GB/T 18281.5-2024 Active National standards

GB/T 18281.5-2024 Sterilization of health care products—Biological indicators—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes

Publish Date: 2024-11-28 Implement Date: 2025-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 18281.5-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2024-11-28

Implement Date: 2025-12-01

Pages: 12 pages

Scope

This document specifies the requirements for test microorganisms, bacterial suspensions, contaminated carriers, biological indicators, and testing methods intended to evaluate the performance of the sterilization process using low-temperature steam formaldehyde as a sterilization agent.
Note 1: The requirements for the validation and routine control of the low-temperature steam formaldehyde sterilization process are described in ISO 14937.
Note 2: Regulations in some countries or regions may specify safety requirements for workplaces.

Development Information

Word Count: 15 Thousand words Pages: 12 pages

Same series standard

GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB/T 18281.3-2024 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB/T 18281.4-2024 Sterilization of health care products—Biological indicators—Part 4:Biological indicators for dry heat sterilization processes GB/T 18281.7-2024 Sterilization of health care products—Biological indicators—Part 7:Guidance for the selection,use and interpretation of results GB/T 18281.8-2024 Sterilization of health care products—Biological indicators—Part 8:Method for validation of a reduced incubation time for a biological indicator

Replace the following standards

GB 18281.5-2015 Sterilization of health care products—Biological indicator—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes

Referenced Standards

ISO 11138-1 GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements

Adopt standards

ISO 11138-5:2017

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