SIST CR 14252:2002
(Main)Co-ordination on microbiological Standards - Register of work items of common interest
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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST CR 14252:2002
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
SIST CR 14252:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST CR 14252:2002
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SIST CR 14252:2002
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.
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SIST CR 14252:2002
CR 14252:2001 (E)
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.
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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).
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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
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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
5
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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)
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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)
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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
102
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
medium, enrichment medium, non-
selective enrichment medium,
isolation medium, selective isolation
medium, non-selective isolation
medium, differentiation medium, dry
medium, partially complete medium,
ready-to-use medium
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work in ISO
140031 In vitro diagnostic medical devices - TC 216 ISOTC Published standard
Culture media for microbiology TC 230 34/SC9
- Performance criteria for culture TC 275 Possible relationship with work items
media (EN 12322:1999) TC 204 concerning culture media in several
TC 243 TCs (e.g. TC 216, TC 230, TC 275).
Possible relationship with ISO/TC
212.
153 Food processing machinery TC 233 TC 153 deals with „Food processing The aim of the TC 153 – work is to give
(various) TC 205 machinery“, most of which are open, assistance to the manufacturer and to
Example: TC 216 batch-operated machines, used in the officials to meet the essential
small shops (bakeries, butcheries, hygiene requirements of the Machinery
EN 1672-2 Food processing catering companies, retaurants, etc.) Directive Annex, 1.2 „Food processing
machinery – and also in food industry. machinery“ by elaborating appropriate
Basic concepts – Part 2: Hygiene There are several Working Groups e.g. clauses.
requirements“ WG 1 „Bakery Machinery“, WG 4
„Catering equipment“ a.s.o. In addition to this, the Working Groups
We elaborated a „basic“ harmonized elaborated an Annex to the product (C-
European Standard, which shall be ) standards, called „Principles of
valid for all machinery dealt with in TC design to ensure the cleanability of.
153. (name of type of machine)“. This annex
is nearly identical for all standards of
CEN/TC 153 and gives additional and
more detailed specifications than EN
1672-2.
170048 Ophthalmic optics – Contact lens CEN/TC Work
care products – Antimicrobial 216 done in Published standard
preservative efficacy of multi-dose ISO/TC
preserved contact lens care products 172/SC 7
(EN ISO 14730:2000)
170049 Ophthalmic optics – Contact lens CEN/TC Work
care products –microbiological 216 done in Project at Formal Vote
requirements and test methods for ISO/TC
products and regimes for hygenic 172/SC7
management of contact lenses
(prEN ISO 14729)
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work in ISO
204005 Sterilization of medical devices - TC 102 ISO/TC Specifies requirements for the Related to ISO 11135.
Validation and routine control of 198 development, validation, process
ethylene oxide sterilization control and monitoring of the
EN 550:1994 sterilization of medical devices using Mandated (BC/CEN89/9.13)
ethylene oxide. Includes requirements
for microbiological performance
qualification using either survivor
curve or fraction-negative method.
204007 Sterilization of medical devices - TC 102 ISO/TC Specifies requirements for the Related to ISO 11137.
Validation and routine control of 198 validation, process control and
sterilization by irradiation monitoring of the radiation sterilization Mandated (BC/CEN/89/9.15)
EN 552:1994 of medical devices using 60 Co or 137
Cs, or electrons at or below an energy
level of 10 MeV.
204009 Sterilization of medical devices - TC 102 ISO/TC Specifies requirements for the Related to ISO 11134.
Validation and routine control of TC 233 198 process development, validation,
sterilization by moist heat process control and monitoring of the
EN 554:1994 sterilization of medical devices using Mandated (BC/CEN/89/9.17)
moist heat.
204011 Sterilization of medical devices - TC 102 __ Specifies requirements for a Of possible interest to other sectors,
Requirements for medical devices to TC 233 terminally-sterilized medical device to especially definitions of "bioburden",
be labelled "sterile" TC 316 be labelled "STERILE". "sterility" and "sterile".
EN 556:1994 TC 140
TC 170 Not applicable to IVDs. Mandated (BC/CEN/89/9.19)
204012 Sterilization of medical devives - TC 243 ISO/TC Specifies general criteria to be applied Related to ISO 11737-1.
Estimation of the population of TC 216 198 in the estimation of the population of
micro-organisms on product - Part 1: TC 233 ISO/TC viable micro-organisms on a medical
Requirements TC 205 209 device or on a component, raw Mandated (BC/CEN/89/9.36)
EN 1174-1:1996 material or package. This estimation
consists of both identification and
enumeration of the population. Does
not apply to viruses.
