YY/T 1688-2021Medical devices for human assisted reproductive technology—A method for blastocyst cell staining and counting (English PDF)
人类辅助生殖技术用医疗器械 囊胚细胞染色和计数方法
This is a limited preview
Buy now to download the full PDF (24 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1688-2021 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1688-2021 is the English-translated version of 人类辅助生殖技术用医疗器械 囊胚细胞染色和计数方法.
YY/T 1688-2021 is the Chinese pharmaceutical industry standard that gives the method for staining and counting the cells of a mouse blastocyst.
The count is used in the safety evaluation of medical devices for human assisted reproduction that touch gametes or embryos directly or indirectly: embryos are cultured in contact with the device or its extract and the number of cells reached at the blastocyst stage shows whether the material impairs development.
The standard sets out the reagents, the staining procedure, the counting and the way the result is expressed, and takes its terms from YY/T 0995. Issued on 9 March 2021, it has applied since 1 April 2022.
Found what you need?
Document preview — YY/T 1688-2021
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, definitions and abbreviations
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the test methods for staining and counting mouse blastocyst cells.
This standard applies to the safety evaluation of medical devices used in human assisted reproductive technology that come into direct or indirect contact with gametes and/or embryos.
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.
YY/T 0995 Terms and definitions of medical devices used in human assisted reproductive technology
YY/T 1434 In vitro mouse embryo test for medical devices used in human in vitro assisted reproductive technology
3 Terms, definitions and abbreviations
The following terms and definitions apply to this document.
3.1 Terms and definitions
The following terms and definitions defined in YY/T 0995 and YY/T 1434 apply to this document.
3.1.1 Expanded blastocyst
The blastocyst cavity has been fully expanded and the zona pellucida is thinned.
3.1.2 Hatching or hatching blastocyst
A blastocyst in which some or all of the blastocyst cells escape from the zona pellucida.
3.1.3 Innercelmass
A group of cells in the inner layer of a blastocyst, distributed in clusters, and eventually develop into a fetus.
3.1.4 Trophectodermcel
The outer cells of the blastocyst will eventually develop into the placenta.
3.2 Abbreviations
The following abbreviations apply to this document.
PBS. phosphate buffer saline Hoechst33342.bisbenzimide PFA. paraformaldehyde BSA. Bovine Serum Albumin (bovineserum albumin)
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
Similar standards
How to Download YY/T 1688-2021
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 0995-2015 — Medical devices for human assisted reproductive technology—Terminology and definitions
YY/T 1434-2016 — Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assay
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 1688-2021
$95.00