YY/T 0640-2016
Non-active surgical implants.General requirements (English Version)

Standard No.

YY/T 0640-2016

Language

Chinese, Available in English version

Release Date

2016

Published By

Professional Standard - Medicine

Latest

YY/T 0640-2016

Replace

YY/T 0640-2008

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, transendodontic root implants, intraocular lenses and implants of viable animal tissue. With regard to safety aspects, this standard specifies requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer, as well as tests to verify compliance with these requirements. Other tests are given in secondary and tertiary standards.

YY/T 0640-2016 Referenced Document

• GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
• GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
• GB/T 19974-2005 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
• GB/T 7408-2005 Data elements and interchange formats-Information interchange-Representation of dates and times
• ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 80000 Quantities and units — Part 9: Physical chemistry and molecular physics — Amendment 1
• YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants
• YY/T 0297-1997 Clinical investigation of medical devices
• YY/T 0316-2008 Medical devices.Application of risk management to medical devices
• YY/T 0567.1-2013 Aseptic processing of health care products.Part 1:General requirements
• YY/T 0771.2-2009 Medical devices utilizing animal tissues and their derivatives.Part 2:Controls on sourcing,collection and handling
• YY/T 0771.3-2009 Medical devices utilizing animal tissues and their derivatftives Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy(TSE) agents
• YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices

YY/T 0640-2016 history

• 2016 YY/T 0640-2016 Non-active surgical implants.General requirements
• 2008 YY/T 0640-2008 Non-active surgical implants-General requirements