J i m c o I n d u s t r i e s
|
|
|
- Susanna Perkins
- 6 years ago
- Views:
Transcription
1 Page. # 3 DEVICE SPECIFICATION /DATA SHEET INTODUCTION This document considers the requirements of technical documentation/ Device Master ecord/ Product Specifications to satisfy the applicable requirements of Medical Device Directive number 93/42/EEC as amended up to Directive 2007/47/EC and the applicable clauses of ISO 13485: 2003, Good Manufacturing Practice (GMP)/Quality System egulation (QS) and other applicable international standards. 4.0 Name and Address of the Manufacturer 4.1. Manufacturer:, 4-Km, Aimen Abad oad, Near Akbar Abad Chowk, Sialkot, Pakistan 4.2. Authorized epresentative : Healthcare UK, 16 Devonshire oad, Middlesbrough TS5 6DP, London, UK. 5.0 Name and Address of the facilities 5.1 Manufacturer:, (Same as above) 4-Km, Aimen Abad oad, Near Akbar Abad Chowk, Sialkot, Pakistan
2 Page. # 4 NUMBE OF DEVICES SPECIFICATION:- 03- BIEF INTENDED USE:- SEE BELOW COLUMN FO EACH DECEIVE. Class:- ule #:- Justification IIA 6 Single use Surgically invasive transient use FAMILY:- NEEDLE HOLDES JUSTIFICATION:- SINGLE USE SUGICALLY INVASIVE TANSIENT USE Art Numbers Common / Usual Name Classification & relevant rule ule# Class Justification Intended use (brief description of the devices) eference to Manufacturing procedure/ Method AF D Single Use MAYO-HEGA NEEDLE HOLDE 14CM Made of stainless steel of Grade- 410 HOLD AND PASS THE NEEDLE Single use Surgically 6 Iia THOUGH THE TISSUE WHILE invasive transient use JI/CE/FCP2 SUTUING AF D Single Use MAYO-HEGA NEEDLE HOLDE 16CM Made of stainless steel of Grade Iia Single use Surgically invasive transient use HOLD AND PASS THE NEEDLE THOUGH THE TISSUE WHILE SUTUING JI/CE/FCP2 AF D Single Use CILE WOOD NEEDLE HOLDE 15CM Made of stainless steel of Grade IIa Single use Surgically invasive transient use HOLD AND PASS THE NEEDLE THOUGH THE TISSUE WHILE SUTUING JI/CE/FCP2
3 Page. # 5 DEVICE SPECIFICATION /DATA SHEET Common / Usual Name STEILE MAYO-HEGA NEEDLE HOLDE 14CM STAINLESS STEEL - (DISPOSABLE METAL STEILE INSTUMENTS) Family :- NEEDLE HOLDE / Material:- AISI 410 / Hardness: 40 TO 44 HC. Components:- 02 / Products Weight :- 30 TO 40 Grm Appox Code:- AF D Size:- 14.0cm / STAIGHT Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- SINGLE USE SUGICALLY INVASIVE TANSIENT USE Intended Use:- HOLD AND PASS THE NEEDLE THOUGH THE TISSUE WHILE SUTUING eference To Manufacturing Procedure:- JI/CE/FCP2 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: cm Symbol To Be Used On Packing :- PEEL Harmonized Standards:- Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE ISO , EN ISO :2006, ISO ISO ,EN ISO :2006, ISO 14644
4 Page. # 6 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN NEEDLE HOLDE Detail of Material for Non Cutting Instruments GADE-410 Composi on of aw Material stainless steel to 0.15 % 0.040% maximum 0.030% maximum 11.5% to 13.5% Code AF D Material Type AISI 410 AISI 304 AISI 420 Customer Code evision No Date Description Type-Single Use Product: Mayo-Hegar needle holder - 14cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: Fax: ISO Certified info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A: Departmet xx Approved By x Managing Director
