BS 3970-1-1990 Sterilizing and disinfecting equipment for medical products - Specification for general requirements《医疗制品用灭菌消毒设备 第1部分 一般要求规范》.pdf

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1、BRITISH STANDARD BS 3970-1: 1990 Sterilizing and disinfecting equipment for medical products Part 1: Specification for general requirements UDC 615.478.73.74:006.3/.8BS3970-1:1990 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublish

2、ed under the authorityof the Board of BSIandcomes into effect on 29June1990 BSI 10-1999 First published January 1966 Second edition June 1990 The following BSI references relate to the work on this standard: Committee reference HCC/14 Draft for comment 85/53987 DC ISBN 0 580 17940 0 Committees respo

3、nsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/14, upon which the following bodies were represented: Associated Offices Technical Committee Association of British Sterilizer Manu

4、facturers Association of Clinical Pathologists Association of National Health Service Supplies Officers British Dental Trade Association British Health-Care Trade and Industry Council British Surgical Trades Association Incorporated Central Sterilising Club Department of Health Guild of Hospital Pha

5、rmacists Health and Safety Executive Infection Control Nurses Association Institute of Hospital Engineering Institute of Purchasing and Supply Institute of Sterile Services Management Joint Committee of Professional Nursing, Midwifery and Health Visiting Associations (England) Medical Sterile Produc

6、ts Association National Blood Transfusion Service Public Health Laboratory Service Regional Hospital Boards Engineers Association Royal College of Pathologists Royal Pharmaceutical Society of Great Britain Scottish Home and Health Department Stainless Steel Fabricators Association of Great Britain A

7、mendments issued since publication Amd. No. Date of issue CommentsBS3970-1:1990 BSI 10-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Definitions 1 3 Testing for compliance 3 4 Size, shape and designation of the chamber 3 5 Vessel and its components 4 6 Doors

8、and their controls 5 7 Control valves and over-pressure protection devices 7 8 Hydraulic test 8 9 Airborne noise emission 8 10 Thermal insulation 8 11 Electrical requirements 8 12 Steam and water supply 11 13 Instrumentation and controls 11 14 Fault 14 15 Air filters 14 16 Load supporting and handli

9、ng equipment 15 17 Information to be supplied by the manufacturer 15 18 Marking 15 Appendix A Information to be supplied by the purchaser 17 Appendix B Copper and copper alloy vessels 17 Appendix C Design of pressure vessels with rectangular section 19 Appendix D Determination of sound power levels

10、34 Appendix E Sterilizer performance and steam quality 34 Index 39 Figure 1 Certificate of compliance form 6 Figure 2 Unreinforced vessels 21 Figure 3 Reinforced vessels 22 Figure 4 Partially reinforced vessels 23 Figure 5 Jacketed vessels 24 Figure 6 Slot and plug welds 25 Figure 7 Door with horizo

11、ntal reinforcing members 27 Figure 8 Design fatigue curves 32 Figure 9 Fatigue strength of steel bolts 33 Figure 10 Apparatus for the determination of the dryness value of steam 35 Figure 11 Apparatus for the determination of non-condensable gases in steam 37 Table 1 British Standards for receivers,

12、 pipes and pipe fittings 5 Table 2 Copper and copper alloys: nominal design strength values 18 Table 3 Size of rounded indications in radiographic tests 18 Table 4 Classification of welds and joints 29 Table 5 Pitot tube diameters 36 Publications referred to Inside back coverBS3970-1:1990 ii BSI 10-

13、1999 Foreword This Part of BS3970 has been prepared under the direction of the Health Care Standards Policy Committee. It is published simultaneously with BS3970-3 and, together, they supersede BS3970-1:1966 which is withdrawn. Parts1 and2 of the first edition of BS3970 were both published in1966 an

14、d covered two specific types of sterilizer. However, in this revision the structure of BS3970 has been changed so that general requirements applicable to all sterilizers and disinfectors are now given in this Part. Those requirements that are not common to most types of sterilizer are specified in s

15、ubsequent Parts of BS3970. These Parts, giving particular requirements, should be read in conjunction with BS3970-1, which they supplement or modify. The titles of these Parts are expected to be as follows: Part 3: Specification for steam sterilizers for wrapped goods and porous loads; Part 4: Speci

