MADCAD.com - The Cloud-Based Reference Library

- Free Trial - Webinar - Feedback

Cart (0)

No items in cart.

Total

There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.

Home

Content

Tour

eLibrary

Store

Not a subscriber? Register for a trial account.

Username:
Password:

Incorrect username/password.

Already a subscriber?

MADCAD.com Free Trial

Sign up for a 3 day free trial to explore the MADCAD.com interface, PLUS access the
2009 International Building Code to see how it all works.

If you like to setup a quick demo, let us know at support@madcad.com
or +1 800.798.9296 and we will be happy to schedule a webinar for you.

Email *
Password *
Confirm *
First Name *
Last Name *
Title
Company Name *
Company Size *
Industry *
Address *
Address 2
City *
State *	Zip *
Country *
Phone *
How did you hear about MADCAD.com? *

Print page(s), starting from page (current page)

Continue to Print

Reset password

Enter your personal account email address to request
a password reset:

Reset password

Enter your account email address to request
a password reset:

Save As:

Are you sure you want to delete this group?

Security check

Please check the following box:

Please login to your personal account to use this feature.

Email:

Password:

Forgot your password?

Remember me for one month

Need a login? Register now.

Please login to your authorized staff account to use this feature.

Username:

Password:

Are you sure you want to empty the cart?

There were no books found for the applied search filters.

CLICK TO START OVER

Report To Us

Please fill the form below so that we can contact you.

Full name*
Email*
Phone

Contact us for a custom quote

Please fill the form below and a member of our staff will contact you shortly. The contents of your cart will automatically be sent to us so we can provide an accurate custom quote.

Company*
Full name*
Email*
Phone

⨯To continue with accurate pricing,
please select your company type below:

Large goverment organizations

Large multi-national corporation (more than $5B annual revenue)

None of the above

Your company has a special pricing case for IEEE.
For pricing, please contact us by filling out the form.

Full name*
Email*
Phone
Your selection

⨯We need your input!

Are you a code official in a jurisdiction with less than 300,000 population?

Yes No

This item is only available for the code officials of jurisdictions less then 300K population.

If you do not meet the criteria item will be removed and you will be able to continue shopping other items.

⨯ We need your input!

Your company has a special pricing case for ASME.
Please make sure the information you provide below is accurate.

Company Industry
Number Of Employees
Revenue

Pricing for the ASME publications in the store is for a 1-4 employee company in Construction Industry with revenue under $500,000.
If correct company info does not match what is publicly available info we will suspend the access and contact you for correction.
Please call 1-800-798-9296 if you have any questions.
If your company has more than 5,000 employee or more than 500 mil revenue please email us at info@madcad.com to receive a special quote, use "ASME Quote" on the subject line.

Cart Warning

Search book title

Search book content

Clear all filters Advanced Search Basic Search

Download File

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

Expand All

TOC Search:

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]

About Us / Careers / support@madcad.com / 1.800.798.9296

MADCAD.com Free Trial

Report To Us

Contact us for a custom quote

⨯To continue with accurate pricing, please select your company type below:

⨯We need your input!

⨯ We need your input!

Cart Warning

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

⨯To continue with accurate pricing,
please select your company type below: