An overview of sterilizer equipment standards current and planned. Richard Bancroft Science & Technical Director STERIS
|
|
- Juniper Wiggins
- 5 years ago
- Views:
Transcription
1 An overview of sterilizer equipment standards current and planned Richard Bancroft Science & Technical Director STERIS #deconevent2018
2 An Overview of Sterilization & Equipment Standards Current & Planned Richard Bancroft, B.Sc (Hons), FRSB Science & Technical Director STERIS Corporation Registered Authorising Engineer (Decontamination) Convenor, ISO/TC 198 WG 6 Convenor, CEN/TC 102 WG 7 Cochair, AAMI ST/WG 06
3 Equipment & Process Standards Equipment standard STANDARDS FOR DECONTAMINATION Supporting standards Process standard
4 High Temperature Sterilization Standards Equipment standard EN Equipment standard EN 285 STEAM Process standard EN ISO 17665
5 Low Temperature Sterilization Equipment standard EN 1422 Standards Equipment standard EN Equipment standard EN EO VHP FORM Process standard EN ISO Process standard EN ISO Or ISO Process standard EN ISO 25454
6 High Temperature Equipment Standards EN EN Sterilization. Steam sterilizers. Small Sterilizers EN 285 EN 285 Sterilization. Steam sterilizers. Large Sterilizers
7 EN Small Steam sterilizers EN first published in 2004 Latest version published in November 2014 Revised to align with machinery directive in Europe Small sterilizers differ from large porous load sterilizers (EN 285) in: size (less than 54 litres) Performance low steam supply capacity small vacuum pumps Minor amendment underway to correct text confusion regarding allowance of 134 C 138 C with older sterilizers versus 134 C- 137 C with 2014 version
8 EN 285 Large Steam Sterilizers EN 285 first published in 1996; major revision in 2006 Two amendments to 2006 version published in 2008 (A1) and 2009 (A2) EN 285:2015 is latest version Revision/amendment needed to resolve technical comments deferred from main revision Revision/amendment underway to address pressure gauge requirements
9 High Temperature Process Standard EN ISO Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
10 EN ISO EN ISO replaced EN 554, ISO and ISO in 2006 Specifies methods for validation and routine control for moist heat (steam) sterilization Revision underway to incorporate guidance (currently in part 2) and product families (currently in part 3) into a single standard Significant changes to EN ISO are likely to occur
11 Low Temperature Equipment Standards EN 1422 Sterilizers for medical purposes Ethylene oxide sterilizers - Requirements and test methods EN Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing pren Sterilizers for medical purposes Low temperature vaporized hydrogen peroxide sterilizers Requirements and testing
12 EN 1422 EO Sterilizers EN 1422:2014 is latest version; superseded EN 1422:1997+A1:2009 Harmonised EU standard (harmonised against EU MDD 93/42/EEC) Major revision in 2014: Scope changes Explicit exclusion of sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber Removal of types A and B of EO sterilizers A - user programmable (industrial) B - typically smaller and have fixed cycles (health care) Alignment with structure of LTSF standard EN Annex D deleted (sound power test)
13 EN Formaldehyde Sterilizers EN 14180:2014 is latest version; superseded EN 14180:2003+A2:2009 Harmonised EU standard (harmonised against EU MDD 93/42/EEC) Major revision in 2014: The terms risk assessment, risk analysis and software validation added Biological testing aligned with method from ISO Machinery safety requirements, mainly as a consequence of compliance with the machinery directive added Requirements and testing for sound power and vibration updated
14 Vaporized hydrogen peroxide sterilizers Work item to develop a sterilizer standard for vaporized hydrogen peroxide sterilizers; approved in September 2015 Work began at a meeting in Brussels in February 2016 Uses vaporized hydrogen peroxide [VH2O2] as the sterilant Standard defines the design & performance of the sterilizer, rather than the process Work likely to take at least another year (mid-2019 publication)
15 Low Temperature Process Standards EN ISO Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices EN ISO Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices EN ISO Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
16 EN ISO Formaldehyde Process EN ISO 25424:2011 is latest version; superseded EN 15424:2007 Harmonised EU standard Harmonised against EU MDD 93/42/EEC on Medical Devices Harmonised against 90/385/EEC on Active Implantable Medical Devices Harmonised against 98/79/EC on in vitro diagnostic medical devices
17 EN ISO EO Process EN ISO 11135:2014 is latest version; superseded ISO :2007 and ISO/TS :2008 Harmonised EU standard Harmonised against EU MDD 93/42/EEC on Medical Devices Harmonised against 90/385/EEC on Active Implantable Medical Devices Updated in 2014: It replaces ISO :2007 and ISO/TS :2008 Part 1 was requirements and part 2 was guidance on the application of part 1 Both technically revised and condensed into a single standard Guidance placed in annex D
18 EN ISO Generic Process EN ISO 14937:2009 is latest version Currently used for novel sterilization processes, e.g. hydrogen peroxide sterilization processes Harmonised EU standard Harmonised against EU MDD 93/42/EEC on Medical Devices Harmonised against 90/385/EEC on Active Implantable Medical Devices
