1、BRITISH STANDARD BS 2646-1: 1993 Autoclaves for sterilization in laboratories Part 1: Specification for design, construction, safety and performanceBS2646-1:1993 This British Standard, having been prepared under the directionof the Laboratory Apparatus Standards Policy Committee, was published under
2、the authority of the Standards Board and comes intoeffect on 15 March 1993 BSI 01-2000 First published December 1955 First revision as BS 2646-1 August 1988 Second edition March 1993 The following BSI references relate to the work on this standard: Committee reference LBC/35 Draft for comment 91/530
3、15 DC ISBN 0 580 21336 6 Committees responsible for this BritishStandard The preparation of this British Standard was entrusted by the Laboratory Apparatus Standards Policy Committee (LBC/-) to Technical Committee LBC/35, upon which the following bodies were represented: Association of British Healt
4、h Care Industries Association of National Health Service Supplies Officers Association of Sterilizer and Disinfector Equipment Manufacturers British Dental Trade Association Central Sterilising Club Department of Health Health and Safety Executive Infection Control Nurses Association Institute of Ho
5、spital Engineering Institute of Purchasing and Supply Institute of Sterile Services Management Joint Committee of Professional Nursing, Midwifery and Health Visiting Associations (England) Medical Sterile Products Association National Blood Transfusion Service Public Health Laboratory Service Region
6、al Hospital Boards Engineers Association Royal College of Pathologists Royal Pharmaceutical Society of Great Britain Society for General Microbiology Stainless Steel Fabricators Association of Great Britain The following bodies were also represented in the drafting of the standard, through subcommit
7、tees and panels: Association of Clinical Pathologists British Glass Manufacturers Confederation British Laboratory Ware Association Copper Development Association Institute of Medical Laboratory Sciences Manufacturing Science Finance Ministry of Agriculture, Fisheries and Food Royal Association of B
8、ritish Dairy Farmers Society for Applied Bacteriology Amendments issued since publication Amd. No. Date CommentsBS2646-1:1993 BSI 01-2000 i Contents Page Committees responsible Inside front cover Foreword iii Section 1. General 1.1 Scope 1 1.2 References 1 1.3 Definitions 1 1.4 Classification 3 1.5
9、Responsibilities 3 1.6 Information and requirements to be agreed and to be documented 6 Section 2. Materials 2.1 Selection of materials 8 2.2 Nominal design strength 8 Section 3. Autoclave chamber 3.1 General 11 3.2 Chamber doors 11 Section 4. Steam generators 4.1 General 12 4.2 Generator-to-chamber
10、 pipework assemblies 12 Section 5. Design 5.1 General 13 5.2 Construction categories 13 5.3 Design stress 13 5.4 Wall thickness 13 5.5 Vessels under internal pressure 13 5.6 Vessels under vacuum (subject to external pressure) 14 5.7 Doors and frames 14 Section 6. Manufacture and workmanship 6.1 Gene
11、ral aspects of construction 16 6.2 Cutting, forming and tolerances 16 6.3 Welded joints 16 6.4 Brazed joints 16 Section 7. Inspection and testing of pressure vessels 7.1 General 17 7.2 Approval testing of welding procedures 17 7.3 Welder and operator approval 17 7.4 Production control test plates 17
12、 7.5 Non-destructive testing of pressure vessels 17 7.6 Visual examination of pressure vessels 18 7.7 Pressure tests 18 7.8 Stamping and marking of pressure vessels 19 Section 8. Inspection and testing of the completed autoclave 8.1 General 20 8.2 Commissioning 20 Section 9. Safety and safety device
13、s 9.1 General 21 9.2 Provision of pressure vessel safety devices 21 9.3 Attachments for autoclaves heated by electrical immersion heaters 22 9.4 Safety devices for pressure vessels 22BS2646-1:1993 ii BSI 01-2000 Page 9.5 Safety devices to protect the operator when unloading the autoclave 23 9.6 Elec
14、trical safety requirements 23 9.7 Temperature of autoclave surfaces 24 Section 10. Load supporting and handling equipment 10.1 Internal shelf framework system 25 10.2 Loading trolley 25 Section 11. Instrumentation and control 11.1 General 26 11.2 Gauge dials 26 11.3 Illuminated digital displays 26 1
15、1.4 Pressure gauges 26 11.5 Pressure indicators 26 11.6 Temperature indicators 26 11.7 Temperature recorders 27 11.8 Controller settings 27 11.9 Microprocessor control systems 27 11.10 Radio-frequency (RF) interference 28 11.11 Testing 28 Section 12. Performance requirements 12.1 Performance test fo
16、r autoclaves designed for a liquids sterilization process 29 12.2 Performance tests for autoclaves designed for make-safe 29 12.3 Performance tests for autoclaves designed for equipment and glassware sterilization 29 Section 13. Marking 13.1 General 31 13.2 Information relating to the autoclave 31 1
