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YY/T 1884-2023Fixed copper intrauterine device (English PDF)

固定式含铜宫内节育器

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 20, 2023

Implementation date

July 1, 2024

Scope

YY/T 1884-2023 is the English-translated version of 固定式含铜宫内节育器.

YY/T 1884-2023 is the Chinese standard "Fixed copper intrauterine device". Its scope clause reads: This document specifies the composition and basic dimensions, requirements, test methods, information provided by the manufacturer, and packaging of fixed copper intrauterine devices. and expiry date.

This document applies to fixed copper-containing intrauterine devices, which are fixed in the uterine cavity of women and used for contraception. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY/T 1884-2023

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 and basic dimensions, requirements, test methods, information provided by the manufacturer, and packaging of fixed copper intrauterine devices.

and expiry date.

This document applies to fixed copper-containing intrauterine devices, which are fixed in the uterine cavity of women and used for contraception.

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

GB/T 16886.13-2017 Biological evaluation of medical devices Part 13.Qualification and analysis of degradation products of polymer medical devices

Quantitative

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

YY/T 1404-2016 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 fixedtype

The instrument is suspended in the uterine cavity by being fixed to the myometrium with non-absorbable sutures.

3.2 indomethacin

A non-steroidal anti-inflammatory drug loaded on a copper-containing intrauterine device (IUD), which has anti-inflammatory and analgesic effects.

3.3 biodegradablepolymer

Polymer materials that can be degraded by microorganisms or secretions in organisms under the action of enzymes or chemical substances within a certain period of time.

3.4

There is no hook force after the needle tip is loaded with external force.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 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

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