Product: Spinal Needle. Zhejiang Runqiang Medical Instruments Co., Ltd

Transcription

1 Product: Spinal Needle Zhejiang Runqiang Medical Instruments Co., Ltd Parameter Method Specification Product Description - The product spinal needle is made up of three parts: - Spinal needle (needle tube + needle hub) - Stylet (stylet blade + button) - Sheath There are two different types of spinal needles available: Spinal Needle Type I: Quincke needle (AN-SI) [Source: Design dossier of anaesthesia needle and anaesthesia kit CE/AS Zhejiang Runqiang Medical Co., Ltd.) Spinal Needle Type II: Pencil point needle (AN-SII) Intended Use MDD 93/42/EEC Risk Class MDD 93/42/EEC UMDNS-Code Manufacturing date - YYYY/MM Expiry Date - YYYY/MM Sterility EN ISO EN ISO EN ISO [Source: Design dossier of anaesthesia needle and anaesthesia kit CE/AS Zhejiang Runqiang Medical Co., Ltd.) For regional anaesthesia involving injection of local anaesthetic into subarachnoid space (subarachnoid block) in clinics. Class III, rule 6 Sterile by EO Gas Shelf Life EN ISO years EN ISO Cytotoxicity ISO Product + packaging: Viability 70 % Sensitization ISO Product + packaging: No visible change Irritation or intracutaneous ISO Product + packaging: No erythema, no oedema reactivity Acute Systemic Toxicity ISO Product: Normal, no symptoms Bacterial Endotoxins GB/T < 2.15 EU/product EO-Residuals ISO < 0.1 mg Limits for acidity and alkalinity ISO 9626 Annex A 0.04 ml Sodium Hydroxide or 0.12 ml Hydrochloric Acid 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 1 von 14

2 Product: Spinal Needle Zhejiang Runqiang Medical Instruments Co., Ltd Parameter Method Specification Shelf Life ISO years ISO Batch numbers - Printed as variable data on primary, secondary and tertiary packing 4 figures YYYY taken from purchase confirmation XXX/0YYYY adding 2 figures AA as running no. starting with 01 batch no.: YYYYAA Generation of Analytical Certificates - Where definite figures are applicable statements like complies are not acceptable. Storage Conditions ISO Not allowed to pressed under heavy load 2. No direct sun 3. To be stored dry (away from rain and snow) 4. Soft handling during transportation 5. Stored in cool, dry (humidity < 80%), well-ventilated and clean place 6. Stored free of caustic gases Components: [Source: Design dossier of anaesthesia needle and anaesthesia kit CE/AS Zhejiang Runqiang Medical Co., Ltd.) Materials - Needle tube & stylet blade: 304 stainless steel Hub: K-resin Button: ABS Sheat: PP L1 Effective needle length in mm YY For Spinal Needle Type I: L2 Overall needle length in mm L3 Sheath length in mm (Definition of L1, L2, L3 see Appendix II: Technical Drawings) L1 (+/- 1mm) L2 (+/- 1mm) For Spinal Needle Type II: L1 (+/- 1mm) L2 (+ 0.3/ - 0.5mm) L3 (+ 8/ - 2mm) L3 (+ 8/ - 2mm) 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 2 von 14

3 Product: Spinal Needle Zhejiang Runqiang Medical Instruments Co., Ltd Parameter Method Specification Outer diameter needle tube in G/ mm ISO 9626:1991 In mm to the nearest 0.05mm for O.D. < 0.6mm In mm to the nearest 0.1mm for O.D. 0.6mm Spinal Needle Type I OD in G OD in mm OD Tolerances in mm Inner diameter needle tube in mm ISO 9626:1991 Spinal Needle Type II OD in G OD in mm OD Tolerances in mm Spinal Needle Type I OD OD ID IDmin Specification [G] [mm] [mm] [mm] Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled Spinal Needle Type II OD OD ID IDmin Specification [G] [mm] [mm] [mm] Thin-walled Thin-walled Thin-walled Thin-walled Thin-walled 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 3 von 14

4 Product: Spinal Needle Zhejiang Runqiang Medical Instruments Co., Ltd Parameter Method Specification Thin-walled Thin-walled Needle tube BS / ISO 9626: Tubing made from austenitic stainless steel in accord. with ISO9626: straight - regular cross section - regular wall thickness - free from defects - smooth - no impurities - should be parallel: Deviation max. +/- 15 Needle point BS no cutting edges around inner aspect of the bevel (only applicable for Spinal Needle Type I) - tip should be burr free, no flat head and no hook Needle deflection/ stiffness Needle toughness/ resistance to breakage ISO 9626:1991 Annex C ISO 9626:1991 Annex D Designated metric size in mm Span in mm +/- 0.1 Bending force in N +/ Designated metric size in mm Distance between rigid support and point of application of bending force in mm +/ Bending Angle Max. deflection in mm No breakage during 20 cycles of reversal force at a rate 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 4 von 14

5 Product: Spinal Needle Zhejiang Runqiang Medical Instruments Co., Ltd Parameter Method Specification of 0.5 Hz with above parameters. Flow-rate through needle Spinal Needle Type II YY For O.D. > 0.5 mm: 6 ml/min For O.D mm: 3 ml/min Flow for Spinal Needle Type II Needle hub BS With female 6% luer taper conical fitting - Tapered pin connector blocks shall comply with the requirements of ISO594-1 or ISO No edge, plastic flow, bubbles and other defects Connection between Needle and Needle Hub YY Has to withstand: OD = mm: 20 N for 10 s OD = mm: 30 N for 10 s OD = mm: 45 N for 10 s Groove for location of the Stylet - Present Button Needle stylet - Consisting of button and stylet blade Needle stylet button designed with tongue for fixing position with needle hub Shall not protrude from the needle point Shall fill the lumen of the needle completely to avoid coring Connection between Needle Stylet Button and Blade Corrosion resistance (requirement for all metal parts) YY ISO 9626:1991 Annex E Has to withstand: Tensile Strength: OD < 0.5 mm: 5 N for 10 s OD mm: 10 N for 10 s OD > 1.0 mm:15 N for 10 s Compressive Force: NONE No visible signs of corrosion Particle pollution 5 µm particles: max. 100 particles/ ml eluent Colour Coding Outer diameter in G Colour Needle Hub/ Needle Sty et Button 27 Med-grey 26 B own 25 Orange 24 Purple 23 Deep blue 22 Black 21 Dark green 20 Yellow 19 Cream 18 Pink 17 Red-purple 16 White 15 Blue-gray Metal Ions GB/T Pb 5 µg/ml Cd 0.1 µg/ml ph GB/T ph = max. 1.0 EO-residuals - 0.1mg/ml 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 5 von 14

6 Product: Spinal Needle Zhejiang Runqiang Medical Instruments Co., Ltd Parameter Method Specification Primary Packaging Material ISO Poly-Paper-Pouch: Tyvek Dimensions ISO mm Layout / Printing EN 980 EN 1041 Material - Label printed in paper side - Accord. to latest HELM Layout - Colour: Blue (Pantone 294C) and Black - Printing is clean, straight and legible Secondary Packaging Paper box: ivory board Dimensions n/a mm Layout / Printing EN Accord. to latest HELM Layout EN Colour: Blue (Pantone 294C) and Black No. of blisters in one inner carton n/a - Printing is clean, straight and legible 50 pouches/ paper box Tertiary Packaging Material Export box: Double Wall+ kraft Dimensions n/a mm Layout / Printing EN 980 EN 1041 No. of inner cartons in one master carton No. of blisters in one master carton n/a n/a - Accord. to latest HELM Layout - Colour: Blue (Pantone 294U) and Black - Printing is clean, straight and legible 20boxes 1000pcs Annex 1: Product Range HELM Medical GmbH Spinal Needle Type I Product Specification Spinal Needle Type I, 27G, 38mm WWS-Code HMC Product Code Runqiang 20001P Spinal Needle Type I, 27G, 58mm 20002P Spinal Needle Type I, 27G, 75mm 20003P Spinal Needle Type I, 27G, 88mm 20004P Spinal Needle Type I, 27G, 100mm 20005P Spinal Needle Type I, 27G, 110mm 20006P Spinal Needle Type I, 27G, 120mm 20007P 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 6 von 14

