EN ISO 17665-1:2006 – Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

4 Quality management system elements
4.1 Documentation
4.1.1 Procedures for the development, validation, routine control and product release from sterilization shall be specified.
4.1.2 Documents and records required by this part of ISO 17665 shall be reviewed and approved by designated personnel (see 4.2.1). Documents and records shall be controlled in accordance with the applicable clauses of ISO 13485.
4.2 Management responsibility
4.2.1 The responsibility and authority for implementing and meeting the requirements described in this part of ISO 17665 shall be specified. Responsibility shall be assigned to competent personnel in accordance with the applicable clauses of ISO 13485.
4.2.2 If the requirements of this part of ISO 17665 are undertaken by organizations with separate quality management systems, the responsibilities and authority of each party shall be specified.
4.3 Product realization
4.3.1 Procedures for purchasing shall be specified. These procedures shall comply with the applicable clauses of ISO 13485.
4.3.2 Procedures for identification and traceability of product shall be specified. These procedures shall comply with the applicable clauses of ISO 13485.
4.3.3 A system complying with the applicable clause(s) ISO 13485 or ISO 10012 shall be specified for the calibration of all equipment, including instrumentation for test purposes, used in meeting the requirements of this part of ISO 17665.
4.4 Measurement, analysis and improvement — Control of non-conforming product Procedures for control of product designated as non-conforming and for correction, corrective action and preventive action shall be specified. These procedures shall comply with the applicable clauses of ISO 13485.
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.1.1 For the purposes of this part of ISO 17665 the sterilizing agent shall be moist heat.
5.1.2 Contaminants contained within the sterilizing agent shall not impair the safety of the product for its intended use.
5.2 Microbicidal effectiveness If moist heat is used outside of the range of conditions that are widely recognised, then the microbicidal effectiveness shall be established and documented. NOTE The microbicidal effectiveness of moist heat and its use in sterilization processes has been comprehensively documented and is available in the published literature.
5.3 Materials effects The effect of the sterilizing agent on materials shall be assessed in accordance with the requirements of Clauses 6 and 7.
5.4 Environmental consideration Moist heat is not normally considered as having a significant environmental effect; however, the potential impact on the environment of the operation of the sterilization process shall be assessed and any measures necessary to protect the environment shall be identified. This assessment, including potential impact (if any) and measures for control (if identified), shall be documented.
EN ISO 17665-1:2006 – Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices