YY/T 0640-2016 Active Industry standards-Medicine

YY/T 0640-2016 Non-active surgical implants—General requirements

Publish Date: 2016-07-29 Implement Date: 2017-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0640-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2016-07-29

Implement Date: 2017-06-01

Pages: 15 pages

Scope

This standard specifies the general requirements for passive surgical implants (hereinafter referred to as implants). This standard does not apply to dental implants, dental restorative materials, endodontic implants, intraocular lenses, and implants of viable animal tissues.
Regarding safety, this standard specifies the requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information, as well as the tests to verify compliance with these requirements.
Other tests are provided in secondary and tertiary standards.
Note: This standard does not require a quality management system for implant manufacturers, but if manufacturers have a quality management system in accordance with ISO 13485, it will greatly assist in ensuring the achievement of the expected performance of implants.

Development Information

Word Count: 26 Thousand words Pages: 15 pages

Replace the following standards

YY/T 0640-2008 Non-active surgical implants—General requirements

Referenced Standards

ISO 8601 ISO 10993-1 ISO 10993-7 ISO 11135-1 ISO 11137-1 ISO 11137-2 ISO 11607-1 ISO 13408-1 ISO 14155 ISO 14160 ISO 14937 ISO 14971 ISO 17664 ISO 17665-1 ISO 22442-1 ISO 22442-2 ISO 22442-3 ISO 80000(所有部分)