19 EN ISO Information to be provided EN ISO Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices First published in 2004, then significantly revised and published in edition was for devices intended to be sterilized for their subsequent use 2017 edition is for devices intended to be disinfected and/or sterilized for their subsequent use e.g. endoscopes Specifies information to be provided by the medical device manufacturer on the processing of medical devices Includes medical devices that are intended for reuse and require processing by way of cleaning, disinfection and/or sterilization Single use devices supplied non-sterile but intended to be used in a clean, disinfected and/or sterile state
20 Scope of EN ISO Processing instructions are NOT defined (although format is ) Gives requirements to assist manufacturers in providing: initial treatment at the point of use; preparation before cleaning cleaning disinfection drying inspection and maintenance packaging sterilization storage Transport Non-critical medical devices not intended for direct patient contact are not included
21 EN ISO Requirements Requires MD manufacturers to: validate the decontamination processes identified in the instructions for use perform risk analysis in accordance with ISO to determine the content and detail of the information provided state limitations or service life of the device with processing provide cleaning, disinfection and/or sterilization information method specified shall be relevant to the market available in electronic or printed form Provides an example pro-forma template for standardisation of IFUs
22 EN ISO Example Format
23 ISO Common Aspects of Sterilizers ISO has just started developing a new standard on common aspects of sterilizers; work is likely to take 3 years Its application would potentially include all types of sterilizers for health care applications It would enable common requirements across a range of equipment Scope consists of: Material, design and construction Chamber requirements Doors and interlocks Noise, heat, vapour, vibration and EMC emissions Quality & risk management Safety requirements Service and local environment Information to be provided by the manufacturer Test Equipment etc Information being considered from EN, US, Japanese and Australian sterilizer standards, as well as IEC and IEC
Does your equipment meet your needs and the operational capacity stated by the manufacturer?
Does your equipment meet your needs and the operational capacity stated by the manufacturer? Richard Bancroft, B.Sc (Hons) Registered Authorising Engineer (Decontamination), UK Convenor, ISO/TC 198 WG
More informationC 183/10 Official Journal of the European Union
C 183/10 Official Journal of the European Union 7.7.2010 Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2015/C 014/04)
C 14/36 EN Official Journal of the European Union 16.1.2015 Commission communication in the framework of the implementation of Council Directive 90/385/ EEC of 20 June 1990 on the approximation of the
More information(Notices) EUROPEAN COMMISSION
24.1.2013 Official Journal of the European Union C 22/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Commission communication in the framework
More informationNotification of a Body in the framework of a technical harmonization directive
Notification of a Body in the framework of a technical harmonization directive From : Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Heinrich-Böll-Ring 10 53119
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2017/C 389/02)
C 389/22 EN Official Journal of the European Union 17.11.2017 Commission communication in the framework of the implementation of Council Directive 90/385/ EEC on the approximation of the laws of the Member
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 173/02)
C 173/92 EN Official Journal of the European Union 13.5.2016 Commission communication in the framework of the implementation of Council Directive 90/385/ EEC on the approximation of the laws of the Member
More information(Notices) EUROPEAN COMMISSION
18.1.2011 Official Journal of the European Union C 16/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Commission communication in the framework
More informationInstitute of Decontamination Sciences Blackburn House, Redhouse Road, Seafield, Bathgate, West Lothian EH47 7AQ
Institute of Decontamination Sciences Blackburn House, Redhouse Road, Seafield, Bathgate, West Lothian EH47 7AQ www.idsc-uk.co.uk 1. BS EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits,
More informationOMAN November 2nd 2006 Middle East WFHSS Workshop
OMAN November 2nd 2006 Middle East WFHSS Workshop TIM GALEKOP Director of Global Business Development Medical Fabrics Convenor CEN TC 102 WG 4 Expert ISO TC 198 WG 7 Expert CEN TC 205 WG 14 CEN / ISO Council
More informationOFFICIAL JOURNAL OF ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE (90/385/EEC)
OFFICIAL JOURNAL OF ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE (90/385/EEC) Try it for free on: https://ce-marking.help This Free of Charge application was designed to help manufacturers, consultants,
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2015/C 226/03)
10.7.2015 EN Official Journal of the European Union C 226/43 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2017/C 389/04)
C 389/62 EN Official Journal of the European Union 17.11.2017 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on
More information(Text with EEA relevance) First publication OJ EN 12322:1999/A1: Note 3 Date expired ( ) 19.8.
