SIST CR 14252:2002

Co-ordination on microbiological Standards - Register of work items of common interest

This CEN Report is designed to give a view of CEN Standards activity containing microbiological aspects.  It takes the form of a register of work items.  The register includes current work items and published Standards from TCs which are working on standards containing microbiological aspects.  The information in this register was produced on February 2001.
The intended audience of this Report is those people working in Standardization who have an interest in microbiological aspects.  It will be particularly useful for those people working on a subject with microbiological aspects, who wish to co-ordinate their efforts and therefore avoid duplication of work. In particular, this report is intended to assist in the evolution of common terms and definitions in standards that involve microbiological aspects.
The register is not exhaustive.  There may be other CEN TCs with microbiological aspects but these are not known at the time of writing this CEN Report.
Not all the information is available for all the work items listed.

Uskladitev mikrobioloških standardov – Seznam delovnih osnutkov standardov splošnega pomena

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2002
• Withdrawal Date: 18-Aug-2020
• ICS: 01.120 - Standardization. General rules
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: KAT - Soil quality
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 19-Aug-2020
• Due Date: 11-Sep-2020
• Completion Date: 19-Aug-2020
• Ref Project: CR 14252:2001 - Co-ordination on microbiological Standards - Register of work items of common interest

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2002
Uskladitev mikrobioloških standardov – Seznam delovnih osnutkov standardov
splošnega pomena
Co-ordination on microbiological Standards - Register of work items of common interest
Ta slovenski standard je istoveten z: CR 14252:2001
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
07.100.01 Mikrobiologija na splošno Microbiology in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN REPORT
CR 14252
RAPPORT CEN
CEN BERICHT
August 2001
ICS
English version
Co-ordination on microbiological Standards - Register of work
items of common interest
This CEN Report was approved by CEN on 16 June 2001. It has been drawn up by the Technical Committee CEN/CS SUBSECTOR S99.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. CR 14252:2001 E
worldwide for CEN national Members.

