|
US$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1914-2023: Medical devices for human assisted reproductive technology - General requirements of apparatus products
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1914-2023 | English | 139 |
Add to Cart
|
3 days [Need to translate]
|
Medical devices for human assisted reproductive technology - General requirements of apparatus products
| Valid |
YY/T 1914-2023
|
PDF similar to YY/T 1914-2023
Basic data | Standard ID | YY/T 1914-2023 (YY/T1914-2023) | | Description (Translated English) | Medical devices for human assisted reproductive technology - General requirements of apparatus products | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 7,744 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the general requirements for medical devices for human assisted reproductive technology, including requirements and test methods. This standard applies to medical devices and equipment for human assisted reproductive technology, including assisted reproductive catheters, assisted reproductive puncture and egg retrieval/sperm collection needles, and assisted reproductive micro-tools. | YY/T 1914-2023: Medical devices for human assisted reproductive technology - General requirements of apparatus products
---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.
ICS 11.040.30
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Medical devices for human assisted reproductive technology
General requirements for appliance products
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
1 Scope 1
2 Normative reference documents 1
3 Requirements and test methods 1
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the China Institute for Food and Drug Control.
This document was drafted by. China Institute of Food and Drug Control, Shandong Institute of Medical Device and Drug Packaging Inspection, Ruibo Biotechnology
(China) Co., Ltd., Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd., and Ayers (Zhejiang) Medical Technology Co., Ltd.
The main drafters of this document. Li Chongchong, Han Qianqian, Mao Xin, Zhao Danmei, Wang Han, Lu Wenbo, Feng Huailiang, Bi Shengcheng, Qian Richeng, Fu Bufang,
Liu Li, Chen Dandan, Liu Ye.
Medical devices for human assisted reproductive technology
General requirements for appliance products
1 Scope
This document specifies the general requirements for medical devices used in human assisted reproductive technology, including requirements and test methods.
This document applies to medical devices and appliances for human assisted reproductive technology, including assisted reproductive catheters and assisted reproductive egg retrieval/
Sperm retrieval needles, and micro-tools for assisted reproduction.
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 14233.1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process
YY/T 1434 In vitro mouse embryo testing of medical devices for human in vitro assisted reproductive technology
YY/T 1535 Human sperm survival test for biological evaluation of medical devices used in human in vitro assisted reproductive technology
YY/T 1688 Blastocyst cell staining and counting methods for medical devices used in human assisted reproductive technology
Pharmacopoeia of the People's Republic of China (2020 Edition) Part Four
3 Requirements and test methods
3.1 General
The applicability and limit range of the following items can be determined based on the intended use and usage of the product, and can also be adjusted according to actual needs.
3.2 Physical properties
3.2.1 Dimensions
Use general or special measuring tools for measurement. Product dimensions, such as length, diameter, capacity, etc., should comply with regulations.
3.2.2 Appearance
Use normal or corrected vision to observe under specified conditions. The surface of the product should be clean, free of impurities, burrs, and cracks. If there is a mark
Knowledge should be clear. The area where the product comes into contact with the gametes/embryos should be smooth.
3.2.3 Mechanical properties
The main components of the product and their connections should be evaluated for mechanical properties according to the selected method (if applicable).
3.2.4 Other performance
Performance that meets the intended design and use of the product, such as puncture performance, conical joints, sealing performance, corrosion resistance, special surface treatment
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1914-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 1914-2023_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 1914-2023_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1914-2023_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+ countriesQuestion 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 [email protected]. 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.
|