Management. National Standards Authority of Ireland

Transcription

1 Medical Equipment Quality Management NSAI: Role and Structure of Standards Brian Cunningham National Standards Authority of Ireland Statutory body Formed in 1947 as IIRS 1996 NSAI Act Functions include writing National Standards, Metrology, Certification Total staff ~150 Standards staff ~30 1

2 All NSAI Functions are Components of Trade/ Quality Infrastructure Mission of NSAI Standards is to further the social and economic interests of the consumer and industry through the development and promotion of Irish, European and international Standards for products and services. This is achieved: By developing the national position through consensus taking account of the best practice on performance, safety, quality and environmental impact. Through a consultative process which includes consultative committees and public comment. By representing Irish interests in the development of European and international standards. Through publishing, marketing and promoting the use of Standards 2

3 Standards Facts & Figures Purely indigenous Irish Standards 300 Indigenous Irish Standards d published/year 4t to 6 Number of Items in NSAI Catalogue 18,000 International / European Standards Published in ,400 No. of Experts on NSAI CC s 800 No. of Other Experts Consulted 600 Standardization towards the global level International level ISO IEC ITU European level CEN CENELEC ETSI National level NSAI (ETCI for Electro-Technical) Industry and other stakeholders 3

4 CEN National Members NSAI supplies European Standards as national standards and draft standards. NSAI develops and votes for the ratification of European Standards. NSAI must implement such standards as national standards, withdrawing all conflicting national standards on the same subject. Standard Questions and Answers from Standards Why use Standards? Where can I find Standards? What are standards? Who writes Standards? How can I see what is changing now? How can I contribute?? 4

5 Basis of Standardization is 1996 Act (Art.7) Encourage use of standards Formulate standards for Minister Declare under seal of NSAI as Standard Specification Formulate Guides, Codes of Practice Participate in national, regional, international work Perform any standardization function arising from EU or International treaties Disseminate info re standards Status of Standard Specifications Standards are voluntary Compulsory standards (1996 Act, Art. 28) Standards adopted by legislation e.g. Health and Safety Authority Gas Act Quasi-mandatory standards (EU Directives) 5

6 Benefits of Standard Specifications Provide a level playing field for trade & business Provide minimum level of quality & safety protecting reputable manufacturers & suppliers from short-cutting competitors. Provide part of the industrial & commercial infrastructure of a developed market economy Part of obligations of EU membership What is Standardization for? Facilitate trade by Removal of trade barriers (opening markets) Identify minimum characteristics/quality Perfect competition Interchangeability & Interoperability for Products & Services. Reduces needless variation and Thus Reduces Costs Standards improve Safety 6

7 Who is Standardization for? Industry Manufacturers, purchasers Citizens Public, consumers Government Trade, health and environment regulators How we achieve a Standard with broad consensus Involve widest possible: Technological lexperts Industry representatives Regulators Safety interests Social Partners Consultative Committee + Public Enquiry Performance driven - Technology neutral 7

8 Indigenous Standards Uniquely Irish Projects e.g. Hurling Helmets Portable Goalposts Cash in Transit Security Signed and Sealed under the NSAI Act, 1996 Voluntary Standards, not mandatory Value of Standards Work Enabling Enterprise and Protecting the Consumer by assisting in the development of European and International Standards which: Provide a level playing field for national, European and international trade Safeguard the consumer by improving i product and service standards. 8

9 What are Standards? Standards are not written in Stone... Role of Standards To Enable Enterprise and Protect the Consumer by: Facilitating Irish Stakeholder involvement in National, European and Global Standardization Producing and Promoting Standards Publishing, Sales, Information Seminars, Public Training, Notifications of new Stds/Regs In-Company Training for in-depth help with application of Standards 9

10 Indigenous Standards Uniquely Irish Projects e.g. Hurling Helmets Portable Goalposts Cash in Transit Security Signed and Sealed under the NSAI Act, 1996 Voluntary Standards, not mandatory Value of Standards Work Enabling Enterprise and Protecting the Consumer by assisting in the development of European and International Standards which: Provide a level playing field for national, European and international trade Safeguard the consumer by improving i product and service standards. 10

