11.140 医院设备 标准查询与下载

GSO ASTM D3577:2021 橡胶手术手套的标准规范

This specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2). The gloves shall be manufactured from any rubber polymer compound, with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content shall be performed to assess the conformance of the rubber gloves with the requirements specified.

Standard Specification for Rubber Surgical Gloves

GSO ASTM D7103:2021 医用手套评估标准指南

1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards. 1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk. 1.3 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. 1.4 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 Assessment of Medical Gloves

GSO ASTM D5151:2021 医用手套破洞检测的标准测试方法

1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test. 1.3 The smallest hole size that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method. 1.4 The safe and proper use of medical gloves is beyond the scope of this test method. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Detection of Holes in Medical Gloves

GSO ISO 22882:2021 脚轮和轮子 医院病床脚轮的要求

ISO 22882:2016 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

GSO ASTM D6319:2021 医疗应用丁腈检查手套的标准规范

This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile. An approved lubricant for absorbable dusting powder may be applied to the gloves. Other lubricants may also be used, provided, that their safety and efficacy have been previously established. Both the inside and outside surface of the glove should be free of talc. All products should meet the required degree of sterility, freedom from holes, physical requirements before and after ageing, amount of powder on the glove, tensile strength and ultimate elongation.

Standard Specification for Nitrile Examination Gloves for Medical Application

GSO ASTM D6124:2021 医用手套上残留粉末的标准测试方法

1.1 This test method covers the determination of average powder or filter-retained mass found on a sample of medical gloves as described in the introduction. 1.2 The average powder mass per glove is reported in milligrams. 1.3 The safe and proper use of medical gloves is beyond the scope of this test method. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 and health practices and determine the applicability of regulatory limitations prior to use. 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 Test Method for Residual Powder on Medical Gloves

GSO ASTM D7161:2021 确定典型仓库条件下储存的成熟医用手套的实时有效期的标准实施规程

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 12 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

GSO ASTM D3578:2021 橡胶检查手套的标准规范

This specification covers certain requirements for natural rubber gloves intended for use in medical examinations and diagnostic and therapeutic procedures as well as in handling contaminated medical material. Material under this specification consists of Type I and Type II gloves, which shall be manufactured from any natural rubber compound, with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content shall be performed to assess the conformance of the rubber gloves with the requirements specified.

Standard Specification for Rubber Examination Gloves

GSO ASTM D7160:2021 确定医用手套有效期的标准实施规程

This practice establishes methods for testing and determination of expiration dating of medical gloves. This covers all surgeon's and examination gloves made from either synthetic or natural rubber latex. Gloves shall be tested for stability and shelf life in accordance with the test method requirements. Expiration date shall be determined from accelerated stability tests and real time aging test.

Standard Practice for Determination of Expiration Dating for Medical Gloves

GSO ASTM D5250:2021 医用聚氯乙烯手套的标准规范

This specification contains procedures for evaluating the performance and safety of poly(vinyl chloride) gloves for use in conducting medical examinations, diagnostic and therapeutic procedures, and handling contaminated medical materials. The products covered by this specification include poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile. This specification does not include two-dimensional heat sealed poly(vinyl chloride) gloves. An approved lubricant for absorbable dusting powder may be applied to the gloves. Other lubricants may also be used, provided, that their safety and efficacy have been previously established. Both the inside and outside surface of the glove should be free of talc. All products should meet the required degree of sterility, freedom from holes, physical requirements before and after ageing, amount of powder on the glove, tensile strength and ultimate elongation.

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

GSO ASTM D6978:2021 评估医用手套抗化疗药物渗透性的标准实施规程

1.1 This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time. 1.2 It is emphasized that the conditions used in this assessment are intended to approximate the worst-case condition for clinical uses. The data should be restricted to use on a relative basis when comparing glove materials. 1.3 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 Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drug

EN 455-1:2000/prA1:2021 一次性用医用手套.第1部分:防洞要求和试验 包含修改件prA1,2021

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

DIN/TS 13081:2021 临时医疗设施指南 医院扩建

In the case of mass infections or other scenarios, further treatment capacities are required in addition to the existing hospital capacities. Different occasions or situations come into question, i.e. not only infectious mass illnesses (e. g. Covid-19). This document publishes gu

Guideline for Temporary Medical Facilities - Hospital extensions

T/GDPMAA 0006-2021 应用于医院VTE防治的临床决策支持系统（CDSS）建设规范

本规范以国内外已发布的VTE诊治与预防指南为参考，依托医院VTE智能防治项目的应用研究，及成熟团队的CDSS实施经验，对CDSS建设要素与应用管理，诸如数据集成、模块功能设计、质控指标设计、评价方法等提供建议，以期达到CDSS在VTE防治中的规范建设，助力院内VTE规范防治，保障患者安全。

Specification for the Construction of Clinical Decision Support System for Venous Thromboembolism Prevention and Treatment in Hospital

ONR CEN/TS 14237-2021 用于医疗保健和社会服务设施的纺织品

Textiles for healthcare and social services facilities

DB52/T 1598-2021 水泥企业能源计量数据采集与监测实施规范

Code of practice for energy metering data collection and monitoring in cement enterprises

ASTM D3772-15(2021) 工业用橡胶指套标准规范

1.1 This specification covers the requirements for finger cots used in industrial applications which are made from natural rubber latex or a synthetic nitrile polymer. The purpose of this specification is to obtain consistent performance among products produced in various locations or at various times in the same location. 1.2 This specification does not cover the safe and proper use of finger cots or products of special construction for special use. 1.3 The values stated in SI units are to be regarded as the standard. 1.4 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. 1.5 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 Industrial Rubber Finger Cots

IEC 60364-7-710:2021 低压电气设施. 第7-710部分: 特殊设施或场所的要求. 医疗场所

Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations

FprCEN/TS 14237-2021 用于医疗保健和社会服务设施的纺织品

Textiles for healthcare and social services facilities

YY 9706.102-2021 医用电气设备 第1-2部分：基本安全和基本性能的通用要求 并列标准：电磁兼容 要求和试验

Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests