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YY/T 0506.1-2023Surgical drapes, gowns and clean air suits - Part 1: General requirements (English PDF)

医用手术单、手术衣和洁净服第1部分：通用要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

January 15, 2024

Scope

YY/T 0506.1-2023 is the English-translated version of 医用手术单、手术衣和洁净服第1部分：通用要求.

YY/T 0506.1 sets the general requirements for surgical drapes, surgical gowns and clean air suits, the barrier textiles that separate a sterile field from everything outside it.

It defines what such products have to achieve and how it is demonstrated, covering resistance to microbial penetration wet and dry, cleanliness in terms of particles and microbes, linting, tensile and burst strength, and the marking and information supplied.

It is Part 1 of a series, so it carries the definitions and the common requirements that the product-specific parts build on. Surgical textiles are bought in enormous volume by Chinese hospitals and exported in larger volume still, and this is the document a tender or an export contract names. The 2023 edition supersedes the earlier text.

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Document preview — YY/T 0506.1-2023

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 13 January 2023 by the National Medical Products Administration and takes effect on 15 January 2024.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

1 Scope

YY/T 0506.1 sets the general requirements for surgical drapes, surgical gowns and clean air suits, the barrier textiles that separate a sterile field from everything outside it. It defines what such products have to achieve and how it is demonstrated, covering resistance to microbial penetration wet and dry, cleanliness in terms of particles and microbes, linting, tensile and burst strength, and the marking and information supplied. It is Part 1 of a series, so it carries the definitions and the common requirements that the product-specific parts build on. Surgical textiles are bought in enormous volume by Chinese hospitals and exported in larger volume still, and this is the document a tender or an export contract names. The 2023 edition supersedes the earlier text.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Cited by

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