BS 3970-2:1991
Current
The latest, up-to-date edition.
Sterilizing and disinfecting equipment for medical products Specification for steam sterilizers for aqueous fluids in sealed rigid containers
Hardcopy , PDF
English
09-30-1991
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Foreword
Specification
1. Scope
2. Definitions
3. General requirements
4. Design pressure
5. Design of spray-jets
6. Operating cycle
7. Instrumentation and controls
8. Performance requirements
9. Load-handling equipment
10. Information to be supplied by the manufacturer
Appendices
A. Recommendations for information to be supplied by
the purchaser
B. Test for sterilizer function without a load
C. Test for sterilizer function with a small load of
low thermal capacity
D. Test for sterilizer function with a full load
E. Test for coolant water quality
F. Test for F subzero (Fo) control compliance
G. Test for performance of reference instrument
H. Potential hazards associated with the sterilization
Tables
1. Operating cycle conditions for acceptable
temperature band
2. Permitted ranges for Fo values
Figure
1. Pressure generated in a nominal 1 L bottle,
containing different volumes of water, when heated
to 121 deg C
Requirements, additional to those in Part 1, for sterilizers in which heat transfer is effected by saturated steam under phase-boundary conditions.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 90/54474 DC and BS 3970-2(1966). (07/2005) Reviewed and confirmed by BSI, December 2011. (11/2011)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This Part of BS3970 specifies particular requirements for sterilizers intended to be used for the sterilization of aqueous fluids in sealed rigid containers in which the heat transfer is effected by saturated steam under phase-boundary conditions, having a steady-state equilibrium during the holding phase. These requirements apply in addition to the general requirements specified in BS3970-1.
NOTE1 Recommendations for the information to be supplied by the purchaser to the manufacturer are given in Appendix A.
NOTE2 The attention of both the sterilizer manufacturer and the user is drawn to the hazards associated with processing fluids in sealed rigid containers described in Appendix H.
NOTE3 The titles of the publications referred to in this standard are listed on the inside back cover.
| BS 2646-1:1993 | Autoclaves for sterilization in laboratories Specification for design, construction, safety and performance |
| BS 2646-5:1993 | Autoclaves for sterilization in laboratories Methods of test for function and performance |
| BS 5076:1974 | Specification for hospital storage cabinets for bottled fluids (electrically heated) |
| ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
| DIN 58363-1:1984-03 | TRANSFUSION, INFUSION; INFUSION CONTAINERS AND ACCESSORIES; INFUSION BOTTLES (HEAVY) |
| ISO 8362-3:2001 | Injection containers and accessories Part 3: Aluminium caps for injection vials |
| ISO 8362-1:2009 | Injection containers and accessories Part 1: Injection vials made of glass tubing |
| BS 795:1983 | Specification for ampoules |
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