• BS 2646-1:1993

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Autoclaves for sterilization in laboratories Specification for design, construction, safety and performance

    Available format(s):  Hardcopy, PDF

    Superseded date:  26-04-2021

    Language(s):  English

    Published date:  15-03-1993

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Committees responsible
    Foreword
    Specification
    Section 1. General
    1.1 Scope
    1.2 References
    1.3 Definitions
    1.4 Classification
    1.5 Responsibilities
    1.6 Information and requirements to be agreed and to
           be documented
    Section 2. Materials
    2.1 Selection of materials
    2.2 Nominal design strength
    Section 3. Autoclave chamber
    3.1 General
    3.2 Chamber doors
    Section 4. Steam generators
    4.1 General
    4.2 Generator-to-chamber pipework assemblies
    Section 5. Design
    5.1 General
    5.2 Construction categories
    5.3 Design stress
    5.4 Wall thickness
    5.5 Vessels under internal pressure
    5.6 Vessels under vacuum (subject to external
           pressure)
    5.7 Doors and frames
    Section 6. Manufacture and workmanship
    6.1 General aspects of construction
    6.2 Cutting, forming and tolerances
    6.3 Welded joints
    6.4 Brazed joints
    Section 7. Inspection and testing of pressure vessels
    7.1 General
    7.2 Approval testing of welding procedures
    7.3 Welder and operator approval
    7.4 Production control test plates
    7.5 Non-destructive testing of pressure vessels
    7.6 Visual examination of pressure vessels
    7.7 Pressure tests
    7.8 Stamping and marking of pressure vessels
    Section 8. Inspection and testing of the completed
               autoclave
    8.1 General
    8.2 Commissioning
    Section 9. Safety and safety devices
    9.1 General
    9.2 Provision of pressure vessel safety devices
    9.3 Attachments for autoclaves heated by electrical
           immersion heaters
    9.4 Safety devices for pressure vessels
    9.5 Safety devices to protect the operator when
           unloading the autoclave
    9.6 Electrical safety requirements
    9.7 Temperature of autoclave surfaces
    Section 10. Load supporting and handling equipment
    10.1 Internal shelf framework system
    10.2 Loading trolley
    Section 11. Instrumentation and control
    11.1 General
    11.2 Gauge dials
    11.3 Illuminated digital displays
    11.4 Pressure gauges
    11.5 Pressure indicators
    11.6 Temperature indicators
    11.7 Temperature recorders
    11.8 Controller settings
    11.9 Microprocessor control systems
    11.10 Radio-frequency (RF) interference
    11.11 Testing
    Section 12. Performance requirements
    12.1 Performance test for autoclaves designed for a
           liquids sterilization process
    12.2 Performance tests for autoclaves designed for
           make-safe
    12.3 Performance tests for autoclaves designed for
           equipment and glassware sterilization
    Section 13. Marking
    13.1 General
    13.2 Information relating to the autoclave
    13.3 Information relating to each pressure vessel
    Annexes
    A (informative) Description of the testing
           programme
    B (informative) Optional requirements to be agreed
           between the purchaser and the manufacturer
    Tables
    1 Materials
    2 Copper and copper alloys: nominal design strength
           values
    3 Construction categories
    4 Minimum wall thickness
    5 Values of K for use in equation (1)
    6 Inspection and testing stages
    7 Maximum surface temperature increases
    Figures
    1 Certificate of compliance
    2 Stiffeners for flat plates
    List of references

    Abstract - (Show below) - (Hide below)

    Specifies requirements for the design, construction and performance of autoclaves operating with saturated steam at temperatures up to 138°C and pressure not exceeding 2.4 bar nominal and for operation under vacuum (subject to external pressure).

    Scope - (Show below) - (Hide below)

    This Part of BS2646 specifies requirements for the design, construction, safety and performance of autoclaves for operation with saturated steam at temperatures up to 138°C and pressure not exceeding 2.4 bar2) nominal and for operation under vacuum (subject to external pressure).

    This standard covers laboratory autoclaves for the sterilization of goods and material which could be infected with organisms categorized as Hazard Group 1, 2 or 33) It does not cover autoclaves for use with material infected with organisms in Hazard Group 4, for which complete containment and sterilization 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 are required to be dry at the end of the cycle. These are covered by BS3970.

