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YY/T 1912-2023Biological evaluation and testing of medical devices for soft tissue regeneration (English PDF)

用于软组织再生医疗器械的生物学评价与试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 5, 2023

Implementation date

September 15, 2024

Scope

YY/T 1912-2023 is the English-translated version of 用于软组织再生医疗器械的生物学评价与试验.

YY/T 1912-2023 is the Chinese standard "Biological evaluation and testing of medical devices for soft tissue regeneration". Its scope clause reads: This document describes biological evaluation and testing methods for soft tissue regenerative medical devices.

This document is applicable to the biological evaluation of soft tissue regeneration medical devices based on GB/T (Z) 16886. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY/T 1912-2023

National Standard of the People's Republic of China

ICS: 11.040.01
Classification: C30

Issued by: National Medical Products Administration

Foreword
Introduction
1 Scope
2 Normative reference documents
3 Terms and definitions

1 Scope

This document describes biological evaluation and testing methods for soft tissue regenerative medical devices.

This document is applicable to the biological evaluation of soft tissue regeneration medical devices based on GB/T (Z) 16886.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process

3 Terms and definitions

The terms and definitions defined in GB/T 16886.1 and the following apply to this document.

3.1 soft tissue

Relative to hard tissues such as bones, tissue that connects, supports, or surrounds other structures and organs of the body.

Note. Soft tissues include tendons, ligaments, fascia, skin, fibrous tissue, fat, and sarcolemma (i.e., connective tissue) as well as muscles, nerves, and blood vessels (not connective tissue).

Weaving) etc.

[Source. ASTMF3515-21,3.1.5, modified]

3.2 regeneration

The replacement, restoration or growth of new functional tissue for tissue failure due to aging or disease, or due to injury or congenital defects.

Loss of tissue caused by collapse.

3.3 tissue

Through their migration, differentiation and proliferation, cells deposit extracellular matrix with normal structure, function and appearance to replace the healing of damaged tissue.

combination process.

[Source.ASTMF3163-22,3.3.7]

3.4 scaffoldscaffold

Biomaterial structures used as matrices and guides for tissue repair and regeneration.

3.5

A cell-free scaffold formed by removing cells from the extracellular matrix through biological, chemical and/or physical treatment.

[Source. ASTMF3163-22, 3.5.18, modified] […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Similar standards

YY/T 1943|YY/T 1942|YY/T 1897|YY/T 1909|YY/T 1907

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