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 11135:2011)
Ngày phát hành
2011-09-00
Tiêu chuẩn tương đương
DIN EN ISO 11135 (2011-09), IDT * 11/30244091 DC (2011-09-20), IDT * ISO/DIS 11135 (2011-09), IDT * OENORM EN ISO 11135 (2011-10-15), IDT
Từ khóa
Acceptance (approval) * Acceptance specification * Checks * Commissioning * Definitions * Ethylene oxide * Evaluations * Examination (quality assurance) * Germicides * Hygiene * Inspection * Instructions * Maintenance * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Microbiological analysis * Operation * Operators (personnel) * Personnel * Public health * Public health protection * Qualifications * Quality management * Routine tests * Safety * Safety engineering * Safety requirements * Specification (approval) * Sterilization (birth control) * Sterilization (hygiene) * Sterilizers * Storage * Surveillance (approval) * Testing * Validation * Bearings