30.8.2012 Official Journal of the European Union C 262/29 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October
More informationBUSINESS PLAN CEN-CLC/TC 3 QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN-CLC/TC 3 QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES EXECUTIVE SUMMARY Business Environment The area of responsibility of CEN-CLC/TC 3 Quality management
More informationOFFICIAL JOURNAL OF IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE (98/79/EC)
OFFICIAL JOURNAL OF IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE (98/79/EC) Try it for free on: https://ce-marking.help This Free of Charge application was designed to help manufacturers, consultants,
More informationCEN TC 10 (Lifts, escalators and moving walks) Introduction to EN 81-20/50 (revision of EN 81-1/2)
Introduction to EN 81-20/50 (revision of EN 81-1/2) CEN/TC 10: August 6 th, 2014 CEN/TC 10 Work Program CEN/TC 10 Structure European Standardization for Lifts, Escalators and Moving Walks 3 CEN/TC 10 Work
More informationBUSINESS PLAN CEN/TC 58 SAFETY AND CONTROL DEVICES FOR BURNERS AND APPLIANCES BURNING GASEOUS OR LIQUID FUELS EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 58 SAFETY AND CONTROL DEVICES FOR BURNERS AND APPLIANCES BURNING GASEOUS OR LIQUID FUELS Scope EXECUTIVE SUMMARY Safety and control devices for equipment burning gaseous or
More informationBUSINESS PLAN CEN/TC 10 LIFTS, ESCALATORS AND MOVING WALKS EXECUTIVE SUMMARY
BUSINESS PLAN CEN/TC 10 LIFTS, ESCALATORS AND MOVING WALKS CEN/TC 10 Business Plan Page: 1 EXECUTIVE SUMMARY Lifts, escalators, moving walks and building hoists are essential elements in providing safe
More informationThis document is a preview generated by EVS
EESTI STANDARD EVS-EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment Sterilization of health care products - Biological and chemical indicators
More informationBUSINESS PLAN CEN/TC 305 POTENTIALLY EXPLOSIVE ATMOSPHERES EXPLOSION PREVENTION AND PROTECTION EXECUTIVE SUMMARY
BUSINESS PLAN CEN/TC 305 POTENTIALLY EXPLOSIVE ATMOSPHERES EXPLOSION PREVENTION AND PROTECTION CEN/TC 305 Business Plan Page: 1 Business environment, benefits and priorities EXECUTIVE SUMMARY CEN/TC 305
More informationLow Temperature Sterilisation ISO 14937
Low Temperature Sterilisation ISO 14937 Validation and Performance Jon Mulhall Senior Validation Engineer ASP Johnson & Johnson Medical 27 th March 2018 What is ISO 14937? A (very) brief history.. In the
More informationVHP M100 Biodecontamination Systems: Closed Loop
LOW TEMPERATURE BIODECONTAMINATION* VHP M100 Biodecontamination Systems: Closed Loop The proven technology of vaporized hydrogen peroxide biodecontamination for a variety of applications Proven Technology
More informationBest Practice Guidelines For Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices
Best Practice Guidelines For Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices In BC Health Authorities THIS DOCUMENT IS INTENDED TO DESCRIBE BEST PRACTICES HEALTH
More informationIntroducing the latest model in Prestige Medical s first-class range of Advance autoclaves - Advance Pro.
