DECLARATION OF CONFORMITY FOR THE MEDICAL DEVICE FAMILY LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
|
|
- Drusilla Hancock
- 5 years ago
- Views:
Transcription
1 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società DECLARATION OF CONFORMITY FOR THE MEDICAL DEVICE FAMILY LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES whose codes are specified in the attachment, to the essential requirements described in Annex I of Directive 93/42/EEC, as amended by Directive 2007/47/EC and as prescribed by Annex II of Directive 93/42/EEC and following amendments. FLOW METER S.p.A., with registered office and operation site in Via del Lino, 6, zip code Levate (BG) - I, manufacturer of the medical devices named LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, whose codes are reported in the attachment, declares under its own responsibility that the devices in question satisfy all the essential requirements of Annex I of Directive on Medical Devices 93/42/EEC, amended by Directive 2007/47/EC. For this purpose it hereby guarantees and declares under its own responsibility that: 1. The devices in question satisfy the dispositions applicable under Directive 93/42/EEC, amended by Directive 2007/47/EC. 2. The devices in question should be considered as belonging to Class II B, following rules 2 and 9 of Annex IX of the above mentioned Directives. 3. The devices in question are sold in NON STERILE packaging. 4. The devices in question are manufactured in different versions as stated in the list of product codes in the attachment. 5. The design and manufacturing procedures comply with the requirements of the Company Quality System, as prescribed in the Annex II of the a.m. Directive. 6. The Product Technical File will be filed and available to the Notified Body, as specified by Annex II of Directive 93/42/EEC of reference, amended by Directive 2007/47/EC, for a period of at least ten years from the last placing on the market of the product with the last product batch record, under the responsibility of the Technical Director and Legal Representative below mentioned. 7. The a.m. medical devices comply with all the requirements of the following standards: - EN ISO 5359 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases. - EN ISO Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum. - EN ISO Medical supply units. - EN ISO Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation. - EN ISO Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators + EN ISO /AC - EN ISO Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum. - UNI ENV Medical gas pipeline systems Part 6: Dimensions and allocation of s for terminal units for compressed medical gases and vacuum. + EC UNI ENV UNI 9507 Impianti di distribuzione dei gas per uso medico Unità terminali. - BS 5682 Specification for s (quick connectors) for use with medical pipeline systems. - DIN Versorgungsanlagen für medizinische Gase - Teil 2: Maße und Zuordnung von Steckern und gasartspezifischen Verbindungsstellen für Entnahmestellen. - NF-S Matériel médico-chirurgical - Prises murales et fiches correspondantes pour fluides médicaux. - ISO 1402 Rubber and plastics hoses and hose assemblies Hydrostatic testing. - ISO 554 Standard atmospheres for conditioning and/or testing Specifications. - ISO 1307 Rubber and plastics - Hose sizes, minimum and maximum inside diameters, and tolerance on cut-to-length hoses. - ISO 8033 Rubber and plastic hoses Determination of adhesion between components. 8. The devices in question have been manufactured and placed on the market as indicated in the Product Technical File and according to the company Quality System declared to be compliant by CERTIQUALITY, Notified Body number 0546 according to Directive 93/42/EEC, as prescribed in annex II of the aforementioned Directive amended by Directive 2007/47/EC (certificate no /2, first issue of 04/07/2017, current issue of 04/07/2017 and valid up to 03/07/2022). This system, adopted for the design and manufacturing of all devices, is declared as conforming to standards ISO 9001:2008 (ref. certificate no. 421) and EN ISO 13485:2012 (ref. certificate no ). 9. The placing on the market of the above mentioned devices has already been notified to the Italian Competent Authority by FLOW METER S.p.A.. A suitable procedure has been established and is maintained in order to guarantee the post-marketing surveillance required by Directive 93/42/EEC, amended by Directive 2007/47/EC. This declaration of conformity content is confirmed at every placing on the market of a new device batch, manufactured since 28/02/2018. This declaration of conformity is valid until the expiry date of the certificate. Attachments: List of models with codes to which this declaration refers; Copy of EC marking certificate. Witnessed Flow Meter S.p.A. The legal representative Roberto Paratico Date of issue of the declaration: 28/02/ Ed. / Is.: 03/5 Updated 28/02/2018 Page 1/10
2 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società Attachment 01 List of models Updated 28/02/2018 Code Description Side 1 Side AFNOR NF-S terminal AFNOR NF-S unit AFNOR NF-S UNI length =1,5 m. for O2 BS 5682 BS Low pressure hose O2 assembly length 1,5 m. Probe AFNOR NF-S Outlet UNI AFNOR NF-S Low pressure hose O2 assembly length 1,5 m. Probe UNI 9507 Outlet UNI UNI DIN BS UNI 9507 UNI AFNOR NF-S AFNOR NF-S outlet AFNOR NF-S UNI 9507 outlet UNI 9507 AFNOR NF-S outlet AFNOR NF-S AFNOR NF-S AFNOR NF-S UNI UNI 9507 outlet Low pressure hose O2 assembly length 2,5 m. length =4,5 m. for O2 length =4,5 m. for O2 length =4,5 m. O2 length =4,5 m. for O2 length =4,5 m. for O2 length =1,5 m. for AIR UNI UNI 9507 UNI 9507 Probe DIN Probe EN ISO 5359 AFNOR NF-S outlet BS 5682 AFNOR NF-S UNI EN ISO 5359 outlet BS 5682 AFNOR NF-S EN ISO 5359 NIST UNI 9507 outlet EN ISO 5359 BS 5682 Updated 28/02/2018 Page 2/10
3 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società length=1,5 m. for air 4 bar Low pressure hose air assembly length 1,5 m length =1,5 M. AIR length =1,5 M. AIR length =2,5 M. AIR length=2,5 m. for air 4 bar length=2,5 m. for air 4 bar length=2,5 m. for air 4 bar Low pressure hose air assembly length 2,5 m length =1,5 m. for vacuum length=1,5 m. for N2O length=2,5 m. for N2O length=2.5 m - N2O length =4,5 m. for N2O length=4,5 m. - N2O length=3 m. for O length =1,5 m. for N2O length=1.5 m for vacuum length =2,5 M. vacuum length =2,5 M. vacuum length =2,5 M. vacuum AFNOR NF-S Probe UNI 9507 Outlet UNI 9507 UNI 9507 DIN AFNOR NF-S AFNOR NF-S AFNOR NF-S UNI 9507 UNI 9507 NIST AFNOR NF-S outlet AFNOR NF-S Probe DIN Probe EN ISO 5359 BS5682 AFNOR NF-S AFNOR NF-S BS 5682 AFNOR NF-S Probe AFNOR NF-S EN ISO 5359 AFNOR NF-S outlet AFNOR NF-S Probe AFNOR NF-S EN ISO 5359 DIN BS 5682 AFNOR NF-S BS 5682 Probe UNI Outlet UNI 9507 AFNOR NF-S UNI 9507 DIN EN ISO 5359 EN ISO 5359 EN ISO length =2,5 M. vacuum AFNOR NF-S AFNOR NF-S outlet length=2,5 m. for VACUUM AFNOR NF-S AFNOR NF-S length =2,5 m. for AIR 800 EN ISO 5359 outlet EN ISO length =4,5 m. for AIR AFNOR NF-S outlet AFNOR NF-S AFNOR NF-S length=4,5 m. for air 4 bar length UNI UNI 9507 outlet Updated 28/02/2018 Page 3/10
4 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società =4,5 m. for AIR length=4,5 m. for air 4 bar UNI 9507 Updated 28/02/2018 Page 4/10
5 Updated 28/02/2018 Page 5/10
6 Updated 28/02/2018 Page 6/10
7 Updated 28/02/2018 Page 7/10
8 Updated 28/02/2018 Page 8/10
9 Updated 28/02/2018 Page 9/10
10 Updated 28/02/2018 Page 10/10
Updated 04/07/2017 Page 1/8
FLOW METER S.p.A. Capitale Sociale: 234.000 int. versato Sede legale: Via del Lino, 6 24040 LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, 6-24040 LEVATE (Bg) Tel. +39/035/594047 - Telefax +39/035/594821
More informationUE/CE DECLARATION OF CONFORMITY
Viale XIII Luglio, 160 60044 Fabriano (AN) Italy Phone +39 0732 6911 www.faberspa.com UE/CE DECLARATION OF CONFORMITY We, Faber spa addressed in Viale XIII Luglio 160 Fabriano (AN) 60044 ITALY, declare
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 80601-2-13 First edition 2011-08-01 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation Appareils
More informationSOUTH AFRICAN NATIONAL STANDARD
ISBN 978-0-626-21896-6 Edition 1 SOUTH AFRICAN NATIONAL STANDARD Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum This national standard is a modified adoption
More informationCouncil Directive 93/68/EEC of 22 July 1993 amending Directives
Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility),
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD IEC 60601-2-13 Third edition 2003-05 Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems Appareils électromédicaux
More informationNON ELECTRICAL EQUIPMENT IN HAZARDOUS AREAS
NON ELECTRICAL EQUIPMENT IN HAZARDOUS AREAS The ATEX Directive consists of two EU Directives, ATEX Directive 2014/34/EU and ATEX Directive 99/92/EC. ATEX Directive 2014/34/EU embodies the European minimum
More informationCertificato numero: 300 RIVA TECNOIMPIANTI S.R.L. UNI EN ISO 9001 : 2015 ISO 9001 : 2015
IIS - Founding Member of IIS - Founding Member of Si certifica che la Società We hereby certify that the Company Unità operativa / Branch Certificato numero: 300 Certificate number applica un Sistema di
More informationThis document is a preview generated by EVS
EESTI STANDARD EVS-EN ISO 7396-2:2007 Meditsiinilise gaasi torusüsteemid. Osa 2: Anesteetiliste gaaside evakuatsioonija kahjutustamissüsteemid Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging
More informationEuropean Technical Approval ETA-08/0035 This ETA replaces ETA-08/0035 with validity from till
SINTEF Building and Infrastructure P.O.Box 124 Blindern N-0314 Oslo Tel. 47 22 96 55 55 Fax 47 22 69 54 38 Authorised and notified according to Article 10 of the Council Directive 89/106/EEC of 21 December
More informationPACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES
IRISH STANDARD I.S. EN 868-10:2000 ICS 11.080.30 55.040 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES National
More informationVarioAir Medical Suction Solutions Consumables and Accessories
VarioAir Medical Suction Solutions Consumables and Accessories Whether in the operating room or in the intensive care unit, when it comes to suction, you need high-performance, reliable devices that are
More informationZakres notyfikacji UE dla IMQ. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Via Quintiliano, MILANO Country : Italy
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd= EPOS_43373&version_no=20&lst_version_no=20,9,8,7,6,5,4,3,2,,0,9,8,7,6,5,4,3,2,&max_ver sion=20&history_flg=y
More informationWhat can we do for you?
Istituto Giordano S.p.A. Cod. Fis./P. Iva 00 549 540 409 - Cap. Soc. 1.500.000 i.v. R.E.A. c/o C.C.I.A.A. (RN) 156766 Registro Imprese di Rimini n. 00 549 540 409 Organismo Europeo notificato n. 0407 Accreditamenti
More informationBiological evaluation of medical devices
BRITISH STANDARD Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) ICS 11.100.20 NO COPYING WITHOUT BSI PERMISSION
More informationTechnical Assessment Guideline Applicable for the Kiwa KQ Certification Scheme:
Technical Assessment Guideline Applicable for the Kiwa KQ Certification Scheme: Solar products and components Accreditation Kiwa Italia S.p.A. Via Treviso 32/34 31020 San Vendemiano (TV) Italia Tel: +39
More informationCPX RIGID PENDANT INSTALLATION, OPERATIONS & MAINTENANCE MANUAL
CPX RIGID PENDANT INSTALLATION, OPERATIONS & MAINTENANCE MANUAL O&M Manual Rigid Pendant Page 1 of 17 VERSION HISTORY Version Implemented Revision Approved Approval Reason # By Date By Date 1.0 Kevin Pugh
More informationMedical gloves for single use - Part 2: Requirements and testing for physical properties
Irish Standard I.S. EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties CEN 2015 No copying without NSAI permission except as permitted by copyright law.
More informationCERTIFICATE. Conformity of the Factory Production Control CPR TÜVRh
CERTIFICATE Conformity of the Factory Production Control 0035-CPR-1090-1.00794.TÜVRh.2017.003 In compliance with Regulation 305/2011/EU of the European Parliament and of the Council of 9 March 2011 (the
More informationInstructions for use Vacuum regulation valve with water trap
Instructions for use Vacuum regulation valve with water trap Table of Contents Introduction 1. Description of Functions 2. Putting into Operation 3. Instructions for Cleaning and Care 3.1 Disassembling
More informationCertificate of Registration
Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2003 & EN ISO 13485:2012 This is to certify that: Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd. Faiskola u. 5. 3300
More informationRVTM3 SUCTION VACUUM REGULATORS
RVTM3 SUCTION VACUUM REGULATORS English Version 09/2015 AFNOR rail mounting systems BS rail mounting systems Neutral DIN rail mounting systems US OHMEDA rail mounting systems NORDIC rail mounting systems
More informationMGN 453 (M) Maritime and Coastguard Agency Logo MARINE GUIDANCE NOTE
Maritime and Coastguard Agency Logo MARINE GUIDANCE NOTE MGN 453 (M) FIRE PROTECTION Fire Retardant Treatment for Floor Coverings, Suspended Textile Materials, Upholstery Materials and Bedding Components
More informationRVTM3 SUCTION VACUUM REGULATORS
RVTM3 SUCTION VACUUM REGULATORS English Version 11/2018 AFNOR rail mounting systems BS rail mounting systems Neutral DIN rail mounting systems US OHMEDA rail mounting systems NORDIC rail mounting systems
More informationBIOLOGICAL EVALUATION OF MEDICAL
IRISH STANDARD I.S. EN ISO 10933-12:2007 ICS 11.100.20 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION National Standards Authority of Ireland Glasnevin, Dublin 9 Ireland Tel: +353
More informationCONTRACT AGREEMENT FOR THE MAINTENANCE SERVICE AND INVERTER WARRANTY UP TO 20 YEARS (so-called Super Service Contract)
GENERAL BUILDING SpA Capitale sociale 1.000.000,00 Sede e stabilimento: Via Roncolina, 3-60020 POLVERIGI (AN) Contatti: Tel 071 9090261 Fax 071 9090714 Web www.fotovoltaici.org CONTRACT AGREEMENT FOR THE
More informationMeasurement of force - UNI EN 12453(2002) point 5 30,0 33,0
ORGA NISMO NOTIFICATO P ER LA CPD N 600 BFT S.p.A. Via Lago di Vico, 44 605 - Schio (VI) Test report n 5/05 Composed of 5 pages of test report and 75 of attachment - date 005-07-04 - request 7 - date 005-04-
More informationed DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit
European notified body Identification number 0736 ed DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 109.022
More informationDECLARATION OF PERFORMANCE
Edition 05.2014 Identification no. 02 08 02 02 001 0 000017 Version no. 02 EN 1504-2: 2004 EN 13813: 2002 13 0086 DECLARATION OF PERFORMANCE Sikafloor -24 PurCem EN 13813:2002 02 08 02 02 001 0 000017
More information7.3 Design and Development Design and development planning Design and development inputs Design and development outputs 7.3.
