G45 医用和食品工业用橡胶制品 标准查询与下载

BS ISO 23409:2011 男用避孕套.合成材料制避孕套用试验方法和要求

Male condoms. Requirements and test methods for condoms made from synthetic materials

ISO 23409:2011 男用避孕套.由合成材料制成的避孕套要求与试验方法

This International Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.

Male condoms - Requirements and test methods for condoms made from synthetic materials

ASTM D6324-11 合成材料制男用避孕套标准试验方法

New polymer materials for male condoms are being developed. This standard is intended to describe the test methods whose results shall adequately describe the design and the quality of condoms made of polyurethane material. These test methods are not intended to be design restrictive. The condom design shall be validated prior to use.1.1 These test methods cover and shall be used to evaluate male condoms made only of polyurethane. These test methods also describe the minimum inspection and quality levels that shall be utilized in referee tests. It is not intended to be a routine quality control specification for polyurethane condom manufacturing operations. 1.2 These test methods are intended to assist buyers in obtaining polyurethane condoms of consistent quality. The safe and proper use of polyurethane condoms is excluded from the scope of these test methods. 1.3 The annexes in these test methods include important information, such as that on apparatus or materials, that is a mandatory part of these test methods but too detailed for inclusion in the main text. 1.4 The appendixes in these test methods contain information intended to provide guidance. 1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 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 and health practices and determine the applicability of regulatory limitations prior to use. A1.1.1 This annex covers the method for determining the length of polyurethane male condoms. A2.1.1 This appendix covers the test method for determining the tensile properties of polyurethane condoms. Specimen elongation may be measured by extension indicators or displacement of gauge marks. A4.1.1 Experience has shown that the water leakage test is most sensitive when the condom is filled while hanging vertically, its top is closed off, and the condom is placed in a horizontal position while it is examined for leaks. With this technique, the internal pressure over the entire condom surface is approximately uniform. X1.1.1 This appendix covers the methods for determining the thickness of polyurethane male condoms. X2.1.1 This appendix outlines a test method for determining the bursting volume and bursting pressure of polyurethane condoms. This test method is patterned after standard methods typically used in determining the air inflation properties of latex condoms. The testing apparatus and the procedure may not be appropriate for all types of polyurethane materials and product designs, and, therefore, it is inappropriate to establish a minimum requirement for volume. X2.1.2 Following a more extensive review of existing and proposed polyurethane condom products, it may be more appropriate to categorize the marketed products by material type and design, and to develop separate test methods for each, after which, appropriate minimum requirements for volume can be established, consistent with the physical properties of the individual material types. X3.1.1 This appendix covers the test method for determining the strength of welded seams of polyurethane condoms.

Standard Test Methods for Male Condoms Made from Polyurethane

HG/T 2584-2010 橡胶工业手套

本标准规定了橡胶工业手套的技术要求、试验方法、验收规则及标志、包装、运输、贮存等。 本标准适用于以天然胶乳为主体材料制成的工、农、林、牧、渔业等使用的劳动保护手套。

Rubber industry gloves

ASTM F997-10 医用聚碳酸酯树酯的标准规范

1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy. 1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application. 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 Polycarbonate Resin for Medical Applications

