Số hiệu tiêu chuẩn
EN ISO 11137-1/prA1
Tên tiêu chuẩn
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd.1:2012)
Ngày phát hành
2012-05-00
Tiêu chuẩn tương đương
DIN EN ISO 11137-1/A1 (2012-05), IDT * ISO 11137-1 DAM 1 (2012-05), IDT * OENORM EN ISO 11137-1/A1 (2012-06-15), IDT
Từ khóa
Acceptance (approval) * Biological hazards * Calibration * Characterisations * Checks * Clearing * Containers * Definitions * Dose * Dosimeters * Dosimetry * Efficiency * Elections * Electron beams * Evaluations * Gamma-radiation * Germicides * Guide books * Health protection * Hygiene * Inspection * Ionizing radiation * Irradiation apparatus * Jets * Maintenance * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Methods * Performance * Personnel * Phototherapy * Plant * Product information * Public health * Qualifications * Quality management * Radiation * Ray treatment * Routine tests * Specification (approval) * Sterilization by irradiation * Sterilization (hygiene) * Surveillance (approval) * Validation * Verification * X-rays * Procedures * Tanks * Release * Processes