5 Page. # 7 DEVICE SPECIFICATION /DATA SHEET Common / Usual Name STEILE MAYO-HEGA NEEDLE HOLDE 16CM STAINLESS STEEL - (DISPOSABLE METAL STEILE INSTUMENTS) Family :- NEEDLE HOLDE / Material:- AISI 410 / Hardness: TO 44 HC. Components:- 02 / Products Weight :- 35 TO 45 Grm Appox Code:- AF D Size:- 16.0cm / STAIGHT Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- SINGLE USE SUGICALLY INVASIVE TANSIENT USE Intended Use:- HOLD AND PASS THE NEEDLE THOUGH THE TISSUE WHILE SUTUING eference To Manufacturing Procedure:- JI/CE/FCP2 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: cm Symbol To Be Used On Packing :- PEEL Harmonized Standards:- Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE ISO , EN ISO :2006, ISO ISO ,EN ISO :2006, ISO 14644
6 Page. # 8 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN NEEDLE HOLDE Detail of Material for Non Cutting Instruments GADE-410 Composi on of aw Material stainless steel to 0.15 % 0.040% maximum 0.030% maximum 11.5% to 13.5% Code AF D Material Type AISI 410 AISI 304 AISI 420 Customer Code evision No Date Description Type-Single Use Product: Mayo-Hegar needle holder - 16cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: Fax: ISO Certified info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A: Departmet xx Approved By x Managing Director
7 Page. # 9 DEVICE SPECIFICATION /DATA SHEET Common / Usual Name STEILE CILE WOOD NEEDLE HOLDE 15CM STAINLESS STEEL - (DISPOSABLE METAL STEILE INSTUMENTS) Family :- NEEDLE HOLDE / Material:- AISI 410 / Hardness: TO 44 HC. Components:- 02 / Products Weight :- 30 TO 40 Grm Appox Code:- AF D Size:- 15.0cm / STAIGHT Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- SINGLE USE SUGICALLY INVASIVE TANSIENT USE Intended Use:- HOLD AND PASS THE NEEDLE THOUGH THE TISSUE WHILE SUTUING eference To Manufacturing Procedure:- JI/CE/FCP2 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: cm Symbol To Be Used On Packing :- PEEL Harmonized Standards:- Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE ISO , EN ISO :2006, ISO ISO ,EN ISO :2006, ISO 14644
8 Page. # 10 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN NEEDLE HOLDE Detail of Material for Non Cutting Instruments GADE-410 Composi on of aw Material stainless steel to 0.15 % 0.040% maximum 0.030% maximum 11.5% to 13.5% Code AF D Material Type AISI 410 AISI 304 AISI 420 Customer Code evision No Date Description Type-Single Use Product: Crile wood needle holder 15cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: Fax: ISO Certified info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A: Departmet xx Approved By x Managing Director
TECHNICAL DATA SHEET BD Emerald Syringe with and without needle Sterile, Single Use, Latex free
BD Sàrl TECHNICAL DATA SHEET BD Emerald Syringe with and without needle Sterile, Single Use, Latex free 1.0 General Information 1.1 General The BD Emerald syringe is a medical single use product for injection
Global provider of medical devices, plastics solutions and pharmaceutical systems. Guide Wires
Guide Wires 3 A Brief Introduction 4 Accoat Standard Guide Wire Seldinger 5 Accoat Standard Guide Wire Double ended Seldinger 6 Accoat Standard Guide Wire Movable 7 Accoat Standard Guide Wire Lunderquist
Global provider of medical devices, plastics solutions and pharmaceutical systems. Guide Wires
Guide Wires 3 A Brief Guide Wire Introduction 4 Accoat Guide Wire Seldinger 5 Accoat Guide Wire Double ended Seldinger 6 Accoat Guide Wire Movable 7 Accoat Standard Guide Wire Lunderquist PTC 8 Accoat
SITE MASTER FILE For MHRA
ABC CO., LTD. For MHRA Prepared by Date Approved by Date Verified by Date Document No.: SMF, Version No: 01, Effective Date: 09/05/06 Document No.: SMF Version No.: 01 Effective Date: 09/05/06 Page 2 of
The challenges of software medical device regulation.
The challenges of software medical device regulation. david.grainger@mhra.gov.uk Introduction A brief history of software device regulation A look at the new device regulations 2 Current framework In Vitro
Implications of the new MDR from a Product Testing and Certification Perspective
Implications of the new MDR from a Product Testing and Certification Perspective Helping You to Access Global Markets FAST and PREDICTABLY www.test-medical-devices.com 1 Hans Gerd Evering MDR - Implications
EU MDR 10 Things Packaging Engineers Should Know
EU MDR 10 Things Packaging Engineers Should Know networkpartners.com NUMBER ONE THE TIME FOR ACTION IS NOW First, some background: The EU Medical Device Regulation (MDR) was approved by the European Parliament
APPLICATION PACKET. Professional Use Waiver
Professional Use Waiver InnoPen InnoPen (Microneedle Therapy System ) is a skin treatment device designed and manufactured by - Clinical Resolution Laboratory, Inc. (a California corporation). All InnoPen
REFERENCE CAPACITY TIP SCALE BOX (UNITS) CASE (UNITS)
BD Medical The Danby Building Edmund Halley Road Oxford Science Park Oxford, Oxfordshire, OX4 4DQ tel: +44 (0)1865 748844 fax: +44(0)1865 717313 www.bd.com TECHNICAL DATA SHEET BD Discardit II Syringe
Regulatory Framework for Medical Device
Regulatory Framework for Medical Device International Seminar Safety of Health Products French Ministry of Labour, Employment and Health Paris, 26 May 2011 Peter Bischoff-Everding European Commission EU
LARGE CAPACITY PHARMACEUTICAL AUTOCLAVES
LARGE CAPACITY PHARMACEUTICAL AUTOCLAVES www.eryigit.com.tr Our Vision Our vision is to make Eryiğit an example among its class on its way to become the first medical device manufacturer that comes to
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 EXECUTIVE SUMMARY Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part
SAUTER Declaration on materials and the environment
MD 21.700 SAUTER Declaration on materials and the environment Product Type Designation Product range Product group of eco-balance TUC Universal thermostat 2-point controllers / thermostats Controller Manufacturer
Manufacturers of specialist surgical instruments.
Manufacturers of specialist surgical instruments www.surgitrac.com www.surgitrac.com Welcome to Surgitrac Instruments It is envisaged that Surgitrac Instruments will double its capacity by 2020. Manufacturers
COLD STORAGE SOLUTIONS
COLD STORAGE SOLUTIONS +2 C TO +20 C / -40 C TO -80 C FOR THE PHARMACEUTICAL, BIOTECHNICAL INDUSTRY, HEALTH CARE ORGANISATIONS AND NGO S Arctiko engineering PROJECT ENGINEERING OF COLD STORAGE ROOMS FOR
Flash Back Function - During the insertion of the cannula, blood flow is visualized by blood flash back in the hub of the cannula.
BD Medical The Danby Building Edmund Halley Road Oxford Science Park Oxford, Oxfordshire, OX4 4DQ tel: +44 (0)1865 748844 fax: +44(0)1865 717313 www.bd.com TECHNICAL DATA SHEET BD Venflon Pro Safety IV
Part 1: Surgical instruments Materials. Metals. Instruments chirurgicaux Matériaux Partie 1: Métaux. Third edition
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 7153-1 Third edition 2016-10-01 Surgical instruments Materials Part 1: Metals Instruments chirurgicaux Matériaux Partie 1: Métaux Reference number
COMMISSION RECOMMENDATION. of XXX. on the audits and assessments performed by notified bodies in the field of medical devices
EUROPEAN COMMISSION Brussels, XXX [ ](2013) XXX draft COMMISSION RECOMMENDATION of XXX on the audits and assessments performed by notified bodies in the field of medical devices (Text with EEA relevance)
Notification of a Body in the framework of a technical harmonization directive
Notification of a Body in the framework of a technical harmonization directive From : Department of Health Medicines and Healthcare Products Regulatory Agency (MHRA) 151 Buckingham Palace Road, Victoria,
European Technical Assessment ETA-10/0415 of 25/02/2016
ETA-Danmark A/S Göteborg Plads 1 DK-2150 Nordhavn Tel. +45 72 24 59 00 Fax +45 72 24 59 04 Internet www.etadanmark.dk Authorised and notified according to Article 29 of the Regulation (EU) No 305/11 of
Standard and Directives on Medical Devices
Standard and Directives on Medical Devices Definition A Medical Device is identified by means of its INTENDED PURPOSE Intended to treat, prevent or control physiological characteristics of a living being
ASME AWS AISC API AISI DOT PED SELO NAT'L. BOARD
ASME AWS AISC API AISI DOT PED SELO NAT'L. BOARD 650 North Emerson Cambridge, Minnesota 55008 Nationwide (763) 689-3360 Arrow...The Plate Fabrication and Engineering Experts. The following pages present
Getinge HS66 Turbo Combi steam sterilizer for ordinary. Always with you
Getinge HS66 Turbo Combi steam sterilizer for ordinary and heat-sensitive goods Always with you 2 Getinge HS66 Turbo Combi lights on for the new generation sterilizers The new Getinge HS66 Turbo Combi
This document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 7153-1 Third edition 2016-10-01 Surgical instruments Materials Part 1: Metals Instruments chirurgicaux Matériaux Partie 1: Métaux Reference number ISO 7153-1:2016(E) ISO 2016
Changes to the Medical Devices Directive and affect on Manufacturers
TÜV Product Service Ltd Webinar 18 th November 2009 Changes to the Medical Devices Directive and affect on Manufacturers Henry Sibun Manager, Medical & Health Services UK CONTENTS / 1. Introduction 1.
UNICEF TECHNICAL REQUIREMENTS FOR MEDICAL DEVICES (MD)
UNICEF TECHNICAL REQUIREMENTS FOR MEDICAL DEVICES (MD) A. Background January 2019 UNICEF Technical requirements for Medical Devices are the requirements that suppliers need to comply with, and that products
Getinge HS55 Hospital sterilizer
Getinge HS55 Hospital sterilizer The most versatile, reliable and Easy-to-use hospital sterilizer in the world The Getinge HS55 is a fully automatic steam sterilizer. It has pre-set programs for the most
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards. 26 th September / V. Fischer / Rev. 01
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards 26 th September / V. Fischer / Rev. 01 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards
HANDLING OF WRIGHT DISPOSABLE PROPHECY ANKLE INSTRUMENTS
HANDLING OF WRIGHT DISPOSABLE PROPHECY ANKLE INSTRUMENTS 150870-0 English (en) The following languages are included in this packet: For additional information and translations please contact the manufacturer
2-110 mm 4-70 mm 4-50 mm 2-12 mm 4-14 mm 4-14 mm Dimensions- ground steel Bars: (round) 5-70 mm. (hexagon) (square) (hexagon) (square)
Dimensions - bright drawn mat. and free cutting steel Bars: (hexagon) (square) Coil mat: (hexagon) (square) 2-110 mm 4-70 mm 4-50 mm 2-12 mm 4-14 mm 4-14 mm Dimensions- ground steel Bars: 5-70 mm Dimensions-tolerances.
SUTURES. 9 Circuit Drive Hendon SA 5014 AUSTRALIA
D Y N E K SUTURES G L O B A L Marketing Division, Manufacturing Facility & Orders 9 Circuit Drive Hendon SA 5014 AUSTRALIA Postal Address PO Box 2346 Port Adelaide SA 5015 Telephone +618 8268 2033 Facsimile
Lotus handpiece Technical data sheet
Lotus handpiece Technical data sheet Manufacturer s details SRA Developments Bremridge Ashburton Devon, UK TQ13 7JX Intended use The Series 4 Lotus Coagulation and Cutting System is indicated for soft
DRUG DRAFT GUIDELINE FOR REGISTRATION OF MEDICAL DEVICES FOR HUMAN USE IN UGANDA, SEPTEMBER 2009
DRUG NATIONAL AUTHORITY DRAFT GUIDELINE FOR REGISTRATION OF MEDICAL DEVICES FOR HUMAN USE IN UGANDA, SEPTEMBER 2009 TABLE OF CONTENTS: 1 INTRODUCTION 2 DEFINITION OF MEDICAL DEVICE 3 SCOPE OF THE GUIDELINE
Stericool H 2 O 2. plasma sterilizers Affordable low temperature solution
Stericool H 2 plasma sterilizers Affordable low temperature solution Getinge Stericool H 2 plasma sterilizers Meeting everyday demands of the CSSD An affordable low temperature solution Since many components
Medical Device Software: A new challenge
Medical Device Software: A new challenge Daniela Luzi and Fabrizio Pecoraro National Research Council Institute for Research on Population and Social Policies, Rome Italy Main issues Q.1 Is a software
Part I General information
MD TECHNICAL FILE: INFORMATION TO PROVIDE IN THE FRAME OF AN INITIAL ASSESSMENT Directives 90/385/EEC and 93/42/EEC Annex III: EC Type-Examination Annex II.4: EC Design Examination In the case of an initial
PARBOND EPOXY & POLYURETHANE ADHESIVES
PARBOND EPOXY & POLYURETHANE ADHESIVES PARBOND Epoxy Adhesives Parson formulates wide range of epoxy adhesives for variety of industrial bonding, potting and sealing applications. These adhesives are approved
ISO Medical devices symbols to be used with medical device labels, labeling and information to be supplied Part 1: General requirements
Explanation of the symbols used on Dentsply Sirona Implants packaging Manufacturer Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. This symbol
POSITION PAPER Moving from the MDD to the MDR
A summary of Key Changes regarding Sterile Packaging and considerations on recommended changes to standards Introduction EN ISO 11607 specifies the requirements and test methods for materials, preformed
CARES Technical Approval Report TA1-B 5054
CARES Technical Approval Report TA1-B 5054 Issue 1 Shanxi Taigang Stainless Steel Standard Couplers Assessment of the Shanxi Taigang Stainless Steel Standard Coupler Product and Quality System for Production
BACKFLUSH INSTRUMENTS
BACKFLUSH INSTRUMENTS Versatility designed to handle all your surgical backflush needs. VitreQ a company of: About VitreQ VitreQ creates products for the ophthalmic society with a special focus on vitreoretinal
Medical Devices. The technical requirements also apply when the submitter is not the legal manufacturer 1 (i.e: a distribution company).
