1、BRITISH STANDARD BS 2646-3: 1993 Autoclaves for sterilization in laboratories Part 3: Guide to safe use and operationBS2646-3:1993 This British Standard, having been prepared under the directionof the Laboratory Apparatus Standards Policy Committee, was published underthe authority of the Standards
2、Board and comes intoeffect on 15December1993 BSI 07-1999 The following BSI references relate to the work on this standard: Committee reference LBC/35 Draft for comment 92/54443 DC ISBN 0 580 22511 9 Committees responsible for this British Standard The preparation of this British Standard was entrust
3、ed by the Laboratory Apparatus Standards Policy Committee (LBC/-) to Technical Committee LBC/35, upon which the following bodies were represented: Association of British Health Care Industries Association of Sterilizer and Disinfector Equipment Manufacturers British Dental Trade Association British
4、Stainless Steel Association Central Sterilising Club Department of Health Health and Safety Executive Infection Control Nurses Association Institute of Hospital Engineering Institute of Sterile Services Management Medical Sterile Products Association National Blood Transfusion Service Public Health
5、Laboratory Service Regional Hospital Boards Engineers Association Royal College of Pathologists Royal Pharmaceutical Society of Great Britain Society for General Microbiology The following bodies were also represented in the drafting of the standard, through subcommittees and panels: Association of
6、Clinical Pathologists British Glass Manufacturers Confederation BLWA Ltd. (The Association of the Laboratory Supply Industry) Copper Development Association Institute of Medical Laboratory Sciences Manufacturing Science Finance Ministry of Agriculture, Fisheries and Food Royal Association of British
7、 Dairy Farmers Society for Applied Bacteriology Amendments issued since publication Amd. No. Date CommentsBS2646-3:1993 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii Introduction 1 1 Scope 1 2 References 1 3 Definitions 1 4 Operation of autoclaves 2 5 Maintenance
8、2 6 Protective clothing 3 7 Loading the autoclave 3 8 Unloading the autoclave 3 9 Discard-containers 4 10 Potential hazards in the use of laboratory autoclaves 4 11 Operating cycles 5 12 Autoclave performance 6 13 Validation 6 14 In-use testing 8 Annex A (informative) Concept of sterility 9 Annex B
9、(normative) Validation 10 Table 1 Typical operating cycle conditions 6 List of references Inside back coverBS2646-3:1993 ii BSI 07-1999 Foreword This Part of BS2646 was prepared under the direction of the Laboratory Apparatus Standards Policy Committee, to provide guidance to laboratory personnel an
10、d others concerned with the supervision and management of microbiology laboratories equipped with autoclaves conforming to BS 2646-1. It will also be of value to safety supervisors and should be read in conjunction with Safety in Health Service Laboratories: Safe working and the prevention of infect
11、ion in clinical laboratories 1, produced by the Health and Safety Commission, Health Services Advisory Committee (seenote to3.2) and Categorization of pathogens according to hazard and categories of containment, 2nd edition 2, produced by the Advisory Committee on Dangerous Pathogens (seenote to cla
12、use1); attention is also drawn to the Control of Substances Hazardous to Health Regulations (COSHH) 1988 3. BS 2646 comprises several separate Parts. The other Parts of the standard are as follows. Part 1: Specification for design, construction, safety and performance; Part 2: Guide to planning and
13、installation; Part 4: Guide to maintenance; Part 5: Methods of test for function and performance. It is anticipated that autoclaves to which this standard applies will be used for the following processes: a) liquids sterilization; b) equipment and glassware sterilization; c) make-safe. A British Sta
14、ndard 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 cover
15、, an inside front cover, pagesi andii, pages1 to12, 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.BS2646-3:1993 BSI 07-1999 1 Introduction Ma
16、ny laboratory procedures require the use of sterile materials including glassware, apparatus, instruments, and liquids in a variety of container types. Because pathogenic micro-organisms and pathological specimens may be examined or stored in microbiology laboratories it is also necessary to ensure
17、that all such material is rendered safe for subsequent handling or before it leaves the laboratory. Acceptable methods are autoclaving and/or incineration. When selecting an autoclave or an autoclaving process there is a clear need to differentiate between: a) the sterilization of liquid media and a
