YY/T 0467-2016 in English

VALID

Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Issued on:2016-01-26
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $310.00
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Standard No:	YY/T 0467-2016
Document status:	VALID
Title in English:	Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
Title in Chinese:	医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2016-01-26
Implemented on:	2017-01-01
Superseding:	YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
ICS Classification:	11.040.01-Medical equipment in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	standard type coverage typical standards basic standards general safety requirements animal-derived medical device standards performance standards basic standards key standards
Related Topics:	Principles of Medical Devices yy/t0467-2016 Guidelines for the Selection of Standards to Ensure the Recognized Fundamental Principles of Safety and Performance of Medical Devices yy/t 0467-2016 Sales of medical devices Collagen Medical Grade Medical equipment incubator Zhiben Medical Medical warmer Medical equipment incubator yy/t+0467 medical safety box baseline medical care Shi Yigong, medical yy t0467-2003 Principles of Medical Devices Are Class II Medical Devices Safe? baseline medical care Types of medical devices yy/t0467 Non-medical devices use those descriptions General Medical Devices Medical device raw material selection Medical device noise standard requirements Medical device cybersecurity capabilities Suture strength test standard medical equipment Medical term recognition Which medical device noise is applicable? Moisturizing test of medical device products What are the standards for transcranial medical devices? Medical device packaging design Standards and regulations for heavy metal content in medical devices Fluorescence standard requirements for medical devices Medical device standard sample Medical device standard upgrade evaluation Class II medical device selection

本标准规定了评定医疗器械安全和性能的公认基本原则，提供了有关重要标准和指南。
本标准适用于医疗器械安全和性能的符合性评定。
本标准代替YY/T 0467-2003医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南。

Introduction

Analysis of the core content of the standard

This standard replaces YY/T 0467-2003, is equivalent to the ISO/TR 16142:2006 international standard, and constructs a three-tier architecture system for medical device safety and performance standards:

Standard type	Coverage	Typical standards
Basic standards	General safety requirements and quality management	ISO 13485/YY/T 0287, ISO 14971
Class standards	Specific product family requirements	IEC 6001-1:2003 60601 Series (Medical Electrical Equipment)
Product Standards	Single Product Technical Requirements	GB 9706 Series

Key Technical Requirements

The standard emphasizes the six core principles that medical devices must meet:

Clinical safety (corresponding to ISO 14971 risk management)
The latest safety design principles (reference ISO 13485 quality management)
Achievement of expected performance (needs to comply with ISO 14155 clinical evaluation)
Life cycle stability (reference ISO 11737 sterilization control)
Storage and transportation adaptability (related to ISO 11607 packaging standard)
Risk-benefit balance (based on YY/T 0316 Risk Assessment)

Application Case: Sterile Medical Devices

For sterilized packaging instruments, the standard combination is recommended:

Basic standard: ISO 13485 Quality Management System
Class standard: ISO 11135 Ethylene Oxide Sterilization
Product standard: GB 19633 Terminal Sterilization Packaging

Key Points for Standard Implementation

Manufacturers should pay attention to:

Allow standards to be used in combination (Clause 4.3)
Be cautious when citing basic standards (Special Tips for Clause 4.4)
Appendix A provides a principle-standard correspondence table (including 82 key standards)

Version Update Highlights

Main enhancements compared to the 2003 version:

Newly added animal-derived medical device standards (YY/T 0771 series)
Expanded basic standard definitions (Clause 4.1)
Introduction to standard recognition mechanism (Clause 4.2)

More samples: YD/T 3934-2021 DL/T 5154-2012 JGJ 94-2008

Sample only — not a preview of YY/T 0467-2016

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