Powered by Google-Search & Google-Books www.ChineseStandard.net Database: 169759 (Apr 11, 2021)
HOME   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart

YY 0285.1-2004

Chinese Standard: 'YY 0285.1-2004'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)Related StandardStatusGoogle Book
YY 0285.1-2004English70 Add to Cart 0--10 minutes. Auto-delivered. Sterile, single-use intravascular catheters. Part 1: General requirements YY 0285.1-2004 Obsolete YY 0285.1-2004

  In 0~10 minutes time, full copy of this English-PDF will be auto-delivered to your email. See samples for translation quality.  

Standard ID YY 0285.1-2004 (YY0285.1-2004)
Description (Translated English) Sterile, single-use intravascular catheters. Part 1: General requirements
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 12,161
Date of Issue 2004-07-16
Date of Implementation 2005-08-01
Older Standard (superseded by this standard) YY 0285.1-1999
Adopted Standard ISO 10555-1-1995, IDT; ISO 10555-1/Amd 1-1999, IDT
Drafting Organization Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Proposing organization National Standard Committee on Medical Infusion Equipment
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the state of supply and sterile single-use intravascular catheters for various uses generic requirements. YY 0285 does not apply to this part of intravascular catheter accessories.

YY 0285.1-2004
ICS 11.040.20
C 31
YY 0285.1-2004 / ISO 10555-1.1995
Replacing YY 0285.1-1999
Sterile, single-use intravascular catheters –
Part 1. General requirements
一次性使用无菌血管内导管 第 1部分. 通用要求
ISSUED ON. JULY 16, 2004
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Definitions ... 4 
4 Requirements ... 6 
5 Designation of nominal size ... 8 
6 Information to be supplied by manufacturer ... 8 
Annex A (Informative) Test method for corrosion resistance ... 10 
Annex B (Normative) Method for determining force at break ... 11 
Annex C (Normative) Test method for liquid leakage under pressure ... 13 
Annex D (Normative) Test method for air leakage into hub assembly during
aspiration ... 15 
Bibliography ... 17 
This Part of YY 0285 identically uses the International Standard ISO
10555-1.1995 and ISO 10555-1/Amendment 1-1999 Sterile, single-use
intravascular catheters - Part 1. General requirements. Meanwhile, it is also
the revision to YY 0285.1-1999.
This edition and main technical differences of YY 0285.1-1999 are mainly
based on ISO 10555-1 Amendment 1-1999. It added the relevant
requirements for hydrated ducts.
Requirements of clause 5 of this Part are recommendatory.
Annex A ~ Annex D of this Part are normative.
This Part was proposed by National Technical Committee on Medical Infusion
Equipment of Standardization Administration of China.
This Part shall be under the jurisdiction of State Drug Administration Jinan
Medical Device Quality Supervision and Inspection Center.
Main drafting organization of this Part. Shandong Medical Equipment Product
Quality Inspection Center.
Main drafters of this Part. Wang Yanwei, Wu Ping, Qian Chengyu.
Sterile, single-use intravascular catheters –
Part 1. General requirements
1 Scope
This Part of YY 0285 specifies general requirements for intravascular
catheters, supplied in the sterile condition and intended for single use, for any
It does not apply to intravascular catheter accessories, which will be covered
by a separate standard.
NOTE Requirements for accessories are specified in YY 0450.
2 Normative references
The provisions in following documents become the provisions of this Part
through reference in this Part. For dated references, the subsequent
amendments (excluding corrigendum) or revisions do not apply to this Part,
however, parties who reach an agreement based on this Part are encouraged
to study if the latest versions of these documents are applicable. For undated
references, the latest edition of the referenced document applies.
GB/T 1962, The conical fittings with a 6% (Luer) taper for syringes, needles
and certain other medical equipment (idt ISO 594)
GB 15810, Sterile hypodermic syringes for single use (GB 15810-1995,
eqv ISO 7886-1.1993)
3 Definitions
For the purposes of this document, the following definitions apply.
3.1 intravascular catheter
tubular device single or multilumen, designed to be partially or totally inserted
or implanted into the cardiovascular system for diagnostic and/or therapeutic
3.2 distal end
[1] GB/T 16886.1-2001, Biological evaluation of medical devices - Part 1.
Evaluation and testing (idt ISO 10993-1997)
[2] GB 18278-2000, Sterilization of......
Related standard: YY/T 0285.6-2020    YY 0285.5-2018
Related PDF sample: YY 0285.1-2017    YY 0285.3-2017