GB 18280.1-2015: Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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Scope

1.1 GB 18280 of the provisions of this part of the development of medical devices in the radiation sterilization process, validation and routine control.
Note. This section applies to medical devices, but these requirements and guidelines can be used to provide other products and equipment.
This section applies to the use of the following sources of radiation irradiation apparatus.
a) use of radionuclides cobalt-60 or cesium-137;
b) electron beam emitted from an electron accelerator;
c) X-rays emitted by the X-ray generator.
The provisions of section 1.2 are not used to inactivate such as scrapie, bovine spongiform encephalopathy, g - Jakob disease and other spongiform encephalopathies open pathogens sterilization process
Hair, confirmed that the conventional control. For processing by such pathogens potentially contaminated material in a particular country, there are detailed provisions introduced.
Example. ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.1 This section does not specify detailed in sterile medical equipment requirements.
Note. Please specify the attention of medical equipment sterile regional and national requirements, such as. EN556-1 or ANSI/AAMIST67.
1.2.2 This section does not provide for medical device production process control of the quality management system.
Note. This section does not need to establish a complete quality management system during manufacture, but the elements of a quality management system to control the sterilization process at least with reference to Part
Sub-terms (see Chapter 4) applies. Taking into account the quality management system standards (see YY/T 0287) including a sterilization process for medical devices production
The whole process of application. Some regional and national regulations on medical devices, it is required to implement a complete quality management system by the third-party audit
system.
1.2.3 This section does not require the use of biological indicators in identifying and monitoring radiation sterilization, and does not require the use of a sterile examination Pharmacopoeia
The release of product.
1.2.4 This section does not specify the irradiation plant design, operations related to occupational safety requirements.
Note. Some countries should take into account the radiation-related occupational safety regulations.
1.2.5 The provisions of this section does not already used the sterilized and re-processed medical devices requirements.

Basic Data

Standard ID	GB 18280.1-2015 (GB18280.1-2015)
Description (Translated English)	Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	31,330
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