17、3.3 Information relating to each pressure vessel 31 Annex A (informative) Description of the testing programme 32 Annex B (informative) Optional requirements to be agreed between the purchaser and the manufacturer 32 Figure 1 Certificate of compliance 4 Figure 2 Stiffeners for flat plates 15 Table 1
18、 Materials 9 Table 2 Copper and copper alloys: nominal design strength values 10 Table 3 Construction categories 13 Table 4 Minimum wall thickness 13 Table 5 Values of K for use in equation (1) 14 Table 6 Inspection and testing stages 18 Table 7 Maximum surface temperature increases 24 List of refer
19、ences 35BS2646-1:1993 BSI 01-2000 iii Foreword This Part of BS2646 has been prepared under the direction of the Laboratory Apparatus Standards Policy Committee. It specifies requirements for the design, construction, safety and performance of laboratory autoclaves for the purposes of sterilization.
20、It does not cover autoclaves for use with material infected with organisms in Hazard Group4 (see1.1, footnote3). This Part of BS2646 supersedes BS2646-1:1988 which is withdrawn. This new edition introduces requirements for function and performance, related to the methods of test contained in BS2646-
21、5. BS2646 comprises several separate Parts. The other Parts of the standard are as follows. Part 2: Guide to planning and installation; Part 3: Guide to safe use and operation 1) ; Part 4: Guide to maintenance; Part 5: Methods of test for function and performance. This Part of BS2646 specifies requi
22、rements for the design and construction of the pressure vessel and also includes details of necessary pressure vessel and electrical safety features. It is intended that in conforming to this standard the design and manufacture of autoclave pressure vessels will also conform to the relevant requirem
23、ents of BS5500:1991. It is acknowledged that copper and copper alloys are not covered by BS5500, and neither are rectangular pressure vessels. The design criteria for autoclave pressure vessels constructed of copper or copper alloys and for rectangular chambers are included in this Part of BS2646. A
24、 section has also been included on steam generators heated by electricity where these form part of the autoclave unit. This new edition of the standard introduces requirements for the performance and testing of autoclaves. Autoclaves may be suitable for a single process where the displacement of air
25、 is by steam, or they may be multi-purpose and incorporate a number of operating cycles for more than one process, some having a mechanical air removal system such as vacuum and/or a succession of pressure reductions and steam pulses. The testing programme is described inAnnex A and covers tests on
26、the pressure vessel and on the completed and installed autoclave, including commissioning. The tests themselves are described in BS2646-5. Guidance on validation and in-use tests will be given in BS2646-3. Autoclaves covered by this standard are not intended for the sterilization of goods or fluids
27、which are directly concerned with patient care nor for fabrics subjected to sterilization which are required to be dry at the end of the cycle. Sterilizers suitable for these applications are covered by Parts of BS3970. It is intended that consideration will be given to replacement of the references
28、 to BS3456-101:1987 in 9.6, relating to electrical safety requirements, by references to BS EN61010-1, when that standard is published. BS EN61010-1 will include safety requirements for various types of laboratory equipment. Product certification. Users of this British Standard are advised to consid
29、er the desirability of third party certification of product conformity to this British Standard based on testing and continuing product 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 p
30、arty certification schemes are 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 from the list of Association members. 1) In preparation.BS2646-1:1993 iv BSI 01-2000 A Briti
31、sh 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 document comprises a front
32、 cover, an inside front cover, pages i to iv, pages1 to 36, 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.BS2646-1:1993 BSI 01-2000 1 Section
33、 1. General 1.1 Scope This Part of BS2646 specifies requirements for the design, construction, safety and performance of autoclaves for operation with saturated steam at temperatures up to138 C and pressure not exceeding2.4bar 2)nominal and for operation under vacuum (subject to external pressure).
