T/CITS 0006-2023 Active Group standards

T/CITS 0006-2023 The general principles of application technology for nucleic acid mass spectrometry in medicine

Publish Date: 2023-03-07 Implement Date: 2023-09-06 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/CITS 0006-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Mass spectrometers, liquid chromatographs, energy spectrometers, and their combined devices

ICS Name: Integrated medical equipment

Publish Date: 2023-03-07

Implement Date: 2023-09-06

Pages: 24 pages

Scope

This document specifies the technical requirements, test methods, detection technical indicators, sample detection requirements, sample detection methods, labeling, packaging, transportation and storage, and quality commitments for the application of medical nucleic acid mass spectrometry technology.

Development Information

Word Count: 45 Thousand words Pages: 24 pages

Referenced Standards

GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.9-2013 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 9:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment GB/T 26810-2011 Visible spectrophotometer GB/T 34797-2017 Quality technical requirements of primers and probes JJF 1527-2015 Calibration Specification for Polymerase Chain Reaction Analyzers JJF 1836-2020 Calibration Specification for Micro-spectrophotometers JJF 1874-2020 Calibration Specification for (Automatic) Nucleic Acid Extractors JTG B01-2003 YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment YY/T 1173-2010 Polymerase chain reaction analyzer YY/T 1740.2-2021 Clinical mass spectrometer—Part 2:Matrix-assisted laser desorption ionization-time of flight mass spectrometer YY/T 1244-2014 Purified water for in vitro diagnostic reagents YY/T 1717-2020 Nucleic acid extraction kit(magnetic beads method)

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