YY/T 0567.6-2011 Replaced Industry standards-Medicine

YY/T 0567.6-2011 Aseptic processing of health care products—Part 6:Isolator systems

Publish Date: 2011-12-31 Implement Date: 2013-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0567.6-2011

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2011-12-31

Implement Date: 2013-06-01

Pages: 16 pages

Scope

This part of YY/T 0567 specifies the requirements for isolator systems used in aseptic processing, and provides guidance on the identification, disinfection, validation, operation, and control of isolator systems used in the aseptic processing of medical products.
This part focuses on the use of isolator systems to maintain aseptic conditions and may include the application of hazardous raw materials.
This part does not replace or substitute for national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or simplified requirements that belong to national or regional jurisdictions.

Development Information

Word Count: 28 Thousand words Pages: 16 pages

Same series standard

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

Superseded by the following standards

YY/T 0567.6-2022 Aseptic processing of health care products—Part 6:Isolator systems

Referenced Standards

YY/T 0567.1-2005 Aseptic processing of health care products—Part 1:General requirements ISO 14644-7:2004 GB/T 19003-2008 Software engineering—Guidelines for the application of GB/T 19001—2000 to computer software 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

Adopt standards

ISO 13408-6:2005

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05