Specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process and control of routine sterilization. Covers all moist heat processes, including saturated steam and air-steam mixtures, and applies to all industrial manufacturers and all others who perform contract moist heat sterilization. Although moist heat sterilization in non-industrial health care facilities is not specifically covered, the principles outlined may be useful to the user of moist heat sterilization in these facilities.
Số hiệu tiêu chuẩn
ISO 11134
Tên tiêu chuẩn
Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
Ngày phát hành
1994-02-00
Tiêu chuẩn tương đương
ANSI/AAMI/ISO 17665-1 (2005), IDT * ABNT NBR ISO 11134 (2001-01-30), IDT * GB 18278 (2000), IDT * CAN/CSA-ISO 11134-98 (1998-03-01), IDT * GOST R ISO 11134 (2000), IDT
Thay thế cho
ISO/DIS 11134 (1992-04)
Từ khóa
Checks * Health protection * Hygiene * Industrial * Medical sciences * Specification (approval) * Steam sterilization * Steam sterilizers * Sterilization (hygiene) * Superheated steam
ISO 11134
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