16、fication for transportable steam sterilizers for unwrapped instruments and utensils 1) ; Part 5: Specification for low-temperature steam disinfectors 1) ; Part A: Specification for steam sterilizers for fluids in sealed rigid containers 1) ; Part B: Specification for steam sterilizers for fluids in

17、unsealed vented containers 1) ; Part C: Specification for steam sterilizers for fluids in sealed non-rigid containers 1) ; Part D: Specification for sterilizers using low-temperature steam with formaldehyde 1) ; Part E: Specification for sterilizers using ethylene oxide or ethylene oxide mixtures 1)

18、 ; Part F: Specification for steam sterilizers for unwrapped utensils, instruments and holloware 1) . This Part and BS3970-A which is to be published shortly will together supersede BS3970-2:1966. BS3970-5:1968 “Electrically heated steam generators for use with hospital sterilizers” no longer forms

19、part of BS3970 and has been withdrawn. Other British Standards related to sterilizing and disinfecting equipment include the following: BS 2646, Autoclaves for sterilization in laboratories. BS 2745, Specification for bed pan and urine bottle washers. BS 2904, Specification for hospital sterilizers

20、(boiling water type). BS 3281, Rectangular metal boxes for use in high vacuum steam sterilizers. BS 3421, Electrically heated sterilizing ovens. BS 5076, Hospital storage cabinets for bottled fluids. BS 6254, Specification for creped sterilization paper for medical use. BS 6255, Specification for pl

21、ain sterilization paper for medical use. BS 6256, Specification for paper for steam sterilization paper bags for medical use. BS 6257, Specification for paper bags for steam sterilization for medical use. BS 6871, Specification for heat-sealable pouches and tube material converted from transparent p

22、lastics film and paper for steam sterilization for medical use. 1) In preparation; each Part will be allocated a number in its respective order of publication.BS3970-1:1990 BSI 10-1999 iii The United Kingdom statutory requirements given in Section6 of the Health and Safety at Work etc. Act1974 are a

23、pplicable to sterilizers and the practice of sterilization. That Section describes the general duties of manufacturers, etc., regarding articles and substances for use at work and covers the design, manufacture, import and supply of any articles for use at work. However, for sterilizers that are cla

24、ssed as steam boilers or steam receivers, there are additional legal requirements which are set out in Sections32 to35 of the FactoriesAct,1961. In addition, Health Technical Memorandum (HTM) 10 “Sterilizers”, published by the Department of Health and Social Security, contains further information on

25、 installation and maintenance as well as on the subsequent use of sterilizers. BS3970 has been prepared on the basis that every individual sterilizer or disinfector will be subjected to functional performance tests. Unless otherwise stated in this standard, compliance with the performance requiremen

26、ts are checked by visual inspection or direct measurement. Reference is also made to the Electrical Safety Code for Hospital Laboratory Equipment 2)(ESCHLE), since sterilizers are required to comply with some of its provisions. The test methods and requirements of this British Standard are equally a

27、pplicable for assessing the functional performance of the sterilizer throughout its life. It is essential that a sterilizer is used only for sterilizing the type of goods for which it is designed. It is normally undesirable for a sterilizer to be designed to process more than one type of goods. The

28、choice of type of sterilizer, operating cycle or quality of the services provided may be inappropriate for a particular load although means cannot necessarily be provided to detect an incorrect choice or a misuse. For goods infected with dangerous pathogens in Hazard Group4 (as given in the Report o

29、f the DHSS Advisory Committee on Dangerous Pathogens 3) ), additional precautions are needed in the design of the drainage and ventilation systems to protect both users and the environment. Attainment of sterilization conditions should be assured by validation procedures. For steam sterilization, th

30、e attainment of certain specified sterilizing conditions is indicated by physical measurements because sufficient data exist to substantiate this approach. This is not the case for sterilizers using gaseous agents where other validation procedures are necessary. This Part of BS3970 requires the pres

31、sure vessel to be constructed to comply either with BS5500 or with the relevant requirements of this standard. If the latter, the manufacturer or his agent is required to satisfy the Inspecting Authority that the sterilizer is safe in respect of its use as a pressure vessel (see5.6). The vessel may

