4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time or by subsequent dynamic events during shipping and handling, or both. Accelerated and real time aging verifies the time-related aspects of potential integrity loss only.4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall provide physical protection in order to maintain integrity of the sterile barrier system.” Sub-clause 6.1.6 states that, “A terminally sterilized sterile barrier system with its protective packaging, if included, shall be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.” Sub-clause 8.3.1 states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.” Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.”4.3 Real time aging programs provide the best data to ensure that sterile barrier system/medical device materials and sterile barrier system/medical device integrity do not degrade over time. However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means of screening for possible aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.4.4 Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.4.5 When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor (that is, Q10) and is tentative until the results of real time aging studies are completed on the sterile barrier system.NOTE 1: Determining AAFs are beyond the scope of this guide.61.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available.1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019.1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide.1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.”1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for sterile barrier systems.1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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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定价： 515元 / 折扣价： 438 元 加购物车

定价： 515元 / 折扣价： 438 元 加购物车

5.1 This practice accelerates the natural aging of pressure-sensitive tapes so that the response to the usual physical property tests changes to the same extent as with an exposure to approximately two years of natural aging when compared with the response to tests before aging.5.1.1 Natural aging in this context means a continuous period of aging of tape in a closed fibreboard container (in darkness) in the variable climate of either the warm moist south, the warm dry southwest or the moderate midcontinent, USA.5.2 The extent of change for one physical property should be expected to be different than for another property and so would also relate to different natural aging time.5.3 An abnormal product lot may cause differences in testing response that throw off the expected time patterns.5.4 Appearance of normal tape product will usually change only slightly on two years natural aging. This accelerated exposure usually produces an exaggerated change in appearance which would be seen under natural conditions only in abnormal product.5.5 There is no present experience to relate this accelerated exposure to responses of tape in applications where the tape is under a use stress.1.1 This practice provides one environment in which to expose finished pressure-sensitive tape material for the purpose of accelerating the aging of it. It is applicable to tape in roll form when the user observes the precautions detailed within the procedure. The practice does not provide for a conclusion within itself, but is for use in conjunction with appearance or physical property tests to follow the accelerated exposure. While this practice was developed using packaging type tapes, its use on other types of tape with similar construction is encouraged. It is not intended for use on electrical grade tapes (see Test Methods D1000).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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4.1 This practice summarizes a method that may be used to accelerate the oxidation of UHMWPE components using elevated temperature and elevated oxygen pressure. Under real-time conditions, such as shelf aging and implantation, oxidative changes to UHMWPE after sterilization using high-energy radiation may take months or years to produce changes that may result in deleterious mechanical performance. The method outlined in this practice permits the evaluation of oxidative stability in a relatively short period of time (for example, weeks).4.2 This practice may also be used to oxidize UHMWPE test specimens and joint replacement components prior to characterization of their physical, chemical, and mechanical properties. In particular, this practice may be used for accelerated aging of UHMWPE components prior to evaluation in a hip or knee joint wear simulator as outlined in Guide F1714 (hip wear), Guide F1715 (knee wear), ISO 14242 (hip wear), or ISO 14243 (knee wear), or combination thereof.1.1 It is the intent of this practice to permit an investigator to evaluate the oxidative stability of UHMWPE materials as a function of processing and sterilization method. This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical and mechanical stability.1.2 Although the accelerated aging method described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method may not precisely simulate the degradative mechanisms for an implant during real-time shelf aging and implantation.1.3 The accelerated aging method specified herein has been validated based on oxidation levels exhibited by certain shelf-aged UHMWPE components packaged in air and sterilized with gamma radiation. The method has not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. For example, this practice has not been directly correlated with the shelf life of components that have been sealed in a low-oxygen package, such as nitrogen. This practice is not intended to simulate any change that may occur in UHMWPE following implantation.1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are for information only and are not considered 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.

