Số hiệu tiêu chuẩn
prEN ISO 11135
Tên tiêu chuẩn
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2004)
Ngày phát hành
2004-05-00
Tiêu chuẩn tương đương
DIN EN ISO 11135 (2004-08), IDT * 04/30048118 DC (2004-05-24), IDT * ISO/DIS 11135 (2004-05), IDT * OENORM EN ISO 11135 (2004-08-01), IDT
Từ khóa
Acceptance (approval) * Acceptance specification * Biological hazards * Calibration * Checks * Clearing * Commissioning * Compatibility * Conditioning * Cycle * Cyclic * Definitions * Developments * Equipment * Ethylene oxide * Evaluations * Examination (quality assurance) * Germicides * Hygiene * Inspection * Instructions * Maintenance * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Methods * Microbiological * Microbiological analysis * Operation * Operators (personnel) * Performance * Personnel * Physical * Public health * Public health protection * Qualifications * Quality management * Routine tests * Rules of procedure * Safety * Safety engineering * Safety requirements * Specification (approval) * Sterilization (birth control) * Sterilization (hygiene) * Sterilizers * Storage * Surveillance (approval) * Testing * Validation * Ventilation * Procedures * Release * Bearings * Processes