YY/T 0802-2010
Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices (English Version)
- Standard No.
- YY/T 0802-2010
- Language
- Chinese, Available in English version
- Release Date
- 2010
- Published By
- Professional Standard - Medicine
- Status
- 2021-12
- Replace By
- YY/T 0802-2020
- Latest
- YY/T 0802-2020
- Scope
- This standard specifies the information that medical device manufacturers should provide regarding the reprocessing of resterilable medical devices and medical devices intended to be sterilized by handlers. This standard specifies the requirements for handling information provided by manufacturers to ensure that medical devices are handled safely and continue to meet their performance requirements. This standard specifies requirements for all or some of the following processes: ——site preparation after use; ——preparation, cleaning, disinfection; ——drying; ——inspection, maintenance and testing; ——packaging; ——sterilization; ——storage. If instructions for use of the above procedures are provided, medical device manufacturers should consider providing relevant procedural training, instructions, and useful instructions for handling devices. Certain processing procedures may be common, common, and recognized standards requiring the use of equipment and consumables, in which case the instructions for use should include all requirements. When there is no need to come with an instruction manual, information can be communicated through methods, such as providing a separate user manual, symbols or wall charts, etc. This standard does not apply to textiles such as patient drapes or surgical gowns. Note: The principles of this standard can also be applied to the processing information that should be provided for medical devices that only require disinfection.
YY/T 0802-2010 history
- 2020 YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers
- 2010 YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
