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YY 0598-2006Concentrates for haemodialysis and related therapies (English PDF)

血液透析及相关治疗用浓缩物

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

August 29, 2006

Implementation date

August 1, 2007

Scope

YY 0598-2006 is the English-translated version of 血液透析及相关治疗用浓缩物.

YY 0598-2006 is the Chinese pharmaceutical industry standard covering concentrates for haemodialysis and related therapies. It was issued on 29 August 2006 and has been in force since 1 August 2007, 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 2006 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 0598-2006

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 Overview
4.1 General requirements
5 Technical Requirements
6 Calibration conditions
6.1 Environmental conditions
6.2 Measurement standards and other equipment
7 Calibration items and calibration methods
7.1 Calibration Items
7.2 Calibration method
8 Expression of calibration results
9 Recalibration interval

1 Foreword

YY 0598-2006 was issued by National Medical Products Administration of the People's Republic of China on 29 August 2006 and has been in force since 1 August 2007.

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 0598-2006 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 0598-2015 (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 0603-2024 — Cardiopulmonary bypass systems - Hard-shell cardiotomy/venous reservoirs (with or without filter) and soft venous reservoir bags

YY/T 0606.15-2023 — Tissue engineered medical products - Standard practice for evaluation of immune response to matrices and scaffolds: lymphocyte proliferation test

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.

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