TECHNICAL DATA SHEET Plastipak Syringes Without Needles .

Transcription

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comTECHNICAL DATA SHEETBD Plastipak syringes without needles andBD General Syringes without needleSterile, Single Use, Latex free1. General Information1.1 GeneralBD Plastipak syringes are used for general purpose injection and aspiration of fluids from vials,ampoules and parts of the body below the surface of the skin. Perfusion syringes, 50ml syringes,are designed for short term use in syringe pumps (active IIa devices) for the administration ofpharmaceuticals. The 50 ml Catheter Tip Syringes have a long tapered tip designed to aid inirrigation or for connection to non-ISO compatible Luer connections such as nasogastric tubes.DEAD SPACE (maximum, without needle) (except for catheter tip syringes)SYRINGE SIZEDead Space1 ml0.07 l50ml0.20ml100ml0.20ml

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016LUER SLIP 7300605309654Capacity1 ml1 ml1 ml1 ml1 ml1 ml2/ 2.5 ml5 ml10 ml20 ml20 ml30 ml50/ 60 ml50/ 60 ml100 ml60mlDescriptionInsulin 40 I.U.Insulin 100 I.U.Insulin 100 I.U.Insulin 40 I.U.Central coneCentral coneCentral coneCentral coneEccentric coneEccentric coneEccentric coneEccentric coneEccentric coneCatheter tipCatheter tip with Luer adaptorSlip tipScale GraduationInternational unitsInternational unitsInternational unitsInternational units0.01 ml0.01 ml0.1 ml0.2 ml0.5 ml1 ml1 ml1 ml1 ml1 ml2 ml1 mlBox ase 0160Scale Graduation1 ml1 ml1 ml1 ml1 ml1 ml1 ml0.01 ml0.1ml0.2ml0.2ml0.2ml1 mlBox (units)60120606050504010020012510010060Case (units)240480240240100100160800800500400400240LUER LOK city20 ml20 ml30 ml50/60 ml50 ml50 ml60ml1 ml3ml5ml10ml10ml50/ 60 mlDescriptionLuer Lok Luer Lok Luer Lok Luer Lok Luer Lok PerfusionLuer Lok Perfusion AmberLuer Lok Luer Lok Luer Lok Luer Lok Luer Lok Luer Lok Luer Lok AMBER*305959 will be preferred to supply to European customers as this catalogue number of 10ml Luer Lok Plastipakis manufactured in Europe.This document is approved electronicallyThis document can be changed without further notificationPage 2 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20161.2 09653309654BDMANUFACTURERBecton Dickinson &Company LimitedDonore RoadDroghedaCo. LouthIrelandISOCERTIFICATIONNSAI - CertificateMD 19.1609 I.S. ENISO 13485:2012Becton DickinsonS.A. - Camino deValdeoliva, s/n.28750, San Agustindel Guadalix (Madrid)SpainAENOR –N. ER0264/1994 – ISO9001:2008;Becton, Dickinsonand Company1 Becton DriveFranklin Lakes, NJ07417, USANSAI - ISO9001 :20008CertificateMD19.2305CE MARKINGNSAI NB no0050: CertifícateN 252.156BD MANUFACTURINGSITEBecton Dickinson S.A. Camino de Valdeoliva, s/n.28750, San Agustin delGuadalix (Madrid) SpainAEMPS 0318:Certifícate N 2000 06 0273CPBecton Dickinson S.A. Camino de Valdeoliva, s/n.28750, San Agustin delGuadalix (Madrid) SpainNSAI 0050:Certifícate N 252.231Becton, Dickinson andCompanyRoute 7 & Grace Way,Canaan CT 06018USAAEMPS N. 2012 070013 EN - EN – ISO13485:2013NSAI ISO13485 :2012CertificateMD19.2305*Catalogue number 309628 used to be manufactured in BD Singapore Branch, 30 Tuas Avenue 2, Singapore 639461.No changes to form, fit or function when transferred to BD Canaan.This document is approved electronicallyThis document can be changed without further notificationPage 3 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20161.3 MaterialCOMPONENTMATERIALSYRINGEBarrels, plunger rodsPOLYPROPYLENEBarrel cat# 309628POLYCARBONATEStoppersLATEX FREE ELASTOMER2LubricantMEDICAL GRADE SILICONE OIL, 0.25 mg/cmAMBER syringes have the barrel colored to reduce U.V. light; for administration of light sensitive medicationsPACKAGINGWeb packagingInkBoxPOLYAMIDE/POLYETHYLENE, PAPER WITH MEDICAL GRADEPrinting InkHARD PAPER1.4 Material of concernMaterials of concern are chemicals or substances that have been identified as having the potentialto cause long term effects on humans or the environment.MATERIALPhthalatesLatexBisphenol ASubstances of animalorigin BSE/TSEPolyvinyl chloride (PVC)COMMENTThe products do not contain phthalates in general and as such the products do not containdi (2ethylhexyl) phthalate DEHP as CAS number 117-81-7, EC number 204-211-0.The products do not contain natural latex.The products do not contain Bisphenol A.Catalogue number 309628 contain polycarbonate and hence Bisphenol AThe products do use industrial raw materials which contain small amounts of tallow ortallow derivatives (e.g. stearates in polymers). Such substances are not considered asderivatives of animal tissues for the purpose of this rule (EU regulation 722/2012) whichtherefore does not applyThe products do not contain polyvinyl chloride1.5 REACH informationBased on information available and BD’s continuous data collection efforts throughout the supplychain, BD have not identified any chemicals in the articles and packaging with the ProductNumbers as referenced above, in an individual concentration above 0.1% weight by weight(w/w), which have been listed as SVHC and included in the "Candidate List" published by theEuropean Chemical Agency (ECHA. The substances published in such list are candidates foreventual inclusion in the List of Substances Subject to Authorization (Annex XIV of REACH).1.6 BiocompatibilityBD Medical products comply with the requirements of the standard for biocompatibility ofmedical devices, ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting.This document is approved electronicallyThis document can be changed without further notificationPage 4 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20161.7 Sterilization Ethylene Oxide Sterilization following EN ISO 11135-1. ETO residues are withinapplicable regulations. All references except references below are sterilized with EO Radiation Sterilization following EN ISO 11137-1 References sterilized with radiation:309628, 309658, 309649, 300910, 300911, 300912, 309653 and 309654.1.8 Shelf lifeShelf life 5 yearsNo special storage or transportation condition. Recommendations to store in room temperature.Store in dry and warm place and not exposed to strong light.1.9 StandardsHARMONISED STANDARDSSterilisation of Medical Devices – requirements for medical devices to be labelledEN 556-1:2001/ AC:2006“sterile”.EN 980: 2008Graphical Symbols for use in the labelling of medical devices.Terminology, symbols and information provided with medical devices. InformationBS EN 1041 A1: 2013supplied by the manufacturer with medical devicesConical fittings with a 6 % (Luer) taper for syringes, needles and certain other medicalEN 1707:1996equipment - Lock fittingsEN 20594Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical1:1993/AC:1996equipment - Part 1: General requirementsEN IS010993-seriesBiological evaluation of medical devicesSterilization of health care products - Ethylene oxide - Part 1: Requirements forEN ISO 11135-1:2007development, validation and routine control of a sterilization process for medicaldevicesEN ISO 11137-1EN ISO 11137-2EN ISO 11138-2:2009EN ISO 11607-1:2009EN ISO 11607-2:2006EN ISO 117371:2006/AC:2009EN ISO 11737-2:2009Sterilization of health care products - Radiation. Part1.Requirements for development,validation and routine control of sterilization process for medical devicesSterilization of health care products – Radiation. Part2. Establishing the sterilizationdoseSterilization of health care products - Biological indicators - Part 2: Biological indicatorsfor ethylene oxide sterilization processesPackaging for terminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging systemsPackaging for terminally sterilized medical devices - Part 2: Validation requirements forforming, sealing and assembly processesSterilization of medical devices - Microbiological methods - Part 1: Determination of apopulation of microorganisms on productsSterilization of medical devices - Microbiological methods - Part 2: Tests of sterilityperformed in the definition, validation and maintenance of a sterilization process (ISO11737-2:2009)This document is approved electronicallyThis document can be changed without further notificationPage 5 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016HARMONISED STANDARDS, continueEN ISOMedical devices – Quality management Systems Requirements for Regulatory13485:2012/AC:2012PurposesEN ISO 14155:2011Clinical investigation of medical devices for human subjects - Good clinical practiceEN ISO 14971:2012Medical Devices. Application of risk management to medical devicesNON HARMONISED STANDARDIS EN ISO 7864-1: 1996Sterile hypodermic needles For Single UseIS EN ISO 7886-1:1998Sterile hypodermic syringes For Single use - Part 1:Syringes for manual useSterile Hypodermic Syringes for Single Use. Part 2: Syringes for Use with PowerEN ISO 7886-2:1998Driven Syringe Pumps.See notes 2 and 3 belowConical fittings with a 6% (Luer) taper for syringes, needles and certain other medicalISO 594-1:1993equipment - Part 1: General requirementsConical fittings with 6 % (Luer) taper for syringes, needles and certain other medicalISO 594-2:1998equipment -- Part 2: Lock fittingsISO 9626: 1995Stainless steel needle tubing for the manufacture of medical devicesMedical devices – Quality management Systems Requirements for RegulatoryISO 13485:2003PurposesCleanrooms and associated controlled environments Part 1: Classification of airISO 