UNFPA Technical requirements for medical devices 1. Introduction The following document provides UNFPA s technical requirements in the procurement of medical devices (medical equipment, renewable medical
Audion Medical. Impulse & vacuum Rotary sealers Heat sealer Packaging standards Measuring devices
Audion Medical Impulse & vacuum Rotary sealers Heat sealer Packaging standards Measuring devices STERILE PACKAGING IN THE MEDICAL INDUSTRY Healthcare is one of the most important fundamentals in our life;
Combination Products Part 4 Compliance and Implementation at multi-site Network
Combination Products Part 4 Compliance and Implementation at multi-site Network Vijay Damodaran Eli Lilly & Company September 27, 2017 Contents Key cgmp requirements for combination products How to perform
EZPlus Fully Automatic Sterilizers
EZPlus Fully Automatic Sterilizers EZPlus Fully Automatic Sterilizers The new face of Tuttnauer At Tuttnauer, our single focus on sterilization and infection control enables us to offer products to help
TAIZHOU ROUTE METAL PRODUCTS CO.,LTD
TAIZHOU ROUTE METAL PRODUCTS CO.,LTD Stainless Steel Round Bar, Stainless Steel Angle Bar, Stainless Steel Flat Bar, Stainless Steel Square Bar, Stainless Steel Hexagon Bar, Stainless Steel Channel Bar,
hm 780 DC / DC-V THE INTELLIGENT GENERATION EASY ROTARY SEALERS WITH INTEGRATED PRINTER
hm 780 DC / DC-V THE INTELLIGENT GENERATION EASY ROTARY SEALERS WITH INTEGRATED PRINTER GENERATION EASY THE HM 780 DC AND HM 780 DC-V (V = VALIDATABLE) ROTARY SEALERS WITH INTEGRATED PRINTER ARE THE ANSWER
BEST PARTER & BEST SOLUTION RENO Plasma Sterilizer
Web: www.medcon.com.au Email: info@medcon.com.au MED-CON PTY LTD SOLUTIONS FOR BIO-SECURITY Phone: 03 9753 2710 Fax: 03 9753 2722 BEST PARTER & BEST SOLUTION RENO Series - Benefits Rapid Sterilization
GETINGE HS44 STERILIZERS FOR HIGH CAPACITY AT POINT OF USE. Always with you
GETINGE HS44 STERILIZERS FOR HIGH CAPACITY AT POINT OF USE Always with you 2 Getinge HS44 lights on for the new generation sterilizers The new Getinge HS44 is one of the new breed of state-of-the art sterilizers
May 22, Ranfac Corporation Mr. Christopher Whelan Senior Vice President 30 Doherty Avenue, P.O. Box 635 Avon, Massachusetts 02322
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Ranfac Corporation Mr.
