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 companies that (a) produce medical devices to be sterilized by ethylene oxide whether by the producing firm or by another firm on a contractual basis, prior to their sale; and (b) perform only sterilization services on a contractual basis.
1.2 This Standard has as its objectives the achievement of an adequate level of sterility assurance for a device and the reduction of the residual effect of ethylene oxide on the recipient of the device. Note: In order to implement the requirements of this Standard, it is recommended that company management take into account government statutes, regulations, and guidelines.
1.3 In order to achieve the objectives of Clause 1.2, this Standard includes requirements for (a) the construction and maintenance of buildings and equipment; (b) production procedures; and (c) sterility assurance.
1.4 This Standard does not inc