Introducing the latest model in Prestige Medical s first-class range of Advance autoclaves - Advance Pro. Advance Pro is a Class B sterilizer available in 16 or 22 litre capacity units, they offer superior
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
More informationInstitut pro testování a certifikaci, a.s. Management System Certification Body třída Tomáše Bati 299, Louky, Zlín
1 1 code 1) name 1) Limited to (CZ- Agriculture, hunting, forestry, fishing and aquaculture 01 except 01.7 01 01.6 02 EN EN EN EN EN EN Page 1 of 21 code 1) name 1) Limited to (CZ- 2 2 Mining and quarrying
More informationBUSINESS PLAN CEN/TC 79 RESPIRATORY PROTECTIVE DEVICES EXECUTIVE SUMMARY
CEN/TC 79 Business Plan Page: 1 BUSINESS PLAN CEN/TC 79 RESPIRATORY PROTECTIVE DEVICES EXECUTIVE SUMMARY Scope To prepare European Standards for respiratory protective devices (RPD) for work and rescue
More informationJBCE input for the RoHS FAQ document
JBCE input for the RoHS FAQ document JBCE welcomes the recast of the RoHS Directive 2011/65/EU (hereafter generally referred to as RoHS 2 ) 1 and appreciates the ongoing work by the Commission in realizing
More informationReport on the activities of the ATEX consultant. Xavier Lefebvre. Contract : CENELEC/NA Consultant/2013-1
Report on the activities of the ATEX consultant Xavier Lefebvre Contract : CENELEC/NA Consultant/2013-1 Period covered: from 1 January 2013 to 1 July 2013 1. Attended meetings Date Subject Location 2013.01.28
More informationAmerican National Standard
American National Standard ANSI/AAMI/ ISO 7199:2009/ (R)2014 & A1:2012(R) 2014 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators) Objectives and uses of AAMI standards and
More informationMedical devices and electromagnetic compatibility. Addressing the requirements of IEC , 4 th Edition
Medical devices and electromagnetic compatibility Addressing the requirements of IEC 60601-1-2, 4 th Edition Executive Summary Risk of electromagnetic interference and immunity have long been important
More informationVHP M100 Biodecontamination Systems
LOW TEMPERATURE BIODECONTAMINATION* VHP M100 Biodecontamination Systems The proven technology of vaporized hydrogen peroxide biodecontamination for a variety of enclosures Proven Technology in Two New
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 054/02)
12.2.2016 EN Official Journal of the European Union C 54/9 Commission communication in the framework of the implementation of Regulation (EC) No 765/ 2008 of the European Parliament and of the Council
More informationEUROPEAN COMMITTEE FOR ELECTROTECHNICAL STANDARDIZATION (CENELEC) TECHNICAL COMMITTEE No. 62: ELECTRICALEQUIPMENT IN MEDICAL PRACTICE
TC62/SEC1015/INF October 2009 EUROPEAN COMMITTEE FOR ELECTROTECHNICAL STANDARDIZATION (CENELEC) TECHNICAL COMMITTEE No. 62: ELECTRICALEQUIPMENT IN MEDICAL PRACTICE SOFTWARE AND MEDICAL DEVICES WORKING
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 informationSCESm Directory Accreditation number: SCESm 0047
International standard: ISO/IEC 17021-1:2015 Swiss standard: SN EN ISO/IEC 17021-1:2015 QS Zürich AG Postfach 6335 8050 Zürich QS Zürich AG Branch Basel Erlenstrasse 31 4106 Therwil Head: Responsible for
More informationPodiaclave+ The PodiaClave+ is specifically designed for the clinic based podiatrists and chiropodists.
Classic PodiaClave Podiaclave+ The PodiaClave+ is specifically designed for the clinic based podiatrists and chiropodists. Easy to use, reliable and cost-effective, its outstanding performance comes from
More informationHARMONISATION STATUS OF SELECTED ELECTRICAL AND NON-ELECTRICAL Ex STANDARDS MARCH 2018
Harmonisation status of selected electrical and non-electrical ex standards BAS-PS-010 - Issue 1 - March 2018 P. 1 HARMONISATION STATUS OF SELECTED ELECTRICAL AND NON-ELECTRICAL Ex STANDARDS MARCH 2018
More informationBUSINESS PLAN CEN/TC 142 WOODWORKING MACHINES SAFETY EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 142 WOODWORKING MACHINES SAFETY EXECUTIVE SUMMARY Business environment largest in the world, covering more than 50% of the world market. CEN TC 142 activity deals with standardization
More informationTable of correspondence between ISO :2003, ISO :2003, ISO :2007 and the new ISO 12100:2010. Date of document
ISO/TC 199 N 833 ISO/TC 199 Safety of machinery E-mail of Secretary: christian.thom@din.de Secretariat: DIN Table of correspondence between ISO 12100-1:2003, ISO 12100-2:2003, ISO 14121-1:2007 and the
More informationPart 2-55: Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors
This is a preview - click here to buy the full publication INTERNATIONAL STANDARD ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment Part 2-55: Particular requirements for the basic safety
More informationVHP ARD Mobile Biodecontamination System
LOW TEMPERATURE BIODECONTAMINATION VHP ARD Mobile Biodecontamination System The proven technology of vaporized hydrogen peroxide biodecontamination validated by our customers worldwide for isolators, rooms
More informationCE Marking and Technical Standardisation
EDITION 3.0 CE Marking and A G A M B I C A T E C H N I C A L G U I D E Technical Standardisation Guidelines for application to Electrical Power Drive Systems CE Marking and Technical Standardisation Guidelines
More informationBUSINESS PLAN. CEN/TC 137 Assessment of workplace exposure to chemical and biological agents EXECUTIVE SUMMARY
Business Environment BUSINESS PLAN CEN/TC 137 Business Plan Date: 01.09.04 Version: 2 Approved BP Page: 1 CEN/TC 137 Assessment of workplace exposure to chemical and biological agents EXECUTIVE SUMMARY
More informationRequest for tender regarding the validation of ammonia testing methods as supplement to pren 16516
Secretariat: Nederlands Normalisatie-instituut doc.nr. Vlinderweg 6 P.O. Box 5059 2623 AX DELFT 2600 GB DELFT date The Netherlands The Netherlands 2015-10-01 Telephone: +31 15 2 690 280 CEN/TC 351 N 0644
More informationBUSINESS PLAN CEN/TC 208 ELASTOMERIC SEALS FOR JOINTS IN PIPEWORK AND PIPELINES EXECUTIVE SUMMARY
Page: 1 Business environment BUSINESS PLAN CEN/TC 208 ELASTOMERIC SEALS FOR JOINTS IN PIPEWORK AND PIPELINES EXECUTIVE SUMMARY The 5 standards published by CEN/TC 208 since 1996 are used throughout the
More information(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2018/C 209/02)
C 209/12 EN Official Journal of the European Union 15.6.2018 Commission communication in the framework of the implementation of Regulation (EC) No 765/ 2008 of the European Parliament and of the Council,
More informationAustralian Standard. Fire detection and alarm systems. Part 6: Carbon monoxide fire detectors using electro-chemical cells
AS 7240.6 2006 ISO 7240-6:2004 AS 7240.6 2006 Australian Standard Fire detection and alarm systems Part 6: Carbon monoxide fire detectors using electro-chemical cells This Australian Standard was prepared
More informationBUSINESS PLAN CEN/TC 159 HEARING PROTECTORS EXECUTIVE SUMMARY
Date:2014-07-10 Page: 1 BUSINESS PLAN CEN/TC 159 HEARING PROTECTORS EXECUTIVE SUMMARY Business Environment CEN/TC 159 is preparing standards on: Hearing protectors Safety requirements and testing Hearing
More informationBUSINESS PLAN CEN/TC 250 STRUCTURAL EUROCODES EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 250 STRUCTURAL EUROCODES EXECUTIVE SUMMARY Scope CEN/TC 250 covers the standardization of structural and geotechnical design rules for building and civil engineering works
More informationISO INTERNATIONAL STANDARD. Rotating shaft vibration measuring systems Part 1: Relative and absolute sensing of radial vibration
INTERNATIONAL STANDARD ISO 10817-1 First edition 1998-12-15 Rotating shaft vibration measuring systems Part 1: Relative and absolute sensing of radial vibration Systèmes de mesure des vibrations des arbres
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD IEC 60770-3 First edition 2006-04 Transmitters for use in industrial-process control systems Part 3: Methods for performance evaluation of intelligent transmitters IEC 2006 Copyright
More informationInformation and Notices
Official Journal of the European Union ISSN 1725-2423 C 183 English edition Information and Notices Volume 53 7 July 2010 Notice No Contents Page IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES,
More informationNOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
Official Journal of the European Union C 226 English edition Information and Notices Volume 58 10 July 2015 Contents IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES European
More informationVHP M100 BIODECONTAMINATION SYSTEM
VHP M100 BIODECONTAMINATION SYSTEM APPLICATION The VHP M100 Small Volume Biodecontamination System is a hydrogen peroxide vapor generator for biodecontamination* of clean, dry, sealed Enclosures** used
More informationBUSINESS PLAN CEN/TC 164 WATER SUPPLY EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 164 WATER SUPPLY EXECUTIVE SUMMARY Business Environment Nearly almost 100% of the 450 M European people are supplied with drinking water (DW) Europe represents approximately
More informationBUSINESS PLAN CEN/TC 162 PROTECTIVE CLOTHING INCLUDING HAND AND ARM PROTECTION AND LIFEJACKETS EXECUTIVE SUMMARY
BUSINESS PLAN CEN/TC 162 Business Plan Page: 1 CEN/TC 162 PROTECTIVE CLOTHING INCLUDING HAND AND ARM PROTECTION AND LIFEJACKETS EXECUTIVE SUMMARY Business Environment CEN/TC 162 is preparing standards
More informationAnnex of the certificate (Page 1/1) Accreditation Scope
Accreditation Nr: ISO 22000:2005 Food Safety Management System Certification Address : E-Mail Website : kys@szutest.com.tr : www.szutest.com.tr Class/Category Food and Feed Processing - C Food and Feed
More informationAMSCO STERILIZATION CONTAINER SYSTEM User s Guide
AMSCO STERILIZATION CONTAINER SYSTEM User s Guide . AMSCO STERILIZATION CONTAINER SYSTEM User s Guide TABLE OF CONTENTS 1. Unpacking...2 2. Container transport and handling...2 3. General cleaning, decontamination,
More informationCOMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
EUROPEAN COMMISSION Strasbourg, 25.10.2016 COM(2016) 710 final ANNEX 5 ANNEX to the COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
More informationThe Appendix is an integral part of Certificate of Accreditation No. 742/2017 of 14/12/2017
Field code 1) Field name 1) Limited to (CZ-NACE codes) 2) 1 1 Agriculture, hunting, forestry, fishing and aquaculture Specification of standards 01, 02, 03 2 2 Mining and quarrying 05, 06, 07, 08, 09 3
More informationSVENSK STANDARD SS-EN 556-1
SVENSK STANDARD SS-EN 556-1 Fastställd 2001-11-23 Utgåva 1 Sterilisering av medicintekniska produkter Krav för märkning med symbolen STERIL Del 1: Krav för medicintekniska produkter steriliserade i sluten
More informationBUSINESS PLAN CEN/TC 231 MECHANICAL VIBRATION AND SHOCK EXECUTIVE SUMMARY
Business Environment BUSINESS PLAN CEN/TC 231 MECHANICAL VIBRATION AND SHOCK EXECUTIVE SUMMARY CEN/TC 231 Business Plan Page: 1 In Europe, a large number of machines generating exposure to mechanical hand-arm-vibration
More informationNew Approach vs Standards and Regulation: how it all works
New Approach vs Standards and Regulation: how it all works between the EU and an EU Member State (UK example) Volodymyr Yakubov Senior Standardization Expert, INOGATE Head of International Projects, BSI
More informationCouncil of the European Union Brussels, 5 September 2017 (OR. en) Mr Jeppe TRANHOLM-MIKKELSEN, Secretary-General of the Council of the European Union
Council of the European Union Brussels, 5 September 2017 (OR. en) 11882/17 COVER NOTE From: date of receipt: 4 September 2017 To: No. Cion doc.: Subject: ENV 727 MI 607 AGRI 443 CHIMIE 78 SAN 319 CONSOM
More informationWhat now for home building?
