定价： 819元 / 折扣价： 697 元 加购物车

定价： 689元 / 折扣价： 586 元 加购物车

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定价： 481元 / 折扣价： 409 元 加购物车

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.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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 This practice provides a study design for determining shelf life of medical gloves using product in its final packaging configuration that has been stored under typical warehouse conditions.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.

定价： 515元 / 折扣价： 438 元 加购物车

4.1 This RIPT method assesses the potential of skin sensitization with a particular medical product by repeated topical applications to the skin of selected subjects. This is a procedure that has the potential to detect many, but not all, sensitzers. This requires multiple applications to induce a cell-mediated Type IV immune response sufficient to cause an allergic reaction.4.2 In general, the sensitization procedure requires 10 multiple 48-h (72-h on weekends) applications of patches containing the study material over a three-week induction phase. Induction is followed by approximately a 21 day rest phase to allow the development of any latent sensitization. Study subjects are then challenged by the application of two consecutive 48-h patches of the study material to naive sites. Responses are evaluated and graded after the removal of each consecutive 48-h patch application.4.3 Although this test method is a clinical method, it may be used as part of a risk analysis to determine the potential for Type IV allergic contact dermatitis.4.4 This test method assumes that good clinical practices will be utilized, including adequate training of practitioners.1.1 This test method is designed to evaluate the potential of glove materials under test to induce and elicit Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans.1.2 This test method should be used by individuals experienced in or under the supervision of those experienced in the use of good clinical practice procedures.1.3 During the performance of the Human Repeat Insult Patch Test (RIPT) for determining sensitization, investigators are confronted with skin responses that represent skin irritation (non-immunologic responses) or allergic contact dermatitis (ACD). The numerical scoring system for grading the intensity of both are similar and test facilities may vary in their scores that describe intensities of allergic and irritant skin responses. The hallmark of a mild allergic contact dermatitis is a sustained palpable erythematous reaction. Delayed-type allergic contact reactions from patch tests have intensity characteristics that favor scores of higher values for longer periods of time and typically do not produce a minimal score (score of 1, a just-perceptible erythema) for short durations (less than 48 h). It is the responsibility of the investigator to evaluate the scores in light of irritant reactions so that the responses are allergic in nature and not irritant. The investigator should denote a final score as either due to contact allergy or irritation. Paragraphs 9.5 – 9.5.5 describe a commonly used scoring system and discuss allergic and irritant responses in detail.1.4 The Draize RIPT was published in 1944 as an attempt to decrease the frequency ACD.2 The test techniques at that time were just being validated and this experimental design was largely empiric.3 The principle of the test is as follows:1.4.1 Multiple inductions of the study material at relatively non or low irritancy levels,1.4.2 Approximately a two-week rest period, and1.4.3 A standard diagnostic challenge of approximately 48 h and a delayed reading at approximately 96 h after patch application.1.5 In the intervening years, with further experimentation added to this empiric approach, three additional principles have been learned:1.5.1 Increasing the concentration of the study material,1.5.2 Defining a no effect level (this is possible with only individual ingredients and not the final study material), and1.5.3 The enhanced sensitivity and the use of occlusion (where occlusion would not ordinarily be present).1.6 In 1945, Henderson and Riley4 demonstrated that a test panel sample size of 30 000 subjects would have to be employed to ensure statistically that there would be no more than 0.1 % sensitization. If there are no allergic responses in a test panel of 200 subjects with exposures comparable to those of the population, then there could be as many as 1.5 allergic reactions per 100 users.1.7 All medical devices must be safe and effective for their intended use. Since medical devices such as gloves come in contact with human tissue, they should be tested for biocompatibility in animals first. The human repeat insult patch test (RIPT) is one test that can be used to test rubber gloves for skin sensitization to chemicals used in the manufacture of gloves.1.7.1 Since various forms of the RIPT exist, a single standardized test method that outlines the testing protocol, scoring system, and the criteria for skin sensitization should be developed.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.

