GB 18280.2-2015: Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

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Scope

GB 18280 of the provisions of this part of the setting method and confirmed to meet the special requirements of sterile minimum dose of 25kGy or
15kGy as to achieve the 10-6 sterility assurance level (SAL) of the sterilization dose approach. This section also provides a dose audit approach to
As evidenced by sustained and effective sterilization dose.
This section defines for dose establishment and dose auditing product family.

Basic Data

Standard ID	GB 18280.2-2015 (GB18280.2-2015)
Description (Translated English)	Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	55,582
Date of Issue	2015-12-31
Date of Implementation	2017-07-01
Older Standard (superseded by this standard)	GB 18280-2000
Regulation (derived from)	State Standard Announcement 2015 No.43
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China