GS Hospital Autoclaves
GS Hospital Autoclaves For CSSDs, OR & Medical Centers 155 Liters & 245 Liters 1 StU & 2 StU GS Economic Line Hospital Autoclaves GS hospital autoclaves are designed for Hospital CSSD, OR, and Medical
VHP M100 Biodecontamination Systems: Open Loop
LOW TEMPERATURE BIODECONTAMINATION* VHP M100 Biodecontamination Systems: Open Loop The proven technology of vaporized hydrogen peroxide biodecontamination for a variety of applications Proven Technology
WELMEC Application of module D Quality assurance Under directive 2014/32/EU (MID) or directive 2014/31/EU (NAWID)
WELMEC 8.4 2017 Application of module D Quality assurance Under directive 2014/32/EU (MID) or directive 2014/31/EU (NAWID) WELMEC is a cooperation between the legal metrology authorities of the Member
STERIVAPHP. Original without compromises. protecting human health. new line steam sterilizers
STERIVAPHP new line steam sterilizers Original without compromises protecting human health Tradition, quality, innovation Long-term experiences of BMT Medical Technology s.r.o., advanced patented solutions
Roofing. Sika-Trocal SG 1.5 mm. Polymeric membrane for roof waterproofing. Product Description
Roofing Product Data Sheet Edition 02.2015 Identification no. 02 09 01 01 122 0 150000 Version no. 02 Sika-Trocal SG 1.5 mm Polymeric membrane for roof waterproofing Product Description Sika-Trocal SG
STERILIZATION DEVICES
STERILIZATION DEVICES I. Central Sterilization Units II. Prismatic Steam Sterilizer III. Washing Steam Sterilizer IV. Laboratory Type Vertical Steam Sterilizer 2195 13485 14001 9001 About us Sümer A.Ş.
Instruction for Use of Disposable Endoscopic Hose-type Biopsy Forceps JS-CE-SM-09-01, A/0
Instruction for Use of Disposable Endoscopic Hose-type Biopsy Forceps JS-CE-SM-09-01, A/0 Instruction for use of Disposable Endoscopic Hose-type Biopsy Forceps Product name Disposable Endoscopic Hose-type
WELMEC European cooperation in legal metrology
WELMEC 8.6 Issue 1 WELMEC European cooperation in legal metrology Measuring Instruments Directive 2004/22/EC Presumption of Conformity of the Quality System of Manufacturers with Module D or H 1 when EN
Technical specifications for 54E1 and 60E1 rails
Technical specifications 1 (4) Based on decree Replaces/amends - Technical specifications for 54E1 and 60E1 rails (4483/068/2013) Targeted at - Period of validity Key words Railway, Technical specification,
Bridging gaps: medical device directive vs regulation. Geert Corstens 1 November 2018
Bridging gaps: medical device directive vs regulation Geert Corstens 1 November 2018 Agenda Current Medical Device regulatory landscape New Medical Device Regulation EU Interaction & impact Medical device
APPLICATION FORM for the international quality label for electrically driven heat pumps
APPLICATION FORM for the international quality label for electrically driven heat pumps Version 1.4 European Heat Pump Association Rue d Arlon 63-67 B-1040 Brussels www.ehpa.org phone +32 24 00 10 17 fax
International Standards and EU regulation of medical device software an update
International Standards and EU regulation of medical device software an update Sherman Eagles Partner, SoftwareCPR seagles@softwarecpr.com 612 865 0107 1 Who am I? 18 years at Medtronic, retired 2008 Last
Guidance Notes for imports of organic products according to Article 19 Regulation (EC) No. 1235/2008 from third countries into the European Union
ANNEX 3 Guidance Notes for imports of organic products according to Article 19 Regulation (EC) No. 1235/2008 from third countries into the European Union All produce from third countries labelled as organic
NEW Faster, more versatile!
