G44 胶乳制品 标准查询与下载

ASTM D6355-98 医用手套人重复损害修补试验的标准试验方法

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 reponses 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 dermatitits 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. The test techniques at that time were just being validated and this experimental design was largely empiric. 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, and 1.4.3 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), and 1.5.3 The enhanced sensitivity and the use of occlusion (where occlusion would not ordinarily be present). 1.6 In 1945, Henderson and Riley 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 standardization 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

BS ISO 8009-5:1997 可重复使用的橡胶避孕工具.第5部分:抗拉性能的测定

Describes a method for determining the tensile properties of the dome of reusable rubber contraceptive diaphragms. Replaces the first edition.

Reusable rubber contraceptive diaphragms - Determination of tensile properties

BS ISO 8009-1:1997 可重复使用的橡胶避孕工具.第1部分:分类、取样和要求

This part of ISO 8009 gives a classification of, and specifies requirements for, reusable rubber diaphragms (hereafter called diaphragms) supplied in consumer packages for contraceptive use. This part of ISO 8009 does not cover other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges and vaginal sheaths.

Reusable rubber contraceptive diaphragms - Classification, sampling and requirements

BS ISO 8009-2:1997 可重复使用的橡胶避孕工具.第2部分:尺寸测定

ncludes a measuring method consisting in the measurement of the external diameter by a measuring device the scale of which is graduated in millimeters.

Reusable rubber contraceptive diaphragms - Determination of size

BS ISO 8009-9:1997 可重复使用的橡胶避孕工具.第9部分:包装和标签

Gives requirements. Each article shall be individually packaged in a container designed to protect it from contamination and mechanical damage during normal handlung, transport and storage. Articles and containers shall be legibly marked with some important information.

Reusable rubber contraceptive diaphragms - Packaging and labelling

BS ISO 8009-8:1997 可重复使用的橡胶避孕工具.第8部分:卷簧和板簧避孕工具压缩时的扭转测定

Specifies a measuring method. This method is not applicable to diaphragms with springs designed to form an arc when compressed. Compression of the rim of the article across its diameter using a suitable apparatus. Determination of the deviation of the rim from the horizontal plane.

Reusable rubber contraceptive diaphragms - Determination of twisting during compression of coil spring and flat spring diaphragms

BS ISO 8009-7:1997 可重复使用的橡胶避孕工具.第7部分:卷簧和板簧避孕工具耐压缩性测定

Specifies a measuring method. This method is not applicable to diaphragms with springs designed to form an arc when compressed. Compression of the article across its diameter with a mass of 280 g using a suitable apparatus. Determination of the change in diameter after 15 s.

Reusable rubber contraceptive diaphragms - Determination of compression resistance of coil spring and flat spring diaphragms

BS ISO 8009-10:1997 可重复使用的橡胶避孕工具.第10部分:储存的推荐标准

Lays down recommendations on storage conditions to be considered by manufacturers and distributors.

Reusable rubber contraceptive diaphragms - Recommendations for storage

BS ISO 8009-3:1997 可重复使用的橡胶避孕工具.第3部分:子宫帽厚度测定

Gives a method for measurement by means of a specified dial gauge which is graduated in divisions of not more than 0, 01 mm.

Reusable rubber contraceptive diaphragms - Determination of dome thickness

BS ISO 8009-4:1997 可重复使用的橡胶避孕工具.第4部分:无明显陷缺

Specifies two alternative methods for determining visible defects in reusable rubber contraceptive diaphragms, the inspection over a lamp and inspection by inflation. The methods are of equal validity. Replaces the first edition.

Reusable rubber contraceptive diaphragms - Freedom from visible defects

BS ISO 8009-6:1997 可重复使用的橡胶避孕工具.第6部分:加速老化后的变质测定

Includes methods for determining the resistance to deterioration. Conditioning of the test pieces at an elevated temperature for a specified time. Examination of the test pieces followed by measuring of the tensile strength and elongation at break in accordance with ISO 8009-5.

Reusable rubber contraceptive diaphragms - Determination of deterioration after accelerated ageing

HG/T 2888-1997 橡胶家用手套

Rubber Household Gloves

HG/T 2889-1997 胶乳胶丝

Latex Thread

ASTM D3772-97 橡胶指套标准规范

1.1 This specification covers the requirements for finger cots made from natural rubber latex. The purpose of this specification is to obtain consistent performance among products produced in various locations or at various times in the same location.1.2 This specification does not cover the safe and proper use of finger cots or products of special construction for special use.1.3 The values stated in SI units are to be regarded as the standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Rubber Finger Cots

DIN ISO 506:1995 天然橡胶胶乳浓缩物.挥发脂肪酸数值的测定 (ISO 506:1992)

This document specifies a method for the determination of the volatile fatty acid number of natural rubber latex concentrate. The method is not necessarily suitable for latices from natural sources other than Hevea brasiliensis and is not applicable to compounded latex, vulcanized latex, artificial dispersions of rubber or synthetic rubber latices.

Rubber latex, natural, concentrate - Determination of volatile fatty acid number (ISO 506:1992)

HG/T 2723-1995 胶乳彩色气球

本标准规定了胶乳彩色气球的技术要求，试验方法、检验规则、标志、包装、运输和贮存。 本标准适用于天然胶乳制成的用于节日庆祝、广告宣传和儿童玩乐的10g以内的各种形状、花纹、图案的气球。

latex color balloons

ASTM D4316-95(2005) 弹性水瓶标准规范

1.1 This specification covers requirements for molded, non-fabric reinforced, elastomeric water bottles with closure and screw stopper, generally used with hot or cold water in personal hygiene and health care. 1.2 The safe and proper use of elastomeric water bottles is beyond the scope of this specification except for the user instructions in 9.2.

Standard Specification for Elastomeric Water Bottles

ASTM E1731-95e1 重量分析测定清洁室手套的非挥发性残余物的标准试验方法

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.

Standard Test Method for Gravimetric Determination of Nonvolatile Residue from Cleanroom Gloves

ISO 10282:1994 单用无菌外科橡胶手套的规范

Single-use sterile surgical rubber gloves - Specification

BS 6057 Sec.3.13:1993 橡胶乳.第3部分:试验方法.第13节:污物含量的测定

Rubber latices. Methods of test. Determination of sludge content