-2016 医用防护口罩材料病毒过滤效率评价测试方法 Phi-X174噬菌体测试方法

Test method for virus filtration efficiency evaluation of medical protective mask materials Phi-X174 bacteriophage test method

ASTM D3738-16 医院用上胶床单的标准规格

1.1 This specification covers rubber-coated cloth sheeting intended for use in the protection of mattresses on hospital beds. 1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.3 The following safety hazards caveat pertains only to the test methods portion, Section 9, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Rubber-Coated Cloth Hospital Sheeting