NEW Faster, more versatile! > 35min flexible cycle > Process Single Channel surgical flexible endoscopes > Process Dual Channel surgical flexible endoscopes > Process 10.89 kg of Load including 1 surgical
PROPOSED DOCUMENT. Global Harmonization Task Force
PROPOSED DOCUMENT Global Harmonization Task Force Title: Quality management system Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange Authoring Group: Study
Precision etching of micro components
Precision etching of micro components A High-Tech Profile Micrometal manufactures customized, highly accurate etched components. We photochemically etch these parts from thin materials (starting at 0.025
With Vaporized Hydrogen Peroxide
L o w Te m p e r a t u r e H 2 O 2 P l a s m a S t e r i l i z e r With Vaporized Hydrogen Peroxide PLAZSTER LINE Hydrogen Peroxide H2O2 Plasma Sterilizer Once again B SCIENCE GLOBAL has raised the bargain
GUIDELINE ON DOSSIER REQUIREMENTS FOR TYPE IA AND TYPE IB NOTIFICATIONS July 2003
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Final Revision 0 NOTICE TO
MICRO FORCEPS & SCISSORS
MICRO FORCEPS & SCISSORS Every aspect of how the product could enhance control and precision was considered in development. VitreQ a company of: About VitreQ VitreQ creates products for the ophthalmic
Stainless Steel Bright Bars (Cold Drawn)
Stainless Steel Bright Bars (Cold Drawn) Applications : Machined Components, Pump Shafts, Valves, Fasteners, Machine Tools, Dairy Equipments, Surgical & Medical Parts, Threaded Bars, Studs, Bolts, Pins,
IE in Erstellung KRUEGAN AF Freigabeanford. WILKEP FR freigegeben ENGLEMI
Seite 1 von 5 Änderungsnummer / Change Master: 4.00.001 Objektverknüpfungen / Object Links: JBX 40008421 000 01 BPF Leukotape K Dokumentenstückliste / Document Structure: Status Responsible Date IE in
GETINGE HS55 HOSPITAL STERILIZER. Always with you
GETINGE HS55 HOSPITAL STERILIZER Always with you 2 Getinge HS55 GETINGE HS55 The most versatile, reliable and EAsy-to-use hospital sterilizer in the world The Getinge HS55 is a fully automatic steam sterilizer.
March 22, Atricure, Inc Mark Job Responsible Third Party Official Regulatory Technology Services, LLC th Street, NW Buffalo, MN 55313
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 22, 2016 Atricure,
New Product Brief PreVAS Single-use Dosing System. Packaging Technology. 3 Disposable Dosing Systems
3 Disposable Dosing Systems New Product Brief PreVAS Single-use Dosing System Packaging Technology Copyright 2010 Bosch Packaging Technology. PreVAS Brochure V3 7-2010. Subject to change without notice.
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods (Medical Devices) Regulations 2002 Statutory Rules No. 236, 2002 as amended made under the Therapeutic Goods Act 1989 Compilation start date: 1 May 2014 Includes amendments up to: SLI
Regulations governing the application of medical accelerators
Regulations governing the application of medical accelerators in 50 minutes. marko.mehle@cosylab.com 2 1.The wonderland of STANDARDS AND REGULATIONS 3 Laws and standards Medical devices (and systems) are
An Urgent Bulletin from CSA Group
An Urgent Bulletin from CSA Group Electrical Tools No. 23D (Supplementary to Notices Electrical Tools Nos. 23, 23A, 23B, 23C) Date: September 3, 2014 See Attachment 1 for Effective Dates. See Attachment
Standards: Overview and Up-date
Standards: Overview and Up-date Quality Assurance in CSSD by Compliance to Standards Klaus Hahnen, 3M, Germany Purpose of the Presentation Provide a brief introduction to standards, standardization bodies
Product Specification Sheet
(EAB-LGN/LOE/LPK/LRD/LYW) Permanent, matte colored paper labels Facestock 82 (77-87) micron ISO 534 Adhesive 15 micron Liner (glassine) 52 (50-58) micron ISO 534 Shear Strength 100 min FTM 8 Initial Tack
DILLARD'S INC TEST PROTOCOL FOR DILL USA- (V19) HAIR ACCESSORIES (HAIR / BOBBY PINS / CLIPS) (ADULT / CHILD & INFANT)
By/Date: Page 1 of 5 Evaluation Citation / ethod No. of Criteria Notes esult ating SCOPE: This protocol is applicable for testing of hair accessories (Hair bobby pins clips) for children, infant and adult.
