GB 18278-2000
Replaced
YY/T 1737-2020
Active
Industry standards-Medicine
YY/T 1737-2020 Analytical method for bioburden control level of medical device
YY/T 1737-2020 Analytical method for bioburden control level of medical device
Basic Information
Standard Code:
YY/T 1737-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2020-09-27
Implement Date:
2021-09-01
Pages:
16 pages
Scope
This standard specifies the analytical methods for controlling the bioburden level of medical devices.
This standard is applicable to the analysis of the bioburden control level of sterile and implantable medical device products.
This standard is not applicable to the analysis of the bioburden test values of products in the validation development phase.
Development Information
Referenced Standards
GB/T 19971-2005 Sterilization of health care products—Vocabulary
GB/T 19971-2015 Sterilization of health care products—Vocabulary
GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products
GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products
YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
GB/T 19971-2026 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced