YY/T 1512-2017 in English

VALID

Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

Issued on:2017-07-17
Implemented on:2018-07-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $140.00
$136.00

Standard No:	YY/T 1512-2017
Document status:	VALID
Title in English:	Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
Title in Chinese:	医疗器械生物学评价风险管理过程中生物学评价的实施指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2017-07-17
Implemented on:	2018-07-01
ICS Classification:	11.040.01-Medical equipment in general
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	biological evaluation risk management process introduction analysis biological evaluation plan risk management system risk management integration
Related Topics:	biology medical molecular biology Medical Device Biology Medical Device Biology biological evaluation biological evaluation Biology Triathlon Chemical Evaluation of Medical Devices university evaluation Evaluate Physics Biological Evaluation Program The Next 10 Years of Biomedical Engineering Biomedical Frontiers Biocenter Guide biomedical engineering Biological Evaluation of Medical Devices Biological Evaluation of Medical Devices biomedical talent Biology Triple Evaluation Medical Device Evaluation systems biomedicine contemporary biology biological evaluation Bioprocess instrument biological evaluation Bioresource Evaluator biological standard Medical Device Evaluation Biocompatibility Evaluation molecular biology medicine Biocompatibility Evaluation biocentre via iso Toxicity Risk Assessment Instruments in Biochemistry Biomedical Engineering Abroad Biomedicine and Biomedical Engineering Frontiers in Biomedical Engineering Process monitoring and evaluation biomedical medicine Biological evaluation of metals Biomedical Summit Fund Lighting evaluation index for experimental animals Zou MingCentral South UniversityBiotechnology Biomedical Engineering Changjiang Scholars Chemical biological toxicity evaluation Biosensor evaluation Air microbiology assessment Toxicological evaluation of medical devices Texture evaluation

本标准规定了依据ISO10993-1的要求，实施医疗器械的生物学评价的要求。
本标准适用于包括有源、无源、植入和非植入医疗器械在内的各种类型医疗器械的所有生物学评价。

Introduction

Analysis of the core content of the standard

Comparison dimensions	ISO/TR 15499:2016	YY/T 1512-2017
Reference standard system	ISO 10993 series	GB/T 16886 seriesEquivalent conversion
Risk management framework	ISO 14971:2007	YY/T 0316-2016Latest version
Material characterization requirements	Basic Chemical Analysis	Addition of Physical Morphology Characterization (GB/T 16886.19)

Key Technical Points

1. Risk Management Integration of Biological Evaluation

The standard explicitly incorporates biological evaluation into the risk management system of the medical device life cycle and requires the establishment of a biological evaluation plan that includes the following elements:

Information collection strategy (literature/supplier data/internal information)

Multidisciplinary team review mechanism

Step-by-step evaluation process based on GB/T 16886.1

Residual Risk Communication Scheme

2. Material Characterization Technology Upgrade

Phase Key Actions Standard Basis

Design Input Establish Material Biosafety Acceptance Criteria Chapter 4.2

Risk Analysis Conduct Chemical Characterization + Toxicology Dossier Review Article 5.1.2

Production Changes Re-evaluate the impact of changes in processing parameters Article 6.5.1

Laboratory Capacity Building

The standard requires that biological tests should be conducted under a system that complies with CNAS-CL01 (equivalent to ISO/IEC 17025), with particular attention to:

Determination of Leachable Matter Limits (GB/T 16886.17)

Analysis of Degradation Products (GB/T 16886.13-15)

Simulation of Physiological Conditions in In Vitro Tests (Article 6.2.2)

Standard Evolution Trend

This standard adopts ISO technical reports through modification to reflect the characteristics of China's medical device supervision:

Strengthening the integration of quality management systems (citing YY/T 0287-2017)

Adding evaluation requirements for emerging technologies such as nanomaterials

Refining the connection method between chemical characterization and toxicology data

More samples: DL/T 368-2010 NB/T 47013.2-2015 QC/T 942-2021

Sample only — not a preview of YY/T 1512-2017

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Phase	Key Actions	Standard Basis
Design Input	Establish Material Biosafety Acceptance Criteria	Chapter 4.2
Risk Analysis	Conduct Chemical Characterization + Toxicology Dossier Review	Article 5.1.2
Production Changes	Re-evaluate the impact of changes in processing parameters	Article 6.5.1