7 Spinal Needle Type I, 26G, 38mm Spinal Needle Type I, 26G, 58mm Spinal Needle Type I, 26G, 75mm Spinal Needle Type I, 26G, 88mm Spinal Needle Type I, 26G, 100mm Spinal Needle Type I, 26G, 110mm Spinal Needle Type I, 26G, 120mm Spinal Needle Type I, 25G, 38mm Spinal Needle Type I, 25G, 58mm Spinal Needle Type I, 25G, 75mm Spinal Needle Type I, 25G, 88mm Spinal Needle Type I, 25G, 100mm Spinal Needle Type I, 25G, 110mm Spinal Needle Type I, 25G, 120mm Spinal Needle Type I, 24G, 38mm Spinal Needle Type I, 24G, 58mm Spinal Needle Type I, 24G, 75mm Spinal Needle Type I, 24G, 88mm Spinal Needle Type I, 24G, 100mm Spinal Needle Type I, 24G, 110mm Spinal Needle Type I, 24G, 120mm Spinal Needle Type I, 23G, 38mm Spinal Needle Type I, 23G, 58mm Spinal Needle Type I, 23G, 75mm Spinal Needle Type I, 23G, 88mm 20008P 20009P 20010P 20011P 20012P 20013P 20014P 20015P 20016P 20017P 20018P 20019P 20020P 20021P 20022P 20023P 20024P 20025P 20026P 20027P 20028P 20029P 20030P 20031P 20032P 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 7 von 14

8 Spinal Needle Type I, 23G, 100mm Spinal Needle Type I, 23G, 110mm Spinal Needle Type I, 23G, 120mm Spinal Needle Type I, 22G, 38mm Spinal Needle Type I, 22G, 58mm Spinal Needle Type I, 22G, 75mm Spinal Needle Type I, 22G, 88mm Spinal Needle Type I, 22G, 100mm Spinal Needle Type I, 22G, 110mm Spinal Needle Type I, 22G, 120mm Spinal Needle Type I, 21G, 38mm Spinal Needle Type I, 21G, 58mm Spinal Needle Type I, 21G, 75mm Spinal Needle Type I, 21G, 88mm Spinal Needle Type I, 21G, 100mm Spinal Needle Type I, 21G, 110mm Spinal Needle Type I, 21G, 120mm Spinal Needle Type I, 20G, 38mm Spinal Needle Type I, 20G, 58mm Spinal Needle Type I, 20G, 75mm Spinal Needle Type I, 20G, 88mm Spinal Needle Type I, 20G, 100mm Spinal Needle Type I, 20G, 110mm Spinal Needle Type I, 20G, 120mm Spinal Needle Type I, 19G, 38mm 20033P 20034P 20035P 20036P 20037P 20038P 20039P 20040P 20041P 20042P 20043P 20044P 20045P 20046P 20047P 20048P 20049P 20050P 20051P 20052P 20053P 20054P 20055P 20056P 20057P 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 8 von 14

9 Spinal Needle Type I, 19G, 58mm Spinal Needle Type I, 19G, 75mm Spinal Needle Type I, 19G, 88mm Spinal Needle Type I, 19G, 100mm Spinal Needle Type I, 19G, 110mm Spinal Needle Type I, 19G, 120mm Spinal Needle Type I, 18G, 38mm Spinal Needle Type I, 18G, 58mm Spinal Needle Type I, 18G, 75mm Spinal Needle Type I, 18G, 88mm Spinal Needle Type I, 18G, 100mm Spinal Needle Type I, 18G, 110mm Spinal Needle Type I, 18G, 120mm Spinal Needle Type I, 17G, 38mm Spinal Needle Type I, 17G, 58mm Spinal Needle Type I, 17G, 75mm Spinal Needle Type I, 17G, 88mm Spinal Needle Type I, 17G, 100mm Spinal Needle Type I, 17G, 110mm Spinal Needle Type I, 17G, 120mm Spinal Needle Type I, 16G, 38mm Spinal Needle Type I, 16G, 58mm Spinal Needle Type I, 16G, 75mm Spinal Needle Type I, 16G, 88mm Spinal Needle Type I, 16G, 100mm 20058P 20059P 20060P 20061P 20062P 20063P 20064P 20065P 20066P 20067P 20068P 20069P 20070P 20071P 20072P 20073P 20074P 20075P 20076P 20077P 20078P 20079P 20080P 20081P 20082P 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 9 von 14

10 Spinal Needle Type I, 16G, 110mm Spinal Needle Type I, 16G, 120mm Spinal Needle Type I, 15G, 38mm Spinal Needle Type I, 15G, 58mm Spinal Needle Type I, 15G, 75mm Spinal Needle Type I, 15G, 88mm Spinal Needle Type I, 15G, 100mm Spinal Needle Type I, 15G, 110mm Spinal Needle Type I, 15G, 120mm 20083P 20084P 20085P 20086P 20087P 20088P 20089P 20090P 20091P Spinal Needle Type II Product Specification Spinal Needle Type II, 27G, 75mm WWS-Code HMC Product Code Runqiang 30001P Spinal Needle Type II, 27G, 88mm 30002P Spinal Needle Type II, 27G, 100mm 30003P Spinal Needle Type II, 27G, 110mm 30004P Spinal Needle Type II, 27G, 120mm 30005P Spinal Needle Type II, 26G, 75mm 30006P Spinal Needle Type II, 26G, 88mm 30007P Spinal Needle Type II, 26G, 100mm 30008P Spinal Needle Type II, 26G, 110mm 30009P Spinal Needle Type II, 26G, 120mm 30010P Spinal Needle Type II, 25G, 75mm 30011P Spinal Needle Type II, 25G, 88mm 30012P Spinal Needle Type II, 25G, 100mm 30013P 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 10 von 14

11 Spinal Needle Type II, 25G, 110mm Spinal Needle Type II, 25G, 120mm Spinal Needle Type II, 24G, 75mm Spinal Needle Type II, 24G, 88mm Spinal Needle Type II, 24G, 100mm Spinal Needle Type II, 24G, 110mm Spinal Needle Type II, 24G, 120mm Spinal Needle Type II, 23G, 75mm Spinal Needle Type II, 23G, 88mm Spinal Needle Type II, 23G, 100mm Spinal Needle Type II, 23G, 110mm Spinal Needle Type II, 23G, 120mm Spinal Needle Type II, 22G, 75mm Spinal Needle Type II, 22G, 88mm Spinal Needle Type II, 22G, 100mm Spinal Needle Type II, 22G, 110mm Spinal Needle Type II, 22G, 120mm Spinal Needle Type II, 21G, 75mm Spinal Needle Type II, 21G, 88mm Spinal Needle Type II, 21G, 100mm Spinal Needle Type II, 21G, 110mm Spinal Needle Type II, 21G, 120mm Spinal Needle Type II, 20G, 75mm Spinal Needle Type II, 20G, 88mm Spinal Needle Type II, 20G, 100mm 30014P 30015P 30016P 30017P 30018P 30019P 30020P 30021P 30022P 30023P 30024P 30025P 30026P 30027P 30028P 30029P 30030P 30031P 30032P 30033P 30034P 30035P 30036P 30037P 30038P 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 11 von 14

12 Spinal Needle Type II, 20G, 110mm Spinal Needle Type II, 20G, 120mm 30039P 30040P Appendix II: Technical Drawings Spinal Needle Type I: 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 12 von 14

13 Remark: Lengths parameters, including tolerances, are valid for all Gauge-sizes! Spinal Needle Type II: 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 13 von 14

14 Remark: Lengths parameters, including tolerances, are valid for all Gauge-sizes! 10/VA/07/AH Gültig ab Bereitstellung im Dokumentenmanagementsystem Seite 14 von 14