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YY 0464-2003Single-use hemoperfusion devices (English PDF)

一次性使用血液灌流器

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 20, 2002

Implementation date

January 1, 2004

Scope

YY 0464-2003 is the English-translated version of 一次性使用血液灌流器.

YY 0464-2003 is the Chinese pharmaceutical industry standard covering single-use hemoperfusion devices. It was issued on 20 June 2002 and has been in force since 1 January 2004, as a first edition.

The document is under the responsibility of the National Medical Products Administration. This page is published from the official record of the 2003 edition. The figures, limits and tables the standard contains are those of the document itself, delivered in full with the English translation.

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Document preview — YY 0464-2003

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

[Preview only]
1 Scope
2 Normative references
2.1 Terms
3 Terms and definitions
4 Classification and model designation
5 Requirement
6 Test method
7 Signs and instructions
8 Packaging, transportation, storage

1 Foreword

YY 0464-2003 was issued by National Medical Products Administration of the People's Republic of China on 20 June 2002.

The YY prefix, without a suffix, marks a mandatory standard: within its scope, compliance is required.

The document runs to 15 pages in English translation.

2 Scope Preview

YY 0464-2003 carries no ICS number and no Chinese Standard Classification code.

This catalogue holds 944 other YY standards.

Of the 199 YY standards that do carry an ICS number, 198 (99%) fall under ICS 11, in the field of health care technology.

3 About this standard

Issued by: National Medical Products Administration of the People's Republic of China

English translation: about 15 pages

4 Related standards

Other editions:

YY 0464-2009 (later edition)

Standards on related subjects:

YY/T 0663.2-2016 — Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

YY/T 0640-2016 — Non-active surgical implants - General requirements

YY/T 0606.9-2007 — Tissue Engineered Medical Products - Part 9: Sodium Hyaluronate

YY/T 0954-2026 — Nonactive surgical implants - Type I collagen implants

YY 0465-2019 — Medical Devices — Disposable membrane plasmaseparator and plasma component separator

5 Classification and status

Chinese Standard Classification (CCS): C 45

Prefix YY: mandatory standard.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Cited by

YY 1290-2016Single-use bilirubin plasma haemoperfusion device

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