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1、BRITISH STANDARD BS EN ISO 10079-2:1997 BS 7259-1: 1993 BS 7259-1:1993 renumbered incorporating Amendment No. 1Medical suction equipment Part 2: Manually powered suction equipment The European Standard EN ISO 10079-2:1996 has the status of a British Standard ICS 11.140 Licensed Copy: sheffieldun she
2、ffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:1997 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 Febr
3、uary 1993 BSI 03-1999 The following BSI references relate to the work on this standard: Committee reference HCC/4 Draft for comment 90/55541 DC ISBN 0 580 21625 X Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Poli
4、cy Committee (HCC/-) to Technical Committee HCC/4, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association British Association of Otolaryngologists British Dental Trade Associa
5、tion British Society for Restorative Dentistry British Surgical Trades Association Department of Health Electro Medical Trade Association Limited Intensive Care Society Medical Sterile Products Association Ministry of Defence Amendments issued since publication Amd. No.DateComments 9350January 1997
6、Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:1997 BSI 03-1999i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Introduction3 1Scope3 2Normative r
7、eference3 3Definitions3 4Cleaning, disinfection and sterilization4 5Design requirements6 6Operational requirements6 7Physical requirements7 8Performance requirements for vacuum and flow7 9Resistance to environment8 10Marking8 11Information to be supplied by manufacturer8 Annex A (normative) Test met
8、hods9 Annex B (informative) Table of typical range of volumes for collection containers for specific uses12 Annex C (informative) Rationale statement12 Annex ZA (informative) Clauses of this European standard addressing essential requirements or other provisions of EU Directives13 Figure 1 Schematic
9、 drawing illustrating suction equipment5 Figure A.1 Apparatus for flexible tubing tests9 Figure A.2 Apparatus for testing resistance to implosion, cracking or permanent deformation10 Figure A.3 Apparatus for testing free air flow11 Table ZA.1 Correspondence between this European Standard and EU Dire
10、ctives13 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10079-2:1997 ii BSI 03-1999 National foreword This Part of BS 7259 has been prepared under the direction of the Health Care Standards Poli
11、cy Committee and is identical with ISO 10079-2:1992 Medical suction equipment Part 2: Manually powered suction equipment, prepared under the direction of Technical Committee 121, Anaesthetic and respiratory equipment, of the International Organization for Standardization (ISO). In 1996 the European
12、Committee for Standardization (CEN) accepted ISO 10079-2:1992 as European Standard EN ISO 10079-2:1996. As a consequence of implementing the European Standard, this British Standard is renumbered as BS EN ISO 10079-2:1997. Attention is drawn to BS EN ISO 10079-3 which specifies requirements for non-
13、electrical medical suction equipment powered from a vacuum or pressure source and to BS EN ISO 10079-1 which specifies requirements for safety of electrically-powered medical suction equipment. A British Standard does not purport to include all the necessary provisions of a contract. Users of Britis
14、h Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-references International standardCorresponding British Standard ISO 5356-1:1987BS 3849 Conical connectors for anaesthetic and respiratory equ
15、ipment Part 1:1988 Specification for cones and sockets (excluding 8.5 mm size) (Identical) Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, pages 2 to 14, an inside back cover and a back cover. This standard has been updated (see c
16、opyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10079-
17、2 May 1996 ICS 11.040.10 Descriptors: Medical equipment, hand-operated devices, medical suction equipment, specifications, performance evaluation, safety requirements, tasks, marking, instructions for use English version Medical suction equipment Part 2: Manually powered suction equipment (ISO 10079
18、-2:1992) Appareils daspiration mdicaux Partie 2: Appareils daspiration manuels (ISO 10079-2:1992) Medizinische Absauggerte Teil 2: Handbetriebene Absauggerte (ISO 10079-2:1992) This European Standard was approved by CEN on 1996-04-05. CEN members are bound to comply with the CEN/CENELEC Internal Reg
19、ulations 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 obtained on application to the Central Secretariat or to any CEN member. This
20、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 Secretariat has the same status as the official versions. CEN members are the
21、national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee f
22、r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN ISO 10079-2: 1996 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10079-2:1996 BSI 03-1999 2 Foreword The text of
23、the International Standard ISO 10079-2:1992 from Technical Committee ISO/TC 121 Anaesthetic and respiratory equipment, of the International Organization for Standardization (ISO) has been taken over as a European Standard by the Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment,
24、the secretariat of which is held by BSI. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). This European Standard shall be given the status of a national st
25、andard, either by publication of an identical text or by endorsement, at the latest by November 1996, and conflicting national standards shall be withdrawn at the latest by June 1998. ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically p
26、owered suction equipment; Part 2: Manually powered suction equipment; Part 3: Suction equipment powered from vacuum or pressure source. According to CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austri
27、a, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. For this relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. Annex A form
