Standard

Standard name

GB/T 191-2008

packaging-pictorial markings for handling of goods

YY/T 0316-2016

Application of Risk Management to Medical Devices

YY/T 0466.1-2016

Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements

GB 9706.1-2020

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

GB 9706.218-2021

Medical electrical equipment-Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

GB/T 14710—2009

Environmental test requirements and test methods for medical electrical appliances

GB/T 16886.1-2011

Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process

GB/T 16886.5-2017

Biological evaluation of medical devices/Part 5: Tests for in vitro cytotoxicity

GB/T 16886.10-2017

Biological evaluation of medical devices-Part 10: Tests for irritation and delayed hypersensitivity