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BS 3970-1:1990



The latest, up-to-date edition.

Sterilizing and disinfecting equipment for medical products Specification for general requirements

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Committees responsible
1. Scope
2. Definitions
3. Testing for compliance
4. Size, shape and designation of the chamber
5. Vessel and its components
6. Doors and their controls
7. Control valves and over-pressure protection devices
8. Hydraulic test
9. Airborne noise emission
10. Thermal insulation
11. Electrical requirements
12. Steam and water supply
13. Instrumentation and controls
14. Fault
15. Air filters
16. Load supporting and handling equipment
17. Information to be supplied by the manufacturer
18. Marking
A. Information to be supplied by the purchaser
B. Copper and copper alloy vessels
C. Design of pressure vessels with rectangular section
D. Determination of sound power levels
E. Sterilizer performance and steam quality
1. British Standards for receivers, pipes and pipe
2. Copper and copper alloys: nominal design strength
3. Size of rounded indications in radiographic tests
4. Classification of welds and joints
5. Pitot tube diameters
1. Certificate of compliance form
2. Unreinforced vessels
3. Reinforced vessels
4. Partially reinforced vessels
5. Jacketed vessels
6. Slot and plug welds
7. Door with horizontal reinforcing members
8. Design fatigue curves
9. Fatigue strength of steel bolts
10. Apparatus for the determination of the dryness
    value of steam
11. Apparatus for the determination of non-condensable
    gases in steam

For sterilizers used in hospitals and other medical, clinical and ancilliary institutions.

Supersedes BS 3970-1(1966) and 85/53987 DC (03/2003) Inactive for the new design. (01/2012)
British Standards Institution

This Part of BS3970 specifies general requirements for sterilizers, including disinfectors, comprising a pressure-tight vessel capable of operating up to a design pressure of 6.0 bar4). These sterilizers and disinfectors are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.

NOTE1 Not all sterilizer vessels specified by BS3970 are required to withstand a design pressure of 6.0 bar. 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 all 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 to the manufacturer.

NOTE2 Purchasers 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 addition, 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.

NOTE3 It is essential that a sterilizer should be used only for sterilizing the type of goods for which it is designed (see foreword). In selecting the appropriate sterilizer, reference should be made to the list of Parts of BS3970 given in the foreword.

NOTE4 The titles of the publications referred to in this standard are listed on page 41.

BS 2646:1955 Specification for copper laboratory autoclaves
BS 4937-4:1973 International thermocouple reference tables Nickel -chromium/nickel - aluminium thermocouples. Type K
BS 4206:1967 Methods of testing fusion welds in copper and copper alloys
BS 604:1982 Specification for graduated glass measuring cylinders
BS 5222-2:1976 Specification for aluminium piping systems Design
BS 2745:1966 Specification for bed pan and urine bottle washers
BS 6581:1985 Specification for common requirements for high-voltage switchgear and controlgear standards
BS 5750-4:1990 Quality systems Guide to the use of BS 5750:Part 1 \'Specification for design/development, production, installation and servicing\', Part 2 \'Specification for production and installation\' and Part 3 \'Specification for final inspection and test\'
BS 5076:1974 Specification for hospital storage cabinets for bottled fluids (electrically heated)
BS 3281:1960 Specification for rectangular metal boxes for use in high vacuum steam sterilizers
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 1965-1:1963 Specification for butt-welding pipe fittings for pressure purposes Carbon steel
BS 6700:1987 Specification for design, installation, testing and maintenance of services supplying water for domestic use within buildings and their curtilages
BS 5235:1975 Specification for dial-type expansion thermometers
BS 5346:1976 Specification. ISO metric trapezoidal screw threads
BS 5304:1988 Code of practice for safety of machinery
BS 7139:1989 Guide to graphical symbols for use on medical electrical equipment
BS 1387:1985 Specification for screwed and socketed steel tubes and tubulars and for plain end steel tubes suitable for welding or for screwing to BS 21 pipe threads
BS 6759-1:1984 Safety valves Specification for safety valves for steam and hot water
BS 5222-1:1975 Specification for aluminium piping systems Dimensions, materials and construction of components
BS 846:1985 Specification for burettes
BS 1845:1984 Specification for filler metals for brazing
BS 2904:1957 Specification for hospital sterilizers (boiling water type)
BS 2871-2:1972 Specification for copper and copper alloys. Tubes Tubes for general purposes
BS 5500:1988 Specification for unfired fusion welded pressure vessels
BS 1740-1:1971 Specification for wrought steel pipe fittings (screwed BS 21 R-series thread) Metric units
BS 3928:1969 Method for sodium flame test for air filters (other than for air supply to I.C. engines and compressors)
BS 1723-1:1986 Brazing Specification for brazing
BS 5970:1981 Code of practice for thermal insulation of pipework and equipment (in the temperature range -100°C to +870°C)
BS 3970-3:1990 Sterilizing and disinfecting equipment for medical products Specification for steam sterilizers for wrapped goods and porous loads
BS 6255:1989 Specification for plain sterilization paper for medical use
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 5169:1975 Specification for fusion welded steel air receivers
BS 4504-2:1974 Circular flanges for pipes, valves and fittings (PN designated) Copper alloy and composite flanges
BS 1723-4:1988 Brazing Methods for specifying brazing procedure and operator approval testing
BS 4504-1:1969 Circular flanges for pipes, valves and fittings (PN designated) Ferrous
BS 5969:1981 Specification for sound level meters
BS 4196-6:1981 Sound power levels of noise sources Survey method for determination of sound power levels of noise sources
BS 4937-8:1986 International thermocouple reference tables Nickel-chromium-silicon/nickel-silicon thermocouples including composition Type N
BS 3421:1961 Specification for performance of electrically heated sterilizing ovens

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