1.1 本规范涵盖了用于外科植入物的非制造和制造形式的水合硫酸钙的材料要求。制造形式可能包括各种几何形状的压制和铸造外科植入物。未制备形式的半水硫酸钙可以通过向制备的二水硫酸钙形式中添加水或其他含水溶液来转化。 1.2 本规范的要求适用于与两个水分子结合的硫酸钙或共享一个水分子的两个硫酸钙分子。 近似化学公式: 二水硫酸钙 卡索 4. ·2小时 2. O 半水硫酸钙 卡索 4. ·1/2小时 2. O或CaSO 4. ·H 2. O·CaSO 4. 1.3 本规范明确排除了含有添加剂（例如增强相、药物、生物剂等）的硫酸钙硬石膏和硫酸钙形式。 1.4 加工助剂的存在并不排除产品符合本规范的物理和机械要求。 1.5 规范的一些规定 C59/C59M 和试验方法 C472型 申请本规范中详细说明的特殊要求用于表征将用于外科植入物的材料。 1.6 骨组织对硫酸钙的生物反应具有良好的临床应用历史 ( 1- 14 ) 2. 通过实验室研究 ( 15- 18 ) . 1.7 以下预防性警告仅适用于试验方法部分，章节 4. , 5. 和 6. ，符合本规范。 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。

1.1 This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form. 1.2 The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule. Approximate chemical formulae: Calcium Sulfate Dihydrate CaSO 4 ·2H 2 O Calcium Sulfate Hemihydrate CaSO 4 ·1/2H 2 O or CaSO 4 ·H 2 O·CaSO 4 1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth. 1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification. 1.5 Some provisions of Specification C59/C59M and Test Methods C472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants. 1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use ( 1- 14 ) 2 and by laboratory studies ( 15- 18 ) . 1.7 The following precautionary caveat pertains only to the test method portion, Sections 4 , 5 , and 6 , 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. 1.8 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.