11.140 医院设备 标准查询与下载

ASTM D6978-05(2023) 评估医用手套对化疗药物渗透的耐受性的标准实施规程

Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ASTM D6319-19(2023) 医用腈类检查手套标准规范

Standard Specification for Nitrile Examination Gloves for Medical Application

DB4212/T 57-2023 流动宴席运营管理规范

Mobile banquet operation and management specifications

T/CASMES 171-2023 基层医疗废物数智化体系建设与管理规范

本文件规定了基层医疗废物数智化体系建设与管理规范的基本要求、设计原则和目标、平台架构、体系组成、功能、安全保障。

Construction and management norms of grassroots medical waste mathematical intelligence system

ISO/CD 11193-1:2023 一次性医用检查手套 第1部分：橡胶乳胶或橡胶溶液制成的手套规范

Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution

ISO/CD 11193-2:2023 一次性医用检查手套 第 2 部分：聚氯乙烯手套规范

Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)

ASTM F2407/F2407M-23a 医疗机构用手术服的标准规范

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

IEC 60601-2-46:2023 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 60601-2-46:2023 CMV 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

ASTM D7161-16(2023) 在典型仓库条件下储存的成熟医用手套的实时过期测定的标准实施规程

1.1 This practice covers all surgeon’s and examination gloves, made from either synthetic or natural rubber latex, marketed at the time this practice is published, for which there is no previous real time aging data available, and for which there are at least twelve months of storage as finished goods under typical warehouse conditions. This practice describes how to develop real time aging data for gloves that are part of finished goods inventory (including gloves that may no longer be manufactured) in order to verify the estimated expiration date (see Note 1). Manufacturers may use this data as a starting point for real time aging studies as described in Practice D7160. NOTE 1—Accelerated aging for three-year shelf life is described in Practice D7160. 1.2 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. 1.3 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 Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

ASTM D7198-05(2023) 一次性使用的一次性防腐手套的标准规范

1.1 This specification covers certain requirements for natural rubber (Latex), synthetic rubber (Polychloroprene and Nitrile), and vinyl (PVC) disposable gloves for use in conducting single-use embalming procedures. 1.2 This specification covers natural rubber (Latex), synthetic rubber (Polychloroprene and Nitrile), and Vinyl (PVC) disposable gloves that fit either hand, paired gloves, gloves by size, and gloves packed in bulk. 1.3 An assessment to measure the chemical resistance performance of the glove can be made based on the ultimate permeation (breakthrough) of embalming chemicals through the glove material over a specified period of time. 1.4 This specification is similar to the following specifications: D3578, D4679, D5250, D6319, and D6977. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

Standard Specification for Disposable Embalming Gloves for Single-Use Applications

ASTM D7160-16(2023) 医用手套有效期测定的标准实施规程

1.1 This practice covers all surgeon’s and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and analyzing the data to determine their shelf life. 1.2 This standard does not purport to address all of the label claims and 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. 1.3 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 Practice for Determination of Expiration Dating for Medical Gloves

23/30462494 DC BS EN 455-5 一次性医用手套 第 5 部分：可萃取化学残留物

BS EN 455-5. Medical gloves for single use - Part 5. Extractable chemical residues

ASTM F2100-23 医用面罩材料性能标准规范

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks). 1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. 1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to their overall barrier and breathability properties. 1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face. 1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards. NOTE 1—Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 The following precautionary 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, 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.

Standard Specification for Performance of Materials Used in Medical Face Masks

ASTM F2101-23 使用金黄色葡萄球菌生物气溶胶评估医用口罩材料细菌过滤效率（BFE）的标准试验方法

1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. 1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %. 1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications. 1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material do not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties. 1.5 Units—The values stated in 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 of the standard. 1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material. 1.7 This test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such as surgical gowns, surgical drapes, and sterile barrier systems. 1.8 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. 1.9 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 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

ISO 10282:2023 单用无菌外科橡胶手套的规范

This document specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. This document is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. This document covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. This document is intended to be a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this document.

Single-use sterile rubber surgical gloves — Specification

T/CASME 302-2023 一次性使用医用病毒灭活口罩

本文件规定了一次性使用医用病毒灭活口罩的要求、试验方法、检验规则、标志、包装、贮运。

Single-use medical virus inactivation face mask

ASTM F2407/F2407M-23 医疗保健设施用外科手术服标准规范

1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes. NOTE 1—Some properties require minimum performance and others are for documentation only. NOTE 2—ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown. 1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. 1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as the basis for selecting test requirements. 1.4 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 1.5 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 This specification 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 Feb. 1, 2023. Published February 2023. Originally approved in 2006. Last previous edition approved in 2022 as F2407/F2407M – 22a. DOI: 10.1520/F2407_F2407M-23. 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 1.6 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 Specification for Surgical Gowns Intended for Use in Healthcare Facilities

23/30465955 DC BS EN 455-1 AMD2 一次性医用手套 第 1 部分：无孔要求和测试

BS EN 455-1 AMD2. Medical gloves for single use - Part 1. Requirements and testing for freedom of holes

YY/T 1106-2023 电动手术台

本文件规定了电动手术台的性能要求和试验方法。本文件适用于电动手术台。

Electric operating table