BS EN ISO 8282-1997 Dental equipment Mercury and alloy mixers and dispensers《牙科设备 汞和合金混合器与分配器》.pdf

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1、BRITISH STANDARD BS EN ISO 8282:1997 Dental equipment Mercury and alloy mixers and dispensers The European Standard EN ISO 8282:1997 has the status of a British Standard ICS 11.060.20BSENISO8282:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector

2、Board, waspublished under the authorityof the Standards Boardand comes into effect on 15 June 1997 BSI 09-1999 ISBN 0 580 27766 6 National foreword This British Standard is the English language version of ENISO8282:1997. It is identical with ISO8282:1994. The UK participation in its preparation was

3、entrusted to Technical Committee CH/60, Dental equipment, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor relat

4、ed international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that Annex ZA lists normative references to international publications with the

5、ir corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or using the “Find” facility of the BSI Standards Electron

6、ic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This docum

7、ent comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 4 andaback cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment ta

8、ble on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSENISO8282:1997 BSI 09-1999 i Contents Page National foreword Inside front cover Foreword 2 Foreword iii Text of ISO 8282 1ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8282 March 1997 ICS 11

9、.060.20 Descriptors: See ISO document English version Dental equipment Mercury and alloy mixers and dispensers (ISO 8282-1994) Matriels dentaires Mlangeurs et distributeurs de mercure et dalliages (ISO 8282:1994) Zahnrztliche Ausrstung Mischgerte und Dosierer fr Quecksilber und Legierungen zur Herst

10、ellung von Amalgam (ISO 8282:1994) This European Standard was approved by CEN on 1997-02-28. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date

11、 lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the re

12、sponsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Nor

13、way, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members Ref. No. EN ISO 8282:1997 EENISO8282:

14、1997 BSI 09-1999 2 Foreword The text of the International Standard from Technical Committee ISO/TC106 “Dentistry” of the International Organization for Standardization (ISO) has been taken over as a European Standard by the Technical Committee CEN/TC55 “Dentistry”, the secretariat of which is held b

15、y DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 1997, and conflicting national standards shall be withdrawn at the latest by September1997. According to the CEN/CENELEC Internal R

16、egulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdo

17、m. Endorsement notice The text of the International Standard ISO8282:1994 has been approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed inAnnex ZA (normative).ENISO8282:1997 ii BSI 09-1999 Contents Page Foreword iii 1 Scope 1

18、 2 Normative reference 1 3 Classification 1 4 Requirements 1 5 Sampling 2 6 Test methods 2 7 Manufacturers instructions 3 8 Marking 3 9 Packaging 3 Annex ZA (normative) Normative references to international publications with their relevant European publications 4ENISO8282:1997 BSI 09-1999 iii Forewo

19、rd ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technic

20、al committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of el

21、ectrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least75% of the member bodies casting a vote. International Standard ISO8282 was prepared

22、 by Technical Committee ISO/TC106, Dentistry, Subcommittee SC6, Dental equipment. Descriptors: Dentistry, dental equipment, amalgams, mixers, dispensers, classification, specifications, tests, marking, packaging, instructions for use.iv blankENISO8282:1997 BSI 09-1999 1 1 Scope This International St

23、andard specifies requirements and test methods for devices used for dispensing dental amalgam alloys and/or mercury. It includes the dispensing portion of devices which dispense the correct portions of alloy and mercury as well as mix the amalgam in a single, continuous operation. It does not specif

24、y requirements and test methods for the efficacy of mixing. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are sub

25、ject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 1560:1985, Den

26、tal mercury. 3 Classification Dispensers covered by this International Standard shall be classified as follows: 4 Requirements 4.1 Construction Dispensers shall not exhibit any defects such as cracks or missing adhesive which could lead to failure of the dispenser during normal usage resulting in a

27、sudden release of mercury or alloy. Dispensers shall be made of materials that do not react with or contaminate the alloy or mercury. No deterioration of the surface of the reservoir shall be visible after the test and no visible change in the alloy or mercury is acceptable. Testing shall be in acco

28、rdance with6.1 and6.2. 4.2 Adjustment Adjustable dispensers shall be provided with a means of ensuring that the adjustment will not change during normal use. Testing shall be in accordance with6.1. 4.3 Mercury leakage Mercury dispensers shall not exhibit a static leakage exceeding1mg. NOTE 1While1mg

29、 leakage is currently acceptable, the goal is to reach zero leakage in the near future. Mercury leakage deposited during function after100dispensings shall not exceed0,10g. For devices of type4 no mercury should be visible after100dispensings in the interior of the, dispensing and mixing device exce

30、pt the mercury container, the connecting tube and the capsule. Testing shall be in accordance with6.3. 4.4 Filling The device shall be capable of being filled with mercury without spillage. Testing shall be in accordance with6.4. 4.5 Accuracy and performance 4.5.1 Mercury and/or alloy powder dispens

31、ers At each dispensing the mass of mercury or alloy powder shall fall within 3% for powder and 1,5% for mercury of the value claimed by the manufacturer. Testing shall be in accordance with6.5.1. 4.5.2 Alloy tablet dispensers In addition to the requirement in4.5.1, alloy tablet dispensers shall disp

