Eighteen Industry Standards Issued In One Day

Republished By Plato

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Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions.

Mandatory Standards

YY 0315—2023 Titanium and titanium alloy dental implants
YY 0469-2023 Medical surgical mask
YY 0793.2—2023 Preparation and quality management of liquids for hemodialysis and related treatments Part 2: Water for hemodialysis and related treatments
YY 1042—2023 Dentistry Polymer-based restorative materials

Recommended Standards

YY/T 0003—2023 Manual hospital bed
YY/T 0127.4—2023 Biological evaluation of oral medical devices Part 4: Bone implant test
YY/T 0127.19—2023 Biological evaluation of oral medical devices Part 19: Subacute and subchronic systemic toxicity test: Implantation route
YY/T 0489—2023 Disposable sterile drainage catheters and auxiliary devices
YY/T 0929.3—2023 Medicinal fluid filters for infusion Part 3: Liquid bacterial retention test method for medicinal fluid filters with nominal pore size 0.22 μm
YY/T 0969—2023 Disposable medical masks
YY/T 1842.3—2023 Medical Devices – Connectors for Medical Liquid Storage Container Delivery Systems Part 3: Gastrointestinal Application
YY/T 0951—2015 Interfering electrical therapy equipment
YY/T 0919—2014 Passive surgical implants, joint replacement implants, special requirements for knee replacement implants
YY/T 0966—2014 Surgical implants, metal materials, pure tantalum
YY/T 1426.1—2016 Surgical implants wear of total knee prostheses Part 1: Load and displacement parameters of load-controlled wear testing machines and related test environmental conditions
YY/T 1426.2—2016 Surgical implants Wear of total knee prostheses Part 2: Measurement methods
YY/T 1426.3—2017 Surgical Implants Wear of total knee prostheses Part 3: Load and displacement parameters of displacement-controlled wear testing machines and related test environmental conditions
YY/T 1447—2016 Surgical implants In vitro evaluation of apatite-forming ability of implant materials

Industry mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.

The industry recommended standards are not legally binding but recommended by regulatory authorities.

For English version of any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.