ASTM F2450-10 组织工程医用产品用聚合物工作台的微观结构的评估的标准指南

The ability to culture functional tissue to repair damaged or diseased tissues within the body offers a viable alternative to xenografts or heterografts. Using the patient’s own cells to produce the new tissue offers significant benefits by limiting rejection by the immune system. Typically, cells harvested from the intended recipient are cultured in vitro using a temporary housing or scaffold. The microstructure of the scaffold, that is, its porosity, the mean size, and size distribution of pores and their interconnectivity is critical for cell migration, growth and proliferation (Appendix X1). Optimizing the design of tissue scaffolds is a complex task, given the range of available materials, different manufacturing routes, and processing conditions. All of these factors can, and will, affect the surface texture, surface chemistry, and microstructure of the resultant scaffolds. Factors that may or may not be significant variables depend on the characteristics of a given cell type at any given time (that is, changes in cell behavior due to the number of passages, mechanical stimulation, and culture conditions). Tissue scaffolds are typically assessed using an overall value for scaffold porosity and a range of pore sizes, though the distribution of sizes is rarely quantified. Published mean pore sizes and distributions are usually obtained from electron microscopy images and quoted in the micrometer range. Tissue scaffolds are generally complex structures that are not easily interpreted in terms of pore shape and size, especially in three dimensions. Therefore, it is difficult to quantifiably assess the batch-to-batch variance in microstructure or to make a systematic investigation of the role that the mean pore size and pore size distribution has on influencing cell behavior based solely on electron micrographs (Tomlins et al, (1)). Fig. 1 gives an indication of potential techniques that can be used to characterize the structure of porous tissue scaffolds and the length scale that they can measure. Clearly a range of techniques must be utilized if the scaffold is to be characterized in detail. The classification and terminology of pore sizes, such as those given in Table 2, has yet to be standardized, with definitions of terms varying widely (as much as three orders of magnitude) between differing applications and industries. Both Table 2 and the supporting detailed discussion included within Appendix X2 describe differences that exist between IUPAC (International Union of Pure and Applied Chemistry) definitions and the common terminology currently utilized within most life science applications, which include both implant and tissue engineering applications. Since the literature contains many other terms for defining pores (Perret et al (3)), it is recommended that the terms used by authors to describe pores be defined in order to avoid potential confusion. Additionally, since any of the definitions in Table 2 can shift, dependending on the pore size determination method (see Table 1 and Fig. 1), an accompanying statement describing the utilized assessment technique is essential. All the techniques listed in Table 1 have limitations for assessing complex porous structures. Fig. 2a and Fig. 2b show a through- and a blind-end pore respectively. Porometry measurements (see 7.4) are only sensitive to the narrowest point along a variable diameter through-pore and therefore can give a lower measure of the pore diameter than other investigative techniques, such as scanning electron microscope (SEM), which may sample at a different point along the pore. The physical basis of porometry depends on the passage of gas through the material. Therefore, the technique is not sensitive to blind-end or closed pore.......

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

ASTM D7661-10 测定人体滑润剂与天然橡胶避孕套亲和性的标准试验方法

Weakening of natural rubber latex is known to occur after contact with certain lubricants, particularly petroleum-based products. , This procedure was developed as a screening method for lubricant manufacturers to determine whether or not a particular personal lubricant has a significant effect on the tensile and airburst properties of an NRL condom. This test method is designed for use on NRL condoms that meet the criteria of Specification D3492 and can: (1) have a ring specimen cut in compliance with Appendix X1 of Specification D3492 and (2) be tested for burst properties in compliance with Annex A2 of Specification D3492. This test method is not to be used to determine the safety of either the test lubricant or NRL condom. This test method is to be used only to determine if the tensile or airburst properties of the NRL condom have been significantly affected by the test lubricant.1.1 This test method covers procedures used to detect a shift in physical properties of non-lubricated natural rubber latex (NRL) condoms after immersion in a personal lubricant. “Personal lubricants” are lubricants such as liquids or gels that are applied by the consumer at the time of condom use. 1.2 This test method does not attempt to address compatibility of lubricants applied to a condom at the time of manufacture (“manufacturer lubricants”). It shall be the responsibility of the condom manufacturer to verify the long-term stability (shelf life) of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

KS M ISO 11193-1:2009 一次性医用检验手套.第1部分:胶乳或橡胶溶液制成的手套规范

이 표준은 의학적 진찰과 진단 또는 치료 과정에서 환자와 사용자 간의 교차 오염을 방지하기

Single-use medical examination gloves-Part 1:Specification for gloves made from rubber latex or rubber solution

BS EN 455-4:2009 一次性医用手套.第4部分:测定货架寿命的试验和要求

This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Medical gloves for single use Part 4: Requirements and testing for shelf life determination

ASTM D3577-09e1 橡胶外科手套标准规范

The specification is intended as a reference to the performance and safety of rubber surgical gloves. The safe and proper use of rubber surgical gloves is beyond the scope of this specification.1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Rubber Surgical Gloves

KS M ISO 8009:2008 机械避孕剂.可重复使用的天然和硅胶避孕器具.要求和试验

이 표준은 천연 고무 및 실리콘 고무로 만들어진 재사용이 가능한 질격막(diaphragms

Mechanical contraceptives-Reusable natural and silicone rubber contraceptive diaphragms-Requirements and tests

SN/T 0678-2008 进出口一次性使用医用.橡胶检查手套检验规程

本标准规定了灭菌或非灭菌进出口一次性使用医用橡胶检查手套的抽样、检验和检验结果的判定。 本标准适用于医护人员检查、诊断或治疗病患时为防止交叉感染以及处理污染性医疗材料时所使用的光面或部分麻面和全麻面的橡胶检查手套。其他用途的橡胶检查手套可以参照使用。

Rules for the inspection of single-use medical rubber examination gloves for import and export

ISO 11193-1:2008 一次性医用检验手套.第1部分:用胶乳或胶水制成的手套规范

This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. This part of ISO 11193 is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.

Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

ASTM D3492-08 橡胶避孕套(男用避孕套)标准规范

1.1 This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the specifications for lubricants or other dressing materials that may be applied to condoms except as noted in 3.2. 1.2 This specification is intended to assist buyers in obtaining condoms of consistent quality. The safe and proper use of condoms is excluded from the scope of this specification. 1.3 The applicability of this specification is as a design guideline and a reference test specification. It is not intended to be a routine quality control specification for condom manufacturing operations. 1.4 The annexes in this specification include important information, such as that on apparatus or materials, that is a mandatory part of the specification but too detailed for inclusion in the main text. 1.5 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification. 1.6 It shall be the responsibility of the manufacturer for any condom design that falls outside the specifications of this standard to determine testing methodology and substantiate the appropriateness of that methodology to assure the quality of the condoms to the purchaser and to the government regulatory authority having jurisdiction. 1.7 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

Standard Specification for Rubber Contraceptives (Male Condoms)

ASTM D6976-08 橡胶避孕用具的标准规范.女用安全套

1.1 This specification covers requirements for contraceptive vaginal diaphragms, hereafter called diaphragms. 1.2 Vaginal barrier devices known as cervical caps, vaginal sponges and female condoms are not included in this specification.

Standard Specification for Rubber Contraceptivesx2014;Vaginal Diaphragms

ASTM D6324-08 聚氨酯造男用避孕套的标准试验方法

New polymer materials for male condoms are being developed. This standard is intended to describe the test methods whose results shall adequately describe the design and the quality of condoms made of polyurethane material. These test methods are not intended to be design restrictive. The condom design shall be validated prior to use.1.1 These test methods cover and shall be used to evaluate male condoms made only of polyurethane. These test methods also describe the minimum inspection and quality levels that shall be utilized in referee tests. It is not intended to be a routine quality control specification for polyurethane condom manufacturing operations. 1.2 These test methods are intended to assist buyers in obtaining polyurethane condoms of consistent quality. The safe and proper use of polyurethane condoms is excluded from the scope of these test methods. 1.3 The annexes in these test methods include important information, such as that on apparatus or materials, that is a mandatory part of these test methods but too detailed for inclusion in the main text. 1.4 The appendixes in these test methods contain information intended to provide guidance. 1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 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 and health practices and determine the applicability of regulatory limitations prior to use. A1.1.1 This annex covers the method for determining the length of polyurethane male condoms. A2.1.1 This appendix covers the test method for determining the tensile properties of polyurethane condoms. Specimen elongation may be measured by extension indicators or displacement of gauge marks. A4.1.1 Experience has shown that the water leakage test is most sensitive when the condom is filled while hanging vertically, its top is closed off, and the condom is placed in a horizontal position while it is examined for leaks. With this technique, the internal pressure over the entire condom surface is approximately uniform. X1.1.1 This appendix covers the methods for determining the thickness of polyurethane male condoms. X2.1.1 This appendix outlines a test method for determining the bursting volume and bursting pressure of polyurethane condoms. This test method is patterned after standard methods typically used in determining the air inflation properties of latex condoms. The testing apparatus and the procedure may not be appropriate for all types of polyurethane materials and product designs, and, therefore, it is inappropriate to establish a minimum requirement for volume. X2.1.2 Following a more extensive review of existing and proposed polyurethane condom products, it may be more appropriate to categorize the marketed products by material type and design, and to develop separate test methods for each, after which, appropriate minimum requirements for volume can be established, consistent with the physical properties of the individual material types. X3.1.1 This appendix covers the test method for determining the strength of welded seams of polyurethane condoms.

Standard Test Methods for Male Condoms Made from Polyurethane

ISO 11193-1:2002/Amd 1:2007 一次性医用检验手套.第1部分:橡胶乳或胶液制手套规范.修改件1

This standard is about Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution AMENDMENT 1

Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Amendment 1

ASTM D7329-07 食品制备和食品加工(食品服务)手套的标准规范

1.1 This specification covers the properties necessary for thin film, unlined polymer gloves to be used in food preparation and food handling.1.2 This specification is intended to serve as a referee and a guide to permit obtaining gloves of a consistent performance. The safe and proper use of gloves is excluded from the scope of this specification.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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Food Preparation and Food Handling (Food Service) Gloves

ASTM D6355-07(2017) 医用手套人工重复损坏修补试验的标准试验方法

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 expe......

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

SANS 16038:2006 橡胶避孕套.关于天然橡胶胶乳避孕套质量管理的ISO 4047的使用指南

Provides guidance on using ISO 4074 (published in South Africa as an identical adoption under the designation SANS 4074) and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in design, manufacture and delivery of condoms with emphasis on performance, safety and reliability of condoms.

Rubber condoms - Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms