9秒发货/有发票 梧三标准英文版 优质技术翻译  数据库收录:159759 最近更新:2020-02-08  
支付宝/对公账号 首页   询价  购买流程  英文样品 公司简介   购物车

YY/T 1192-2011

标准搜索结果: 'YY/T 1192-2011'
标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 1192-2011 英文版 580 购买 现货,9秒内自动发货PDF,有增值税发票。 人绒毛膜促性腺激素(HCG)定量测定 试剂(盒)(化学发光免疫分析法) 有效

   
标准详细信息 YY/T 1192-2011; YY/T1192-2011; YYT 1192-2011; YYT1192-2011
中文名称: 人绒毛膜促性腺激素(HCG)定量测定 试剂(盒)(化学发光免疫分析法)
英文名称: Human chorionic gonadotropin (HCG) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
行业: 医药行业标准 (推荐)
中标分类: C44
国际标准分类: 11.100
字数估计: 9,000
发布日期: 2011-12-31
实施日期: 2013-06-01
引用标准: GB/T 21415-2008
起草单位: 北京市医疗器械检验所、北京源德生物医学工程有限公司、北京科美东雅生物技术有限公司、罗氏诊断产品(上海)有限公司、郑州安图绿科生物工程有限公司
归口单位: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
标准依据: 国家食品药品监督管理局公告2011年第106号;行业标准备案公告2013年第6号(总第162号)
提出机构: 国家食品药品监督管理局
发布机构: 国家食品药品监督管理局
范围: 本标准规定了人绒毛膜促性腺激索(HCG)定量测定试剂(盒)(化学发光免疫分析法)分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存等。本标准适用于以化学发光免疫分析为原理的定量检测人血液基质或其他体液成分中的人绒毛膜促性腺激索(HCG)试剂(盒)[以下筒称"HCG试剂(盒)"]。包括以微孔板、管、磁颗粒、微珠和塑料珠等为载体的酶促及非酶促化学发光免疫分析测定试剂(盒)。本标准不适用于:a)拟用于单独销售的人绒毛膜促性腺激素校准品和人绒毛膜促性腺激素质控品;b)以化学发光免疫分析为原理的生物芯片

YY/T 1192-2011
Human chorionic gonadotropin (HCG) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
ICS 11.100
C44
中华人民共和国医药行业标准
人绒毛膜促性腺激素(HCG)定量测定
试剂(盒)(化学发光免疫分析法)
Humanchorionicgonadotropin(HCG)quantitativedetectionreagent(kit)
(chemiluminescentimmunoassay)
2011-12-31发布
2013-06-01实施
国家食品药品监督管理局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
请注意,本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由国家食品药品监督管理局提出。
本标准由全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC136)归口。
本标准起草单位:北京市医疗器械检验所、北京源德生物医学工程有限公司、北京科美东雅生物技
术有限公司、罗氏诊断产品(上海)有限公司、郑州安图绿科生物工程有限公司。
本标准主要起草人:王瑞霞、唐磊、程英豪、蔡晓蓉、李晓霞。
人绒毛膜促性腺激素(HCG)定量测定
试剂(盒)(化学发光免疫分析法)
1 范围
本标准规定了人绒毛膜促性腺激素(HCG)定量测定试剂(盒)(化学发光免疫分析法)分类、要求、
试验方法、标识、标签、使用说明书、包装、运输和贮存等。
本标准适用于以化学发光免疫分析为原理的定量检测人血液基质或其他体液成分中的人绒毛膜促
性腺激素(HCG)试剂(盒)[以下简称“HCG试剂(盒)”]。包括以微孔板、管、磁颗粒、微珠和塑料珠等
为载体的酶促及非酶促化学发光免疫分析测定试剂(盒)。
本标准不适用于:
a) 拟用于单独销售的人绒毛膜促性腺激素校准品和人绒毛膜促性腺激素质控品;
b) 以化学发光免疫分析为原理的生物芯片。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 21415-2008 体外诊断医疗器械 生物样品中量的测量校准品和控制物质赋值的计量学
溯源性
3 分类
HCG试剂(盒)按照化学发光原理不同可以分为酶促与非酶促化学发光免疫分析试剂(盒);依据固
相载体不同可以分为微孔板式,管式,磁颗粒、微珠和塑料珠等为载体的化学发光免疫分析试剂盒);根
据操作过程的不同可分为手工操作法和仪器自动操作法。
4 技术要求
4.1 外观
外观应符合如下要求:
a) 试剂(盒)各组份应齐全、包装完好,液体无渗漏;
b) 中文包装标签应清晰,无磨损。
4.2 溯源性
生产企业应根据GB/T 21415-2008及有关规定提供所用HCG试剂(盒)校准品的来源、赋值过程
以及测量不确定度等内容。
4.3 准确度
准确度应符合如下要求之一:

