1.范围1。1本标准定义了医疗器械无菌保证计划的基本要素。注:本标准旨在包括（a）生产蒸汽灭菌医疗器械的所有制造商的计划，无论是由生产公司还是由另一家公司根据合同进行；（b）仅在合同基础上提供消毒服务。1.2本标准的目标是实现医疗器械的适当无菌保证水平，并将蒸汽灭菌设备操作人员的人身伤害风险降至最低。 1.3为了实现第1.2条的目标，本标准包括以下要求:（a）建筑物和设备的施工和维护；（b） 灭菌器的结构、安装和性能；（c） 无菌保证；和（d）生产过程。注:括号中给出的值仅供参考。1.4本标准中提及的所有压力计均指海平面。

1. Scope1.1 This Standard defines essential elements in a sterility assurance program for medical devices. Note: This Standard is intended to include the programs of all manufacturers who (a) produce medical devices to be sterilized by steam, whether by the producing firm or by another firm on a contractual basis; and (b) perform only sterilization services on a contractual basis.1.2 The objectives of this Standard are the achievement of an adequate level of sterility assurance for a medical device and the minimization of risk of personal injury to operators of steam sterilization equipment.1.3 In order to achieve the objectives of Clause 1.2, this St andard includes requirements for (a) the construction and maintenance of buildings and equipment; (b) sterilizer construction, installation, and performance; (c) sterility assurance; and (d) production processes. Note: The values given in parentheses are provided for information purposes only.1.4 All references in this Standard to pressures gauge refer to sea level.