1、BRITISH STANDARD BS EN ISO 595-2:1995 Incorporating Amendment No.1 Reusable all-glass or metal-and-glass syringes for medical use Part2: Design, performance requirements and tests The European Standard EN ISO595-2:1994 has the status of a British Standard UDC 615.473.3BSENISO595-2:1995 This British
2、Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Board ofBSIandcomes into effect on 31January1990 BSI 04-2000 First published as BS1263 December1946 First revision in Parts January1990 The following BSI references
3、 relate to the work on this standard: Committee reference HCC/2 Draft for comment 86/52293 DC ISBN 0 580 18118 9 Committees responsible for this British Standard The preparation of this BritishStandard was entrusted by the Health Care Standards Committee(HCC/-) to Technical Committee HCC/2, upon whi
4、ch the following bodies were represented: Association of Clinical Pathologists British Diabetic Association British Surgical Trades Association Incorporated Department of Health Disposable Hypodermic and Allied Equipment Manufacturers Association(UK) Glass Manufacturers Federation Medical Sterile Pr
5、oducts Association Royal Pharmaceutical Society of Great Britain Coopted members Amendments issued since publication Amd. No. Date of issue Comments 8542 January1995 Indicated by a sideline in the marginBSENISO595-2:1995 BSI 04-2000 i Contents Page Committees responsible Inside front cover National
6、foreword ii Foreword 2 Text of ENISO595-2 3 Publications referred to Inside back coverBSENISO595-2:1995 ii BSI 04-2000 National foreword This Part of BS1263 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO595-2:1987 “Reusable all-glass or
7、metal-and-glass syringes for medical use Part2: Design, performance requirements and tests” prepared by Technical Committee84 “Syringes for medical use and needles for injection” of the International Organization for Standardization(ISO). Together with BS1263-1, which specifies dimensional requireme
8、nts and is identical with ISO595-1:1986 (as corrected and reprinted1988-05-15), it supersedes BS1263:1946 which is withdrawn. The principal technical differences from the1946 edition which have arisen in adopting ISO595 are the omission of the0.5mL size of syringe, the introduction of the30mL and100
9、mL sizes and an increase in the options permissible for scale graduation. There are, however, many minor changes in the detail of the requirements which are too numerous to summarize. In1994 the European Committee for Standardization(CEN) accepted ISO595-2:1987 as European Standard EN ISO595-2:1994.
10、 As a consequence of implementing the European Standard this BritishStandard is renumbered as BS EN ISO595-2:1995 and any reference to BS1263-2 should be read as a reference to BS EN ISO595-2. Cross-references The Technical Committee has reviewed the provisions of the draft of ISO594-2, to which ref
11、erence is made in the text, and has decided that they are acceptable for use with this standard. When ISO594-2 is published, it is intended to implement it as BS3930-2. Product certification. Users of this BritishStandard are advised to consider thedesirability of third party certification of produc
12、t conformity with this BritishStandard based on testing and continuing surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. Enquiries as to the availability of third party certification schemes will be forwarded by BSI to the Assoc
13、iation of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standa
14、rds are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. International Standard Corresponding British Standard ISO594-1:1986 BS3930 Conical fittings with a6%(Luer) taper for syringes, needles and other medical eq
15、uipment Part1:1987 Specification for general requirements (Identical) Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theENISO title page, pages2 to6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may hav
16、e had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO595-2 August1994 UDC 615.473.3 Descriptors: Medical equipment, syringes, specifications, tests English version Reusable all-glass or metal-an
17、d-glass syringes for medicaluse Part2: Design, performance requirements and tests (ISO595-2:1987) Seringues rutilisables en verre ou en verre et mtal usage mdical Partie2: Conception, performances et essais (ISO595-2:1987) Wiederverwendbare medizinische Glasspritzen oder Spritzen aus Glas und Metall