32、be certified by the manufacturer or his agent provided that the vessel is manufactured in accordance with the principles described in BS5750-1. Product certification. Users of this British Standard are advised to consider the desirability of third party certification for product conformity with this

33、 British Standard, based on testing and continuing surveillance which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. 2) Published as Health Equipment Information (HEI) No.158 by the UK Departments of Health. 3) The Hazard Groups are listed in “C

34、ategorization of pathogens according to hazard and categories of containment”, the Advisory Committee on Dangerous Pathogens, HMSO, 1984. Attention is also drawn to the requirements of the Health and Safety (Dangerous Pathogens) Regulations1981 which apply to those pathogens listed in Schedule1 of t

35、he Regulations.BS3970-1:1990 iv BSI 10-1999 Enquiries as to the availability of third party certification schemes may be forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body fr

36、om the list of Association members. Alternatively, users of this British Standard may wish to consider the desirability of assessment and registration of a suppliers quality systems against the appropriate Part of BS5750 by a third party certification body. A British Standard does not purport to inc

37、lude 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 document comprises a front cover, an inside front cover, page

38、si toiv, pages1to42, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.BS3970-1:1990 BSI 10-1999 1 1 Scope This Part of BS3970 specifies general

39、requirements for sterilizers, including disinfectors, comprising a pressure-tight vessel capable of operating up to a design pressure of6.0bar 4) . These sterilizers and disinfectors are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes. NOTE 1Not

40、 all sterilizer vessels specified by BS3970 are required to withstand a design pressure of6.0bar. A lower design pressure appropriate to the particular sterilizer and the load to be processed may be specified in relevant subsequent Parts of BS3970. The requirements of this Part of BS3970 apply to al

41、l sterilizers and disinfectors specified in subsequent Parts of BS3970, except insofar as they may be modified or added to by a subsequent Part, in which case the requirements of the particular Part will apply. Appendix A indicates the additional information that should be provided by the purchaser

42、to the manufacturer. NOTE 2Purchasers ordering to this standard are advised to specify in their purchasing contract that the sterilizer manufacturer operate a quality system in accordance with the principles described in BS5750-1. (Guidance on the application of BS5750-1 is given in BS5750-4.) In ad

43、dition, the manufacturer is advised to check that each supplier of accessories, fittings and other materials similarly operates a quality system in accordance with the principles described in BS5750. NOTE 3It is essential that a sterilizer should be used only for sterilizing the type of goods for wh

44、ich it is designed (seeforeword). In selecting the appropriate sterilizer, reference should be made to the list of Parts of BS3970 given in the foreword. NOTE 4The titles of the publications referred to in this standard are listed on page 41. 2 Definitions For the purposes of this Part of BS3970 the

45、 following definitions apply. NOTEThe terms that have been defined in this Part of BS3970 are identified in the index. 2.1 sterilizer equipment that incorporates a pressure vessel with a tightly-fitting door and which is used for the sterilization (2.3) of a load (2.5) 2.2 disinfector equipment inco

46、rporating a pressure vessel used for disinfection (2.4) of a load (2.5) NOTEIn this standard, the term sterilizer is generally used to encompass disinfector unless the latter is specifically stated. 2.3 sterilization the process used to render a load (2.5) free from viable micro-organisms 2.4 disinf

47、ection the process used to reduce the number of viable micro-organisms in a load (2.5) but which may not necessarily inactivate some viruses and bacterial spores 2.5 load collectively, all the goods, equipment and materials that are put into a sterilizer (2.1) or disinfector (2.2) at any one time fo

48、r the purpose of processing it by an operating cycle (2.26) NOTEIn order to manipulate the load, various devices (such as trucks, carriages and shelving) may be necessary to carry the load. These devices (see clause16) are usually provided by the manufacturer of the sterilizer. 2.6 load module a rec

49、tangular container of height300mm, breadth300mm and depth600mm, commonly used to hold the load (2.5) 2.7 vessel collectively, the chamber (2.9), jacket (if fitted), doors and components that are in permanently open connection with the chamber NOTEThe vessel does not include steam generators, pipework and fittings from which it can be isolated. 2.8 small sterilizer a sterilizer (2.1) of such a size that it is unable to accommodate a single load module (2.6) 2.9 chamber that part of the vessel (2.7) in which the load is placed