YY/T 0567.3-2011 Active Industry standards-Medicine

YY/T 0567.3-2011 Aseptic processing of health care products—Part 3:Lyophilization

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 0567.3-2011

Standard Type: Industry standards

Standard Status: Active

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: 12 pages

Scope

This part of YY/T 0567 specifies the dedicated requirements and guidelines for equipment, processes, protocols, and procedures used for freeze-drying as a means of controlling and validating aseptic processing. This part does not discuss the physical/chemical objectives of the freeze-drying process.

Development Information

Word Count: 20 Thousand words Pages: 12 pages

Same series standard

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

Referenced Standards

GB/T 19001-2000 Quality management systems—Requirements GB/T 19001-2008 Quality management systems—Requirements GB/T 19001-2016 Quality management systems—Requirements YY/T 0567.1-2005 Aseptic processing of health care products—Part 1:General requirements YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements 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 13408-3:2006

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