18、 Teil2: Konstruktion, Anforderungen an die Funktion und Prfungen (ISO595-2:1987) This European Standard was approved by CEN on1994-08-09. 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 nationa
19、l standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained 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 ot
20、her language made by translation under the responsibility 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,
21、 Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1994 Copyright reserved to CEN m
22、embers Ref.No.ENISO 595-2:1994EENISO595-2:1994 BSI 04-2000 2 Foreword This European Standard has been taken over by Technical Committee CEN/TC205, Non-active medical devices, from the work of ISO/TC84, Transfusion, infusion and injection equipment, of the International Organization for Standardizati
23、on(ISO). 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 February1995, and conflicting national standards shall be withdrawn at the latest by February1995. According to the CEN/CENELEC Internal Re
24、gulations, 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 United Kingdom. NOTENormative references to international
25、publications are listed in Annex ZA (normative). Contents Page Foreword 2 0 Introduction 3 1 Scope and field of application 3 2 References 3 3 Materials 3 4 Construction and assembly 3 5 Performance requirements 4 6 Test methods 4 Annex ZA (normative) Normative references tointernational publication
26、s with their relevantEuropean publications 6ENISO595-2:1994 BSI 04-2000 3 0 Introduction This International Standard on reusable syringes for medical use comprises two parts: ISO595-1 covers the dimensions and details of the scale and ISO595-2 (this part of ISO595) covers design, performance and tes
27、t methods. 1 Scope and field of application This part of ISO595 specifies the design, performance and the corresponding test methods for reusable syringes having a graduated capacity from1 to100ml, for general medical use. This part of ISO595 is applicable to syringes of all-glass and metal-and-glas
28、s construction. 2 References ISO594-1, Conical fittings with a6%(Luer) taper for syringes, needles and certain other medical equipment Part1: General requirements. ISO594-2, Conical fittings with a6%(Luer) taper for syringes, needles and certain other medical equipment Part2: Lock fittings 1) . 3 Ma
29、terials 3.1 Glass Soda glass shall not be used for the manufacture of syringes. 3.2 Metal If a metal part is protected by means of an electroplated or other type of coating, the base metal shall be capable of passing the test specified in6.3 in the absence of the coating. 4 Construction and assembly
30、 4.1 General 4.1.1 The construction shall be such that the piston is completely removable from the barrel. 4.1.2 The nozzle shall be a male conical fitting with a6% (Luer) taper in accordance with ISO594-1 and/or ISO594-2. 4.1.3 On syringes having a capacity up to2ml, the nozzle shall be situated ce
31、ntrally on the barrel. On syringes having a capacity above2ml, the nozzle shall be situated either centrally or eccentrically on the barrel. If the nozzle is situated eccentrically, the distance between the axis of the nozzle and the nearest point of the internal surface of the barrel shall be not g
32、reater than4mm and the nozzle axis shall be diametrically opposite the scale on the barrel. 4.1.4 In all cases, the axis of the nozzle shall be parallel with the axis of the barrel. 4.1.5 The bore of the nozzle shall be centrally situated in the nozzle. 4.1.6 A means of braking the piston shall be p
33、rovided unless the barrel and packaging are marked to indicate that no means of braking is provided. If a means of braking the piston is provided, it shall be such that when the syringe is held in a vertical position with the nozzle uppermost, the piston shall remain stationary and shall not slide d
34、own under its own weight. The braking action shall be such as not to interfere unduly with the operation of the piston in the syringe. 4.2 All-glass syringes 4.2.1 When examined with normal or corrected vision, the inside of the barrel and the outside of the piston shall have a smooth finish and sha
35、ll be free from surface defects, such as pits, air lines and high spots. NOTEThe surface may be ground. 4.2.2 The glass barrel shall be transparent when wet. 4.2.3 The open end of the barrel shall be slightly bell-mouthed to ensure easy entry of the piston. The open end of the barrel shall have a fl