Successful Partners DELIVERING QUALITY 2017 Residential Seminar What now for home building? The post Brexit world May 2017 Successful Partners DELIVERING QUALITY 2017 Residential Seminar 30 March 2017
More informationCOMMISSION DELEGATED REGULATION (EU) /... of
EUROPEAN COMMISSION Brussels, 8.3.2018 C(2018) 1392 final COMMISSION DELEGATED REGULATION (EU) /... of 8.3.2018 establishing common safety methods on safety management system requirements pursuant to Directive
More informationChanges in international standards relating to diagnostic x-ray equipment, with particular attention to radiation protection
Changes in international standards relating to diagnostic x-ray equipment, with particular attention to radiation protection Tamás Porubszky a*, János Barsai b a Frédéric Joliot-Curie National Research
More informationUsing consumer appliances in Europe the consumer view
Using consumer appliances in Europe the consumer view February 2011 European Association for the Co-ordination of Consumer Representation in Standardisation Av. de Tervueren 32, box 27 B-1040 Brussels,
More informationSVENSK STANDARD SS-EN ISO :2005. Sterilisering av medicintekniska produkter Kemiska indikatorer Del 1: Allmänna krav (ISO :2005)
SVENSK STANDARD SS-EN ISO 11140-1:2005 Fastställd 2005-07-28 Utgåva 1 Sterilisering av medicintekniska produkter Kemiska indikatorer Del 1: Allmänna krav (ISO 11140-1:2005) Sterilization of helath care
More informationBUSINESS PLAN CEN/TC 160 PROTECTION AGAINST FALLS FROM A HEIGHT INCLUDING WORKING BELTS EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 160 PROTECTION AGAINST FALLS FROM A HEIGHT INCLUDING WORKING BELTS EXECUTIVE SUMMARY Business environment Products Personal fall arresting systems and components Personal equipment
More informationISO Safety of machinery Laser processing machines Part 1: General safety requirements
INTERNATIONAL STANDARD ISO 11553-1 First edition 2005-02-01 Safety of machinery Laser processing machines Part 1: General safety requirements Sécurité des machines Machines à laser Partie 1: Prescriptions
More informationDirective 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
European Commission Enterprise and Industry Sitemap Search About this site Contact Legal notice Medical devices Directive 93/42/EEC Short name: Base: Medical devices Council Directive 93/42/EECof 14 June
More informationI.F.U Re/Processing Reusable Medical Devices
I.F.U Re/Processing Reusable Medical Devices Distributed by: MANUFACTURER: GA 26-09-001 -EN /20130719 Contents 1 Overview of preparation methods... 3 2 Safety and responsibility... 4 3 Explanation of symbols...
More informationInternational and European standardization of Nanomaterials
International and European standardization of Nanomaterials Jean-Marc Aublant LNE - France What about standardization of nanotechnologies? Retrospect CEN/BT/WG 166 Nanotechnologies was established in March
More informationBUSINESS PLAN CEN/TC 23 TRANSPORTABLE GAS CYLINDERS
Page:1 BUSINESS PLAN CEN/TC 23 TRANSPORTABLE GAS CYLINDERS 1 BUSINESS ENVIRONMENT OF THE CEN/TC 1.1 Description of the Business Environment The following political, economic, technical, regulatory, legal,
More informationOverview of Emerging Safety Standards Machinery Sector By Phill Carroll Business Development Manager Topics Historical Situation Introduction of New Standards Terminology Safety Integrity identification
More informationAS/NZS :2011. Household and similar electrical appliances Safety AS/NZS :2011. Part 1: General requirements
AS/NZS 60335.1:2011 (IEC 60335-1, Ed 5.2:2016, MOD) Incorporating Amendment No. 1, 2, 3 and 4 Australian/New Zealand Standard Household and similar electrical appliances Safety Part 1: General requirements
More informationFN 032/055/120 DRY HEAT STERILIZERS / OVENS FN 300/400/500 DRY HEAT STERILIZERS / OVENS KD 200/400/700 OVENS EV 018 VACUUM OVEN
FN 032/055/120 DRY HEAT STERILIZERS / OVENS Three different sizes: 32, 55 and 120 liters. Temperature range: Ambient Temperature +5 C / 250 C. Designed for sterilization, drying and heating purposes. User
More informationThis document is a preview generated by EVS
TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 16629 July 2014 ICS 91.140.99 English Version Energy Performance of Buildings - Detailed Technical Rules for the set of EPB-standards
More informationSteelcoSure Independent performance verification of your equipment and processes
SteelcoSure Independent performance verification of your equipment and processes For the Environmentally conscious SteelcoSure Independent performance verification of your equipment and processes Irrespective