Further more detailed information is
given in Parts 2, 3 and 4.
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work in ISO
204015 Sterilization of medical devices - TC 243 ISO/TC Provides guidance on the Related to ISO 11737-1.
Estimation of the population of TC 216 198 implementation of EN 1174-1
micro-organisms on product - Part 2: TC 233 ISO/TC including operation of the laboratory; Mandated (BC/CEN/89/9.37)
Method for validation of technique 209 equipment and materials including
EN 1174-2:1996 computer systems, software, ISO/TC 34/SC9 ISO 7218 also of
microbiological media, selection of relevance
technique, sample selection,
treatment, transfer to culture medium, TC 233 Code of practice also
plating techniques, most probable relevant.
number methods, selection of media
and inoculation conditions, validation
of technique, use of technique.
204016 Sterilization of medical devices - TC 243 ISO/TC Describes approaches which may be Related to ISO 11737-1.
Estimation of the population of 198 taken when validating techniques for
micro-organisms on product - Part 3: ISO/TC bioburden estimation including See comments for WI 204 012 (prEN
Guide to the methods for validation 209 validation using a repetitive treatment 1174-1).
of microbiological techniques method and a method using
EN 1174-3:1996 inoculated product. Guidance is also Mandated (BC/CEN/89/9.38)
given on validation of culture
conditions, colony counts and
correction factors.
204018 Sterilization of medical devices - TC 316 ISO/TC Specifies requirements for the Closely related to work in CEN/TC
Validation and routine control of TC 216 198 development, validation, process 316 concerning validation of virus
liquid chemical sterilization of single- control and monitoring of the removal from animal tissues intended
use medical devices sterilization of singe-use medical for use in medical devices. CEN/TC
EN ISO 14160:1998 devices incorporating materials of 316 work now published as EN
animal origin using liquid chemical 12442-1, -2, -3.
sterilants.
Includes, in an informative annex,
examples of media, inoculation Mandated (BC/CEN/93/8.25)
conditions and text organisms that
may be suitable. Possible relationship with certain
CEN/TC 216 work items.
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work in ISO
204019 Sterilization of medical devices - TC 102 ISO/TC General requirements for sterilization This standard is the template for the
Validation and routine control of TC 233 198 processes not already covered by EN common revisions:
sterilization processes - General TC 316 550, EN 552 and EN 554. WI 204 025, 027, 030, 031, 032 & 033
requirements
EN ISO 14937:2000
204020 Sterilization of medical devices - TC 102 ISO/TC Requirements which enable a user or Vienna Agreement project with CEN
Information to be provided by the TC 205 198 agent to re-sterilize a device prior to lead
supplier for the reprocessing of re- TC 257 its use (or re-use). This applies to
sterilizable devices - Requirements devices intended by the manufacturer Mandated (BC/CEN/95/33.7)
to be resterilized, and not the
reprocessing of single-use devices.
204021 Sterilization of medical devices - TC 233 ISO/TC Requirements specific to ensuring that Closely related to ISO 13408-1
Validation and routine control of TC 170 198 medical devices can be processed
aseptic processes for medical TC 140 aseptically and can therefore be Mandated (BC/CEN/95/33.8)
devices TC 205 called "sterile".
(prEN 13824)
204022 Sterilization of medical devices - TC 102 __ Specifies requirements for a Mandated (BC/CEN/89/9)
Requirements for medical devices to TC 233 terminally-sterilized medical device to
be labelled "sterile" TC 316 be labelled "STERILE".
EN 556:1994 +A1:1998 TC 140
TC 170
TC 102 __ Specifies requirements for a
204023 Sterilization of medical devices - Mandated (BC/CEN/89/9)
Requirements for medical devices to TC 233 terminally-sterilized medical device to
be labelled "sterile" TC 316 be labelled "STERILE".
prEN 556-1 TC 140
TC 170 Part 1 is related to terminally-sterilized
devices
(Part 2 is related to aseptically
processed devices
204024 Sterilization of medical devices - TC 102 ISO/TC Specifies requirements for the Mandated (BC/CEN/89/9.15)
Validation and routine control of 198 validation, process control and
sterilization by irradiation monitoring of the radiation sterilization
EN 552:1994/A1:1999 of medical devices using 60 Co or 137
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work in ISO
Cs, or electrons at or below an energy
level of 10 MeV.
