Valid

YY/T 1921-2023Closed type copper-bearing contraceptive intrauterine devices (English PDF)

闭环式含铜宫内节育器

Preview PDF

This is a limited preview

Buy now to download the full PDF (20 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1921-2023 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 5, 2023

Implementation date

September 15, 2024

Scope

YY/T 1921-2023 is the English-translated version of 闭环式含铜宫内节育器.

YY/T 1921-2023 is the Chinese standard "Closed type copper-bearing contraceptive intrauterine devices".

Its scope clause reads: This document specifies the composition, type, requirements, and information provided by the manufacturer of the closed-loop copper-containing intrauterine device (hereinafter referred to as "IUD"). information, packaging and expiry dates, and the corresponding test methods are described.

This document applies to closed-loop copper-containing intrauterine devices and their inserters, which are placed in the uterine cavity of women for contraceptive purposes. Its clauses include normative reference documents; terms and definitions.

Found what you need?

Document preview — YY/T 1921-2023

National Standard of the People's Republic of China

ICS: 11.200
Classification: C36

Issued by: National Medical Products Administration

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

1 Scope

This document specifies the composition, type, requirements, and information provided by the manufacturer of the closed-loop copper-containing intrauterine device (hereinafter referred to as "IUD").

information, packaging and expiry dates, and the corresponding test methods are described.

This document applies to closed-loop copper-containing intrauterine devices and their inserters, which are placed in the uterine cavity of women for contraceptive purposes.

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 4240 stainless steel wire

GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test methods

GB 11236-2021 Technical requirements and test methods for copper-containing intrauterine devices

GB/T 14233.1 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 0149 Test method for corrosion resistance of stainless steel medical instruments

YY/T 0334-2022 General requirements for silicone rubber surgical implants

YY/T 0640-2016 General requirements for passive surgical implants

YY/T 1404 Technical requirements and test methods for copper used in copper-containing intrauterine devices

YY/T 1471-2016 Technical requirements and test methods for indomethacin-containing silicone rubber for copper-containing intrauterine devices

"Pharmacopoeia of the People's Republic of China" (2020 edition)

3 Terms and definitions

The following terms and definitions as defined in GB 11236-2021 apply to this document.

3.1 closed type

Connected end to end, they form a closed structure similar to the shape of a uterine cavity.

3.2 corrosion

The ability of metallic materials to resist the corrosive and damaging effects of the surrounding medium.

3.3 Deformation recovery abilityvisco-elasticproperty

The IUD can roughly return to its original shape after deformation.

......
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

Similar standards

YY/T 1777|YY/T 1783|YY/T 1797|YY/T 2005|YY/T 2004.1

How to Download YY/T 1921-2023

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.