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

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 843元 / 折扣价： 717 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

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.

定价： 590元 / 折扣价： 502 元 加购物车

1.1 This terminology is a compilation of definitions of terms used in ASTM documents relating to nickel-titanium shape memory alloys used for medical devices. This terminology includes only those terms for which ASTM either has standards or which are used in ASTM standards for nickel-titanium shape memory alloys. It is not intended to be an all-inclusive list of terms related to shape memory alloys.1.2 Definitions that are similar to those published by another standards body are identified with abbreviations of the name of that organization; for example, ICTAC is the International Confederation for Thermal Analysis and Calorimetry.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

1.1 This safety specification establishes requirements for devices intended to address the risk of injury and death associated with accidental falls through open windows by children five years old and younger.NOTE 1: This safety specification is not intended to meet the unique requirements of Americans With Disabilities Act (ADA).1.2 This safety specification applies only to window fall prevention devices, window fall prevention screens, and fall prevention window guards that are to be used on windows that are not intended for escape (egress) and rescue (ingress).NOTE 2: Specification F2090 addresses window fall prevention devices (releasable), including window opening control devices (WOCD(s)) for windows intended for emergency escape and rescue and any other window not covered by this safety specification.1.3 This safety specification applies only to devices intended to be applied to windows installed at heights of more than 75 ft7 (23 m) above ground level in multiple family dwelling buildings. This safety specification is not intended to apply to windows below 75 ft (23 m) because all windows below 75 ft (23 m) that are operable and that meet the requirements for emergency escape and rescue openings could be used as a possible secondary means of escape.8NOTE 3: Users of this safety specification should consult local authorities for other requirements that may apply to the use or installation, or both, of products covered by this safety specification.1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.5 This standard does not purport to address all 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 to 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

5.1 Environment or oxidative time-to-fail data derived from this test method, analyzed in accordance with Section 13, are suitable for extrapolation to typical end-use temperatures and hoop stresses. The extrapolated value(s) provides a relative indication of the resistance of the tested PEX pipe or tubing or system to the oxidative effects of hot, chlorinated water for conditions equivalent to those conditions under which the test data were obtained. The performance of a material or piping product under actual conditions of installation and use is dependent upon a number of factors including installation methods, use patterns, water quality, nature and magnitude of localized stresses, and other variables of an actual, operating hot-and-cold water distribution system that are not addressed in this test method. As such, the extrapolated values do not constitute a representation that a PEX tube or system with a given extrapolated time-to-failure value will perform for that period of time under actual use conditions.1.1 This test method describes the general requirements for evaluating the long-term, chlorinated water, oxidative resistance of cross-linked polyethylene (PEX) pipe or tubing produced in accordance with PEX specifications, such as Specification F876 or Specification F2788/F2788M by exposure to hot, chlorinated water. This test method outlines the requirements of a pressurized flow-through test system, typical test pressures, test-fluid characteristics, failure type, and data analysis.NOTE 1: Other known disinfecting systems (chlorine dioxide, ozone, and chloramines) are also used for protection of potable water. Free-chlorine is the most common disinfectant in use today. A PPI research project examined the relative aggressiveness of free chlorine and chloramines on PEX pipes, both at the same 4.0 ppm concentration and the same test temperatures. The results of the testing showed pipe failure times approximately 40% longer when tested with chloramines compared to testing with free chlorine, at the tested conditions. Based on these results, the data suggests that chloramines are less aggressive than free chlorine to PEX pipes.1.2 Guidelines and requirements for test temperatures, test hoop stresses, and other test criteria have been established by prior testing of PEX pipe or tubing produced by the three most common commercial methods of cross-linking: silane, peroxide, and electron-beam (see Note 2). Other related system components that typically appear in a PEX hot-and-cold water distribution system can be evaluated with the PEX pipe or tubing. When testing PEX pipe or tubing and fittings as a system, it is recommended that the anticipated end-use fitting type(s) and material(s) be included in the test circuit since it is known that some fitting types and materials can impact failure times. Specimens used shall be representative of the piping product(s) and material(s) under investigation.NOTE 2: The procedures described in this test method (with some modifications of test temperatures or stresses, or both) have been used to evaluate pipes manufactured from polybutylene (PB), polyethylene (PE), polypropylene (PP), multilayer (polymer-metal composite), copper, and stainless steel.1.3 This test method is applicable to PEX pipe or tubing and systems used for transport of potable water containing free-chlorine for disinfecting purposes. The oxidizing potential of the test-fluid specified in this test method exceeds that typically found in potable water systems across the United States.1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.5 The following precautionary caveat pertains only to the test method portion, Section 12, 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.1.6 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