GB/T 31995-2015

Active

Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose method VDmax

医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法

Standard Type
GBT
ICS
27.120.99
CCS
F54
Status
Active
Issue Date
2015-09-11
Implementation
2016-04-01
Centralized Committee
国家标准委
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the VDmax method for substantiating a selected sterilization dose for health care products sterilized by radiation. It is applied by medical device manufacturers and sterilization facilities to validate that a radiation dose of 25 kGy or 15 kGy is sufficient to achieve a sterility assurance level (SAL) of 10⁻⁶, based on bioburden testing. The standard is used specifically for products with low bioburden levels and is critical for ensuring the safety of single-use medical devices, surgical instruments, and other sterile health care items.

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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.