YY/T 1775.1-2021Biological evaluation of absorbable medical devices - Part 1: Guidance for absorbable implants (English PDF)
可吸收医疗器械生物学评价 第1部分：可吸收植入物指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1775.1-2021 is the English-translated version of 可吸收医疗器械生物学评价 第1部分：可吸收植入物指南.
YY/T 1775.1-2021 is the Chinese pharmaceutical industry standard that gives the general guidance for the biological evaluation of absorbable medical devices, the implants designed to degrade in the body.
It is the first part of the YY/T 1775 series and works within the risk management process of the GB/T 16886 series, setting out what the evaluation must consider in addition to that of a permanent implant: the degradation products released to the patient over time, the changing surface and mass of the device, the local and systemic exposure this produces and the information needed to judge it. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1775.1-2021
National Standard of the People's Republic of China
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
YY/T 1775 "Biological Evaluation of Absorbable Medical Devices" is planned to be divided into the following parts.
---Part 1: Guidelines for absorbable implants;
---Part 2: Guide to Magnesium Alloy Implants; This part is Part 1 of YY/T 1775.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This part of YY/T 1775 specifies general guidelines for biological evaluation of absorbable implants to support the development of absorbable implants. Safety evaluation.
This section applies to the guidance for the evaluation of absorbable implants based on the GB/T 16886 risk assessment process.
Note. The absorbable implant is expected to be degradable by design, so the degradation products will be released to the patient. This is because this type of product and other products are not expected to be absorbed by the patient's body. Of medical devices have fundamentally different characteristics.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 16886 (all parts) Biological evaluation of medical devices ISO /T R10993-22 Biological Evaluation of Medical Devices Part 22: Guidelines for Nanomaterials (Biologicalevaluationof medicaldevices-Part 22: Guidanceonnanomaterials)
ISO 13781 Homopolymer, copolymer and blend of polylactic acid for surgical implants in vitro degradation test [Implantsforsur- gery-Homopolymers, copolymers and blendsonpoly(lactide)-Invitrodegradationtesting]
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Absorb/absorption
A certain non-endogenous (external) material or substance, or its decomposition product, gradually passes through or is shared by cells and/or tissues. The role of chemistry. [ISO 10993-6:2016, definition 3.1]
3.2 Degradationproduct
All intermediate or final by-products of a material or substance due to physical, metabolic and/or chemical decomposition. [ISO 10993-6:2016, definition 3.3]
3.3 Degrade
The physical, metabolic, and/or chemical decomposition of a material or substance.
3.4 Leachable substance
A substance that a medical device or material can release during clinical use.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
GB/T 16886 · ISO 13781
Similar standards
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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