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JJG 18-2008

Chinese Standard: 'JJG 18-2008'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
JJG 18-2008English559 Add to Cart Days<=5 Verification regulation of syringes for medical use Valid JJG 18-2008
JJG 18-2008Chinese20 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID JJG 18-2008 (JJG18-2008)
Description (Translated English) Verification regulation of syringes for medical use
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A53
Word Count Estimation 24,212
Date of Issue 2008-09-27
Date of Implementation 2009-03-27
Older Standard (superseded by this standard) JJG 18-1990
Quoted Standard GB 15810-2001; YY 1001.1-2004; YY 1001.2-2004; GB/T 6582-1997; GB/T 1962.1-2001; GB/T 1962.2-2001; GB/T 15726-1995; YY 91017-1999; GB 6682 -2008
Adopted Standard ISO 7886-1-1993, NEQ; ISO 595-1-1986, NEQ; ISO 595-2-1987, NEQ; OIML R26-1978, NEQ
Drafting Organization Shanghai Institute of Measurement and Testing
Administrative Organization Flow capacity measured at the National Technical Committee
Regulation (derived from) ?AQSIQ Announcement 2008 No.112
Issuing agency(ies) State Administration of Quality Supervision, Inspection and Quarantine
Summary This standard applies to medical syringes have initial verification, follow-up tests and in-service inspection.

JJG 18-2008
Verification regulation of syringes for medical use
State verification procedures People's Republic of China
Medical syringe
Posted 2008-09-27
2009-03-27 implementation
The State Administration of Quality Supervision, Inspection and Quarantine released
Medical injector test procedures
forMedicalUse
Replacing JJG 18-1990
The regulations by the State Administration of Quality Supervision, Inspection and Quarantine approved on September 27, 2008, and from
From March 27, 2009 into effect.
Focal point. the National Technical Committee on Metering flow capacity
Drafting. Shanghai Institute of Measurement and Testing
Beijing Institute of Metrology detection
This procedure flow capacity commissioned the National Technical Committee responsible for the interpretation of measurement
The main drafters of this procedure.
Zhang Hong Asia (Shanghai Institute of Measurement and Testing)
Xie Junyan (Shanghai Institute of Measurement and Testing)
Brave horse (Beijing Institute of Metrology detection)
Drafters participate.
Zhang Yi (Shanghai Institute of Measurement and Testing)
table of Contents
1 Scope (1)
2. Referenced Documents (1)
3 terminology and units of measurement (1)
3.1 The term (1)
3.2 units of measurement (2)
4 Overview (2)
5 metering performance requirements (4)
6 General Requirements (4)
6.1 Material (4)
Stress 6.2 (4)
6.3 Appearance and logo (4)
6.4 Value-degree line and the amount of (5)
6.5 glass syringe cone firmness (5)
6.6 Performance slide (5)
6.7 Residues (6)
6.8 the body of adhesion (6)
6.9 glass syringe cone adhesion (6)
6.10 plastic syringe cone leakage (6)
6.11 plastic syringe cone separating force (6)
6.12 glass syringes resistant to thermal shock properties (6)
7 control of measuring instruments (7)
7.1 Verification condition (7)
7.2 Verification Project (7)
7.3 test methods (8)
7.4 Verification Results Processing (9)
7.5 test cycle (9)
Appendix A density of pure water table (10)
Appendix B medical syringe capacity test results are reported in Table (for reference only) (11)
Appendix C medical injector calibration certificate (within the page) format (12)
Appendix D medical syringe capacity test results notice (within the page) format (13)
Medical injector test procedures
The regulations refer to international standards ISO 7886-1. PART 11993 "disposable sterile hypodermic
Score. Manual Syringe "; ISO 595-1. 1986" all-reusable glass or metal - glass syringes for medical first
Part 1. Dimensions "; ISO 595-2. 1987" all-reusable glass or metal - glass medical injector 2
Part 1. Structures, performance requirements and test "; International Recommendations OIMLR26. 1978" medical injection with glass sleeve
Device. "
1 Scope
The order applies to medical syringe initial verification, subsequent verification and in-service inspection.
2 Citations
The regulations cited in the following documents.
GB 15810-2001 disposable sterile syringes
YY1001.1-2004 glass syringes - Part 1. all-glass syringes
YY1001.2-2004 glass syringes - Part 2. Blue chip all-glass syringes
GB/T 6582-1997 at 98 ℃ water resistance of glass particles - Test method and classification
GB/T 1962.1-2001 syringes, needles and other medical equipment - 6% (Luer) conical fitting section
Part 1. General requirements
GB/T 1962.2-2001 syringes, needles and other medical equipment - 6% (Luer) conical fitting section
Part 2. Lock fittings
Within the GB/T 15726-1995 glassware stress testing methods
YY91017-1999 all-glass syringe body of adhesion test method
GB 6682-2008 analytical laboratory use specifications and test methods
Should pay attention to the use of this procedure by using the currently valid version of the documents cited.
3 terminology and units of measurement
3.1 Terms
3.1.1 Use disposable sterile syringes (sterilehypodermicsyringesforsingleuse)
Jacket and stem the use of specific grades of polypropylene, made of polystyrene or styrene/acrylonitrile copolymer material,
Piston using high-quality natural rubber or synthetic rubber material, the piston surface by a polydimethylsiloxane (silicone oil) Run
Slip through sterilized medical syringe non-reusable.
3.1.2 All-glass syringes (syringeswithal-glass)
Jacket, core rod and cone are made of aluminum borosilicate glass material, the sterilization of reusable medical injection
Ejector.
Related standard:   JJG(YC)18-2012  JJG 13-2016
Related PDF sample:   JJG 150-2005  JJG 577-2012
   
 
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