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Position: Chinese Standard in English/GB/T 14233.1-2008
GB/T 14233.1-2008   Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods (English Version)
Standard No.: GB/T 14233.1-2008 Status:to be superseded remind me the status change

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Language:English File Format:PDF
Word Count: 9000 words Price(USD):130.0 remind me the price change

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Implemented on:2009-10-1 Delivery: via email in 1 business day
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Standard No.: GB/T 14233.1-2008
English Name: Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
Chinese Name: 医用输液、输血、注射器具检验方法 第1部分:化学分析方法
Chinese Classification: C31    General and microsurgical devices
Professional Classification: GB    National Standard
ICS Classification: 11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Issued by: AQSIQ and SAC
Issued on: 2008-11-03
Implemented on: 2009-10-1
Status: to be superseded
Superseded by:GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use―Part 1:Chemical analysis methods
Superseded on:2023-11-1
Superseding:GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use--Part 1:Chemical analysis methods
Language: English
File Format: PDF
Word Count: 9000 words
Price(USD): 130.0
Delivery: via email in 1 business day
1 Scope This Part of GB/T 14233 specifies the chemical analysis methods for infusion, transfusion, injection equipments for medical use. This Part is applicable to the chemical analysis for infusion, transfusion, injection and supporting equipments for medical use made of medical macromolecular materials; the chemical analysis for other medical macromolecular products may also be carried out by reference to this Part. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this Part of GB/T 14233. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. GB/T 601 Chemical reagent--Preparations of Standard volumetric solutions GB/T 6682 Water for Analytical Laboratory Use-Specification and Test Methods (GB/T 6682-2008, ISO 3696: 1987, MOD) Pharmacopoeia of People's Republic of China (2005 Edition) Volume II 3 General Rules 3.1 All analysis in this Part shall be carried out based on two parallel test groups; the test results shall be within the allowable relative deviation limits; arithmetic mean shall be adopted as the test result; in the case of one portion qualified and the other unqualified, the results shall not be averaged, and tests shall be carried out again instead. 3.2 Unless otherwise specified, all reagents used in this Part are analytically pure. 3.3 Unless otherwise specified, all test water in this Part shall meet the requirements of Class II water in GB/T 6682. 3.4 Term "room temperature" in this Part refers to 10℃~ 30℃. 3.5 Term "accurate weighing" in this Part refers to weighing to the accuracy of 0.1mg. 3.6 Term "accurate measuring" in this Part refers to measure with pipette meeting the requirements of the accuracy specified by corresponding national standards. 3.7 Gravimetric method constant weight refers to that mass difference of test substance after twice continuous flaming or drying shall not exceed 0.3mg. 3.8 Unless otherwise specified, all glass vessels used in this Part are borate ones.
Contents Foreword i 1 Scope 2 Normative References 3 General Rules 4 Preparation for Test Solution 5 Analysis Methods for Leachables of Test Solution 6 Analysis Methods for the Total Content of Heavy Metal in Materials 7 Analysis Methods for the Element Content of Some Heavy Metals in Materials 8 Residue of Burning 9 Measurement of the Residual Quantity of Ethylene Oxide-Gas Chromatography 10 Residue Analysis of Ethylene Oxide-Colorimetric Analysis Bibliography
Referred in GB/T 14233.1-2008:
* GB/T 601-2002 Chemical Reagent - Preparations of Standard Volumetric Solutions
* GB/T 6682-2008 Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008 is referred in:
* YY/T 0821-2010 Dispensing syringe for single use
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY/T 0908-2013 Single-use filter for syringe
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY 0469-2011 Surgical mask
* YY 0502-2005 Knee joint prostheses
* GB 8369-2005 Transfusion sets for single use
* GB 15811-2016 Sterile hypodermic needles for single use
*YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
*YY 0778-2010 Radio frequency ablation catheter
*GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices
*GB 19083-2010 Technical requirements for protective face mask for medical use
*YY 0465-2009 Disposable membrane plasmaseparator
*YY 1272-2016 Dialysis fluid filter
*GB 18671-2009 Intravenous needles for single use
*YY 0502-2016 Joint replacement implants―Knee joint prostheses
*YY 0118-2016 Joint replacement implants - Hip joint prostheses
*YY 0174-2019 Scalpel blade
*GB 15810-2019 Sterile syringes for single use
*GB 19082-2009 Technical requirements for single-use protective clothing for medical use
*GB/T 38880-2020 Technical specification of children mask
*YY 0118-2005 Hip joint prostheses
*T/CAQI 164-2020 Electric mask
*YY/T 1553-2017 Cardiovascular implants-Cardiac occluder
*GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use
*YY/T 1710-2020 Disposable abdominal trocars
*YY/T 1739-2020 Cardiopulmonary bypass systems—Centrifugal pump-head
*GB/T 19335-2022 Blood flow products for single use-General specification
*YY/T 1794-2021 General technical requirements for dental collagen membrane
*YY 0465-2019 Disposable membrane plasmaseparator and plasma component separator
Code of China
Standard
GB/T 14233.1-2008  Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods (English Version)
Standard No.GB/T 14233.1-2008
Statusto be superseded
LanguageEnglish
File FormatPDF
Word Count9000 words
Price(USD)130.0
Implemented on2009-10-1
Deliveryvia email in 1 business day
Detail of GB/T 14233.1-2008
Standard No.
