T/CAMDI 075-2022 Active Group standards

T/CAMDI 075-2022 The production and quality control requirements for total bilirubin measurement reagent kits

Publish Date: 2022-06-21 Implement Date: 2022-07-01 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/CAMDI 075-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Terminology (principles and coordination and cooperation)

Publish Date: 2022-06-21

Implement Date: 2022-07-01

Scope

Scope: This document specifies the technical requirements for the production and quality control of total bilirubin determination kits. This document applies to the production and quality control of total bilirubin determination kits that are subject to medical device registration management. This document can be used by the product registrants and record-keepers of total bilirubin determination kits for process control activities during production and quality management; Main technical contents: 5.1 Personnel management 5.2 Production facility management 5.3 Production equipment management 5.4 Material management 5.5 Process management 5.6 Quality control requirements