Rev. 1 03/05/2015 ANNEX A to the Yokogawa Corporation of America Quality Assurance Manual For Additional Requirements selectively applied to ATEX and IECEx certified products CONTENTS 1. Scope 2. Purpose
More informationInstaller: (Name, address, telephone number)
Installer: (Name, address, telephone number) UNAC GUIDE No. 9 FOR THE INSTALLATION OF MOTORISED VERTICAL UPWARD SLIDING GATES IN ACCORDANCE WITH MACHINERY DIRECTIVE 98/37/EEC AND THE APPLICABLE PARTS OF
More informationMeasurement of force - UNI EN 12453(2002) point 5. C % U.R. Slow-down speed: Opening slow-down torque: Closing slow-down torque: 33,0 28,0
ORGA NISMO NOTIFICATO P ER LA CPD N 6 BFT S.p.A. Via Lago di Vico, 44 65 - Schio (VI) Test report n 9/5 Composed of 4 pages of test report and 5 of attachment - date 5-7-7 - request 47 - date 5-4- Refers
More informationMARKING EC Directive 97/23 PED (Pressure Equipment Directive)
MARKING EC Directive 97/23 PED (Pressure Equipment Directive) Field of application The Directive applies to the design, manufacturing and conformity assessment of the pressure equipment and of their groups
More informationCO-ORDINATION OF NOTIFIED BODIES PPE Regulation 2016/425 RECOMMENDATION FOR USE
CO-ORDINATION OF NOTIFIED BODIES PPE Regulation 2016/425 PPE-R/00.017 Version 2 RECOMMENDATION FOR USE Number of pages: 5 Approval stage : Approved on : Origin : Horizontal Committee, C2D Ad hoc group
More informationEC-Type Examination (Module B) Certificate. A.1/3.11 b "B" dass divisions, fire integrity
European notified body Identification number 0736 ed DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 102.319
More informationei DG UV Test EC-Type Examination (Module B) Certificate A.1/3.27 a Penetrations through "B" Class divisions (electric cable transits)
European notified body Identification number 0736 ei DG UV Test Prüf- und Zertifizierungsstelte BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 108.036
More informationCompany : VALSIR LOCALITA MERLARO 2 IT VESTONE (BS)
SANITARY APPLIANCES CSTB attests that the products referred to in the appendix comply with the characteristics described in the certification system NF 017 (revision 26) after evaluation according to the
More informationInstaller: (Name, address, telephone number)
Installer: (Name, address, telephone number) UNAC GUIDE No. 8 FOR THE INSTALLATION OF MOTORISED BARRIERS IN ACCORDANCE WITH MACHINERY DIRECTIVE 98/37/EEC AND THE APPLICABLE PARTS OF STANDARDS EN 13241-1,
More informationDISPOSABLE CONTAINERS FOR SUCTION APPLICATIONS FLOVAC CONTAINER WITH MECHANICAL VALVE
DISPOSABLE CONTAINERS FOR SUCTION APPLICATIONS FLOVAC CONTAINER WITH MECHANICAL VALVE FLOVAC DISPOSABLE CONTAINERS SYSTEM FOR THE COLLECTION OF SUCTIONED FLUIDS The FLOVAC disposable containers system
More informationEN ISO ÖNORM. Edition: (ISO 14937:2009)
ÖNORM EN ISO 14937 Edition: 2010-03-15 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization
More informationDEPARTMENT OF TRADE AND INDUSTRY DEPARTEMENT VAN HANDEL EN NYWERHEID. NATIONAL REGULATOR FOR COMPULSORY SPECIFICATIONS ACT (Act 5 of 2008)
STAATSKOERANT, 19 NOVEMBER 2010 No.33763 11 No. R. 1072 DEPARTMENT OF TRADE AND INDUSTRY DEPARTEMENT VAN HANDEL EN NYWERHEID 19 November 2010 NATIONAL REGULATOR FOR COMPULSORY SPECIFICATIONS ACT (Act 5
More informationInstaller: (Name, address, telephone)
Installer: (Name, address, telephone) UNAC GUIDE No. 5 FOR THE MOTORISATION OF FOLDING DOORS IN ACCORDANCE WITH MACHINERY DIRECTIVE 98/37/EEC AND THE APPLICABLE PARTS OF STANDARDS EN 13241-1, EN 12453,
More informationInstaller: (Name, address, telephone)
Installer: (Name, address, telephone) UNAC GUIDE No. 2 FOR THE MOTORISATION OF HINGED GATES IN ACCORDANCE WITH MACHINERY DIRECTIVE 98/37/EEC AND THE APPLICABLE PARTS OF STANDARDS EN 13241-1, EN 12453,
More informationYour Key to achieving C.E Marking Compliance