11 How can I contribute?? Consultative Committee Structure Technical Secretary (NSAI) Chairman (Industry) Industry Social Partners Academia Government CEN/ISO TC XXX Produce documents for review CEN/ISO TC XXX Compile votes and publishes new standard Who writes Standards...? NSAI/HCSC Establish Projects Posts on Livelink Reviews Work Submits Vote Project Leader Balance of Experts Work on Livelink How can I contribute?? 11

12 Standard Questions and Answers from Standards When lost contact the following: How can I contribute?? NSAI have mirror committees in the following areas: General HealthCare Standards (HCSC) Electrical Medical Devices (ETCI TC10) Health Informatics (HISC) So, What s happening? Let s take a look... 12

13 How can I see what is changing now? NSAI hosts Standards Consultative Committees: Health Informatics Standard Consultative Committee, HISC, follows the work of CEN TC 251 WG1: Information Models WG2: Terminology and Knowledge WG3: Safety Security and Quality WG4: Technology for Interoperability 79 published standards and 25 developing standards and ISO TC 215 and it s corresponding Working Groups How can I see what is changing now? ETCI hosts Standards Consultative Committees, NSAI provide Technical Secretariat to ETCI TC 10: ETCI TC 10 follows the work of IEC TC 62, TC 62: Electrical equipment in medical practice SC 62A: Common aspects of electrical equipment used in medical practice SC 62B: Diagnostic imaging equipment SC 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry SC 62D: Electromedical equipment Total 164 publications, 57 in progress, IEC series 13

14 How can I see what is changing now? SC 1 Dentistry CEN TC 055 ISO TC 106 TC 106/SC 1 Filling and restorative materials TC 106/SC 2 Prosthodontic materials TC 106/SC 3 Terminology TC 106/SC 4 Dental instruments TC 106/SC 6 Dental equipment TC 106/SC 7 Oral care products TC 106/SC 8 Dental implants What s New? ISO/DIS 7405 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry How can I see what is changing now? SC 2 I.V.Ds CEN TC 140 ISO TC 212 TC 212/WG 1: Quality and competence in the medical laboratory TC 212/WG 2: Reference systems TC 212/WG 3: In vitro diagnostic products TC 212/WG 4: Antimicrobial susceptibility testing What s New? ISO/DIS series Clinical laboratory testing and in vitro diagnostic medical systems -- Information supplied by the manufacturer (labelling) Series of 4 standards 14

15 How can I see what is changing now? SC 3 Ophthalmic CEN TC 170 ISO TC 172 TC 172/SC 1Fundamental standards TC 172/SC 3Optical materials and components TC 172/SC 4Telescopic systems TC 172/SC 5Microscopes and endoscopes TC 172/SC 6Geodetic and surveying instruments TC 172/SC 7Ophthalmic optics and instruments TC 172/SC 9Electro-optical systems What s new? ISO/DIS Optics and photonics -- Specification of reference dictionary -- Part 1: and Part 2 How can I see what is changing now? SC 4 Non Active general devices CEN TC 205: General Devices ISO TC 076: Injectables ISO TC 084: Administration Devices ISO TC 157: Contraceptives What s New? ISO/CD Transfusion equipment for medical use -- Part 4: Transfusion sets for single use ISO/DIS Plastic containers for intravenous injections ISO/DIS 20072Aerosol drug delivery device design verification -- Requirements and test methods ISO/CD Male condoms - Test guidance for condoms made from new materials ISO/DIS Female condoms -- Requirements and test methods 15

16 How can I see what is changing now? SC 5 Respiratory and Anaesthesia CEN TC 215 ISO TC 121 TC 121/SC 1Breathing attachments and anaesthetic machines TC 121/SC 2Tracheal tubes and other equipment TC 121/SC 3Lung ventilators and related equipment TC 121/SC 4Anaesthesia terminology TC 121/SC 6Medical gas systems TC 121/SC 8Suction devices for hospital and emergency care use What s New? ISO/DIS 7376 Anaesthetic and respiratory equipment -- Laryngoscopes for tracheal intubation ISO/DIS Anaesthetic and respiratory equipment -- Nebulizing systems and components ISO/DIS Tracheobronchial tubes -- Sizing and marking How can I see what is changing now? SC 6 Vascular Implants CEN TC 285 ISO TC 150 TC 150/SC 1Materials TC 150/SC 2Cardiovascular implants and extracorporeal systems TC 150/SC 3Neurosurgical implants TC 150/SC 4Bone and joint replacements TC 150/SC 5Osteosynthesis and spinal devices TC 150/SC 6Active implants TC 150/SC 7Tissue-engineered engineered medical products What s New? ISO/DIS Water for haemodialysis and related therapies ISO/DIS 7199 Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators) ISO/DIS Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems Arterial blood line filters 16