European Technical Approval No. ETA-12/0056
SINTEF Building and Infrastructure P.O.Box 124 Blindern N-0314 Oslo Tel. 47 22 96 55 55 Fax 47 22 69 94 38 Authorised and notified according to Article 10 of the Council Directive 89/106/EEC of 21 December
! (PPE/PFN-B-MR/002)
! (PPE/PFN-B-MR/002) Technical File: PPE/PFN-B-MR/002 Effective Date: 29 Jul. 2011 Section: Table of Contents Page 1 of 1 TABLE OF CONTENTS Section Description Revision i Cover Page - ii Content Page -
MAXiTHEN medical. en ISO 13485:2012. Lasermarking for UDI. en ISO 22000:2005
BRINGING LIFE TO PLASTICS MAXiTHEN medical en ISO 13485:2012 en ISO 22000:2005 Lasermarking for UDI MASTERBATCH FOR MEDiCAL PRODUCTS Colours according to DIN EN ISO 6009 PLASTiC, THE MEDiCAL MARVEL Cutting-edge
Avalon CUSTOM. Catheter Solutions
Avalon CUSTOM Catheter Solutions Nordson MEDICAL Nordson MEDICAL is your partner in the global life sciences market providing innovative components, devices and custom OEM solutions for the precision management
(English language translation, the original version is in Czech language) DEWALT BSC-PBZ-PRO. DeWalt Black & Decker Str Idstein Germany
TECHNICKÝ A ZKUŠEBNÍ ÚSTAV STAVEBNÍ PRAHA, s.p. Prosecká 811/76a CZ-190 00 Praha 9 Tel.: +420 286 019 458 Internet: www.tzus.cz Authorised and notified according to Article 10 of the Council Directive
PTV TECHNICAL PRESCRIPTIONS. ELASTOMERIC SEALS: Part 4: Cast polyurethane sealing elements FOR
PTV 8681-4 TECHNICAL PRESCRIPTIONS TECHNICAL PRESCRIPTIONS FOR ELASTOMERIC SEALS: Part 4: Cast polyurethane sealing elements COPRO vzw Version 1.0 dated 2017-10-17 Impartial institute for the monitoring
Technical Specification for Galvanised Fabricated Steelwork
Ergon Energy Corporation Limited Technical Specification for Galvanised Fabricated ETS 01-03-01 Check this is the latest Process Zone version before use. Specification ETS 01-03-01 Ver 1 Contents 1. Purpose
Environmental Product Declaration
Declaration Holder: Program Holder: Validity Date: Zumtobel Lighting GmbH Institute Construction and Environment (IBU) e.v. 2015-07-24 22185107 PCA 2/80 T5 ECEL one4all lp x!tec II Lighting and Sustainability
Environmental Product Declaration
Declaration Holder: Program Holder: Validity Date: Zumtobel Lighting GmbH Institute Construction and Environment (IBU) e.v. 2015-07-25 22185110 PCA 1x21/39 T5 ECEL one4all lp x!tec II Lighting and Sustainability
Application for Examination of a Quality System according to LVFS 2003:11 (for CE marking o medical devices)
Company (applicant): hereby applies to, as Notified Body, in accordance with the EG-directive 93/42/EEC (changed 2007/47/EG) for review according to below Review in accordance with 93/42/EEC Annex Annex
Manufacturers. Factsheet for. of Medical Devices. Medical Devices Regulation (MDR) background. Act now to be ready on time!
Ref. Ares(2018)3873669-20/07/2018 Factsheet for Manufacturers of Medical Devices This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-Vitro Medical
The Medical Device File
The Medical Device File ISO 13485:2016, clause 4.2.3 has the requirements for the Medical Device File (MDF). This article describes these requirements as well as the requirements from EN ISO 13485:2016
Laboratorio di Tecnologie Biomediche
Laboratorio di Tecnologie Biomediche Introduction to medical devices Carmelo De Maria carmelo.demaria@unipi.it Medical Device A Medical Device is identified by means of its INTENDED PURPOSE Intended to
AMSCO 600 STEAM STERILIZERS QUALITY, PERFORMANCE AND RELIABILITY. Premium sterilization for today s CSSD. Central Sterile Services
Central Sterile Services AMSCO 600 STEAM STERILIZERS QUALITY, PERFORMANCE AND RELIABILITY Premium sterilization for today s CSSD One Integrated Approach to Healthcare Throughput and choice Four sizes,
Essential Requirements Straumann Custom-made Dental Restorative Devices According to 93/42/EEC annex I as amended by 2007/47/EC
Straumann's CAD (Computer Aided Design) software CARES Visual has built-in parameter checks to assure that a dental restorative device basically meets the generally applicable requirements. However, Institut
Modular Protection Systems
A Safe factory is a Productive one. Modular Protection Systems Safety Standards EN ISO 14120 - ISO 14122-3 - EN ISO 12100-1 EN ISO 13857 - EN 349 - ISO 13854 - EN ISO 10218-2 EN ISO 14119-2006/42/EC Machinery