YY/T 1454-2016 in English

VALID

General requirements for in vitro diagnostic medical devices for self-testing

Issued on:2016-01-26
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $100.00
$97.00

Standard No:	YY/T 1454-2016
Document status:	VALID
Title in English:	General requirements for in vitro diagnostic medical devices for self-testing
Title in Chinese:	自我检测用体外诊断医疗器械基本要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-01-26
Implemented on:	2017-01-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	vitro diagnostic medical devices diagnostic medical devices self-testing scopethis standard medical characteristics self-testing
Related Topics:	help me another peak in vitro testing genetic testing medical gene self-suppression Medical Device Rhythm Requirements poc in vitro diagnostics General requirements for performance evaluation of in vitro diagnostic medical devices my genes Self-media detection Analytical Testing In Vitro Diagnostic medical consultation box Diagnostic Reagents Medical Devices Exosome diagnosis I check IVD Network Molecular Diagnostic Tests Microbiological detection in vitro diagnostics Diagnostic reagents for medical devices Classification of in vitro diagnostics IVD Network In Vitro Diagnostic Reagents Medical Devices Medical Devices and In Vitro Diagnostic Reagents i made it by myself I side it In vitro diagnostic medical services In vitro diagnostic consumables Medical Devices and In Vitro Diagnostic Reagents Medical diagnostic instrument Basic requirements for in vitro diagnostic medical devices for self-testing Drinking Water Self-Test automated diagnosis infinite self In Vitro Diagnostic Medical Devices sell yourself In Vitro Medical Testing medical diagnosis system Medical Device Testing Requirements Overseas medical testing In vitro diagnostics for medical devices Class III medical device in vitro diagnostic reagents IVD time diagnostic medical Is the outer box required for medical devices? In Vitro Diagnostic Sensors Class III in vitro diagnostic reagents for medical devices mechanical self-activation Foreign medical instrument testing IVD time Diagnostic Reagents Medical Devices Nucleic acid detection in vitro diagnostics Class III medical device in vitro diagnostic reagents In vitro diagnostic reagents and medical devices US IVD in vitro diagnostic pcr In vitro testing industry in vitro diagnostics Global In Vitro Diagnostics In vitro diagnostic exosomes in China Rapid Diagnostic Reagents Medical Devices abs in vitro diagnostics Predictive in vitro diagnostic methods In vitro testing of medical devices IVD Repair Chlamydia self-test Medical device noise standard requirements Veterinary diagnostic and treatment equipment Heavy metal detection of Class I medical devices Medical device environmental residue testing Fluorescence standard requirements for medical devices Medical device testing UV absorbance Medical device infrared spectrum testing Medical device eye fluid testing my country’s refined oil testing

本标准规定了自我检测用体外诊断医疗器械的基本要求，以满足自测用体外诊断医疗器械的安全性以及制造商预期的用途。
本标准不适用于自测用体外诊断医疗器械的医学特性。

Scope

This standard specifies the design principles of in vitro diagnostic medical devices for self-testing (hereinafter referred to as self-testing), marking and information provided by the manufacturer, performance evaluation, user verification, etc. This standard applies to in vitro diagnostic medical devices for self-testing. This standard does not apply to the medical characteristics of in vitro diagnostic medical devices for self-testing.

More samples: GB 50021-2001(2009) DL/T 368-2010 DL/T 5154-2012

Sample only — not a preview of YY/T 1454-2016

Loading PDF document...

Error loading PDF. Please make sure the file is valid and try again.

We also recommend

YY/T 1441-2016 in English

General requirements of performance evaluation of in vitro diagnostic medical devices
2016-01-26
YY/T 1789.1-2021 in English

In vitro diagnostic test systems-Performance evaluation method-Part 1:Precision
2021-09-06

YY/T 1454-2016 in English

General requirements for in vitro diagnostic medical devices for self-testing

We also recommend

YY/T 1441-2016 in English

YY/T 1789.1-2021 in English