1、BRITISH STANDARD BS EN ISO 13402:2001 BS 7891:1997 Incorporating Amendment No.1 to BS 7891:1997 (renumbers the BS as BS EN ISO 13402:2001) Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure The European Standard EN ISO 13402:2000 has
2、the status of a British Standard ICS 11.040.30; 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN ISO 13402:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the St
3、andards Board and comes into effect on 15 March 1997 BSI 03-2001 The following BSI references relate to the work on this standard: Committee reference CH/43 Draft for comment 94/503763 DC ISBN 0 580 26646 X Committees responsible for this British Standard The preparation of this British Standard was
4、 entrusted to Technical Committee CH/43, Surgical instruments, upon which the following bodies were represented: British Iron and Steel Producers Association British Surgical Trades Association Department of Health Institute of Sterile Services Management Medical Sterile Products Association Nationa
5、l Association of Theatre Nurses Royal College of Nursing Royal College of Surgeons of Edinburgh Royal College of Surgeons of England Amendments issued since publication Amd. No. Date Comments 13008 March 2001 Implementation of the European StandardBS EN ISO 13402:2001 BSI 03-2001 i Contents Page Com
6、mittees responsible Inside front cover National foreword ii Introduction 1 1S c o p e 1 2 Normative reference 1 3 Autoclave test for corrosion 1 4 Boiling water test for corrosion 1 5 Copper sulfate test 2 6T h e r m a l t e s t 2 Annex A (informative) Rationale 3 Annex ZA (normative) Normative refe
7、rences to international publications with their relevant European publications 4BS EN ISO 13402:2001 ii BSI 03-2001 National foreword This British Standard is the official English language version of EN ISO 13402:2000. It is identical with ISO 13402:1995. The UK participation in its preparation was
8、entrusted to Technical Committee CH/43, Surgical instruments, 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 r
9、elated 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 CEN and CENELEC Standards normally include an annex which lists normat
10、ive references to international publications with their 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 by
11、 using the “Find” facility of the BSI Standards Electronic 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 immu
12、nity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, the EN ISO foreword page, pages 1 and 4, an inside back cover and a back cover. The BSI copyright displayed in this document indicates when the document
13、was last issued.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13402 October 2000 ICS 11.040.30; 11.060.20English version Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:1995) Instruments chirurgicaux et dentai
14、res main Dtermination de la rsistance au passage la corrosion et lexposition la chaleur (ISO13402:1995) Chirurgische und zahnrztliche Handinstrumente Bestimmung der Bestndigkeit gegenber Sterilisation, Korrosion und Wrmebehandlung (ISO 13402:1995) This European Standard was approved by CEN on 9 Sept
15、ember 2000. 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 lists and bibliographical references concerning such national standards may be o
16、btained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central S
17、ecretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CE
18、N European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13402:2000 EEN
19、 ISO 13402:2000 BSI 03-2001 Foreword The text of the International Standard from Technical Committee ISO/TC 170, Surgical instruments, of the International Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 55, Dentistry, the Secretariat
20、of which is held by 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 April 2001, and conflicting national standards shall be withdrawn at the latest by April 2001. According to the CEN/CENELEC
21、 Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switze
22、rland and the United Kingdom. NOTE Normative references to International Standards are listed in Annex ZA.EN ISO 13402:2000 BSI 3-2001 1 Introduction The procedures described in this International Standard are intended to form a harmonized series of tests that may be referred to, individually or in
23、combination, in other separate product standards. The requirements for such tests shall be defined and stated within the body of the product standard along with the number of cycles for each test procedure. The tests apply to dental and surgical instruments and are already standardized in relevant p
24、roduct standards (e.g. ISO 7151, Surgical instruments Non-cutting, articulated instruments General requirements and test methods; ISO 9173-1 Dental extraction forceps Part 1: Screw and pin joint types). However, the test procedures as stated in the product standards differ in minor details. An align
25、ment and a compilation was established. The most important test methods for dental and surgical instruments have been brought together in one general International Standard. Other, additional, tests may also be required in individual product standards; those procedures and requirements will be deter
26、mined by the members of the working groups concerned. When established, it is intended that these additional test procedures are incorporated in this International Standard as an addendum or at the next revision. This International Standard does not specify any test sequence nor any requirements rel
27、ated to specific instruments. The requirements, the test sequence and the number of test cycles have to be defined in the relevant product standards or, if no standard is available, it has to be left to the decision of the purchaser and/or the manufacturer. Apart from the boiling water test, the aut
28、oclave test applies for determining corrosion resistance. In this sense, this International Standard specifies two test methods for determining corrosion resistance. When placing an order, it is intended that the purchaser state whether both tests are to be carried out or which of the two tests. If
