GB 18279-2023Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices (English PDF)

1.1 of this Edition);

- Added some terms (see 3.10, 3.38, 3.43, 3.57 of this Edition);

- Deleted some terms (see 3.19 of GB 18279.1-2015 and 3.1 of GB/T 18279.2-2015);

- Modified the requirements for the quality management system (see 4.1, 4.2, 4.3 of

this Edition; 4.1, 4.2, 4.3 of GB 18279.1-2015);

- Modified the requirements for sterilizing agent (see 5.1, 5.2, 5.5 of this Edition;

5.1, 5.4 of GB 18279.1-2015);

- Added an overview of process and equipment characteristics (see 6.1 of this

Edition);

- Modified the requirements for process characteristics (see 6.2 of this Edition; 6.1

of GB 18279.1-2015);

- Added the purpose and content of product definition (see 7.1.1, 7.1.5 of this

Edition);

- Deleted the requirements for the most difficult to sterilize location (see 7.1.3 of GB

18279.1-2015);

- Added the purpose of process definition (see 8.1 of this Edition);

- Added general rules for confirmation (see 9.1 of this Edition);

- Added the requirements for installation qualification (see 9.2.1.3, 9.2.2.3, 9.2.2.4,

9.2.2.6 of this Edition);

- Added performance qualification requirements (see 9.4.1.1, 9.4.1.5, 9.4.1.6 of this

Edition);

- Changed the requirements for performance qualification (see 9.4.1.8 of this Edition;

9.3 of GB 18279.1-2015);

- Added requirements for microbial performance qualification (see 9.4.2.5, 9.4.2.6,

9.4.3.2 of this Edition);

- Added parameters that shall be specified in the validation report (see 9.5.4 of this

Edition);

- Added the objectives and requirements of routine monitoring (see 10.1, 10.2, 10.3

of this Edition);

- Changed the requirements for product release (see 11.2, 11.3, 11.4 of this Edition;

Chapter 11 of GB 18279.1-2015);

- Changed the requalification requirements (see 12.3.1, 12.3.3 of this Edition; 12.3

of GB 18279.1-2015);

- Added requirements for change assessment (see 12.4.2, 12.4.6 of this Edition);

- Added the content of equivalence evaluation (see 12.5 of this Edition);

- Deleted the description of the procedures and calculation methods for the biological

indicator/bioburden method (see A.2 and A.3 of GB 18279.1-2015);

- Changed the procedure of the overkill approach (see B.2 of this Edition; B.2 of GB

18279.1-2015);

- Changed the number of sensors and biological indicators (see Table C.1 and Table

C.3 of this Edition; Table C.1 and Table C.3 of GB 18279.1-2015);

- Added content related to single batch release (see Annex E of this Edition).

The modification of this document adopted ISO 11135.2014 "Sterilization of health-

care products - Ethylene oxide - Requirements for the development, validation and

routine control of a sterilization process for medical devices".

The technical differences between this document and ISO 11135.2014 and their reasons

are as follows.

- Changed the description of the requirements for health care facility in the scope

(see 1.1) to avoid conflicts between the mandatory requirements of the standard

and the requirements of the regulations;

- Deleted the term "medical device" (see 3.21 of ISO 11135.2014) to avoid conflict

with Chinese regulations;

- Changed the terminology of "spore-log-reduction" (see 3.41 of this Edition) to

make it easier to understand;

- Deleted the exception for analytical (if used) process variable control (see 6.2.5 of

ISO 11135.2014) to standardize the process control requirements;

- Deleted the specification of the method for proving that the bioburden resistance is

less than the resistance of the biological indicator in the overkill approach (see

B.1.4 of ISO 11135.2014) to avoid limiting the application of the standard;

- Changed the references to other international standards in 4.1.2, 4.3.1, 4.3.2, 4.3.3,

4.4, 7.3.2, 8.9, 11.3, 11.4, and E.1 to notes to suit China's national conditions.

The following editorial changes were made to this document.

- The amendments to ISO 11135.2014/Amd.1.2018 were incorporated. The outer

- Deleted the note in 1.2.2 to adapt to China's national conditions;

- Used YY/T 0287-2017 to replace ISO 13485.2016 to adapt to China's national

conditions;

- Moved the note referring to Annex E in 11.4 into the main text to be consistent with

the normative Annex E;

- Simplified the description of A.2 to make the standard terms clearer;

- Added management standards for health care institutions for reference in applicable

guidelines (see note to D.4.2.2).

- Added two notes in D.5.5.1 to better describe the combustion and explosion of

ethylene oxide;

- Changed the interpretation of D.12.5 to refer to YY/T 1268 to make the standard

content easier to understand.

Attention is drawn to the possibility that some of the elements of this document may be

the subject of patent rights. The issuing authority shall not be held responsible for

identifying any or all such patent rights.

This document was proposed by and shall be under the jurisdiction of State

Administration for Market Regulation.

Versions of standard substituted by this document are.

- It was first published in 2000 as GB 18279-2000;

- It was first revised in 2015 as GB 18279.1-2015 and GB/T 18279.2-2015;

This is the second revision.