36、ange which shall act as a finger grip. The flange shall be manufactured so that it prevents the syringe from rolling when placed on a flat surface inclined at10 to the horizontal. The scale shall be readable when the syringe is resting on a level surface. 4.2.4 The end of the piston which is inserte
37、d into the barrel shall have a clearly defined edge to serve as a fiducial line; if this end is bevelled, the edge of the piston in contact with the barrel shall be taken as the fiducial line. NOTE 1The end of the piston and the bottom of the barrel should be shaped so as to minimize dead space. NOT
38、E 2The piston may be either hollow or solid. 4.2.5 The end of the piston that protrudes from the barrel shall be shaped to form a push-button with a flat or concave surface. 4.2.6 If the syringe has a metal nozzle, the nozzle shall be attached so that, when tested in accordance with6.6, no coloured
39、water shall be visible between the nozzle and the barrel. 1) At present at the stage of draft.ENISO595-2:1994 4 BSI 04-2000 4.3 Metal-and-glass syringes 4.3.1 The barrel shall be made of glass; the detachable cap, the nozzle, the plunger and push-button shall be made of metal; and the piston shall b
40、e made of metal or ceramic material. 4.3.2 When examined with normal or corrected vision, the inside of the barrel shall have a smooth finish and shall be free from surface defects, such as pits, air lines and high spots. 4.3.3 The glass barrel shall be transparent when wet. 4.3.4 A flat surface sha
41、ll be provided on the detachable cap or on the nozzle end of the syringe in such a position that the syringe will not roll when it is placed on a surface inclined at10 to the horizontal. The flat surface shall be such that when the syringe rests on a level surface, the scale will be readable. 5 Perf
42、ormance requirements 5.1 Resistance to thermal shock When tested in accordance with6.1, there shall be no fracture of the barrel or other damage to the barrel or the attached fittings. 5.2 Resistance to dry heat When tested in accordance with6.2, the assembled syringe shall operate satisfactorily. T
43、here shall be no signs of fracture in glass components or deterioration of metal components and markings. 5.3 Resistance to corrosion When tested in accordance with6.3, the assembled syringe shall operate satisfactorily and neither the glass nor metal parts of the syringe shall show signs of attack;
44、 the markings shall not show deterioration in their intensity. 5.4 Freedom from leakage between piston and barrel When tested in accordance with6.4, no leakage of water between the piston and the barrel shall be visible. 5.5 Permanence of markings When tested in accordance with6.5, the markings shal
45、l remain legible. 5.6 Freedom from entrapped fluid When tested in accordance with6.6, no coloured water shall be visible in the joints between metal and glass. 5.7 Freedom from striae and strain When examined in accordance with6.7, glass components shall be free from striae and strain. 6 Test method
46、s 6.1 Test procedure for resistance to thermal shock Dismantle the syringe and bring the components to room temperature. Plunge the components into water at99 1 C. After30s, remove the components from water at99 1 C and plunge them into water at room temperature. Remove the components from the water
47、 and examine them with normal or corrected vision for fractures and damage. 6.2 Test procedure for resistance to dry heat Dismantle the syringe and bring the components to room temperature. Place them in an oven at the same temperature. Increase the temperature of the oven to180 C and maintain this
48、temperature for30min. Remove the components and allow them to cool to room temperature. With normal or corrected vision, examine the glass components for fractures and all components for damage and for deterioration of the markings. Re-assemble the syringe and check for satisfactory operation. 6.3 T
49、est procedure for resistance to corrosion Dismantle the syringe and subject the components to the following treatments: a) autoclave for30min in saturated steam at121 5 C; b) immerse for30min in water at99 1 C; c) immerse for30min in aqueous saline solution containing9g of sodium chloride per litre at99 1 C. Following the above treatments, allow the syringe components to cool to room temperature. Rinse them in clean water and examine them with normal or corrected vision for signs of deterioration. 6.4 Test procedure for leakage between
