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YY 0285.1-2004

标准搜索结果: 'YY 0285.1-2004'
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YY 0285.1-2004 英文版 400 购买 现货,9秒内自动发货PDF,有增值税发票。 一次性使用无菌血管内导管. 第1部分:通用要求 作废

   
标准编号: YY 0285.1-2004 (YY0285.1-2004)
中文名称: 一次性使用无菌血管内导管. 第1部分:通用要求
英文名称: Sterile, single-use intravascular catheters. Part 1: General requirements
行业: 医药行业标准
中标分类: C31
国际标准分类: 11.040.20
字数估计: 12,141
发布日期: 2004-07-16
实施日期: 2005-08-01
旧标准 (被替代): YY 0285.1-1999
采用标准: ISO 10555-1-1995, IDT; ISO 10555-1/Amd 1-1999, IDT
起草单位: 山东省医疗器械产品质量检验中心
归口单位: 国家食品药品监督管理局济南医疗器械质量监督检验中心
提出机构: 全国医用输液器具标准化技术委员会
发布机构: 国家食品药品监督管理局


YY 0285.1-2004
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
IMPLEMENTED ON. AUGUST 1, 2005
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 
Foreword
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
application.
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
Bibliography
[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 health care products - Requirements for
validation and routine control--Industrial moist heat sterilization (idt ISO
11134.1994)
[3] GB 18279-2000, Biological evaluation of medical devices - Part 1.
Evaluation and testing (idt 11135.1994)
validation and routine control--Radiation sterilization (idt 11137.1995)
   
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