ISO radiation sterilization standards

Radiation Physics and Chemistry

Volumn 52, Issue 1-6, 1998, Pages 11-14

  Lambert, Byron J ^a   Hansen, Joyce M ^b  

^a BOSTON SCIENTIFIC CORPORATION   (United States)

^b Sherwood Medical   (United States)

Author keywords

Dose setting; ISO standards; Materials qualification; Radiation sterilization

Indexed keywords

CONFERENCE PAPER; DISINFECTION; DOSIMETRY; HEALTH CARE; INSTRUMENT STERILIZATION; PRACTICE GUIDELINE; RADIATION STERILIZATION;

EID: 0032101099     PISSN: 0969806X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0969-806X(98)00025-5     Document Type: Conference Paper

References (5)

1. ISO 11137:1994, "Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization."
2. ISO TR 13409-1996, "Sterilization of health care products - Radiation sterilization -Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches."
3. ISO Draft TR, "Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch."
4. ISO Draft TR, "Sterilization of health care products - Radiation sterilization - Product Families, Plans for Sampling and Frequency of Dose Audits."
5. AAMI Draft TIR, "Radiation Sterilization Material Qualification," 3330 Washington Blvd, Arlington, VA, 22201-4598, USA.