Your Key to achieving C.E Marking Compliance As of the 1 st July 2013 The Construction Products Regulation 2011 contains clauses relating to C E marking of products. This will therefore mean that a CE
More informationIrish Standard I.S. EN :2009
Irish Standard NSAI 2009 No copying without NSAI permission except as permitted by copyright law. Incorporating amendments/corrigenda issued since publication: This document is based on: This document
More informationICARO. Aircraft Warning Lights GENERAL CATALOGUE.
Aircraft Warning Lights is Sirena s range of high-end Aircraft Warning Lights engineered to last and perform icaro@sirena.it www.icaroawl.com MADE IN ITALY Engineered, Developed and Assembled in Rosta,
More informationCylinder Mortice Dead lock Lockcase(mm) A=87 Backset (mm) B=55. Follower (mm) 8 Latch Bolt
Product ID: KL.1902 Name: Cylinder Mortice Dead lock Lockcase(mm) A=87 Backset (mm) B=55 Centres C=N/A Follower (mm) 8 Latch Bolt N/A Mechanism Euro- Profile Forend Finish SSS Rebates available (mm) KL.1902A
More informationGUIDANCE DOCUMENT ON THE ATEX DIRECTIVE TRANSITION FROM 94/9/EC TO 2014/34/EU
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Industrial Transformation and Advanced Value Chains Advanced Engineering and Manufacturing Systems GUIDANCE
More informationRegulation 574_2014: Annex III CPR. and. Regulation 568_2014: Annex V CPR
TF N 635 Regulation 574_2014: Annex III CPR and Regulation 568_2014: Annex V CPR 30-05-2014 28.5.2014 L 159/41 REGULATIONS COMMISSION DELEGATED REGULATION (EU) No 574/2014 of 21 February 2014 amending
More informationSupplementary Installation and Operating Instructions. Category II2G
Supplementary Installation and Operating Instructions Flap-type Flow Meter Category II2G 2 Contents 1. General safety directions...3 2. Main safety-relevant characteristics...4 2.1. Category / Zone...4
More informationInstaller: (Name, address, telephone)
Installer: (Name, address, telephone) UNAC GUIDE No. 4 FOR THE MOTORISATION OF SECTIONAL GARAGE DOORS IN ACCORDANCE WITH MACHINERY DIRECTIVE 98/37/EEC AND THE APPLICABLE PARTS OF STANDARDS EN 13241-1,
More informationThis document is a preview generated by EVS
EESTI STANDARD EVS-EN 13015:2001 Liftide ja eskalaatorite tehnohooldus. Tehnohooldusjuhendite reeglid Maintenance for lifts and escalators - Rules for maintenance instructions EESTI STANDARDIKESKUS EESTI
More informationValve Manufacturers Association of America
BUSINESS ASSURANCE Valve Manufacturers Association of America 2016 Technical Seminar: EU s New Legislation Framework (NLF) - What this means to you. Mike Norman 1 VMA Technical Session - March 2016 SAFER,
More informationei DG UV Test EC-Type Examination (Module B) Certificate
European notified body Identification number 0736 ei DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 100.185
More informationAchieve Success with European Medical Device Commercialization. By Russ King
Achieve Success with European Medical Device Commercialization By Russ King Achieve Success with European Medical Device Commercialization Given the complexity of the FDA s regulatory pathway, many medical
More informationSTERILIZER STEAM - GLOBO 6412 INNOVATING TRADITION
STERILIZER STEAM - GLOBO 6412 INNOVATING TRADITION GLOBO - HOSPITAL EXCELLENT INSULATION AND A POWERFUL VACUUM SYSTEM GUARANTEE PERFECT STERILIZATION All images in this document are for illustration purposes
More informationISO INTERNATIONAL STANDARD. Fire-fighting hoses Rubber and plastics suction hoses and hose assemblies
INTERNATIONAL STANDARD ISO 14557 First edition 2002-12-01 Fire-fighting hoses Rubber and plastics suction hoses and hose assemblies Tuyaux de lutte contre l incendie Tuyaux d aspiration et flexibles en
More informationICARO. Aircraft Warning Lights GENERAL CATALOGUE
ICARO Aircraft Warning Lights GENERAL CATALOGUE ICARO Aircraft Warning Lights INDEX INTRODUCTION... 2 WARNING LIGHTS AWL 810/AB... 4 AWL 810/AB TWIN... 5 WARNING LIGHTS AWL 864/BC... 6 AWL 864/BC TWIN...
