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eLibrary > 23/30458211 DC BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing >

23/30458211 DC BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing, 2023

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23/30458211 DC BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing, 2023

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

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