GB/T 14233.1-2008
English Name
Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
Chinese Name
医用输液、输血、注射器具检验方法 第1部分:化学分析方法
Chinese Classification
C31
Professional Classification
GB
ICS Classification
Issued by
AQSIQ and SAC
Issued on
2008-11-03
Implemented on
2009-10-1
Status
to be superseded
Superseded by
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use―Part 1:Chemical analysis methods
Superseded on
2023-11-1
Abolished on
Superseding
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use--Part 1:Chemical analysis methods
Language
English
File Format
PDF
Word Count
9000 words
Price(USD)
130.0
Keywords
GB/T 14233.1-2008, GB 14233.1-2008, GBT 14233.1-2008, GB/T14233.1-2008, GB/T 14233.1, GB/T14233.1, GB14233.1-2008, GB 14233.1, GB14233.1, GBT14233.1-2008, GBT 14233.1, GBT14233.1
Introduction of GB/T 14233.1-2008
1 Scope This Part of GB/T 14233 specifies the chemical analysis methods for infusion, transfusion, injection equipments for medical use. This Part is applicable to the chemical analysis for infusion, transfusion, injection and supporting equipments for medical use made of medical macromolecular materials; the chemical analysis for other medical macromolecular products may also be carried out by reference to this Part. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this Part of GB/T 14233. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. GB/T 601 Chemical reagent--Preparations of Standard volumetric solutions GB/T 6682 Water for Analytical Laboratory Use-Specification and Test Methods (GB/T 6682-2008, ISO 3696: 1987, MOD) Pharmacopoeia of People's Republic of China (2005 Edition) Volume II 3 General Rules 3.1 All analysis in this Part shall be carried out based on two parallel test groups; the test results shall be within the allowable relative deviation limits; arithmetic mean shall be adopted as the test result; in the case of one portion qualified and the other unqualified, the results shall not be averaged, and tests shall be carried out again instead. 3.2 Unless otherwise specified, all reagents used in this Part are analytically pure. 3.3 Unless otherwise specified, all test water in this Part shall meet the requirements of Class II water in GB/T 6682. 3.4 Term "room temperature" in this Part refers to 10℃~ 30℃. 3.5 Term "accurate weighing" in this Part refers to weighing to the accuracy of 0.1mg. 3.6 Term "accurate measuring" in this Part refers to measure with pipette meeting the requirements of the accuracy specified by corresponding national standards. 3.7 Gravimetric method constant weight refers to that mass difference of test substance after twice continuous flaming or drying shall not exceed 0.3mg. 3.8 Unless otherwise specified, all glass vessels used in this Part are borate ones.
Contents of GB/T 14233.1-2008
Contents Foreword i 1 Scope 2 Normative References 3 General Rules 4 Preparation for Test Solution 5 Analysis Methods for Leachables of Test Solution 6 Analysis Methods for the Total Content of Heavy Metal in Materials 7 Analysis Methods for the Element Content of Some Heavy Metals in Materials 8 Residue of Burning 9 Measurement of the Residual Quantity of Ethylene Oxide-Gas Chromatography 10 Residue Analysis of Ethylene Oxide-Colorimetric Analysis Bibliography
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Keywords:
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