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BSI 23/30458211 DC:2023 Edition

BSI 23/30458211 DC:2023 Edition

$24.66

BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing

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BSI 2023 121
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1.1 This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. 1.2 This document specifies minimum requirements: – for the performance and design of sterilizers intended to deliver an LTSF-process capable of sterilizing medical devices; – for the equipment and controls of these sterilizers needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process. 1.3 This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document. 1.4 This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

PDF Catalog

PDF Pages PDF Title
1 30458211-NC.pdf
3 41_e_stf (3).pdf
10 1 Scope
2 Normative references
11 3 Terms and definitions
22 4 General
4.1 Sterilizer type definition
23 4.2 Equipment development
24 4.3 Calibration
5 Equipment design and construction
5.1 Safety and security
5.1.1 General
25 5.1.2 Protective measures
26 5.1.3 Risk control and usability
27 5.2 Sterilizer chamber
5.2.1 Materials
5.2.2 Dimensions
28 5.2.3 Doors and interlocks of the sterilizer chamber
29 5.2.4 Temperature control and insulating the sterilizer chamber
5.2.5 Test connections
31 5.3 Further functional components
5.3.1 Pipework and fittings
5.3.2 Evacuation system
5.3.3 Aeration system
5.3.4 Framework and panelling
32 5.4 Vibration
5.5 Ancillary equipment and components
5.6 Transport
33 5.7 User interfaces
34 6 Indicating, monitoring, controlling, and recording devices
6.1 General
6.1.1 Pre-set programme
6.1.2 Automatic controller
6.2 Automatic control
36 6.3 Control and monitoring system
38 6.4 Failures
6.4.1 General
6.4.2 Faults
39 6.4.3 Power failure
6.4.4 Other failures
40 6.5 Instrumentation
6.5.1 General
6.5.2 Temperature measuring devices
6.5.2.1 Temperature parameters
41 6.5.2.2 Temperature probes
6.5.2.3 Temperature measuring chains
6.5.3 Pressure measuring devices
6.5.3.1 Pressure parameters
42 6.5.3.2 Pressure measuring chains
43 6.5.4 Time measuring devices
6.5.5 Sterilizing agent control and measuring devices
6.6 Indicating devices
6.6.1 General
44 6.6.2 Cycle parameter indicating devices
45 6.6.3 Cycle parameter indications
46 6.6.4 Status indicators and indications
47 6.6.5 Operating cycle counter
6.7 Recording systems
6.7.1 General
48 6.7.2 Records
49 6.7.3 Analogue presentation of records
50 6.7.4 Digital records
6.7.5 Data format for applied sterilant amount
6.8 Operating cycle
6.8.1 General
6.8.2 Leak test
51 6.8.3 Sterilization cycles
53 7 Services and local environment
7.1 General
54 7.2 Sterilizing agent and sterilant
7.3 Electrical supply
55 7.4 Water
7.4.1 Water used for sterilizer operation
7.4.2 Feed water
7.5 Steam
7.6 Vacuum
7.7 Drainage and discharges
7.8 Lighting
56 7.9 Compressed air
7.10 Air and inert gases
7.11 Ventilation and environment
8 Emissions
8.1 Electromagnetic emissions
57 8.2 Noise
8.3 Exhaust emissions
58 8.4 Heat emissions
9 Test instrumentation
10 Performance assessment
10.1 General
59 10.2 Attainment of conditions
10.2.1 Physical conditions
10.2.1.1 Pre-heating
10.2.1.2 Sterilization temperature band
10.2.1.3 Temperature profile
60 10.2.1.4 Pressure profile
10.2.2 Sterilant and sterilizing agent
10.2.3 Microbiological performance
61 10.3 Desorption efficacy
10.4 Load dryness
10.5 Pressure change
11 Information to be supplied
11.1 General
62 11.2 Information to be available prior to purchase
63 11.3 Information prior to installation
11.4 Marking and labelling
64 11.5 Instructions for use
65 11.6 Further information to be provided
66 12 Packaging
67 Annex A (normative)Test methods
A.1 General
A.2 Test loads
A.2.1 Small load
A.2.1.1 General
68 A.2.1.2 Small load unit
A.2.2 Full load
A.2.2.1 General
A.2.2.2 Full load unit
69 A.2.3 Simple items test load
A.2.3.1 General
A.2.3.2 Simple items test load unit
A.3 Test procedures
A.3.1 Test equipment
A.3.2 Thermometric tests
A.3.2.1 Sterilizer chamber pre-heating test
70 A.3.2.2 Small load temperature profile test
A.3.2.3 Full load temperature profile test
71 A.3.2.4 Simple items temperature profile test
72 A.3.3 Microbiological test
A.3.4 Pressure profile tests
A.3.4.1 Small load pressure profile test
73 A.3.4.2 Full load pressure profile test
A.3.4.3 Simple items pressure profile test
74 A.3.5 Desorption tests
A.3.6 Drying tests
75 Annex B (normative)Sterilizer testing
B.1 General
B.2 Test concept
B.2.1 Type test
76 B.2.2 Works test
B.2.3 Installation qualification test provisions
77 B.2.4 Operational qualification test provisions
78 Annex C (normative)Test equipment
C.1 Pressure instrumentation
C.2 Temperature sensors
C.3 Temperature recording instrument
79 C.4 Pressure recording instrument
80 C.5 Penetration type test device (PTTD)
C.5.1 PTTD1 for small load and full load units
C.5.2 PTTD2 for simple items test load units
C.6 Residues challenge device
81 C.7 Biological indicators and systems
C.8 Sterile barrier systems
82 Annex D (normative)Determination of formaldehyde residuals in a filter indicator
D.1 Procedure for sample preparation
D.2 Analysis of formaldehyde contents in filter indicator
D.2.1 Equipment
D.2.2 Extraction and evaluation procedure for processed indicators
83 D.2.3 Extraction and evaluation procedure for the reference (blank) indicator
D.2.4 Calibration
D.2.4.1 Principle
D.2.4.2 Procedure
85 Annex E (informative)Application of Formaldehyde in LTSF-processes
E.1 Formaldehyde concentrations, physico-chemical conditions during a cycle
E.1.1 Supply and preparation of sterilant and sterilizing agent
86 E.1.2 Formaldehyde concentrations in LTSF
87 E.2 Formaldehyde residuals on medical devices
E.2.1 Assumptions for calculating limits for formaldehyde residuals on medical devices
88 E.2.2 Determination of formaldehyde residuals in sterilized goods
E.2.2.1 General
89 E.2.2.2 Test methods
90 Annex F (informative)Illustrations of the interrelationship between control and recording
F.1 Introduction
F.2 Illustration 1
92 F.3 Illustration 2
93 F.4 Illustration 3
96 Annex G (normative)Alternative Protective measures
98 Annex H (informative)Environmental aspects
H.1 Environmental aspects regarding the life cycle of LTSF sterilizers
H.2 Formaldehyde (brief description)
H.3 Environmental impact
100 Annex I (normative)Technical information and documentation
102 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered

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