34、This standard covers laboratory autoclaves for the sterilization of goods and material which could be infected with organisms categorized as Hazard Group1, 2 or 3 3) . It does not cover autoclaves for use with material infected with organisms in Hazard Group4, for which complete containment and ster
35、ilization of infected condensate is considered to be essential. This standard does not apply to sterilizers or disinfectors used for medical, dental, pharmaceutical or veterinary purposes which are directly concerned with patient care, or to those used for fabrics subjected to sterilization which ar
36、e required to be dry at the end of the cycle. These are covered by BS3970. 1.2 References 1.2.1 Normative references This Part of BS2646 incorporates, by reference, provisions from specific editions of other publications. These normative references are cited at the appropriate points in the text and
37、 the publications are listed on page35. Subsequent amendments to, or revisions of, any of these publications apply to this Part of BS2646 only when incorporated in it by updating or revision. 1.2.2 Informative references This Part of BS2646 refers to other publications that provide information or gu
38、idance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference should be made to the latest editions. 1.3 Definitions For the purposes of this Part of BS2646, the following definitions apply. 1.3.1 autoclave a machine, which in
39、corporates a steam pressure vessel, designed to sterilize laboratory materials and equipment NOTEIt may also be used for other processes, such as heat disinfection and heat treatment, which may be selected according to the laboratory requirements and the nature of the load. 1.3.2 maximum permissible
40、 working pressure the maximum internal pressure, not higher than the design pressure, at which the autoclave chamber and/or generator can be operated NOTETo prevent unnecessary lifting of the safety valve, there should be an adequate margin between the actual pressure at which the autoclave is opera
41、ting and the lowest pressure at which the safety valve is set to lift. 1.3.3 design pressure the maximum internal pressure, not lower than the safety valve set pressure, that the autoclave chamber and/or generator is designed to withstand and that is therefore used in the design equations 1.3.4 safe
42、ty valve set pressure the pressure at which a safety valve is set to lift 1.3.5 operating pressure the pressure at which the autoclave operates 1.3.6 design temperature the saturated steam temperature corresponding to the design pressure of the autoclave chamber and/or generator. Its value is used t
43、o determine the appropriate nominal design strengths for the selected materials and is not lower than the actual metal temperature prevailing in service (see5.3.1) 1.3.7 door the closure of the autoclave chamber. In the case of a top loading autoclave, it is the lid of the chamber 1.3.8 purchaser th
44、e individual or organization that buys the completed autoclave for its own use or as an agent for the user 1.3.9 manufacturer the organization that designs, constructs and tests the autoclave in accordance with this Part of BS2646 and with the purchasers specification 2) 1 bar = 1 10 5N/m 2= 0.1 N/m
45、m 2= 1 10 2kPa = 14.5038 lbf/in 2 . Pressures referred to are measured from atmospheric and not on the absolute scale. 3) The Hazard Groups of organisms referred to are those listed in Categorization of pathogens according to hazard and categories of containment, Second Edition, 1990 1, produced by
46、the Advisory Committee on Dangerous Pathogens, and published by HMSO.BS2646-1:1993 2 BSI 01-2000 NOTEBy agreement, the design, construction and testing may be carried out by different organizations (see1.5). 1.3.10 inspecting authority the independent body or association appointed to check that the
47、manufacturers quality system, and the design, materials and construction of the autoclave pressure vessel(s) conform to this Part of BS2646 1.3.11 regulating authority the authority, in the country in which the autoclave is to be installed, that is legally charged with the enforcement of the require
48、ments relating to autoclave pressure vessels of the law and regulations of that country 1.3.12 liquids sterilization a process to sterilize a variety of liquids, including culture media, in containers of various types NOTEDue to the heat sensitive nature of some constituents of nutrient media, time
49、and temperature controls should allow the user to select cycle characteristics separately for each load. 1.3.13 make-safe a process which reduces the microbial content of contaminated material so that it can be handled and disposed of without causing an infection hazard or environmental contamination NOTEMaterial may include single-use items to be discarded, e.g.plastics specimen tubes and culture plates, and/or items for cleaning and reuse,e.g.glass containers and filter assemblies. 1.3.14 equipment and glassware sterilization a process s
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