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AS 2225-1994/Amdt 1-1996 Insulating gloves for electrical purposes 现行 发布日期 :  1996-05-05 实施日期 : 

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AS 2225-1994 Insulating gloves for electrical purposes 现行 发布日期 :  1994-06-14 实施日期 : 

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ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves Active 发布日期 :  1970-01-01 实施日期 : 

5.1 The specification is intended as a reference to the performance and safety of natural rubber examination gloves. The safe and proper use of natural rubber examination gloves is beyond the scope of this specification.AbstractThis 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.1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber gloves.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.

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4.1 In the course of patient care, gloves of healthcare providers are often contaminated with microorganisms. This may occur when they come in direct or indirect contact with contaminated skin, oozing wounds, respiratory droplets, blood, amniotic fluid, saliva, or other potentially infectious materials (OPIM). It has been demonstrated that several bacteria known to be nosocomial pathogens, can survive for days, weeks and even months on surfaces that are touched by gloved hands. The presence of an effective antibacterial treatment on or in the glove that can rapidly reduce the number of viable bacteria on its surface, may also decrease the number of bacteria transferred from a contaminated source (reservoir) to a vulnerable patient or naïve site. These test methods enable assessment of bactericidal efficacy against a broad spectrum of bacteria and conditions, providing a means of efficacy comparisons for manufacturers, purchasers and users.4.2 Four specific bacteria are listed to enable inter- and intra- laboratory test calibration and to provide common targets against which to compare antibacterial efficacy among products.4.3 Manufacturers may additionally develop their own list of bacteria against which they will evaluate their products reflecting the circumstances in which their product will be used, the requirements set forth by the various agencies with which they are regulated, and the claims they are seeking. Alterations in test parameters must be validated and documented.1.1 The methods herein specify two analytical tests for quantitatively evaluating surface bactericidal efficacy of medical examination gloves incorporated with bactericidal properties. They may be used for the determination of bactericidal activity on either the outer or inner glove surface. The methods incorporate bacterial challenges in two different formats: Method (A) a saline or buffered saline solution, and Method (B) a saline or buffered saline solution containing an organic load. Each method represents a different means of microbial contamination that can be expected in the healthcare environment.1.2 Methods described herein are not appropriate for virucidal, fungicidal, tuberculocidal or sporicidal evaluations as each of these categories require unique culture techniques and testing conditions. Results of the test methods described in this document are limited to bactericidal efficacy against vegetative bacteria.1.3 A more expansive glove description, such as broad spectrum antimicrobial efficacy, would require testing of a broader list of microbial species than vegetative bacteria alone. It is recommended that interested manufacturers discuss species and strain selections with appropriate regulatory agencies before testing is commenced.1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriate controlled conditions to ensure integrity of results and personnel safety.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. Most regulatory agencies require compliance with Biocompatibility guidelines under ISO 10993.1.7 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.

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4.1 The specification is intended as a referee procedure for evaluating the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper use of poly(vinyl chloride) examination gloves is beyond the scope of this standard.AbstractThis 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.1.1 This specification covers certain requirements for poly(vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material.1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves.1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves.1.4 This specification is similar to that of Specification D3578 for rubber examination gloves.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.

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5.1 This guide establishes a standard sample preparation method and provides a description of three established and recognized test methods for the determination of endotoxin on medical gloves. If interferences in a sample yield suspect results, a second method should be used.5.2 This guide is appropriate for testing final product that has been subjected to all processes that could influence the final endotoxin level (either microbial contamination or processing agents/raw materials contaminated with endotoxin). As raw materials and processing conditions vary from lot to lot with regard to these parameters, it is appropriate to test for endotoxin on a routine basis if a product endotoxin claim is to be made (for example, non-pyrogenic). The user may find it beneficial to incorporate endotoxin testing for vulnerable areas of their manufacturing process as an alert mechanism.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, health, and environmental practices and determine the applicability of regulatory limitations 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.

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ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves Active 发布日期 :  1970-01-01 实施日期 : 

4.1 The standards under the jurisdiction of Committee D11.40 and other technical committees can be used individually or as part of an integrated protocol in the assessment and selection of medical gloves.4.2 The intended use of the standards is as a means by which information can be requested, generated, and reported in a consistent, comparable manner.4.3 The suggested assessments and test methods are recommended guidelines.4.4 Test methods offer procedures for assessing medical gloves at standardized conditions to allow comparison.4.5 The information on medical glove performance must be combined with professional judgment, and a clear understanding of the application, in order for the medical glove to provide the best performance.4.6 Medical gloves intended for use during emergency medical operations may be evaluated and their performance certified to NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations. This certification program is voluntary.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.

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This specification covers leather protectors for rubber insulating gloves and mittens. Leather protectors shall provide mechanical protection only for the rubber insulating gloves and mittens. Leather material shall be grain cowhide, buffled gain cowhide, grain deerskin, grain pigskin, grain horsehide, or grain goatskin. Leather protectors shall be manufactured in clute, gunn, montpelier, or one-finger mitten patterns. Stiching, dimensions, workmanship, and markings shall conform to the requirements of this specification.1.1 This specification covers leather protector gloves and leather protector mittens to be worn over electrical workers' rubber insulating gloves and rubber insulating mittens.1.2 It is intended that the gloves specified herein shall fit snugly and without undue wrinkles over rubber insulating gloves and rubber insulating mittens specified in Specification D120.1.3 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.

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