YY/T 0567.6-2022 Active Industry standards-Medicine

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

Publish Date: 2022-08-17 Implement Date: 2024-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0567.6-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2022-08-17

Implement Date: 2024-03-01

Pages: 28 pages

Scope

This document specifies the requirements for isolator systems used in the aseptic processing of healthcare products, including aspects such as standardization, selection, validation, biological decontamination, confirmation, operation, and control, and provides relevant guidelines.
This document applies to isolator systems used in the aseptic processing of healthcare products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not specify requirements for isolators used in aseptic inspections, but some principles and information contained in this document can also be applied to related applications.
This document does not apply to biosafety protection.

Development Information

Word Count: 52 Thousand words Pages: 28 pages

Replace the following standards

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

Referenced Standards

ISO 11139:2018 ISO 13408-1:2008 ISO 13408-4 ISO 13408-7 ISO 14644-1:2015 ISO 14644-7 ISO 18362 ISO/IEC/IEEE 90003

Adopt standards

ISO 13408-6:2021

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