1 Scope
This part of YY/T 0615 specifies the requirements for a terminally-sterilized medical device to be designated “STERILE”. Part 2 of YY/T 0615 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
Note: Designation of a medical device as “STERILE” is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in GB 18278, GB 18279, GB 18280, GB/T 19974 and ISO 14160.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0615. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
YY/T 0287-2003 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes (ISO 13485:2003, IDT)
3 Terms and Definitions
For the purposes of this part of YY/T 0615, the following terms and definitions apply:
3.1
Bioburden
Population of viable micro-organisms on a product and/or package.
