Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
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.
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 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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