18、pparatus for use in the laboratory where the presence of viable micro-organisms would spoil the medium or confuse an investigation; and b) the treatment of discarded, contaminated material so that it may be handled without causing an infection hazard or contaminating the environment. Three general p
19、rocesses are therefore defined (seeBS 2646-1:1993): liquids sterilization; equipment and glassware sterilization; make-safe. Operating cycles for each process are described in this Part of BS2646 together with recommended time/temperature conditions, and recommendations on validation and in-use test
20、ing. Variations will be adopted within each process for particular load items or for special purposes; the principles which support the conditions recommended in this standard should also form the basis for other requirements a laboratory may have for an autoclave. “Free-steaming” is not defined as
21、an autoclaving process. Steaming is a means of dissolving constituents of nutrient media and also for reducingnumbers of non-sporing and vegetative micro-organisms to acceptable levels in microbiological culture media not able to withstand the higher temperatures of an autoclaving process. It is rec
22、ommended that steaming is carried out in a purpose-designed, non-pressurized vessel of the traditional “Kochs steamer” type. However, the liquids sterilization process of an autoclave may be used for this purpose if the controlled temperature is reduced to approximately 100 C. 1 Scope This Part of B
23、S2646 gives guidance on the factors that should be taken into account when devising procedures to ensure the safe and effective use of laboratory autoclaves of the types specified in BS2646-1, i.e. autoclaves for the sterilization of material and equipment including those which may be contaminated w
24、ith organisms categorized as Hazard Groups 1, 2 or 3(see note). It does not cover the use of autoclaves for material contaminated with organisms categorized as Hazard Group 4, for which complete containment of condensate is considered to be essential. The procedures described are designed to minimiz
25、e hazards to operators and other personnel, and to confirm the ability of the autoclave to carry outeffectively each of the processes defined in BS2646-1. NOTEThe groups of organisms referred to are those listed in Categorization of pathogens according to hazard and categories of containment, 2nd ed
26、ition 1990 2, produced by the Advisory Committee on Dangerous Pathogens and published by HMSO. 2 References 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
27、 in the text and the publications are listed on the inside back cover. 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. 2.2 Informative references This Part of BS2646 refers to other publications t
28、hat provide information or guidance. 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. 3 Definitions For the purposes of this Part of BS2646, the definitions given in BS2646-1:1993 ap
29、ply, together with the following. 3.1 responsible person person responsible for the operating policy of autoclaves within the laboratory 3.2 safety supervisor senior member of the laboratory staff with delegated responsibility for overseeing the management and implementation of safety standards and
30、requirements of local safety rulesBS2646-3:1993 2 BSI 07-1999 NOTEFor duties of safety supervisors (safety officers) seeSafety in Health Service Laboratories: Safe working and the prevention of infection in clinical laboratories 1, produced by the Health Services Advisory Committee of the Health and
31、 Safety Commission and published in 1991byHMSO. 3.3 maintenance/service engineer person who performs maintenance/service work on the autoclave NOTEThis person may be employed by the laboratory, contracted to the laboratory or employed by the autoclave manufacturer. 4 Operation of autoclaves 4.1 Trai
32、ning and instruction of operators Autoclaves should be operated only by persons who have been trained and instructed in their use. Operators should receive the necessary training and instruction from the responsible person (see3.1) and should be warned of the importance of carrying out only the oper
33、ation instructions. 4.2 Operation instructions Operation instructions, including those in the instruction manual, should be provided for the operator by the responsible person (see4.1 of BS2646-4:1991). If the autoclave is provided with keys, switches or codes which can be used to override safety fe
34、atures or manually advance the cycle, the operation instructions should specify the necessary authorization and procedures to be followed before their use. Operation instructions should include details of action to be taken by the operator in the event of a fault or any abnormality in autoclave perf