定价： 590元 / 折扣价： 502 元 加购物车

1.1 This specification establishes specifications and test requirements for protectors to be worn over electrical workers’ rubber insulating gloves.1.2 It is intended that the protectors specified herein fit snugly over rubber insulating gloves specified in Specification D120 without causing mechanical damage to the rubber insulating glove. Cinching at the wrist is allowed.1.3 This specification covers the use of a material or combination of materials which do not compromise the integrity of the rubber insulating glove.1.4 Specification F696 was used to establish minimums for this specification.1.5 Protectors meeting this specification do not provide any electrical shock protection if used on their own.1.6 This specification specifies the response of protectors to electric arc, puncture and cut under controlled conditions.1.6.1 Field conditions will not directly correlate to testing methods.1.7 The values stated in SI units are to be regarded as the standard except as noted. See IEEE/ASTM SI-10.1.8 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.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.

定价： 515元 / 折扣价： 438 元 加购物车

4.1 This test method is designed to determine the amount of residual powder and non-powder solids found on medical gloves.4.2 This test method is suitable and designed as a reference method to evaluate samples of medical gloves.4.3 The mass found using Procedure II, for powdered gloves, is assumed to be a combination of water-insoluble residue remaining after the manufacturing process, former release agents and donning powder.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, health, and environmental 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.

定价： 590元 / 折扣价： 502 元 加购物车

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. 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. 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. The chemical permeation tests described in this specification are intended to be "Type Tests" for these types of gloves. The material shall conform to the required quality performances, which include freedom from holes, width, length, thickness, physical properties before aging and after accelerated aging, powder amount, and permeation. Latex shall be tested for protein content and antigenic protein content.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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 This test method is designed to detect holes in food service gloves made of polyethylene that may compromise the barrier quality of the glove.4.2 This method is suitable and designed as a reference method to evaluate samples of polyethylene food service gloves for holes. The presence of holes is defined as a compromise in barrier quality.4.3 This test method is designed for use as a quality referee for holes in polyethylene food service gloves and for manufacturers to evaluate the ongoing control of holes in food service gloves made of polyethylene.4.4 Test Method D5151 is the test method that shall be used for the detection of holes in a food service glove made of the same material type as that of a medical glove, as specified or described, or both, in each applicable ASTM medical glove standard.4.5 For food service gloves made of a material type not described or specified in an existing ASTM glove standard, and if the material is non-elastic, this test method shall be used for the detection of holes.1.1 This test method covers the detection of holes in polyethylene food service gloves. This test method shall not be used on any medical glove.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 has not been determined and is beyond the scope of this method.1.4 The safe use of polyethylene food service gloves is beyond the scope of this standard.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.

定价： 515元 / 折扣价： 438 元 加购物车

This specification covers certain requirements for polychloroprene rubber gloves intended for use in medical examinations and diagnostic and therapeutic procedures. Gloves shall be manufactured from any polychloroprene rubber compound, with the inside and outside surfaces of the examination 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 and ultimate elongation (both before and after accelerated aging of gloves), powder-free residue, and powder amount shall be performed to assess the conformance of the gloves with the requirements specified.1.1 This specification provides certain requirements for polychloroprene rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.1.2 This specification covers polychloroprene rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or non-sterile or bulk non-sterile polychloroprene rubber examination gloves.1.3 This specification is similar to that of D3578 Standard Specification for Rubber Examination Gloves, and D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications.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.

定价： 515元 / 折扣价： 438 元 加购物车

4.1 The objective of this practice is to provide a uniform procedure for assessing the resistance of medical glove materials to permeation by chemotherapy drugs, and to establish a consistent reporting of the test data.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, 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.

定价： 515元 / 折扣价： 438 元 加购物车

3.1 This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove.3.2 This test method is suitable and designed as a reference method to evaluate samples of medical gloves.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, 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.

定价： 515元 / 折扣价： 438 元 加购物车

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.

定价： 590元 / 折扣价： 502 元 加购物车