14644-1:1999cleanlinessSterilisation of Medical Devices – requirements for medical devices to be labelledISO 15223-1:2012“sterile”.ISO 10993-2:2009Biological Evaluation of Medical Devices Part 2Biological evaluation of medical devices - Part 10: Tests for irritation and delayedISO10993-10:2009type hypersensitivitySampling procedures for inspection by attributes -- Part 1: Sampling schemesISO 2859-1:1999indexed by acceptance quality limit (AQL) for lot-by-lot inspectionINSULIN GRADUATED SYRINGE ALSO MEETS ISO 8537 Sterile single-use syringes, with or withoutneedle, for insulin1.10 Classification Class I Sterile with a measuring function (syringes from 1 to 10 ml) Medical Deviceunder Rule 2, Annex IX of Medical Devices Directive 93/42/EEC as amended. Class IIa (syringes from 20 to 50 ml) Medical Device under Rule 2, Annex V and VII IXof Medical Devices Directive 93/42/EEC as amended.1.11 GMDN codeGMDN code 47017: General purpose syringes.This document is approved electronicallyThis document can be changed without further notificationPage 6 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20161.12 Good Manufacturing practicesThe entire manufacturing and testing processes are following the Good Manufacturing Practicesas specified below Incoming raw materials are verified via material inspection and testing and our suppliersare approved via our vendor management system. In addition to the automatic on-line inspections, in-process inspections are performed inaddition to final product testing to ensure compliance with approved specifications. The manufacturing and testing details of each batch of product are recorded on a batchrecord which is retained in accordance with our document control procedures BD operates a system of Internal and external audits to maintain compliance BD confirms that it will continue to adhere to relevant international standards in designingand manufacturing its products. BD reserves the right to use the internal change control procedure to change raw materialsuppliers and production process1.13 Others The EU representative, for syringes which BD Manufacturer is Becton, Dickinson andCompany, 1 Becton Drive, Franklin Lakes, NJ 07417, USA, is Becton DickinsonDistribution Center, Laagstraat 57, B-9140 Temse -Belgium. Other syringes are producedby a European manufacturer. (Material) Safety Data Sheets are not required for this product Certificate of Food Contact (COMMISSION REGULATION (EU) No. 10/2011 of January14th, 2011 concerning materials and plastic objects intended to get in touch withfoodstuffs) is not required as BD products are used for general purpose injection andaspiration of fluids from vials, ampoules and parts of the body below the surface of theskin.This document is approved electronicallyThis document can be changed without further notificationPage 7 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20162. Packaging2.1 Packaging materialLABELS: according to European Medical Device directive, multilingual2.2 Example labelingLegal Manufacturer and manufacturing site: San Agustin del GuadalixExample Unit pack cat.no 301355Example Shelf box label cat.no 301355This document is approved electronicallyThis document can be changed without further notificationPage 8 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Shelf box graphicsThis document is approved electronicallyThis document can be changed without further notificationPage 9 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Legal Manufacturer: Drogheda/ Manufacturing site San Agustin del GuadalixExample Unit pack cat.no 300867Example Shelf box label cat.no 300867This document is approved electronicallyThis document can be changed without further notificationPage 10 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Shelf box graphicsThis document is approved electronicallyThis document can be changed without further notificationPage 11 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Legal Manufacturer: Franklin Lakes, Manufacturing site CanaanExample Unit pack cat.no 309628Exmaple Shelf box label cat.no 309628This document is approved electronicallyThis document can be changed without further notificationPage 12 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Shelf box ----------------------end of ----------This document is approved electronicallyThis document can be changed without further notificationPage 13 of 13

EN ISO 14971:2012 Medical Devices. Application of risk management to medical devices NON HARMONISED STANDARD IS EN ISO 7864-1: 1996 Sterile hypodermic needles For Single Use IS EN ISO 7886-1:1998 Sterile hypodermic syringes For Single use - Part 1:Syringes for manual use EN ISO