T/CRHA 061-2024 Active Group standards

T/CRHA 061-2024 Requirements for Detection Kits Based on Latex Immunoturbidimetry Technology

T/CRHA 061-2024

Publish Date: 2024-07-05 Implement Date: 2024-07-10 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/CRHA 061-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2024-07-05

Implement Date: 2024-07-10

Scope

Scope: This document specifies the raw materials and the evaluation methods of the raw material performance for kits used in the determination of immunoturbidimetry with latex, the performance requirements of the reagents, the test methods, the identification of the kits, the labels and the instructions for use, the packaging, transportation and storage; Main technical content: The overall structure adopted in this document is as follows: 1. Scope; 2. Normative reference documents; 3. Terms and definitions; 4. Raw materials and evaluation methods of the raw material performance; 5. Performance requirements of the kits; 6. Performance evaluation methods of the kits; 7. Quality assurance; 8. Identification, labels and instructions for use; 9. Packaging, transportation and storage. This document is applicable to kits based on immunoturbidimetry with latex for research and development, production and quantitative detection (hereinafter referred to as kits), including kits used on semi-automatic and fully automatic biochemical analyzers and immunoanalyzers.

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