GB 18278.1-2015: Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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Scope

GB 18278 of the provisions of this part of the development of medical devices moist heat sterilization, validation and routine control.
Note. Although the scope of this section is limited to medical devices, but require it to provide provisions and guidelines applicable to other health-related products.
This section contains the following heat sterilization process, but not limited to.
a) saturated steam - Gravity exhaust system;
b) saturated steam - powered exhaust system;
c) air-vapor gas mixture;
d) water spray;
e) water immersion.
Note. See Appendix E.
This section does not provide for the development of spongiform encephalopathy (disease such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease) pathogen inactivation process, recognition and often
Regulatory control. For dealing with potential contamination by these pathogens in the material, some countries have developed special specifications.
Note. See YY/T 0771.1, YY/T 0771.2, ISO 22442-3.
This section does not apply to moist heat sterilization and other agents (such as. formaldehyde) sterilization sterilization process as a combination of factors.
This section does not indicate specific requirements detailed in "sterile" medical instruments.
Note. It should be noted that different countries and regions for the labeling of medical devices "sterile" have different requirements, for example, YY/T 0615.1 or ANSI/AAMIST67.
This section does not provide for control of all stages of production of medical devices quality management system.
Note. This section is not required for the manufacture of a complete quality management system requirements, it is only the minimum requirements for the control of the sterilization process required for quality management
The basic elements of the system, these elements normative references in the text to the appropriate location (see especially Chapter 4) as. We should focus on controlling medical equipment production
All stages (including the sterilization process including) quality management systems (see ISO 13485). Some countries may require medical devices
By the implementation of a complete quality management system, and evaluated by third parties.
This section does not specify the moist heat sterilization facility design and operation of related occupational safety requirements.
Note. The requirements for the safe operation of the provisions of GB 4793.4.Moreover, some countries also have safety regulations.

Basic Data

Standard ID	GB 18278.1-2015 (GB18278.1-2015)
Description (Translated English)	Sterilization of health care products -- Moist heat -- Part 1: Requirements for the 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	39,364
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Older Standard (superseded by this standard)	GB 18278-2000; GB/T 20376-2006
Quoted Standard	ISO 11138-1; ISO 11138-3; ISO 11140-1; ISO 11140-3; ISO 11140-4; ISO 11140-5; ISO 10012; ISO 11607-1; ISO 11607-2; ISO 11737-1; ISO 11737-2; ISO 13485-2003; ISO 17664
Adopted Standard	ISO 17665-1-2006, IDT
Regulation (derived from)	National Standard Announcement 2015 No.38
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
Summary	This standard specifies requirements for the development, validation and routine control of hygienic sterilization of medical devices. B) saturated steam-powered exhaust systems; c) air-vapor mixed gases; d) water sprays; e) water; e) water vaporization; e) water vaporization; immersion. This International Standard does not specify requirements for the development, validation and routine control of pathogen inactivation of spongiform encephalopathies (eg, itch, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease). Some countries have developed specific specifications for the treatment of materials potentially contaminated with these pathogens. This standard does not apply to the sterilization process that uses a combination of moist heat and other sterilizing agents (eg formaldehyde) as a sterilization factor. This standard does not specify the specific requirements for labeling "sterile" medical devices. This standard is not regulated