1. Council Directive 93/42/EEC of June 14, 1993 concerning medical devices. OJ No. L169/1 of 1993-07-12.
2. EN ISO 14971:2000. Medical devices—application of risk management to medical devices, European Committee for Standardization, Brussels, 03/12/2000.
3. Clinical investigation of medical devices for human subjects. Part 1: General requirements (EN ISO 14155-1:2003) and Part 2: Clinical investigation plans (EN ISO 14155-2:2003). European Committee for Standardization.
4. A revised guideline for medical device clinical investigations: ISO 14155 part 1 and 2:2003;Giroud;Qual Azur J,2003
5. ISO 11138:2006. Sterilization of Health Care Products—Biological Indicators. International Organization for Standardization.