YY/T 0567.1-2013
Aseptic processing of health care products.Part 1:General requirements (English Version)

Standard No.

YY/T 0567.1-2013

Language

Chinese, Available in English version

Release Date

2013

Published By

Professional Standard - Medicine

Latest

YY/T 0567.1-2013

Replace

YY/T 0567.1-2005

Scope

This part of YY/T 0567 specifies the general requirements and guidance on the processes, procedures and execution steps for the development, validation and routine control of the manufacturing process of sterile processed healthcare products. This section covers general requirements and guidance regarding aseptic processing as a whole. Other parts specify specific requirements and guidelines for various dedicated/specialized processes and methods for filtration, lyophilization, online cleaning, online sterilization and isolation systems.

YY/T 0567.1-2013 Referenced Document

• GB/T 19001-2008 Quality management systems.Requirements
• GB/T 25915.1-2010 Cleanrooms and associated controlled environments.Part 1:Classification of air cleanliness
• GB/T 25915.2-2010 Cleanrooms and associated controlled environments.Part 2: Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1
• GB/T 25915.3-2010 Cleanrooms and associated controlled environments.Part 3: Test methods
• GB/T 25915.4-2010 Cleanrooms and associated controlled environments.Part 4:Design,construction and start-up
• GB/T 25915.5-2010 Cleanrooms and associated controlled environments.Part 5:Operations
• ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 13408-6 Aseptic processing of health care products — Part 6: Isolator systems*， 2021-04-13 Update
• ISO 14160 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen*， 2020-09-21 Update
• YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
• YY/T 0567.2-2005 Aseptic processing of health care products - Part 2: filtration
• YY/T 0567.3-2011 Aseptic processing of health care products.Part 3:Lyophilization
• YY/T 0567.4-2011 Aseptic processing of health care products.Part 4:Clean-in-place technologies
• YY/T 0567.5-2011 Aseptic processing of health care products.Part 5:Sterilization in place

YY/T 0567.1-2013 history

• 2013 YY/T 0567.1-2013 Aseptic processing of health care products.Part 1:General requirements
• 2005 YY/T 0567.1-2005 Aseptic processing of health care products - Part 1: General requirements