More informationEnglish Version. This Technical Report was approved by CEN on 11 December It has been drawn up by the Technical Committee CEN/TC 135.
TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 17052 January 2017 ICS 91.080.10 English Version Guidelines on implementing EN 1090-1:2009+A1:2011, Execution of steel structures and aluminium
More informationPressure Equipment Directive PED 2014/68/EU Commission's Working Group "Pressure"
D. EVALUATION ASSESSMENT PROCEDURES Guideline D-01 Guideline related to: Annex III, module G Is design approval by a notified body required under module G? Module G does not explicitly require formal design
More informationCESI EXTENSION D. 02/12 ~ FGH ~ to EC-Type Examination Certificate CESI 03A TEX057X Equipment: Explosion proofsolenoid series OA-; OZA; MZA-A- Manufacturer: ATOS S.p.A. Address: Via alla Piana, 57-21018
More informationYOUR GUIDE TO UNDERSTANDING CPR
YOUR GUIDE TO UNDERSTANDING CPR WITH EXCEL NETWORKING SOLUTIONS ISSUE 2 UPDATED JANUARY 2018 WWW.EXCEL-NETWORKING.COM CONTENTS What is CPR? When will this happen? Why the update? Which products are affected?
More informationESSENTIAL REQUIREMENTS CHECK LIST
Detailed Listing of Products Covered by this Product Group:. I 1 GENERL REQUIREMENTS The device must be designed & manufactured in such a way that, when used under the conditions & for the purposes intended,
More informationInstaller: (Name, address, telephone number)
Installer: (Name, address, telephone number) UNAC GUIDE No. 11 FOR THE MOTORISATION OF HINGED PEDESTRIAN DOORS IN ACCORDANCE WITH THE MACHINERY DIRECTIVE 98/37/EEC AND THE STANDARDS pren 12650-1* - pren
More informationROLA CENTRUM NAUKOWEGO POśARNICTWA W LITEWSKIM SYSTEMIE OCHRONY PRZECIWPOśAROWEJ
Žydrunas KUODIS Jednostka Certyfikująca Centrum Naukowego PoŜarnictwa Republiki Litewskiej ROLA CENTRUM NAUKOWEGO POśARNICTWA W LITEWSKIM SYSTEMIE OCHRONY PRZECIWPOśAROWEJ THE ROLE OF FIRE RESEARCH CENTRE
More informationEuropean Technical Assessment
European Technical Assessment ETA 17/0457 Version 01 Date of issue: 2017-08-09 UBAtc Assessment Operator: Belgian Construction Certification Association Rue d Arlon 53-1040 Brussels www.bcca.be - info@bcca.be
More informationOPERATING MANUAL UNIT 8 - WHITEBRIDGE INDUSTRIAL ESTATE STONE STAFFORDSHIRE ST15 8LQ ENGLAND TEL: +44 (0) FAX: +44 (0)
OPERATING MANUAL UNIT 8 - WHITEBRIDGE INDUSTRIAL ESTATE STONE STAFFORDSHIRE ST15 8LQ ENGLAND TEL: +44 (0) 1785 815651 FAX: +44 (0) 1785 812115 MCP-OM-VACMIX ISSUE 04 THE MCP VACUUM MIXER Thank you for
More informationThe New PPE Regulation (EU) 2016/425
The New PPE Regulation (EU) 2016/425 Dave Tuplin Certification Manager, BSI 1 PPE Regulation (EU) 2016/425 changes Agenda Who is BSI Landscape and timeframes Scope of the new PPE Regulation Categorisation
More informationChief Operating Officer Giampiero Belcredi
CONTENTS 1. PURPOSE AND SCOPE 2. GENERAL PRINCIPLES AND GUARANTEES FOR THE CLIENT 3. ACCESS REQUIREMENTS FOR CERTIFICATION 4. ASSESSMENT PROCESS REQUIREMENTS 5. SUSPENSION AND REVOCATION OF THE CERTIFICATION
More informationTEST REPORT No
Istituto Giordano S.p.A. Via Rossini, 2-47814 Bellaria-Igea Marina (RN) - Italia Tel. +39 0541 343030 - Fax +39 0541 345540 istitutogiordano@giordano.it - www.giordano.it PEC: ist-giordano@legalmail.it
More informationImplementation of the Construction Products Regulation (CPR) in harmonized standards - Template for Annex ZA -
TF N 530 Rev.2 2012-04-13 CONSTRUCTION SECTOR STANDARDIZATION GUIDANCE DOCUMENT Implementation of the Construction Products Regulation (CPR) in harmonized standards - Template for Annex ZA - 1 Drafting
More informationCOMPANY PROFILE
www.stima.it COMPANY PROFILE You can only sell products if you have them Mrs. Elves Valbonesi, founder of STIMA S.p.A. Since 1965, we have been specialising in the supply of components for pneumatics,
More informationEC Type Examination Certificate
EC Examination Certificate No. BSI/A./3.46/56436 This is to certify that: FirePro Systems Ltd 6 Koumandarias Street & Spyrou Araouzou Tonia Court No.2 Limassol 336 Cyprus Holds Certificate Number: BSI/A./3.46/56436
More informationSeat Ventilation offers an extensive range of ATEX certified products and is undertaking great efforts to extend this range even further.
ATEX SOLUTIONS In order to apply a single level for health and safety requirements and to overcome barriers of trade within Europe, national regulations for explosion prevention were harmonized in 1975
More informationFrequently Asked Questions on the Construction Products Regulation (CPR) - Enterprise and Industry
1. Must a construction product bear the CE marking after 30/06/2013? After 30/06/2013, in order to sell a construction product in the European Union (EU) the manufacturer has the obligation to issue a
More informationCE Compliance. Silva Management. September 18th, 2014 David Norris. C Eng. FI Mech E.
David Norris C Eng. FI Mech E. Recent employment positions. Consultant to Machine Tool companies. Technical Director, Bridgeport Machines Ltd. Engineering V.P., Bridgeport Machines Inc. We will consider
More informationSOUTH AFRICAN NATIONAL STANDARD
ISBN 978-0-626-32335-6 Edition 1 (incorporating EN amdt 1) EN 13795:2011 Edition 2 (incorporating amdt 1) SOUTH AFRICAN NATIONAL STANDARD Surgical drapes, gowns and clean air suits, used as medical devices
More informationCE marking & your legal obligations
CE marking & your legal obligations This presentation is intended to provide a practical approach guide to what you need to know about the CE marking requirements for electrical and electronic equipment
More informationDECORATIVE WALLCOVERINGS - ROLL AND PANEL FORM PRODUCTS IRISH STANDARD I.S. EN 15102:2007. Price Code. Údarás um Chaighdeáin Náisiúnta na héireann
IRISH STANDARD I.S. EN 15102:2007 ICS 91.180 National Standards Authority of Ireland Glasnevin, Dublin 9 Ireland Tel: +353 1 807 3800 Fax: +353 1 807 3838 http://www.nsai.ie DECORATIVE WALLCOVERINGS -
More informationThis document is a preview generated by EVS
TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 1555-7 January 2013 ICS 23.040.01; 91.140.40 Supersedes CEN/TS 1555-7:2003 English Version Plastics piping systems for the
More informationCE marking & your legal obligations
CE marking & your legal obligations This presentation is intended to provide a practical approach guide to what you need to know about the CE marking requirements for electrical and electronic equipment
More information- SAFETY MANUAL - DAMPERS
EUROPAIR srl Via Po, 160 20032 - Cormano (Mi) P.IVA C.F. 04009650963 Tel. 39 02 66305530 Fax 39 02 66306876 info@europairitalia.it - www.europairitalia.it UNI EN ISO 9001 - SAFETY MANUAL - DAMPERS This
More informationThe CE Marking Access to the European Market
The CE Marking Access to the European Market The EU dictates the compliance of guidance and a CE marking for many industrial products, so that these products may attain to the market. The experts of Eurofins
More informationThe New EMC Directive 2004/108/EC
The New EMC Directive 2004/108/EC In the process of this review I have tried to spell out in words what is often referred to as a section number while also keeping to location information as used in the
More informationei DG UV Test EC-Type Examination (Module B) Certificate Certificate No
European notified body Identification number 0736 ei DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 223.002
More informationEC CERTIFICATE OF CONFORMITY 0432 CPD 0018
EC CERTIFICATE OF CONFORMITY 0432 CPD 0018 In compliance with the Directive 89/106/EEC of the Council of European Communities of 21 December 1988 on the approximation of laws, regulations and administrative
More informationTECHNICAL APPROVAL. TA no.: AT/ Edition V/2015 Date of expiry: 25 November 2020 Page: 1 of 14
