T/CSBME 003-2018 Active Group standards

T/CSBME 003-2018 The cleanliness requirements for surgical implants and orthopedic implants are general requirements

Publish Date: 2018-12-20 Implement Date: 2019-03-01 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: T/CSBME 003-2018

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2018-12-20

Implement Date: 2019-03-01

Scope

Scope: This standard, based on risk management methods, specifies the requirements for the cleanliness of orthopaedic implants (hereinafter referred to as implants) and the test methods used for process validation and process control of the cleaning process. This standard does not specify requirements for packaging and sterilization, which are governed by other standards. This standard applies to process cleaning and final cleaning. This standard does not apply to liquid and gas implants. This standard does not apply to cleaning processes performed by or under the responsibility of users. Main technical content: This standard, based on risk management methods, specifies the requirements for the cleanliness of orthopaedic implants (hereinafter referred to as implants) and the test methods used for process validation and process control of the cleaning process. The standard also includes general requirements for quality management systems, risk management, cleaning process design, validation, sampling, specimen production, and test methods. Specific provisions are made for implant appearance inspection, bioburden, bacterial endotoxins, organic contamination, inorganic contamination, particulate contamination, and cytotoxicity.