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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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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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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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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5.1  Dialkyldithiocarbamates (DTCs), benzothiazoles, and thiurams are often used as vulcanization accelerators in NRL products. Zinc DTC accelerators are added either directly or are formed in situ during the vulcanization process via reaction between a thiuram(s) and zinc oxide. DTCs, benzothiazoles, and thiurams have been detected in leachates from medical devices made of rubber such as gloves. Studies have shown these chemicals can cause allergic contact dermatitis. A simple selective method to monitor rubber accelerator levels in rubber extracts would be useful for quality control, product screening and research.5.2 This colorimetric assay measures dialkyldithiocarbamates, including zinc dialkyldithiocarbamates (ZDTC), mercaptobenzothiazole (MBT) and thiurams as a total thiol vulcanization accelerator level in rubber products. A UV spectrophotometer with detection at 320 nm is used to measure the ZDTC, mercaptobenzothiazole and thiurams. Sample extracts diluted at 1:20 prior to measurement on the spectrophotometer is usually sufficient to quantify the residual accelerator level from most commercially available rubber gloves; however, sample dilution can be adjusted (from neat extract to > 1:20 dilution) based on analytical needs. Thiurams and ZDTCs complex with cobalt turning the extract to a concentration-dependent shade of green. ZDTCs reacts quickly while thiurams react very slowly (requiring a heat catalyst). Mercaptobenzothiazole does not complex to Co(III), however, it absorbs strongly at 320 nm. It can be distinguished from both ZDTCs and thiurams by its strong absorbance at 320 nm without the cobalt dependent visible green color. Cobalt complexed thiurams and ZDTCs, but not MBT, also have and absorbance at 370 nm (2).1.1 This test method is designed to quantify the amount of total extractable accelerators in natural rubber latex (NRL) and nitrile gloves. Three common classes of rubber accelerators, the mercaptobenzothiazole (MBT), thiuram, and thiocarbamate type compounds can be detected and quantified by this method. If the specific rubber accelerator(s) present in the glove material is not known, quantification is based on zinc dibutyldithiocarbamate (ZDBC) equivalents. This method will not detect all potential rubber accelerators, including mercaptobenzothiazole disulfide, dimorpholine, thioureas and diphenyl diamine.1.2 For the purpose of this test method, the range of chemical accelerator measurement is based on the limit of detection (LOD) established in the performing laboratory.1.3 This test method should be performed by experienced analysts or under the supervision of those experienced in the use of spectroscopy and working with organic solvents.1.4 This test method has not been validated for measurement of long chain dithiocarbamates or accelerators from other rubber products, such as lubricated condoms (1).2 Although this assay has been reported in the literature for the evaluation of accelerator levels in condoms, further validation for accelerator measurement from other rubber products is required by the testing laboratory prior to use.1.5 This test method is not designed to evaluate the potential of rubber materials to induce or elicit Type IV skin sensitization reactions (for Type IV skin sensitization reactions see Test Method D6355). Total extractable accelerator content does not reflect bioavailablity of individual accelerators that are detected and measured by this method. This test method should be used to test and measure the total residual chemical accelerator level in NRL and nitrile gloves under controlled laboratory conditions, and should not be used to describe, appraise, or assess the hazard or risk of these materials or products under actual in-use conditions.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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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This specification covers the requirements for gloves made of rubber-like latex, whether made of natural or synthetic materials, unsupported with or without a flock lining, intended for household, beautician, or general use. This specification serves as a guide to permit obtaining gloves of consistent performance, and does not address the safe and proper use of gloves. Sampled specimens shall be tested and conform accordingly to dimensions (width, length, and finger and palm thickness) in accordance to size, and physical requirements (tensile strength and ultimate elongation) before and after accelerated aging. Gloves shall have surfaces that may be smooth or textured, with or without a pattern on the finger surface, and may have a rolled, natural edge or cut cuff. In any case, the gloves shall either be ambidextrous, or in pairs (right and left hand) and matched in design.1.1 This specification covers requirements for gloves made of rubber-like latex, whether made of natural or synthetic materials, unsupported with or without a flock lining, intended for household, beautician use, or general use.1.2 This specification is intended to serve as a guide to permit obtaining gloves of consistent performance. The safe and proper use of gloves is excluded from the scope of this specification.1.3 The following safety hazards caveat pertains only to the test method portion, Section 8, 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.1.4 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 describes the requirements for packaged, thin film medical protective gloves with radiation attenuating properties intended to protect the operator or other persons from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. It specifies the minimum attenuation values and physical property requirements for these radiation-attenuating gloves, which must be compounded from natural rubber latex, rubber cement or synthetic polymers. This specification also covers labeling requirements.1.1 To describe the requirements for packaged protective gloves with radiation attenuating properties intended to protect the operator or other persons from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Minimum attenuation values will be defined.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.

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5.1 The NVR obtained by this test method is that amount which is available for release by the gloves onto handled surfaces.5.2 Evaporation of solvent at the stated temperature is to quantify the NVR that can be expected to exist at room temperature, since the slight difference between room temperature and the test temperature is not likely to result in significant variances.5.3 This method may be more aggressive than necessary to determine the suitability of cleanroom gloves that are restricted to dry operations only.5.4 Various other methods exist for determining NVR, for example Practice G120 and IEST-RP-CC005. This test is not intended to replace test methods used for other purposes.1.1 This test method covers the determination of solvent extractable nonvolatile residue (NVR) from gloves used in cleanrooms where spacecraft are assembled, cleaned, or tested.1.2 The NVR of interest is that which can be extracted from gloves using a specified solvent that has been selected for its extracting qualities, or because it is representative of solvents used in the particular facility. Alternative solvents may be used, but since their use may result in different values being generated, they must be identified in the procedure data sheet.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

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1.1 This test method covers the determination of solvent extractable nonvolatile residue (NVR) from gloves used in cleanrooms where spacecraft are assembled, cleaned or tested. 1.2 The values stated in SI units are to be regarded as standard. 1.3 The NVR of interest is that which can be extracted from gloves using a specified solvent that has been selected for its extracting qualities, or because it is representative of solvents used in the particular facility. Alternative solvents may be used, but since their use may result in different values being generated, they must be identified in the procedure data sheet. 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 and health practices and determine the applicability of regulatory limitations prior to use.

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