    General Product Information - (Show below) - (Hide below)

    Committee CH/198
    Development Note Supersedes 91/53015 DC and BS 2646-1(1988). (06/2005) Reviewed and confirmed by BSI, December 2011. (11/2011)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    BS 3970-2:1991 Sterilizing and disinfecting equipment for medical products Specification for steam sterilizers for aqueous fluids in sealed rigid containers
    BS 6443:1984 Method for penetrant flaw detection
    BS 4206:1967 Methods of testing fusion welds in copper and copper alloys
    BS 4300-14(1973) : 1973 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 7020 PLATE, SHEET STRIP
    BS 2875:1969 Specification for copper and copper alloys. Plate
    BS 3970-4:1990 Sterilizing and disinfecting equipment for medical products Specification for transportable steam sterilizers for unwrapped instruments and utensils
    BS 4300-15(1973) : 1973 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 7020 BAR, EXTRUDED ROUND TUBE AND SECTIONS
    BS 5164:1975 Specification for indirect-acting electrical indicating and recording instruments and their accessories
    BS 6667-3:1985 Electromagnetic compatibility for industrial-process measurement and control equipment Method of evaluating susceptibility to radiated electromagnetic energy
    BS 5235:1975 Specification for dial-type expansion thermometers
    BS 5304:1988 Code of practice for safety of machinery
    BS 2646-5:1993 Autoclaves for sterilization in laboratories Methods of test for function and performance
    BS 853(1990) : 1990 AMD 8979 SPECIFICATION FOR VESSELS FOR USE IN HEATING SYSTEMS - CALORIFIERS AND STORAGE VESSELS FOR CENTRAL HEATING AND HOT WATER SUPPLY
    BS 759-1:1984 Valves, gauges and other safety fittings for application to boilers and to piping installations for and in connection with boilers Specification for valves, mountings and fittings
    BS 6253-1:1982 Electrical measuring transducers for converting a.c. electrical quantities into d.c. electrical quantities Method for specifying general purpose transducers
    BS 3970-5:1990 Sterilizing and disinfecting equipment for medical products Specification for low temperature steam disinfectors
    BS 2646-3:1993 Autoclaves for sterilization in laboratories Guide to safe use and operation
    BS 6072:1981 Method for magnetic particle flaw detection
    BS 6759-1:1984 Safety valves Specification for safety valves for steam and hot water
    BS 1723-2:1986 Brazing Guide to brazing
    BS 4300-11(1969) : 1969 ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 5454 FORGING STOCK AND FORGINGS
    BS 1845:1984 Specification for filler metals for brazing
    BS 4300-12(1969) : 1969 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 5454 BARS, EXTRUDED ROUND TUBE AND SECTIONS
    BS 2646-2:1990 Autoclaves for sterilization in laboratories Guide to planning and installation
    BS 4300-4(1973) : 1973 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 6464 SOLID EXTRUDED BARS AND SECTIONS SUITABLE FOR BRIGHT TRIM/REFLECTOR APPLICATIONS
    BS 1723-1:1986 Brazing Specification for brazing
    BS 4300-13(1969) : 1969 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 5554 WELDING WIRE
    BS 4300-1(1967) : 1967 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - ALUMINIUM ALLOY LONGITUDINALLY WELDED TUBE
    BS 3970-3:1990 Sterilizing and disinfecting equipment for medical products Specification for steam sterilizers for wrapped goods and porous loads
    BS 5750-1:1987 Quality systems Specification for design/development, production, installation and servicing
    BS 1306:1975 Specification for copper and copper alloy pressure piping systems
    BS 4300-5(1973) : 1973 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 2011 FREE CUTTING BAR AND WIRE
    BS 1470:1987 Specification for wrought aluminium and aluminium alloys for general engineering purposes: plate, sheet and strip
    BS 4300-16:1984 Wrought aluminium and aluminium alloys for general engineering purposes (supplementary series) Specification for sheet and strip in 8011 material
    BS 4870-2:1982 Specification for approval testing of welding procedures TIG or MIG welding of aluminium and its alloys
    BS 4300-10(1969) : 1969 WROUGHT ALUMINIUM AND ALUMINIUM ALLOYS FOR GENERAL ENGINEERING PURPOSES (SUPPLEMENTARY SERIES) - 5454 DRAWN TUBE
    BS 2646-4:1991 Autoclaves for sterilization in laboratories Guide to maintenance
    BS 1504:1976 Specification for steel castings for pressure purposes
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