YY/T 1276-2016Requirements for the development, validation and routine control of dry heat sterilization process for medical devices (English PDF)

1.1 Applicable

1.1.1

This standard specifies the development, validation and routine control requirements of medical devices during dry heat sterilization.

Note. This standard applies to medical devices, but these requirements and the guidelines provided also apply to other health care products.

1.1.2

This standard deals primarily with dry heat sterilization and also provides for the requirement of pyrogenic processes for the use of dry heat for sterilization and provides guide.

Note. Dry heat is usually used for pyrolysis of equipment parts and health care products. The process parameters for sterilization and pyrogenization are time and temperature. Because to the hot conditions

Usually than the sterilization required by the strict conditions, so do not need other confirmation conditions, the product to the pyrogen to confirm the process can guarantee

Products are sterile.

1.2 Not applicable

1.2.1

This standard does not provide for the inactivation of such as scrapie, bovine spongiform encephalopathy, gram - ya and other spongiform encephalopathic pathogens of the sterilization process

Development, confirmation, routine control requirements.

Note. see YY/T 0771.1-2009, YY/T 0771.2-2009, ISO 22442-3.

1.2.2

This standard does not apply to infrared or microwave sterilization.

1.2.3

This standard does not specify the medical device identified as "sterile", see EN556-1.

Note. Pay attention to the requirements of the country or place identified as "sterile" medical devices.

1.2.4

This standard does not specify the quality control system of all production stages of medical device products.

Note. This standard does not need to establish a complete quality management system in the manufacturing process, but the quality management system at least to control the sterilization process with reference to the standard

The applicable clause (see Chapter 4). Should take into account the quality management system standards (see YY/T 0287-2003) in the medical device including the sterilization process

Production of the whole process of production. Certain regions and countries in the provisions of medical devices, requiring the implementation of a complete quality management system, and by the third party review

Nuclear system.

1.2.5

This standard does not specify the occupational safety requirements associated with the design and operation of dry heat sterilization and de-thermal equipment.

Note. The requirements for operational safety are specified in IEC 61010-2-040..2005.