32、ense tablets easily with no tendency for the dispenser to jam or bind, and no evidence of damage to the tablets. Samples of all brands of tablets recommended by the manufacturer shall be tested. Testing shall be in accordance with6.5.2. 4.6 Stability The dispenser shall not tip when submitted to the

33、 test in accordance with6.6. Type 1 Alloy dispensers Category 1 Powder Category 2 Tablet Type 2 Mercury dispensers Category 1 Fixed volume Category 2 Adjustable volume Type 3 Combination alloy/mercury dispensers Category 1 Alloy powder Category 2 Alloy tablet Category 3 Adjustable volume alloy and/o

34、r mercury Type 4 Dispensing and mixing devicesENISO8282:1997 2 BSI 09-1999 4.7 Cleaning Dispensers shall be cleanable following the manufacturers instructions. NOTE 2Cleanability is necessary so that alloy and/or mercury may be changed to different brands and types while maintaining accurate operati

35、on. Testing shall be in accordance with6.7. 5 Sampling One sample of the device shall be procured on the open market for testing for compliance with this International Standard. 6 Test methods 6.1 Visual inspection Visually inspect the test piece at normal visual acuity without magnification to dete

36、rmine compliance with the stated requirements. 6.2 Construction Fill the reservoirs for mercury and alloy to the maximum level and empty after24h. Conduct the tests of6.3 to6.6, and leave the device for a further24h. Then examine the alloy and mercury for visible changes and test the mercury for com

37、pliance with the requirements of ISO1560. Empty the reservoirs and clean them according to the manufacturers instructions. Visually examine the surfaces and note any deteriorations. 6.3 Mercury leakage 6.3.1 Static Select a tray that is large enough to contain the dispenser. Weigh the tray to the ne

38、arest0,1mg. Place the filled dispenser in this tray. Cover the entire device with a cover to prevent contaminants from collecting in the tray from outside. After 24h, brush any adherent mercury into the tray, remove the dispenser and reweigh the tray. 6.3.2 Functional If the dispenser is adjustable,

39、 adjust it to a mid-range setting and fill it with mercury. Weigh a shallow tray to the nearest milligram. Place a small cup away from the weighed tray. Make alternate single and double dispensings into this cup which should be slightly larger than the dispensing port of the device, e.g.a mixing cap

40、sule, precisely following the manufacturers instructions for operation. After each dispensing, set the device down on the previously weighed tray. After 100 dispensings, visually inspect the outside surfaces of the dispenser for any evidence of mercury. Brush any droplets into the tray. Reweigh the

41、tray to the nearest milligram and calculate the amount of the mercury leakage. 6.3.3 Type 4 devices Fill the mercury container to the maximum recommended level. Set the timer to the maximum recommended mixing time. Run the mixing operation five times without dispensing. Brush any mercury out of the

42、connecting tube and the mixing capsule into a preweighed container. Reweigh the container to the nearest milligram and calculate the amount of mercury leakage. Fill the mercury container to the maximum recommended level. Start the mixing device and dispense ten dispensings of mercury. Empty the caps

43、ule. Repeat this operation nine times. After a total of100dispensings (10 operations) examine the device for the presence of mercury. 6.4 Filling Fill the device with mercury following the manufacturers instructions. Visually examine the device for any signs of spillage of mercury. 6.5 Accuracy and

44、performance 6.5.1 Mercury and/or alloy powder dispensers Fill the storage reservoir with the mercury of powder to the maximum recommended setting. Adjust the dispenser to the recommended setting. Following any preconditioning instructions of the manufacturer, weigh out the next10dispensings into a p

45、reweighed container. 6.5.2 Alloy tablet dispensers Fill the alloy tablet reservoir to the maximum recommended level. Dispense all tablets into a suitable tray having a shock-absorbing surface and located25mm below the exit port. Repeat the test on samples of all the brands of tablets recommended by

46、the manufacturer, and observe the dispensing. 6.6 Stability Place the empty device in its normal rest position on a non-skid surface inclined10from the horizontal. Rotate the device on the surface through360in45increments and note whether the device tips at any of the orientations. Repeat the test w

47、ith the device fully loaded with alloy and/or mercury. 6.7 Cleaning Clean the dispenser and the reservoirs with the agents recommended by the manufacturer. Visually inspect the devices and note any signs of debris.ENISO8282:1997 BSI 09-1999 3 7 Manufacturers instructions Instructions for safe and pr

48、oper use shall accompany each dispenser. These instructions shall include the following. 7.1 Loading Instructions shall show how to fill the dispenser safely. This shall include the precautionary notes necessary to avoid spilling the mercury. 7.2 Operation The proper method of holding and operating

49、the dispenser shall be stated. This shall include an illustration of the proper adjustment procedure where appropriate. 7.3 Cleaning and maintenance Procedures for cleaning and maintenance shall be stated along with the recommended frequency of applying these procedures. 7.4 Mercury delivered The average mass, in milligrams, of mercury dispensed shall be stated by the manufacturer. For adjustable-volume dispensers, the average mass of the dispensings taken from at least three of the settings indicated on the dispenser and covering the ent