204025 Sterilization of medical devices - TC 102 ISO/TC Joint revision with ISO 11135, under
Validation and routine control of 198 VA with ISO lead
ethylene oxide sterilization
EN 550:1994 Rev Mandated (BC/CEN89/9)
204027 Sterilization of medical devices - TC 102 ISO/TC Joint revision with ISO 11134 and ISO
Validation and routine control of TC 233 198 13683 and under VA with ISO lead.
sterilization by moist heat
EN 554:1994 Rev
204028 Sterilization of medical devices - TC 102 ISO/TC Mandated (BC/CEN/89/9)
Validation and routine control of 198
sterilization by irradiation
EN 552:1994/A2:2000
204029 Sterilization of medical devices - ISO/TC
Microbiological methods - Part 2: 198
Tests of sterility performed in the
validation of a sterilization process
EN ISO 11737-2:2000
204030 Sterilization of health care products - ISO/TC Joint revision of EN 552 and ISO
requirements for the development, 198 11137, under VA with ISO lead
validation and routine control of a
sterilization process for medical Mandated (BC/CEN89/9)
devices - Radiation - Part 1:
Requirements
prEN ISO 11137-1
204031 Sterilization of health care products - ISO/TC Joint revision of EN 552 and ISO
requirements for the development, 198 11137, under VA with ISO lead
validation and routine control of a
sterilization process for medical Mandated (BC/CEN89/9)
devices - Radiation - Part 2: Dose
setting methods
prEN ISO 11137-2
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work in ISO
204032 Sterilization of health care products - ISO/TC Joint revision of EN 552 and ISO
requirements for the development, 198 11137, under VA with ISO lead
validation and routine control of a
sterilization process for medical Mandated (BC/CEN89/9)
devices - Radiation - Part 3: Dose
substantiation for 25 kGy
prEN ISO 11137-3
204033 Sterilization of health care products - ISO/TC Joint revision of EN 552 and ISO
requirements for the development, 198 11137, under VA with ISO lead
validation and routine control of a
sterilization process for medical Mandated (BC/CEN89/9)
devices - Radiation - Part 4:
Dosimetry, dose mapping and
routine dosimetry
prEN ISO 11137-4
205001 Guidance on the application of EN TC 243 ISO/TC Includes guidance on elements of Possible relationship with TC 243
29001 and EN 46001 and of EN TC 233 210 quality systems relevant o sterile work items in relation to
29002 and EN 46002 for non-active product manufacture including environmentally controlled areas.
medical devices (EN 724) environmentally controlled areas;
hygienic design of equipment; clearing Possible relationship with WI 233 072
of environmentally controlled areas, large scale processes and production
equipment and product training of -personnel codes of practice,
personnel protective clothing procedures, training, control.
microbiological control of production
processes annex on feature of job Attention is drawn to further
descriptions of key individuals discussions on proposed work item on
hygienic design of manufacturing
equipment in BT/WG 87 and to
possible interest of CEN/TC 153 and
CEN/TC 114 in such work.
205131 Concentrates for haemodialysis and
related therapies. (prEN 13867)
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work in ISO
205138 Test methods for primary wound
dressings –Part 5: Bacterial barrier
properties (prEN 13726-5)
205154 Single use and reusable surgical
coverings, used as medical devices
in healthcare facilities for patients,
clinical staff and equipment – Part 3:
Test method for dry microbial
penetration.
205155 Single use and reusable surgical
coverings, used as medical devices
in healthcare facilities for patients,
clinical staff and equipment – Part 4:
Test method for wet microbial
penetration
216001 Chemical disinfectants and Published standard
antiseptics - Basic bactericidal
activity – Test method and
requirements (phase 1)
(EN 1040:1997)
216002 Chemical disinfectants and Published standard
antiseptics – Basic fungicidal activity
- Test method and requirements
(Phase 1) (EN 1275:1997)
216003 Chemical disinfectants and
antiseptics – Basic sporicidal activity
- Test method and requirements
(phase 1)
216004 Chemical disinfectants and Published standard
antiseptics – Quantitative
suspension test for the evaluation of
bactericidal activity of chemical
disinfectants and antiseptics used in
food, industrial, domestic, and
institutional areas - Test method and
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requirements (phase 2, step 1)
(EN 1276:1997)
216005 Chemical disinfectants and Published standard
antiseptics – Quantitative
suspension test for the evaluation of
fungicidal activity of chemical
disinfectants and antiseptics used in
food, industrial, domestic, and
institutional areas - Test method and
requirements (phase 2, step 1)
(EN 1650:1997)
216006 Chemical disinfectants and
antiseptics – Quantitative
suspension test for the evaluation of
sporicidal activity of chemical
disinfectants used in food, industrial,
domestic and institutional areas –
Test method and requirements
(Phase 2/step 1) (prEN 13704)
216007 Chemical disinfectants and Published stan
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