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YY/T 1775.1-2021 English PDF

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US$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1775.1-2021: Biological evaluation of absorbable medical devices - Part 1: Guidance for absorbable implants
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1775.1-2021	189	Add to Cart	3 days	Biological evaluation of absorbable medical devices - Part 1: Guidance for absorbable implants	Valid

Similar standards

YY/T 1754.2 YY/T 1754.1 YY/T 1758 YY/T 1789.6 YY/T 1789.5

Basic data

Standard ID: YY/T 1775.1-2021 (YY/T1775.1-2021)
Description (Translated English): Biological evaluation of absorbable medical devices - Part 1: Guidance for absorbable implants
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 10,170
Issuing agency(ies): State Drug Administration

YY/T 1775.1-2021: Biological evaluation of absorbable medical devices - Part 1: Guidance for absorbable implants

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Biological evaluation of absorbable medical devices - Part 1.Guidance for absorbable implants ICS 11.040.01 C30 People's Republic of China Pharmaceutical Industry Standards Biological evaluation of absorbable medical devices Part 1.A guide to absorbable implants Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

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. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248). Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Medical Device Technical Review of the State Drug Administration center. The main drafters of this section. Shi Yanping, Zhao Peng, Shi Xinli, Zhu Fuyu, Tang Juli, Wang Yan, Shao Guojun. Biological evaluation of absorbable medical devices Part 1.A guide to absorbable implants

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 article Pieces. 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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1775.1-2021_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1775.1-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1775.1-2021_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1775.1-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.