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1.1 This practice is intended to define the exposure conditions of plastics at various temperatures when exposed solely to hot air for extended periods of time. Only the procedures for heat exposure are specified, not the test method or specimen. The effect of heat on any particular property may be determined by selection of the appropriate test method and specimen; however, it is recommended that Practice D 3826 be used to determine the embrittlement endpoint, which is defined as that point in the history of a material when 75 % of the specimens tested have a tensile elongation at break of 5 % or less at an initial strain rate of 0.1 mm/mm min.1.2 This practice should be used as a guide for comparing the thermal-aging characteristics of materials as measured by the change in some property of interest (that is, embrittlement by means of loss of elongation). It is very similar to Practice D3045 but is intended for use in evaluating plastics designed to be oxidized easily after use. The exposure times used for this practice will be significantly shorter than those used for Practice D3045.1.3 The type of oven used can affect the results obtained from this practice. The user can use one of two methods for oven exposure. The results based on one method should not be mixed with those based on the other.1.3.1 Procedure A: Gravity-Convection Oven--Recommended for film specimens having a nominal thickness not greater than 0.25 mm (0.010 in.).1.3.2 Procedure B: Forced-Ventilation Oven--Recommended for specimens having a nominal thickness greater than 0.25 mm (0.010 in.).1.4 This practice recommends procedures for comparing the thermal aging characteristics of materials at a single temperature. Recommended procedures for determining the thermal aging characteristics of a material at a series of temperatures for the purpose of estimating time to a defined property change at some lower temperature are also described. This practice does not predict thermal aging characteristics where interactions between stress, environment, temperature, and time control failure.1.5 The values stated in SI units are to be regarded as the 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 and health practices and determine the applicability of regulatory limitations prior to use.Note 1--There is no ISO standard that is equivalent to this standard.

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5.1 This test method is intended for use on all types of finished leathers.5.2 Finish stability is a significant factor in establishing the application and function of leather.1.1 This test method covers the determination of resistance of leather finish to cracking, flaking or becoming tacky after aging.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 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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定价： 515元 / 折扣价： 438 元 加购物车

5.1 This test method is useful to the adhesive manufacturer in research and development or in manufacturing control. The results are also used for specification acceptance or as a guide in adhesive selection.5.2 The provisions for testing bonded specimens as well as free films are made for two purposes. First, it is possible for an interaction to occur between oxygen and chemicals or degradation products that may affect the degradation of the bonded joints strength. Second, some increase in strength due to oxidative crosslinking may not be detrimental in a bonded assembly and in fact may be beneficial. Adhesives of this behavior are not satisfactorily tested by a film flexibility test.5.3 Some users of this test method will be most interested in the performance of the bonded joint; some will be most interested in the performance of the adhesive. In the latter case, it is important to note that the true variance (error mean square) of the strength of the adhesive may be obscured when the tested control specimens or the tested aged specimens show wood failure.5.4 Conflict of Procedure—If the procedures of this test method conflict with those of detailed product specifications or manufacturer's use instructions for a particular material, then use the latter.1.1 This test method describes how to estimate the relative resistance to deterioration of adhesive films and adhesive-bonded joints placed in a high-pressure oxygen environment. The instructions include both wood-to-wood and wood-to-metal joints as well as free film of adhesive. The effects of chemicals such as fire retardants, preservatives, or wood extractives, can be evaluated by using materials containing these chemicals for adherends.1.2 This test method is primarily intended for elastomer-based construction adhesives, but is also applicable to other types of adhesives that may be susceptible to oxygen degradation. This accelerated test does not correlate exactly with the natural aging of the adhesive because of the varied conditions of natural aging and the absence of factors such as moisture and stress. The results of this accelerated test are only comparative and must be evaluated against the performance of bonded joints whose natural and accelerated aging characteristics are known.1.3 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.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.

定价： 590元 / 折扣价： 502 元 加购物车

定价： 515元 / 折扣价： 438 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

3.1 This test method is not absolute but does give an indication of the useful shelf-life of a liquid water-emulsion floor polish. Will indicate whether a polish will gel or remain a usable liquid over the desired storage life of the product. It should be noted that polishes of different composition types will vary in useful storage life under identical storage conditions.1.1 This test method covers the storage stability of liquid water-emulsion floor polishes.1.2 Storage for 30 days at 52 °C (125 °F), while not a guarantee of one year stability at 21 °C (70 °F), is believed to be a more reliable indicator of storage stability than similar tests of shorter duration.NOTE 1: The 60° specular gloss on black glass determined by Test Method D1455, may be used to confirm this observation. A substantial difference in gloss between aged and unaged samples is an indication of instability. A shelf stability of one year can be reasonably expected of the material in question if duplicate samples remain unchanged for 30 days at 52 °C ± 1.1 °C (125 °F ± 2 °F). If one or both duplicates show more than slight viscosity increases or slight creaming, other evidence of stability must be sought.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

定价： 515元 / 折扣价： 438 元 加购物车

定价： 515元 / 折扣价： 438 元 加购物车