YY/T 0615.1-2007
Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices (English Version)
- Standard No.
- YY/T 0615.1-2007
- Language
- Chinese, Available in English version
- Release Date
- 2007
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 0615.1-2007
- Scope
- This part of YY/T 0615 specifies the requirements for labeling "sterile" terminally sterilized medical devices. Part 2 of YY/T 0615 specifies the requirements for sterile processed medical devices labeled "sterile". Note: Medical devices can be labeled "sterile" only when a confirmed sterilization process is used. GB 18278, GB 18279, GB 18280, GB/T 19974, and ISO 14160 stipulate the confirmation and routine of sterilization of medical devices. control requirements.
YY/T 0615.1-2007 Referenced Document
- YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
YY/T 0615.1-2007 history
- 2007 YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
