T/CAMDI 138-2025 Active Group standards

T/CAMDI 138-2025 Guidelines for Microbial and Particle Control and Monitoring of the Production Environment for Fully Disinfested Medical Products

Publish Date: 2025-01-02 Implement Date: 2025-01-08 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/CAMDI 138-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2025-01-02

Implement Date: 2025-01-08

Scope

Main technical content: This document provides guidelines for microbial and particle control and monitoring in the final sterilization of medical products. In accordance with the current applicable quality system regulations: During the production of medical devices, it is necessary to establish an appropriate environment and maintain and monitor the environment. This document is applicable to the monitoring of microorganisms and particles in the following media: air (microorganisms and particles), object surfaces (microorganisms), process water (microorganisms), and process gas (microorganisms and particles). This document is not applicable to product monitoring, differential pressure, temperature, humidity, and the control and monitoring of chemical indicators in process water and process gas.

Development Information

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24