YY/T 1192-2011 
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Human chorionic gonadotropin (HCG) quantitative
detection reagent (kit) (chemiluminescent immunoassay)
人绒毛膜促性腺激素(HCG)定量测定
试剂(盒)(化学发光免疫分析法)
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Classification ... 4 
4  Technical requirements ... 5 
5  Test methods ... 6 
6  Marks, labels and instructions ... 9 
7  Packaging, transportation and storage ... 11 
Bibliography ... 12 
Foreword 
This standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this document may involve patents. The issuing
organization of this document does not bear the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard shall be centralized by the China Clinical Laboratory Testing and In Vitro
Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organization of this standard. Beijing Institute of Medical Device Testing, Beijing
Yuande Medical Engineering Co., Ltd., Beijing Chemclin Biotech Co., Ltd., Roche
Diagnostic Products (Shanghai) Co., Ltd., and Zhengzhou Autobio Lv Ke Bioengineering
Co., Ltd.
The main drafters of this standard. Wang Ruixia, Tang Lei, Cheng Yinghao, Cai Xiaorong,
and Li Xiaoxia.
Human chorionic gonadotropin (HCG) quantitative
detection reagent (kit) (chemiluminescent
immunoassay)
1  Scope 
This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation and storage etc. of the human chorionic
gonadotropin quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the quantitative detection of human chorionic gonadotropin
(HCG) reagent (kit) [hereinafter referred as “HCG reagent (kit)”] of the human blood matrix
or other body fluid components, based on the principle of chemiluminescent immunoassay.
It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection
reagent (kit) in the carrier of microplates, pipes, magnetic particles, microbeads and
plastic beads.
This standard does not apply to.
a) The calibrators and quality-control materials of human chorionic gonadotropin that
are intended for separate sale;
b) The biochip that uses chemiluminescent immunoassayas the principle.
2  Normative references 
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3  Classification 
HCG reagent (kit) can be divided into enzymatic and non-enzymatic chemiluminescent
immunoassay reagents (kits) according to different principle of chemiluminescence.
According to different solid-phase carriers, it can be divided into the chemiluminescent
a) Product names and packaging specifications;
b) Name, address, contact information of manufacturers or after-sales service
organization;
c) Medical device registration certificate number;
d) Product standard number;
f) Expiration date;
g) Storage conditions.
6.2 Marks and labels of each component package of reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name or trademarks of the manufacturers;
c) Product batch number;
d) Expiration date;
e) Storage conditions.
It shall contain at least the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Detection principle;
e) Main compositions;
f) Storage conditions and expiration date;
g) Applicable instrument;
h) Sample requirement;
j) Reference value (Reference range);
k) Explanation of the detection result;
l) The limitations of detection methods;
m) Product performance index.
n) Instructions for analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for specificity analysis (cross-reactants);
p) Precautions;
q) References;
r) Name, address, contact information of manufacturers or after-sales service
s) License number of medical device manufacturing enterprise (limited to domestic
enterprises);
t) Medical device registration certificate number;
u) Product standard number;
v) Approval and modified date of instructions.
7  Packaging, transportation and storage 
7.1 Package
Reagent (kit) shall be packaged according to the requirements of the manufacturing
enterprise.
Reagent (kit) shall be transported according to the requirements of the manufacturing
enterprise.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by the manufacturing
enterprise.
Bibliography 
1. YY/T 0316-2008 Medical devices — Application of risk management to medical
devices (ISO 14971. 2007, IDT)
2. YY/T 0466.1-2009 Devices — Symbols to be used with medical device labels,
15223.1-2009, IDT)
3. GB/T 191-2008 Packaging - Pictorial marking for handling of goods
4. GB/T 9969-2008 General principles for preparation of instructions for use of
industrial products
   
宁德梧三商贸有限公司 | 纳税人识别号:91350900MA32WE2Q2X | 营业执照:营业执照证书
点击联络我们 联系电邮郑文锐销售经理: Sales@gb-gbt.cn | Sales@ChineseStandard.net | 电话郑经理: 18059327808 | 增值税普通发票 / 增值税专用发票样品
对公开户银行:中国建设银行古田支行 | 账户名称:宁德梧三商贸有限公司 | 账号:35050168730700000955 对公银行账号证书
翻译支持:全资母公司新加坡场测亚洲公司(https://www.ChineseStandard.net 卖欧美后再内销)
网站备案许可:闽ICP备19012676号
隐私   ·  优质产品   ·  退款政策   ·  公平交易   ·  关于我们