ISO 11137, requirements for radiation sterilisation: current revisions.
The major changes that are expected in a revised standard on radiation sterilisation are discussed. Manufacturers should anticipate some challenges in meeting the proposed requirements.
Harries
John
J
Isotron plc, Kembrey Park, Swindon, UK. john.harries@isotron.com
D004866:Equipment Contamination / Q000517:prevention & control*; D004869:Equipment Safety / Q000295:instrumentation / Q000379:methods; D004864:Equipment and Supplies / Q000382:microbiology* / Q000592:standards*; D007391:International Cooperation; D011785:Quality Assurance, Health Care / Q000379:methods / Q000592:standards; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D011874:Radiometry / Q000379:methods / Q000592:standards; D012015:Reference Standards; D013242:Sterilization / Q000295:instrumentation / Q000379:methods* / Q000592:standards*