35、ormance. 4.3 Autoclave process record 4.3.1 An autoclave process record for each operating cycle should be kept by the operator (see4.3 of BS2646-4:1991). This should contain details of each load processed, a chart recording, a record of any fault, and corrective action taken by the operator. 4.3.2
36、Process records should include results of validation tests and in-use testing (seeclauses 13 and 14). 4.3.3 Process records should be examined by the responsible person at an agreed frequency. 5 Maintenance 5.1 Maintenance schedule The continuing safe and effective use of the autoclave depends on a
37、programme of planned maintenance throughout its life. Maintenance schedules should therefore follow all of the recommendations in BS2646-4:1991; guidance on the maintenance log and its use is also given in BS2646-4. The manufacturer should always be consulted on maintenance intervals. NOTEGuidance o
38、n factors that should be taken into account by the manufacturer when devising a maintenance schedule is given in BS 2646-4. 5.2 Precautions before service or repair of autoclaves 5.2.1 Permit to work certificate The use of permit to work certificates is strongly recommended. Guidance on these and th
39、eir use is given in BS2646-4. 5.2.2 Risk of infection during make-safe 5.2.2.1 When a fault occurs (see1.3.30 of BS 2646-1:1993) during a make-safe cycle an assessment of risk should be made and appropriate action taken. The assessment of risk should be carried out in accordance with the safety poli
40、cy of the laboratory. It may be necessary to disinfect those chamber attachments on which engineering work is to be carried out. Knowledge of the contents of the load may help in the choice of method and disinfectant for this. During a make-safe process, chamber condensate should be considered to be
41、 contaminated with viable micro-organisms. 5.2.2.2 Exceptionally, some dismantling of the autoclave may be necessary before disinfection. This should be done in the presence of the responsible person and safety supervisor. Disinfection of the chamber and/or pipework should not involve prolonged cont
42、act with disinfectants corrosive to metal. 5.2.2.3 The responsible person should ensure that appropriate protective clothing is supplied to and used by the maintenance/service engineer. 5.2.2.4 A contaminated laboratory autoclave should never be returned to the manufacturer for servicing or repair.
43、Decontamination should be carried out in accordance with local safety rules. NOTEHealth Service Guidelines HSG(93)26 4 published by the Department of Health gives guidance on the decontamination of equipment prior to servicing.BS2646-3:1993 BSI 07-1999 3 6 Protective clothing 6.1 Laboratory clothing
44、 A protective laboratory coat of side or back fasteningstyle should be worn in the autoclave loading/unloading area. 6.2 Additional protection Additional clothing should be available in the loading/unloading area(s) to protect the operator. The hazards on loading include the following: a) spills of
45、biohazardous material; b) broken glass; c) dropped load contents. The hazards on unloading include the following: 1) splashes and spillage of hot material from the load; 2) hot condensate; 3) hot equipment; 4) broken glass; 5) dropped load contents; 6) vapour from volatile chemicals (see7.3.2). The
46、additional clothing should include an impervious apron, heat-resistant gauntlet gloves, suitable heavy-duty footwear or overshoes and a full-face visor. 7 Loading the autoclave 7.1 Loading area 7.1.1 Access to the loading area should be limited to personnel aware of the hazards from potentially infe
47、ctive material. The loading position should not be obstructed. 7.1.2 All materials awaiting autoclaving should be positioned so that they cannot be overturned, spilled or damaged. 7.1.3 Discard-containers of infected materials should not be stored in the loading area. 7.1.4 Material in discard-conta
48、iners should not be handled prior to autoclaving. 7.2 Operator protection Loading (and unloading) procedures should be designed to avoid health hazards and also injuries to personnel by the elimination of awkward lifting positions and excessively heavy load containers. Heavy loads should not be lift
49、ed into (or out of) vertically mounted chambers by staff of unsuitable build or strength. Consideration should also be given to the provision of mechanical assistance (seesection 10 of BS 2646-1:1993). NOTEAttention is drawn to HSE document Manual handling Guidance on regulations, HMSO 1992 5, which gives guidance on the Manual Handling Operations Regulations1992 (in force from 1 January 1993). 7.3 Care on loading 7.3.1 Items should be packed in a way which ensures that steam will penetrate the load. 7.3.2 Before corrosive chemicals or materials and c
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