This standard specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process.
Số hiệu tiêu chuẩn
DIN EN ISO 11140-1 Berichtigung 1
Tên tiêu chuẩn
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2005, Corrigenda to DIN EN ISO 11140-1:2006-04
Ngày phát hành
2007-10-00
Từ khóa
Biological hazards * Chemical indicators * Classes * Classification * Classification systems * Disposables * Dry heat * Dryness * Equipment * Ethylene oxide * Formaldehyde * Health protection * Heat * Heat treatment * Indicators * Instructions for use * Ionizing * Ionizing radiation * Letterings * Marking * Marking of roads * Medical devices * Medical products * Medical sciences * Medical technology * Non-biological * Packages * Performance * Performance requirements * Phototherapy * Process * Radiation * Shelf life * Specification * Specification (approval) * Steam sterilization * Steam sterilizers * Sterilization (hygiene) * Sterilizers * Surveillance (approval) * Systems * Testing * Tracer methods * Use * Vapours