1. ISO 11137:1995 Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
2. ISO 11137-3:2006 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
3. ISO/TS 11139:2006 Sterilization of health care products — Vocabulary
4. ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
5. ISO 14971 Medical devices — Application of risk management to medical devices