1. Scope
1.1 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.