APPROVAL BODY INSTYTUT NAFTY I GAZU PAŃSTWOWY INSTYTUT BADAWCZY OIL AND GAS INSTITUTE - NATIONAL RESEARCH INSTITUTE (INiG-PIB) PL 31-503 Kraków, ul. Lubicz 25 A tel.: +48 12 4210033 fax: +48 12 4210050
More informationCOMMISSION DELEGATED REGULATION (EU) /... of XXX
Ref. Ares(2017)4156968-24/08/2017 EUROPEAN COMMISSION Brussels, XXX [ ](2017) XXX draft COMMISSION DELEGATED REGULATION (EU) /... of XXX establishing common safety methods on safety management system requirements
More informationZ from: 1 April 2015
Date: Reference: 23 Mar 2015 I 38- Approval number: Validity Z-70.3-153 from: 1 April 2015 Applicant: sedak GmbH & Co. KG Einsteinring 1 86368 Gersthofen, Germany to: 1 April 2020 Subject of approval:
More informationCertificate: _01 / 22 March 2013
Test report: 936/21219384/B of 27 September 2012 Initial certification: 20 July 2012 Expiry date: 19 July 2017 Publication: BAnz AT 05 March 2013 B10, chapter I, No. 1.5 Approved application The tested
More informationgb# DG UV Test EC-Type Examination (Module B) Certificate Certificate No A.1/3.34 Fire resisting divisions for high speed craft
European notified body Identification number 0736 gb# DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 100.218
More informationThis document is a preview generated by EVS
EESTI STANDARD EVS-EN ISO 970-:2000 Tuimastus- ja hingamishoolduse alarmsignaalid. Osa : Juhised alarmide kasutamisele Anaesthesia and respiratory care alarm signals - Part : Guidance on application of
More informationSVENSK STANDARD SS-EN
SVENSK STANDARD SS-EN 13395-4 Fastställd 2002-10-18 Utgåva 1 Betongkonstruktioner Provning av produkter och system för skydd och reparation Arbetbarhet Del 4: Applicerbarhet av bruk på undersida av konstruktion
More informationedr DG UV Test EC-Type Examination (Module B) Certificate Certificate No A.1/3.34 Fire resisting divisions for high speed craft
European notified body Identification number 0736 edr DG UV Test Prüf- und Zertifizierungsstetle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 100.217
More informationDISPOSABLE CONTAINERS FOR SUCTION APPLICATIONS FLOVAC CONTAINER WITH HYDROPHOBIC VALVE
DISPOSABLE CONTAINERS FOR SUCTION APPLICATIONS FLOVAC CONTAINER WITH HYDROPHOBIC VALVE FLOVAC DISPOSABLE CONTAINERS SYSTEM FOR THE COLLECTION OF SUCTIONED FLUIDS The FLOVAC disposable containers system
More informationAD.3.XG... Atex directive ch. I Page 22 Atex classification ch. I Page 23. Tab.1 Assembly ch. I Page 25
Atex directive ch. I Page 22 Atex classification ch. I Page 23 Series ch. I Page 24 Technical specifications Ch. I Page 24 Ordering code ch. I Page 24 Tab. Assembly ch. I Page 25 Tab. 2 Voltages ch. I
More informationgb# DG UV Test EC-Type Examination (Module B) Certificate Certificate No A.1/3.34 Fire resisting divisions for high speed craft
European notified body Identification number 0736 gb# DG UV Test Prüf- und Zertifizierungsstelle BG Verkehr Dienststelle Schiffssicherheit EC-Type Examination (Module B) Certificate Certificate No. 100.218
More informationThis document is a preview generated by EVS
TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 16792 December 2014 ICS 61.020; 97.190 English Version Safety of children's clothing - Recommendations for the design and manufacture of children's
More informationRADAR REFLECTOR STANDARD FOR CERTIFICATION. DET NORSKE VERITAS Veritasveien 1, N-1322 Høvik, Norway Tel.: Fax:
STANDARD FOR CERTIFICATION No. 2.9 RADAR REFLECTOR JANUARY 2003 Veritasveien 1, N-1322 Høvik, Norway Tel.: +47 67 57 99 00 Fax: +47 67 57 99 11 FOREWORD is an autonomous and independent Foundation with
More informationCOMMISSION DELEGATED REGULATION (EU)
28.5.2014 L 159/41 REGULATIONS COMMISSION DELEGATED REGULATION (EU) No 574/2014 of 21 February 2014 amending Annex III to Regulation (EU) No 305/2011 of the European Parliament and of the Council on the
More information