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BS 2646-1:2021

BS 2646-1:2021

$189.07

Autoclaves for sterilization in laboratories – Design, construction, safety and performance. Specification

Published By Publication Date Number of Pages
BSI 2021 48
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This part of BS 2646 specifies requirements for the design, construction, safety and performance of autoclaves for operation with saturated steam and for operation under vacuum (subject to external pressure).

This part of BS 2646 covers laboratory autoclaves for the sterilization of goods and material which could be infected with organisms, the sterilization of growth media or other materials required for the operation of a laboratory.

This part of BS 2646 does not apply to sterilizers or disinfectors used for pharmaceutical production or medical purposes directly concerned with patient care.

NOTE These are covered by BS EN 285 or BS EN 13060 and BS 3970‑2.

This part of BS 2646 does not apply to autoclaves utilizing a fired pressure vessel.

PDF Catalog

PDF Pages PDF Title
5 Foreword
7 1 Scope
2 Normative references
8 3 Terms and definitions
10 4 Classification
4.1 Autoclave class
4.2 Autoclave processes
11 5 Responsibilities
5.1 Responsibilities of the manufacturer
5.2 Certificate of compliance
6 Information and requirements to be agreed, documented and supplied by the manufacturer
12 7 Selection of materials
8 Autoclave chamber
8.1 General
8.2 Chamber doors
8.3 Test connections
13 9 Steam generators
10 Design and manufacture
10.1 General
10.2 Pipework assemblies
11 Type testing
14 12 Inspection and testing of pressure vessels
12.1 General
12.2 Marking of pressure vessels, doors and safety valves
13 Inspection and testing of the completed autoclave
13.1 General
13.2 Factory functional testing
14 Product safety and safety devices
14.1 General
15 14.2 Provision of pressure vessel safety devices
16 14.3 Safety valves – design and construction
14.4 Door interlocking safety devices
17 14.5 Safety devices to protect the operator when unloading the autoclave
18 Table 1 — Thermal door lock temperature settings
14.6 Double door autoclaves
14.7 Electrical safety requirements
14.8 Temperature of autoclave surfaces – Surface temperature increase
19 15 Load supporting and handling equipment
15.1 Load transfer systems
15.2 Loading trolley
15.3 Vertical loading autoclaves
16 Instrumentation and control
16.1 General
20 16.2 Pressure gauges
16.3 Pressure transducers and associated measuring chain
21 16.4 Temperature indicators
22 16.5 Temperature, time and pressure recorders
16.6 Controller settings
16.7 Microprocessor or programme logic control systems
23 16.8 Electromagnetic interference
24 17 Recommended system specification
Table 2 — System options
18 Marking
18.1 General
25 18.2 Information relating to the autoclave
18.3 Information relating to each pressure vessel
19 Test instruments and gauges
26 19.1 General
19.2 Calibration and verification of test instruments and gauges
27 19.3 Test recorders with paper charts
19.4 Data loggers/digital test recorders
28 19.5 Test pressure gauges
19.6 Test pressure transducers
19.7 Temperature sensors
19.8 Timers
19.9 Balances
20 Safe function test methods
20.1 Safety valves
20.2 Tests on door interlocks
30 20.3 Tests on chamber integrity
20.4 Tests on double door autoclaves
21 Performance tests
21.1 Instrument accuracy, calibration and operating cycle controls: performance tests
31 21.2 Liquids sterilization: performance test
33 21.3 Make-safe: performance test, mixed waste
36 21.4 Equipment and glassware sterilization: performance tests
37 21.5 Fabrics and textiles disinfection: performance tests
39 21.6 Materials testing and processing
21.7 Hazard group 4 waste
40 Annex A (informative)  Guidance for the purchaser
42 Annex B (informative)  Environmental aspects
43 Annex C (informative)  Additional considerations for Hazard Group 4 autoclaves
44 Annex D (normative)  Thermometric test pack for fabrics and textiles disinfection performance tests
45 Figure D.1 — Location of temperature probes
46 Bibliography

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BS 2646-1:2021
$189.07