28、s an integral part of EN 10079-2. Annex B and Annex C are given for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 10079-2:1992(E) BSI 03-19993 0 Introduction This International Standard, which has been prepared under
29、the responsibility of Sub-Committee 8 of ISO/TC 121, comprises part 2 of the standard for medical suction equipment, and deals only with manually powered suction equipment. part 1 deals with safety requirements for electrically powered equipment. Part 3 deals with suction equipment powered from a va
30、cuum or pressure source. This International Standard has been prepared in response to a need for a safety and performance standard for suction systems. Suction is used to clear the airway and remove unwanted material from body cavities. Suction is also used to assist drainage and decompress body cav
31、ities. Suction and vacuum systems are used widely both in health care facilities such as hospitals, for domiciliary care of patients who are nursed at home, and in emergency situations both outside hospitals in field conditions, and during transport in ambulances. As far as possible, this Internatio
32、nal Standard has been written specifying performance requirements corresponding with those needed for effective and safe treatment of the patient. Annex A gives test methods to be used to verify compliance with the requirements given in this part of ISO 10079. Annex B gives a table of a typical rang
33、e of volumes for collection containers for specific uses. Annex C gives a rationale statement for some requirements. 1 Scope This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction equipment intended for oro-pharyngeal suction to establish and mainta
34、in the patency of the airway. It covers equipment operated by foot or by hand or both (see Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is within the scope of this part. This part of ISO 10079 does not apply to electrically powered suction equipment,
35、whether mains electricity or battery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressure source which is dealt with in ISO 10079-3, nor to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and
36、buildings, and wall connectors; b) catheter tubes, drains, curettes and suction tips; c) syringes; d) dental suction equipment; e) waste gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) passive urinary drainage; i) closed systems for wound drainage; j) gravity gastric dr
37、ainage; k) orally operated mucous extractors; l) suction equipment where the collection container is downstream of the vacuum pump; m) equipment marked as suction unit for permanent tracheostomy; n) ventouse (obstetric) equipment; o) neonatal mucous extractors; p) breast pumps; q) liposuction; r) ut
38、erine aspiration; s) thoracic drainage. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 10079. At the time of publication, the edition indicated was valid. All standards are subject to revision, and par
39、ties to agreements based on this part of ISO 10079 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 5356-1:1987, Anaesthetic and respiratory equ
40、ipment Conical connectors Part 1: Cones and sockets. 3 Definitions For the purposes of this part of ISO 10079, the following definitions apply. 3.1 collection container container in which liquids or solid particles are collected 3.2 collection container assembly collection container and its closure
41、3.3 end piece that part of the suction equipment applied to the patient. The end piece starts at the site where material is drawn in and ends at the first detachable connection Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 10079-2:1992
42、(E) 4 BSI 03-1999 3.4 exhaust opening part or parts through which exhaust is discharged 3.5 filter device for separation of particulate matter 3.6 free air flow unrestricted flow of air through a nominated inlet 3.7 high vacuum vacuum of at least 60 kPa1) 3.8 inlet part of a component through which
43、fluids and/or solid particles enter 3.9 intermediate tubing tubing between the collection container and the vacuum pump 3.10 low vacuum vacuum not more than 20 kPa 3.11 manually powered (generated) vacuum local generation of vacuum by human effort with a hand or foot or both 3.12 manually powered tr
44、ansportable suction equipment equipment in which vacuum is generated manually 3.13 medium vacuum vacuum less than 60 kPa and greater than 20 kPa 3.14 outlet part of a component through which fluids and/or solid particles exit 3.15 overfill protection prevention of liquid or solid particles entering
45、the intermediate tubing 3.16 overfill protection device any device intended to prevent liquid or solid particles entering the intermediate tubing 3.17 suction application of vacuum to remove fluids and/or solid particles 3.18 suction equipment single self-contained unit or combination of units which
46、 generates or controls suction 3.19 suction tubing tubing for conduction of fluids from the end piece to the collection container 3.20 vacuum pressure less than atmospheric pressure, normally expressed as a difference from atmospheric pressure 3.21 vacuum indicator device for displaying the level of
47、 vacuum 3.22 vacuum pump powered device for generating vacuum 3.23 vacuum source means of generating vacuum. The source may be integral with the suction equipment or be separate from the suction equipment 4 Cleaning, disinfection and sterilization 4.1 The suction equipment shall meet the requirement
48、s specified in 8.1 to 8.3 after those components which are subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer. 4.2 Any filters installed shall either be of the disposable type o
49、r be capable of being cleaned, disinfected and/or sterilized for re-use in accordance with 4.1. 1) 1 kPa = 7,500 63 mmHg or 4,024 619 in H2O or 10,197 16 cm H2O or 19 hPa Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:36:25 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 10079-2:1992(E) BSI 03-19995 4.3 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements specified in 8.1 to 8.3, as appropriate, before and after the collection container has been subjected to 30 cycl