More informationAS/NZS :2014
AS/NZS 4024.1601:2014 (EN 953:1997 inc A1:2009, IDT) Australian/New Zealand Standard Safety of machinery Part 1601: Design of controls, interlocks and guarding Guards General requirements for the design
More informationSOUTH AFRICAN NATIONAL STANDARD
ISBN 978-0-626-22437-0 Any reference to SABS 0114-2 is deemed to be a reference to this standard (Government Notice No. 1373 of 8 November 2002) SOUTH AFRICAN NATIONAL STANDARD Interior lighting Part 2:
More informationInformation and Notices
Official Journal of the European Union ISSN 1977-091X C 22 English edition Information and Notices Volume 56 24 January 2013 Notice No Contents Page IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS,
More informationالمملكة العربية السعودية وزارة الصحة اإلدارة العامة لمكافحة عدوى المنشئات الصحية
1. POLICY STATEMENT: Cleaning, decontamination and sterilization method should be done in CSSD service facility not in the end user department side. 2. PURPOSE: To ensure the proper way of collections,
More informationISO/TS TECHNICAL SPECIFICATION. Road vehicles Air filters for passenger compartments Part 1: Test for particulate filtration
TECHNICAL SPECIFICATION ISO/TS 11155-1 First edition 2001-11-01 Road vehicles Air filters for passenger compartments Part 1: Test for particulate filtration Véhicules routiers Filtres à air pour l'habitacle
More informationThis document is a preview generated by EVS
EESTI STANDARD EVS-EN 13060:2015+A1:2018 VÄIKESEMAHULISED AURUSTERILISAATORID Small steam sterilizers EVS-EN 13060:2015+A1:2018 EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See Eesti standard EVS-EN 13060:2015+A1:2018
More informationBUSINESS PLAN CEN/TC 249 PLASTICS
Page: 1 BUSINESS PLAN CEN/TC 249 PLASTICS 1 BUSINESS ENVIRONMENT OF THE CEN/TC 1.1 Description of the Business Environment The following political, economic, technical, regulatory, legal, societal and/or
More informationSVENSK STANDARD SS-EN 867-2
SVENSK STANDARD SS-EN 867-2 Handläggande organ Fastställd Utgåva Sida Hälso- och sjukvårdsstandardiseringen, HSS 1997-04-30 1 1 (1+8) SIS FASTSTÄLLER OCH UTGER SVENSK STANDARD SAMT SÄLJER NATIONELLA, EUROPEISKA
More informationThe ATEX Directive 94/9/EC
The ATEX Directive 94/9/EC operation and perspectives in Europe and the World The ATEX sector in the European Union From the Market description, competitiveness analysis in the field of products and protective
More informationISO INTERNATIONAL STANDARD. Oscillation-type density meters Part 1: Laboratory instruments
INTERNATIONAL STANDARD ISO 15212-1 First edition 1998-10-01 Oscillation-type density meters Part 1: Laboratory instruments Densimètres à oscillations Partie 1: Instruments de laboratoire A Reference number
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 informationStandards Solution. What it is and how to use it. July 2017
Standards Solution What it is and how to use it July 2017 Who is IOGP? IOGP is the International Association of Oil & Gas Producers IOGP works on behalf of the world's oil & gas exploration and production
More informationBUSINESS PLAN CEN/TC 239 RESCUE SYSTEMS EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 239 RESCUE SYSTEMS EXECUTIVE SUMMARY Business Environment CEN/TC 239 is engaged in the standardization of ambulances as emergency medical vehicles and/or crafts and their associated
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 informationEUROPEAN C O M M I S S I O N
10.7.2015 Official Journal of the European Union C 226/1 NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN C O M M I S S I O N Go to AIMD Go to IVDD Go to MDD C 226/2 Official
More informationCOMMISSION DELEGATED REGULATION (EU) /... of
EUROPEAN COMMISSION Brussels, 29.6.2017 C(2017) 4408 final COMMISSION DELEGATED REGULATION (EU) /... of 29.6.2017 amending Commission Delegated Regulation (EU) No 151/2013 of 19 December 2012 supplementing
More informationKronos Class B Sterilizer
Kronos Class B Sterilizer NOW WITH OUR EXCLUSIVE * PATENTED TECHNOLOGY Meet the NEW Newmed Kronos Class B Sterilizer Good looking and elegant on the outside, but reliable and uncomplicated on the inside,
More informationISO 7439 INTERNATIONAL STANDARD. Copper-bearing intra-uterine contraceptive devices Requirements, tests
INTERNATIONAL STANDARD ISO 7439 Second edition 2002-03-15 Copper-bearing intra-uterine contraceptive devices Requirements, tests Dispositifs intra-utérins contenant du cuivre Spécifications, essais Reference
More information