17 How can I see what is changing now? SC 7 Orthopaedic Implants CEN TC 285 ISO TC 168, 170 Not much happening at the moment... How can I see what is changing now? SC 8 Sterilisers CEN TC 102 CEN TC 204 WG 2: Testing WG 3: Requirements WG 4: Packaging materials WG 5: Small sterilizers WG 6: Gas sterilizers WG 7: Biological and chemical indicators WG 8: Performance requirements and testing for washer-disinfectors What s New? pren 868 2,-10 are all being revised, Final draft due out next year (ISO/DIS 14161:2008): Sterilization of health care products - Biological indicators Guidance for the selection, use and interpretation of results 17

18 How can I see what is changing now? SC 9 Sterilisation, following... CEN TC 204: Sterilization ti of medical devices CEN TC 216: Chemical disinfectants and antiseptics CEN TC 243: Cleanroom technology ISO TC 198:Sterilization of health care products ISO TC 209: Cleanrooms and associated controlled environments How can I see what is changing now? SC 9 Sterilisation TC 198/WG 1 Industrial ethylene oxide sterilization TC 198/WG 2 Radiation sterilization TC 198/WG 3 Moist heat sterilization TC 198/WG 4 Biological indicators TC 198/WG 5 Terminology TC 198/WG 6 Chemical indicators TC 198/WG 7 Packaging TC 198/WG 8 Microbiological methods TC 198/WG 9 Aseptic processing TC 198/WG 10 Liquid chemical sterilization TC 198/WG 11 General criteria for sterilization processes TC 198/WG 12 Information for reprocessing of resterilizable devices TC 198/WG 13 Washer-disinfectors TC 198/WG 14 Dry heat sterilization 18

19 How can I see what is changing now? What s new?... ISO/CD : Washer-disinfectors -- Part 6: Requirements and tests for general purpose washer-disinfector employing thermal disinfection ISO/CD 14160: Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants ISO/DIS : Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process SO/FDIS 15882: Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results How can I see what is changing now? SC 10 Horizontal Standards, following... CEN TC 206: Biological evaluation of medical devices CEN TC 258: Clinical investigation of medical devices CEN TC 316: Medical devices utilizing tissues CEN/CLC/TC3: Quality management and corresponding general aspects for medical devices CEN ABHS: Advisory Body for Healthcare Standards ISO TC 194: Biological evaluation of medical devices ISO TC 210:Quality management and corresponding general aspects for medical devices 19

20 How can I see what is changing now? ISO/IEC NWIP , Small-bore connectors for liquids and gases Part 2: Connectors for breathing systems and driving gases ISO Series, Biological evaluation of medical devices... Part 1: Evaluation and testing within a risk management system (DIS) Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (CD) Part 4: Selection of tests for interactions with blood (NP) Part 7: Ethylene oxide sterilization residuals (FDIS) Part 9: Framework for identification and quantification of potential degradation products (DIS) Part 10: Tests for irritation and delayed-type hypersensitivity (CD) Part 13: Identification and quantification of degradation products from polymeric medical devices (CD) Part 16: Toxicokinetic study design for degradation products and leachables(np) How can I see what is changing now? SC 11 Ambulances CEN TC 239: Rescue Systems What s New? pren Specifications for patient handling equipment used in road ambulances Part 1: General stretcher systems and patient handling equipment Part 2: Power assisted stretchers Part 3: Specification for bariatric stretchers Part 4: Specification for mechanical assisted carrying chair Part 5: Specification for stretcher supports Also, revising.. pren ,-2 rev Rescue systems - Transportation of incubators 20

21 NSAI Standards Presentation Thank you for listening