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 […]
Continue reading »