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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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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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4.1 This guide is intended to assist law enforcement and corrections officers in selecting and purchasing protective gloves that both meet their needs and have been demonstrated to meet relevant performance requirements of Specification E3109.4.2 The guide explains the performance requirements, performance ratings, and test methods for assessing performance.1.1 This guide addresses selection and procurement of protective gloves worn by law enforcement and corrections officers.1.2 This guide explains to end users the content and value of the two below listed standards and how to procure gloves that meet their requirements.1.2.1 Specification E3109: 1.2.1.1 The purpose of Specification E3109 is to provide performance requirements, performance ratings, and test methods for the evaluation of protective gloves used in law enforcement and corrections applications.1.2.1.2 Test methods and performance ratings are included to aid glove purchasers and end users in their evaluation of whether a protective glove meets their needs. It is not required that a glove meet every performance requirement specified in this specification.1.2.2 Practice E3108: 1.2.2.1 Practice E3108 establishes the conformity assessment requirements for protective gloves worn by law enforcement and corrections officers and provides two options for verifying that protective gloves meet requirements: (1) supplier’s declaration of conformity (SDOC) and (2) certification.1.2.2.2 The practice is intended to be used by purchasers and suppliers in the procurement of gloves that meet Specification E3109, and the purchaser is responsible for selecting either SDOC or certification.1.3 This guide and the aforementioned standards were developed based on a survey of end users regarding hazards of concern and operational requirements of officers. (See Section 5.)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 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.1.1 This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.1.2 This specification covers nitrile rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile nitrile rubber examination gloves.1.3 This specification is similar to that of Specification D3578 for rubber examination gloves.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 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 the in-service care, inspection, testing, and use voltage of insulating gloves and sleeves for protection from electrical shock. Gloves and sleeves covered under this specification are designated as type I or type II; class 00, class 0, class 1, class 2, class 3, or class 4. Type I - nonresistant to ozone, made from a high-grade cis-1,4-polyisoprene rubber compound of natural or synthetic origin, properly vulcanized, and type II - ozone resistant, made of any elastomer or combination of elastomeric compounds. The recommended sequence of inspection and testing of gloves and sleeves at an electrical testing facility are: check-in, washing, and preliminary inspection; repair; electrical test; drying; final inspection; record-keeping and marking; and powdering, pairing, and packing for storage or shipment. Electrical testing shall be performed to meet the requirements prescribed.1.1 This specification covers the in-service care, inspection, testing, and use voltage of insulating gloves and sleeves for protection from electrical shock.1.2 The values stated in SI units are to be regarded as the standard. See IEEE/ASTM SI-10.1.3 The following safety hazards caveat pertains only to the test method portion, Sections 6 and 7, 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. For a specific warning statement, see 7.2.1.4 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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1.1 This practice establishes the conformity assessment requirements for protective gloves worn by law enforcement and corrections officers. It was developed based on end user input regarding hazards of concern and operational requirements of officers.21.2 This practice provides two options for conformity assessment: (1) supplier’s declaration of conformity (SDOC) and (2) certification.1.2.1 This practice is intended to be used by purchasers and suppliers in the procurement of gloves that meet Specification E3109, and the purchaser is responsible for selecting either SDOC or certification.NOTE 1: An ASTM guide is being developed to provide agencies and end users with information related to the selection, procurement, and use of protective gloves worn by law enforcement and corrections officers while on duty.1.2.2 The performance, testing, labeling, documentation, and reporting requirements for SDOC and for certification are specified in Specification E3109.1.3 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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1.1 This specification addresses protective gloves worn by law enforcement and corrections officers.1.2 This specification and related standards were developed by subject matter experts, including experienced end users, using data from a survey of more than 800 U.S. law enforcement and corrections officers.1.3 This specification addresses performance requirements, performance ratings, and test methods for whole gloves and for glove components (for example, materials, layers).NOTE 1: This specification references published ASTM standards.1.3.1 A glove is not uniform in terms of the protection it provides, and different portions or areas of a glove (for example, palm, fingertip) may offer different protection.1.3.2 It is not intended that a single glove meet all specified performance requirements within this specification.1.4 The glove supplier will identify which of the performance requirements a specific glove meets and the performance ratings for the different portions or areas of the glove.1.5 This specification specifies performance requirements for (1) physical protection, including resistance to cut, puncture, and needle stick, and (2) resistance to abrasion and tearing to ensure protection is maintained during use.1.5.1 A document outlining dexterity and other physical protection requirements identified by end users as important is being developed.1.6 It is expected that this specification will be used by suppliers, test laboratories, certification bodies, and purchasers.1.7 It is intended that two related standards be used in conjunction with this specification:1.7.1 A Guide for Selection, Procurement, and Use of Protective Gloves Worn by Law Enforcement and Corrections, in development by ASTM.1.7.2 Practice E3108.1.8 Units—The values stated in SI or CGS2 units are to be regarded as standard. The primary units displayed in this standard are consistent with the referenced ASTM test methods. The values given in parentheses are mathematical conversions that are provided for information only.1.9 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.1.10 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 D120-22 Standard Specification for Rubber Insulating Gloves Active 发布日期 :  1970-01-01 实施日期 : 

This specification covers manufacturing and testing of rubber insulating gloves for protection of workers from electrical shock. Two types of gloves are provided and are designated as Type I, non-resistant to ozone, and Type II, resistant to ozone. Six classes of gloves, differing in electrical characteristics, are provided and are designated as Class 00, Class 0, Class 1, Class 2, Class 3, and Class 4. The following tests shall be performed: ac proof test; ac breakdown test; ac moisture absorption/proof test; dc proof test; dc breakdown test; ozone resistance test; chemical tests; tensile strength; tear resistance test; and puncture resistance test.1.1 This specification covers manufacturing and testing of rubber insulating gloves for protection of workers from electrical shock.1.2 Two types of gloves are provided and are designated as Type I, non-resistant to ozone, and Type II, resistant to ozone.1.3 Six classes of gloves, differing in electrical characteristics, are provided and are designated as Class 00, Class 0, Class 1, Class 2, Class 3, and Class 4.1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard. See IEEE/ASTM SI 10.1.5 The following safety hazards caveat pertains only to the test method portion, Sections 16, 17, 18, and 19, 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. For a specific warning statement, see 18.2.1.6 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.

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