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JJG 18-2008 English PDF

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JJG 18-2008: Verification regulation of syringes for medical use
Status: Valid

JJG 18: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
JJG 18-2008559 Add to Cart 5 days Verification regulation of syringes for medical use Valid
JJG 18-2002RFQ ASK 3 days The tobacco special breathable degrees flow disk test procedures Obsolete
JJG 18-1990399 Add to Cart 3 days Verification Regulation of Glass Syringes for Medical Use Obsolete
JJG 18-1980RFQ ASK 3 days (Chinese Industry Standard) Obsolete

Similar standards

GB/T 36126   JJG 139   GB/T 1885   JJG 13   JJG 17   JJG(YC)18   

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: 24,218
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Older Standard (superseded by this standard): JJG 18-1990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
Regulation (derived from): ?AQSIQ Announcement 2008 No.112
Issuing agency(ies): General 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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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.
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