29、the purchaser does not so indicate, the choice is left to the discretion of the manufacturer. 1 Scope This International Standard describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure. The requir
30、ements for such tests are defined and stated in the product standard along with the number of cycles for each test procedure. Other, additional, tests may also be required (see the Introduction). 2 Normative reference The following standard contains provisions which, through reference in this text,
31、constitute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition o
32、f the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. 3 Autoclave test for corrosion The autoclave test attempts to simulate the service environment; it
33、is therefore based on recommended methods of sterilization. 3.1 Reagent The water used for the test shall be of quality 3 in accordance with ISO 3696:1987. 3.2 Apparatus Autoclave, operating in the non-vacuum mode, capable of being operated at 134 C to 138 0,22 MN m 2 . 3.3 Preparation Scrub the ins
34、trument using soap and warm water. Rinse thoroughly in water (3.1) and dry. 3.4 Test procedure Place the instrument, unwrapped on a tray, into the autoclave. Using the water (3.1) subject the instrument to an autoclaving cycle of ( ) min at 134 C to 138 C and 0,22 MN m 2 . After the cycle, open the
35、door. Remove the tray and allow the contents to cool to room temperature. 3.5 Evaluation Refer to the appropriate product standard for specific requirements. 4 Boiling water test for corrosion The boiling water test is specified for determining corrosion resistance. 4.1 Reagent The water used for th
36、e test shall be of quality 3 in accordance with ISO 3696:1987. 4.2 Apparatus Glass or ceramic beaker or suitable corrosion-resistant stainless steel vessel. 3 + 0,5 0EN ISO 13402:2000 2 BSI 3-2001 4.3 Preparation Scrub the instrument using soap and warm water. Rinse thoroughly in water (3.1) and dry
37、. 4.4 Test procedure Immerse the instrument in boiling water (3.1) in the beaker or vessel (4.2) for 30 min. Then allow the instrument to cool for 1 h in the water used for the test. Remove the instrument from the water and leave it exposed to the air for 2 h. Rub the instrument vigorously with a dr
38、y cloth. 4.5 Evaluation Examine the instrument for the presence of blemishes. 5 Copper sulfate test The copper sulfate test is used to detect improper heat treatment (see annex A for the test rationale). 5.1 Reagent Reagents used shall be of recognized analytical grade. 5.1.1 Cupric sulfate: hydrate
39、d cupric sulfate crystals (CuSO 4 5H 2 O), 1 g. 5.1.2 Sulfuric acid: sulfuric acid AR (H 2 SO 4 ), =1 , 8 4 g / c m 3 , 2,5 g. 5.1.3 Water of quality 3 in accordance with ISO 3696:1987. 5.1.4 Isopropyl alcohol or 95 % ethyl alcohol. 5.2 Apparatus Non-reactive vessel, such as glass or ceramic contain
40、er. 5.3 Preparation 5.3.1 Preparation of instrument Scrub the instrument using soap and warm water, rinse thoroughly in water (5.1.3) and dry using isopropyl alcohol or 95 % ethyl alcohol (5.1.4). 5.3.2 Preparation of copper sulfate solution Fill a non-reactive container with 22,5 ml of warm distill
41、ed water (5.1.3). Add 1 g of cupric sulfate crystals (5.1.1) and stir until the crystals are completely dissolved. Then add 2,5 g of sulfuric acid (5.1.2) and mix thoroughly. 5.4 Test procedure Submerge the instrument in a non-reactive container of copper sulfate solution at room temperature. Instru
42、ments too large for complete immersion shall be partially immersed, or tested by drops of the solution. The copper sulfate solution shall remain in contact with the instrument for 5,5 min to 6,5 min. Rinse the instrument thoroughly with tap water and vigorously rub it with a cloth to remove any non-
43、adherent copper plating. 5.5 Evaluation Refer to the appropriate product standard for specific requirements. 6 Thermal test The thermal test is specified for determining the resistance against thermal exposure. 6.1 Apparatus A dry heat oven capable of being operated at (175 5) C. 6.2 Test procedure
44、Place the instrument in the dry heat oven at (175 5) C and, after allowing the oven to recover its set temperature, leave it for (30 1) min. Remove the instrument from the dry heat oven and allow it to cool, in the open air, to room temperature. 6.3 Evaluation Refer to the appropriate product standa
45、rd for specific requirements.EN ISO 13402:2000 BSI 03-2001 3 Annex A (informative) Rationale NOTE 1 This text is taken from ASTM-F 1089-87. A.1 The function of these test methods is to provide test methodology and means of evaluation consistent to both producers and users alike. A.2 The corrosion te
46、sts serve as an indicator of proper material processing selection by the manufacturers and proper care by the user. A.3 The autoclave test, the boil test and copper sulfate test serve as an indicator that the surface has achieved a passive state and as a means of removing chemical and free iron cont
47、aminants. Heat treatment has an important effect on corrosion resistance in martensitic stainless steel. Carbide formation does reduce corrosion resistance. Proper heat treatment dissolves free carbon. The copper sulfate detects carbide formation from the carbon. The copper sulfate test is used in a
48、ustenitic materials to detect chromium depletion at the grain boundary caused by improper heat treatment or improper cold working. The boil test is applicable to martensitic, austenitic and precipitation-hardened materials to detect surface imperfections. A.4 Specific instrument design/manufacturing
49、 processes will influence corrosion test results. Accumulated test experience is an important factor in determining the significance of corrosion results obtained for stainless steel. A.5 The copper sulfate test was developed to detect chromium depletion at the grain boundaries of austenitic material due to improper heat treatment (in the 900 F to 1100 F range) or improper cold working. The boil test would not readily show these defects, but would show cracks and pitting. The austenitic materials sh
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