YY/T 0567.5-2011
Aseptic processing of health care products.Part 5:Sterilization in place (English Version)

Standard No.

YY/T 0567.5-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

Professional Standard - Medicine

Latest

YY/T 0567.5-2011

Scope

This part of YY/T 0567 specifies the general requirements for sterilization in place (SIP) of product contact surfaces of equipment used to produce sterile healthcare products through aseptic processing, and provides guidance on qualification, validation, operation and control. This section applies to processes where the sterilant is introduced into the internal surfaces of the equipment and comes into contact with the product. This section does not apply to the process in which the equipment is disassembled and sent to the sterilizer. This section does not supersede or replace national regulatory requirements, especially those within national or regional jurisdiction, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements. This section does not specify specific requirements for the development, validation and routine control of pathogen inactivation processes for spongiform encephalopathies such as scrapie, mad cow disease and Creutzfeldt-Jakob disease.

YY/T 0567.5-2011 Referenced Document

• GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General
• GB 18281.2-2000 Sterilization of health care products--Biological indicators--Part 2: Biological indicators for ethylene oxide sterilization
• GB 18281.3-2000 Sterilization of health care products--Biological indicators--Part 3: Biological indicators for moist heat sterilization
• GB 18282.1-2000 Sterilization of health care products--Chemical indicators--Part 1: General requirements
• GB 18282.3-2009 Sterilization of health care products-Chemical indicators-Part3：Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
• GB 18282.4-2009 Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
• GB/T 19003 Software engineering.Guidelines for the application of GB/T 19001-2000 to computer software
• GB/T 19972 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results*， 2018-03-15 Update
• GB/T 19974 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices*， 2018-05-14 Update
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• YY/T 0567.1 Aseptic processing of health care products.Part 1:General requirements*， 2013-10-21 Update
• YY/T 0567.4 Aseptic processing of health care products.Part 4:Clean-in-place technologies

YY/T 0567.5-2011 history

• 2011 YY/T 0567.5-2011 Aseptic processing of health care products.Part 5:Sterilization in place