1.1 本指南涵盖了开发和维护机械制冷冷冻柜低温储存设施的推荐程序。 1.2 本指南涵盖了为液氮冷却的冷冻柜开发和维护低温储存设施的推荐程序。 1.3 本指南不包括实践中涉及的冷冻保存实践 E1342 . 1.4 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 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和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1 低温储存设施的适当设计确保敏感生物材料在提供最大储存稳定性的条件下得到维持。 4.2 适当设计和低操作- 温度存储设施确保在低温下处理敏感生物材料不会影响稳定性（见指南 E1565 ). 4.3 适当设计的低温储存设施确保提供足够的保护措施，以防止不良事件损害敏感生物材料的稳定性。

1.1 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers with mechanical refrigeration. 1.2 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers cooled with liquid nitrogen. 1.3 This guide does not cover practices for preservation by freezing which are covered in Practice E1342 . 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety problems, 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. ====== Significance And Use ====== 4.1 The proper design of low-temperature storage facilities ensures that sensitive biological materials are maintained under conditions providing maximum storage stability. 4.2 Properly designed and operated low-temperature storage facilities ensure that the handling of sensitive biological materials at low temperatures does not compromise stability (see Guide E1565 ). 4.3 Properly designed low-temperature storage facilities ensure that adequate safeguards are provided to prevent untoward events from compromising the stability of sensitive biological materials.