Scope
This CEN Report is designed to give a view of CEN Standards activity containing microbiological
aspects. It takes the form of a register of work items. The register includes current work items and
published Standards from TCs which are working on standards containing microbiological aspects.
The information in this register was produced on February 2001.
The intended audience of this Report is those people working in Standardization who have an
interest in microbiological aspects. It will be particularly useful for those people working on a
subject with microbiological aspects, who wish to co-ordinate their efforts and therefore avoid
duplication of work. In particular, this report is intended to assist in the evolution of common terms
and definitions in standards that involve microbiological aspects.
The register is not exhaustive. There may be other CEN TCs with microbiological aspects but
these are not known at the time of writing this CEN Report.
Not all the information is available for all the work items listed.
Additional notes to the table
The degree to which each of the work items and standards listed includes microbiological aspects
will vary. Individual drafts and published Standards should be consulted if a title listed below
indicates that the work may be of interest.
CEN/TC 216 Chemical disinfectants and antiseptics: By the nature of the subject covered by
CEN/TC 216 all of its work items (present and future) can be considered to have microbiological
aspects.
Further research is recommended for people needing complete and more detailed information on
microbiological activity in Standardization.
WI No Title Related Related Scope of WI / principle involved Comments
work in ISO
Requirements and methods of test
102002 Sterilization – Steam sterilizers – CEN/TCs Relationship with WI
Large sterilizers (EN 285:1996) 233 for large steam sterilizers primarily 233 079 – Performance criteria for
216 used in healthcare for sterilization of steam sterilizers and autoclaves (EN
204 one or more sterilization modules for 12347).
wrapped goods (instruments etc.
and porous loads). Can also be Relationship with WI 00204027 and
used during commercial production 00204009 validation and routine
of medical devices. Not applicable to control of moist heat sterilization
small steam sterilizers or those used (process). These work items are
for sterilizing pharmaceutical related to EN 554
products.
CEN/TC 216 corrected the definition
of 'moist heat sterilization conditions'
and conformed it to EN 554
(CEN/TC 204).
EN 285 is now currently under
revision (see WI 102048).
mandated (BC/CEN/93/8.8).
102010 Sterilizers for medical purposes – CEN/TC Requirements and test methods for Related to WI 204025 and 204005.
Ethylene oxide sterilizers – 204 ethylene oxide sterilizers used for These are related to EN 550.
Requirements and test methods medical, dental pharma-ceutical,
(EN 1422:1997) veterinary and industrial or related Mandated (BC/CEN/93/8.13).
purposes.
102026 Sterilizers for medical devices – CEN/TCs Specifies requirements and test Possible relationship with
Steam sterilizers – small 233 methods for small steam sterilizers WI 233 079 and 204005. These are
sterilizers- Requirements and 204 that are used primarily for the related to EN 550.
testing sterilization of medical devices.
Relationship with WI 00204027
Not for use for liquids or validation and routine control of
pharmaceutical products. moist heat sterilization.
Mandated (BC/CEN/93.8.12).
WI No Title Related Related Scope of WI / principle involved Comments
work in ISO
102005 Packaging materials and systems ISO/TC General requirements for single use Some common objective with
for medical devices which are to 198 and reusable materials for CEN/TC 243 work but no overlap.
be sterilized – Part 1 : General packaging of terminally-sterilized
requirements and test methods medical devices. Test methods for Related to ISO 11607.
(EN 868-1:1997) microbial barrier properties are
included in an informative annex. Start of harmonization of ISO 11607
and EN 868 under discussion.
Material specific requirements and
test methods are included in EN 868
part 2 to 10 (WI 00102013 to
00102019; WI 102028 and WI
00102029).
Mandated (BC/CEN/89/9.9).
Biological systems for testing CEN/TCs ISO/TC All parts specify requirements for Related to ISO 11138 Parts 1 to 3;
sterilizers and sterilization 233 198 inocculated carriers and bio-logical harmonization of EN 866 and ISO
processes (EN 866 series) 204 indicators intended for use in 11138 series is in progress (see WI
assessing the performance of 102050 to 102057); deletion of WI
102020 Part 1: General requirements different types of sterilizers. 102053 - biological indicators for
radiation sterilization - is under
102021 Part 2: Systems for use in ethylene Suitable test organisms, e.g. spores consideration;
oxide sterilizers of Bacillus subtilis var.niger (Part 2),
Bacillus stearothermophilus (Part 3), related to 204025 to 204027 -
102022 Part 3: Systems for use in steam are tested in an apparatus harmonization of EN 550/ISO 11135;
sterilizers (resistometer) simulating typical EN 552/ISO 11137; EN 554/ISO
sterilization process and decimal 11134/ISO 13683 dealing with
102031 Part 4: Systems for use in reduction values (D values) validation and routine control of
irradiation sterilizers determined by the survivor curve ethylene oxide sterilization, irradiation
and most probable number (MPN) sterilization and moist heat
102032 Part 5: Systems for use in low methods. sterilization respectively, i. e. as
temperature steam and process and related to EN ISO 14937
formaldehyde sterilizers Specifies recovery conditions. dealing with general requirements for
characterization of a sterilizing agent
WI No Title Related Related Scope of WI / principle involved Comments
work in ISO
102033 Part 6: Systems for use in dry heat and the development, validation and
sterilizers
routine control of a sterilization
process for medical devices.
102034 Part 7: Self-contained biological
indicator systems for use in steam EN 866 Parts 1 to 3 mandated
BC/CEN/89/9
sterilizers
102035 Part 8: Self-contained biological Terminology of culture medium etc.
indicator systems for use in
ethylene oxide sterilizers Terminology of culture medium
would have an impact on this work.
Relationship with preservation of
organisms.
Non-biological systems for use in CEN/TCs ISO/TC Requirements for various types of All parts are published exept part 5
sterilizers (EN 867 series) 233 198 chemical indicators used to monitor which is at formal vote.
204 the presence of attainment of one or
102023 Part 1: General requirements more of the variables required for a - related to ISO 11140 series;
satis-factory sterilization process. harmonization of EN 867 and ISO
102024 Part 2: Process indicators (class A) 11140 series proposed by CEN/TC
No biological systems are involved. 102 and accepted by ISO/TC 198
102025 Part 3: Specification for class B (Vienna Agreement, ISO lead)
indicators for use in the Bowie and Chemical indicators are classified awaiting target dates and work item
Dick test into: proposals from ISO/TC 198/WG 6.
- process indicators (class A)
102036 Part 4: Performance specification - indicators for use in specific tests - related to 204025 to 204027 -
and test methods for indicators as (class B) harmonization of EN 550/ISO 11135;
an alternative for the Bowie and - single-variable indicators (class C) EN 552/ISO 11137; EN 554/ISO
Dick test for the detection of steam - multi-variable indicators (class D) 11134/ISO 13683 dealing with
penetration - integrating indicators (class E) validation and routine control of
ethylene oxide sterilization, irradiation
102037 Part 5: Specification for indicator Guidance for the selection and use sterilization and moist heat
systems and processes challenge of biological indicators and for the sterilization respectively, i. e. as
devices for use in performance interpretation of results when used process and related to EN ISO 14937
testing for small sterilizators class in development, validation and dealing with general requirements for
WI No Title Related Related Scope of WI / principle involved Comments
work in ISO
routine monitoring of sterilization characterization of a sterilizing agent
processes. Assists users in the and the development, validation and
application of biological indicators routine control of a sterilization
for existing and new processes process for medical devices.
which are not addressed by existing
standards. EN 867 parts 1 to 4 :prEN 867 part 5
Mandated
BC/CEN/93/8.14
BC/CEN/93/8.15
BC/CEN/93/8.16
BC/CEN/95/33.1
BC/CEN/95/33.2
102045 Sterilziation of health care ISO/TC
products – Biological indicators – 198
Guidance for the selection, use
and interpretation of results (EN
ISO 14161:2000)
102049 Sterilization of health care ISO/TC Provides guidance for the selection,
products - Chemical indicators - 198 use and interpretation of results of
Guidance for selection, use and chemical indicators used in process
interpretation of results (ISO/DIS definition, validation, and routine
15882:2000) monitoring and control of
sterilization processes. This
document applies to chemical
indicators for which International
Standards exist. (See ISO 11140
series).
Washer disinfectors (prEN ISO CEN/TCs ISO/TC Specifies performance requirements Mandated
15883 Parts 1 to 4) 216 198 for washer-disinfectors and their
233 accessories that are intended to be
102038 Part 1: General requirements, used for cleaning and disinfection of (BC/CEN/95/33.3)
WI No Title Related Related Scope of WI / principle involved Comments
work in ISO
definitions and tests Possible re-usable medical devices and other
relationship articles used in the context of medical,
102039 Part 2: Requirements and tests for dental, pharmaceutical and veterinary (BC/CEN/95/33.4.2)
washer disinfectors for surgical practice. It specifies performance
instruments and trays, anaesthetic requirements for cleaning and
equipment, holloware and disinfection as well as the accessories
glassware. which may be required to achieve the
necessary performance. The methods
102040 Part 3: Requirements and tests for and instrumentation required for
washer disinfectors for human validation, routine control and (BC/CEN/95/33.5.2)
waste containers monitoring and re-validation,
periodically and after essential
102043 Future part 4: Requirements and repairs, are also specified. laundry
tests for washer disinfectors for and general catering purposes are
thermolabile instruments including excluded
endoscopes
102046 Sterilizers for medical purposes – Specifies minimum performance Relation to EN ISO 14937 dealing
Low temperature steam and requirements and test methods for with general requirements for
formaldehyde sterilizers – sterilizers using a mixture of low characterization of a sterilizing agent
Requirements and test methods" temperature steam and formaldehyde and the development, validation and
as sterilizing agent. routine control of a sterilization
These sterilizers are primarily used for process for medical devices;
sterilization of heat labile medical
devices in health care facilities. new work item proposal of CEN/TC
102/WG 6 on validation and routine
control of a low temperature steam
sterilization process under
consideration (this new work item
proposal will be submitted CEN/TC
204 after discussion within CEN/TC
102)
WI No Title Related Related Scope of WI / principle involved Comments
work in ISO
Possible Sterilization of health care products - Work Includes information and methods
addtion Biological indicators - Method for going on used to validate biological incubation
to the validation of biological indicators in period
work growth period (ISO/TS 16342) ISO/TC
program 198
me of
CEN/TC
140 014 In vitro diagnostic medical devices - ISO/TC Published standard
Information supplied by the 212
manufacturer with in vitro diagnostic Relationship with ISO/DIS 19001
reagents for staining in biology (EN
12376:1999)
140 024 In vitro diagnostic systems - Culture TC 216 Applies to culture media for Published standard
media for microbilogy - Terms and TC 230 microbiological purposes and defines
definitions (EN 1659:1996) TC 275 terms associated with culture media. Possible relationship with work items
TC 302 Definitions include those of the concerning culture media in several
following terms: culture medium, TCs (e.g. TC 216, TC 230, TC 275).
chemically defined culture medium,
chemically incompletely defined Some related work in ISO/TC 34/SC9.
culture medium, liquid culture
medium, solid and semi-solid culture Possible relationship with ISO/TC
media, transport medium, 212.
preservation medium, resuscitation
...