HCSC 2013 Q3 Report NSAI
HealthCare Standards Consultative Committee
Current Documents out for vote and comment.
For further information, please contact chrissie.keane@nsai.ie
a)
SC 1 Dentistry: (Following the work of CEN TC 55 and ISO TC 106)
Document Title and Details
CEN/TC 55 prEN ISO 9680 Dentistry - Operating lights (ISO/DIS 9680:2013)
ISO/TC 106/SC 1 ISO/DIS 15841 (Ed 2) Dentistry -- Wires for use in orthodontics
ISO/TC 106/SC 1 ISO/FDIS 17304 Dentistry -- Polymerization shrinkage: Method for
determination of polymerization shrinkage of polymer-based restorative materials
ISO/TC 106/SC 2 ISO/DIS 6872 (Ed 4) Dentistry -- Ceramic materials
ISO/TC 106/SC 1 ISO/DIS 13116 Dentistry -- Test Method for Determining RadioOpacity of Materials
CEN/TC 55 prEN ISO 11499 rev Dentistry - Single-use cartridges for local anaesthetics
(ISO/DIS 11499:2013)
CEN/TC 55 prEN ISO 16443 Dentistry - Terminology of oral implantology (ISO/DIS
16443:2013)
CEN/TC 55 prEN ISO 9687 rev Dentistry - Graphical symbols for dental equipment
(ISO/DIS 9687:2013)
b)
Close
Date
201310-16
201310-16
201310-01
201401-29
201311-06
201309-18
201311-06
201310-04
Owner
SC 2 In Vitro Diagnostics: (Following the work of CEN TC 140 and ISO TC 212)
Document Title and Details
SR ISO/TC 212 Clinical laboratory medicine -- In vitro diagnostic medical devices -Validation of user quality control procedures by the manufacturer
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Date
201309-16
Owner
Note: The Chairman reported that the EU Commission has asked that all TCs review all standards
annually to ensure that normative references are ‘state-of-the-art’ and up-to-date. This proposal is
currently under discussion and the final process not yet established within CEN CLC.
c)
SC 3 Ophthalmics: (Following the work of CEN TC170 and ISO TC172)
Document Title and Details
ISO/TC 172/SC 7 ISO/DIS 11978 (Ed 2) Ophthalmic optics -- Contact lenses and
contact lens care products -- Labelling
ISO/TC 172/SC 7 ISO/DIS 11979-6 (Ed 3) Ophthalmic implants -- Intraocular lenses
-- Part 6: Shelf-life and transport stability
ISO/TC 172/SC 7 ISO 11979-9:2006/DAmd 1 Ophthalmic implants -- Intraocular
lenses -- Part 9: Multifocal intraocular lenses -- Amendment 1
ISO/TC 172/SC 7 ISO 11979-10:2006/DAmd 1 Ophthalmic implants -- Intraocular
lenses -- Part 10: Phakic intraocular lenses -- Amendment 1
ISO/TC 172/SC 7 ISO/DIS 13212 (Ed 3) Ophthalmic optics -- Contact lens care
products -- Guidelines for determination of shelf-life SR
ISO/TC 172/SC 7 ISO/TS 19979:2004 (vers 2) Ophthalmic optics -- Contact lenses - Hygienic management of multipatient use trial contact lenses
ISO/TC 172/SC 7 Call for experts Call for experts for revision of ISO 8980-1, ISO
8980-2 and ISO 21987
HCSC Q3 2013
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Date
201309-11
201309-25
201310-09
201310-09
201309-25
201312-16
201309-15
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HCSC 2013 Q3 Report NSAI
CEN/TC 170 prEN ISO 11979-6 Ophthalmic implants - Intraocular lenses - Part 6:
Shelf-life and transport stability (ISO/DIS 11979-6:2013)
CEN/TC 170 - Adoption of a New Work Item :Adoption of ISO/ NP 19045 as new
CEN work item under VA/ISO-lead
Draft_Decision_119_2013_Adoption_of_ISO_NP_19045
CEN/TC 170 - Adoption of a New Work Item: Adoption of ISO/CD 18259 as new CEN
work item under VA/ISO-lead
Draft_Decision_118_2013_Adoption_of_ISO_CD_18259
CEN/TC 170 - Adoption of a New Work Item: Adoption of ISO/ NP 18189 as new
CEN work item under VA/ISO-lead
Draft_Decision_117_2013_Adoption_of_ISO_NP_18189
d)
201309-25
201310-11
201310-11
201310-11
SC 4 Non Active Devices: (Following the work of CEN TC205 and ISO TC076, 084, 157)
Document Title and Details
SR ISO/TC 76 ISO 8872:2003 (Ed 2, vers 2) Aluminium caps for transfusion,
infusion and injection bottles -- General requirements and test methods
ISO/TC 76 ISO/DIS 11040-4 (Ed 3) Prefilled syringes -- Part 4: Glass barrels for
injectables and sterilized subassembled syringes ready for filling
ISO/TC 76 ISO/DIS 11040-7 Prefilled syringes -- Part 7: Packaging systems for
sterilized subassembled syringes ready for filling
SR ISO/TC 76 ISO 11418-2:2005 (Ed 2, vers 2) Containers and accessories for
pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
SR ISO/TC 76 ISO 11418-3:2005 (Ed 2, vers 2) Containers and accessories for
pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and
liquid dosage forms
SR ISO/TC 76 ISO 11418-4:2005 (Ed 2, vers 2) Containers and accessories for
pharmaceutical preparations -- Part 4: Tablet glass bottles
ISO/TC 76 ISO/CD 15378 Primary packaging materials for medicinal products -Particular requirements for the application of ISO 9001:2008, with reference to
Good Manufacturing Practice (GMP)
CEN/TC 261 prEN 16592 Packaging - Rigid plastic containers - PET finish 29/25
(12,6)
CEN/TC 261 prEN 16593 Packaging - Rigid plastic containers - PET finish BVS
30H60
CEN/TC 261 prEN 16594 Packaging - Rigid plastic containers - PET finish 26/22
(12,0)
ISO/TC 84 ISO 7886-3:2005 (vers 2) Sterile hypodermic syringes for single use -Part 3: Auto-disable syringes for fixed-dose immunization
ISO/TC 84 ISO/DIS 10555-6 Intravascular catheters -- Sterile and single-use
catheters -- Part 6: Subcutaneous implanted ports
ISO/TC 84 ISO/DIS 11070 (Ed 2) Sterile, single-use intravascular catheter
introducers
ISO/TC 84 ISO/DTR 19244 Guidance on ISO Transition Periods -- At the
Publication of New/Updated Device Standards
ISO/TC 157 ISO 8009:2004 (vers 2) Mechanical contraceptives -- Reusable natural
and silicone rubber contraceptive diaphragms -- Requirements and tests
ISO/TC 157 N 786 ISO/NP Tubal ligation/Fallopian rings Mechanical female
contraceptive device - Tubal ligation/Fallopian rings
ISO/TC 157 N 787 ISO/NP 25841 Female condoms (Revision) Female condoms —
Requirements and test methods (Revision of ISO 25841:2011)
CEN/TC 205 prEN 455-2 Medical gloves for single use - Part 2: Requirements and
testing for physical properties
CEN/TC 205 prEN 455-3 Medical gloves for single use - Part 3: Requirements and
testing for biological evaluation
CEN/TC 205 prEN ISO 11070 rev Sterile, single-use intravascular catheter
introducers (ISO/DIS 11070:2013)
CEN/TC 205 Decision 20/2013 - NWIP UAP on ISO 7199:2009 Cardiovascular
implants and artificial organs - Blood-gas exchangers (oxygenators)
HCSC Q3 2013
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Date
201312-16
2013-1204
2013-1204
2013-1216
Owner
2013-1216
2013-1216
2013-1003
2013-0925
2013-0925
2013-0925
2013-0916
2013-1010
2013-1011
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CEN/TC 205 Systematic Review of EN 455-4:2009 Medical gloves for single use Part 4: Requirements and testing for shelf life determination
CEN/TC 261 CEN/TC 261 Draft decision N006/2013 (Doc N 416) New Work Item
Proposal 'Packaging - Braille on packaging for medicinal products'
e)
SC 5 Respiratory and Anaesthesia: (Following the work of CEN TC 215 and ISO TC121)
Document Title and Details
ISO/TC 121 Ad Hoc Committee Internal Ballot on Medical Oxygen Question to ISO
TC 121 Member Bodies: Requirements for a Medical Oxygen Supply Source
Used for a Medical Gas Pipeline System
ISO/TC 121/SC 2 ISO/FDIS 27427 (Ed 3) Anaesthetic and respiratory equipment -Nebulizing systems and components
ISO/TC 121/SC 6 ISO/DIS 7396-1 (Ed 3) Medical gas pipeline systems -- Part 1:
Pipeline systems for compressed medical gases and vacuum
ISO/TC 121/SC 6 ISO/CD 13109.4 Medical gas pipeline systems -- Essential safety
requirements for tubes intended for compressed medical gases and vacuum in
medical gas pipeline systems, anaesthetic gas scavenging disposal systems and
plume evacuation systems
CEN/TC 215 prEN ISO 7396-1 Medical gas pipeline systems - Part 1: Pipeline
systems for compressed medical gases and vacuum (ISO/DIS 7396-1:2013)
CEN/TC 215 N 1377 Decision C03/2013 Replace the nipple ('fir-tree') connector
specified in EN 13544-2 with the new R2 respiratory small-bore connector
f)
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Date
Owner
201312-17
201310-23
201310-23
201310-23
201310-23
201309-27
SC 6 Implants: (Following the work of CEN TC 285 and ISO TC 150, 170)
Document Title and Details
ISO/TC 150 ISO/DIS 16061 (Ed 3) Instrumentation for use in association with nonactive surgical implants -- General requirements
ISO/TC 150/SC 1 ISO/FDIS 15309 Implants for surgery -- Differential scanning
calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in
implantable medical devices
ISO/TC 150/SC 1 ISO/NP 13781 Implants for surgery — Homopolymers, copolymers,
and blends on poly(lactide) — In vitro degradation testing
ISO/TC 150/SC 2 SR ISO 15676:2005 (vers 2) Cardiovascular implants and artificial
organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and
extracorporeal membrane oxygenation (ECMO)
ISO/TC 150/SC 6 ISO/DIS 5841-2 (Ed 3) Implants for surgery -- Cardiac pacemakers
-- Part 2: Reporting of clinical performance of populations of pulse generators or leads
CEN/TC 285 prEN ISO 16061 Instrumentation for use in association with non-active
surgical implants - General requirements (ISO/DIS 16061:2013)
CEN/TC 285 C443/2013 Adoption of a NWIP under the VA - ISO 7198
Cardiovascular implants and extracorporeal systems - Tubular Vascular Prostheses
CEN/TC 205 FprEN ISO 8638 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
(ISO 8638:2010)
CEN/TC 205 FprEN ISO 8637 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO
8637:2010, including Amendment 1 2013-04-01
g)
2013-1113
2013-0911
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Date
201401-22
Owner
201310-20
201309-08
201309-16
201310-29
201401-22
201310-31
201310-30
201310-30
SC 7 Orthopaedic Implants: (Following the work of CEN TC 285 and ISO TC 168)
Document Title and Details
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Date
Owner
No Ballots
HCSC Q3 2013
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h)
SC 8 Sterilisers and Disinfectants: (Following the work of CEN TC 102, 204 and ISO TC
198)
Document Title and Details
CEN/TC 102 prEN 285 Sterilization - Steam sterilizers - Large sterilizers
CEN/TC 216 prEN 12791 Chemical disinfectants and antiseptics - Surgical hand
disinfection - Test method and requirements (phase 2, step 2)
CEN/TC 216 prEN 14675 Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of virucidal activity of chemical disinfectants and
antiseptics used in the veterinary area - Test method and requirements - (phase 2,
step 1)
CEN/TC 216 prEN 16615 Chemical disinfectants and antiseptics - Quantitative test
method for the evaluation of bactericidal and yeasticidal activity on non-porous
surfaces with mechanical action employing wipes in the medical area (4- field test) Test method and requirements (phase 2, step 2)
CEN/TC 216 prEN 16616 Chemical disinfectants and antiseptics - Chemical-thermal
textile disinfection - Test method and requirements (phase 2, step 2)
No comments at this time
CEN/TC 216 Systematic review EN 13610 :2002 Chemical disinfectants and
antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or
tuberculocidal activity of chemical disinfectants used for instruments in the medical
area - Test method and requirements (phase 2, step 2)
CEN/TC 216 Systematic review EN 13704 :2002 Chemical disinfectants 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)
CEN/TC 216 Systematic review EN 14563 :2008 Chemical disinfectants Quantitative suspension test for the evaluation of virucidal activity against
bacteriophages of chemical disinfectants used in food and industrial areas - Test
method and requirements (phase 2, step 1)
CEN/TC 216 FprEN 16438 Chemical disinfectants and antiseptics - Quantitative
surface test for the evaluation of fungicidal or yeasticidal activity of chemical
disinfectants and antiseptics used in the veterinary area on non-porous surfaces
without mechanical action - Test method and requirements - (phase 2, step2)
CEN/TC 216 FprEN 16437 Chemical disinfectants and antiseptics - Quantitative
surface test for the evaluation of bactericidal activity of chemical disinfectants and
antiseptics used in veterinary area on porous surfaces without mechanical action Test method and requirements (phase 2, step2)
CEN/TC 216 EN 13727:2012/FprA1 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity in the medical
area - Test method and requirements (phase 2, step 1)
i)
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Date
201310-09
201312-11
Owner
201312-04
201310-30
201310-30
201309-30
201309-30
201309-30
201310-29
201310-29
201309-13
SC 9 Sterilisation and Packaging: (Following the work of CEN TC 102, 204, 195, 243 and
ISO TC 198, 209)
Document Title and Details
SR CEN TC 102 Systematic review of EN 868-10:2009 EN 868-10, Packaging for
terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials
of polyolefines - Requirements and test methods
SR CEN TC 102 Systematic review of EN 868-2:2009 EN 868-2, Packaging for
terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and
test methods
SR CEN TC 102 Systematic review of EN 868-3:2009 EN 868-3, Packaging for
terminally sterilized medical devices - Part 3: Paper for use in the manufacture of
paper bags (specified in EN 868-4) and in the manufacture of pouches and reels
(specified in EN 868-5) - Requirements and test methods
SR CEN TC 102 Systematic review of EN 868-4:2009 EN 868-4, Packaging for
HCSC Q3 2013
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201310-10
201310-10
201310-10
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HCSC 2013 Q3 Report NSAI
terminally sterilized medical devices - Part 4: Paper bags - Requirements and test
methods
SR CEN TC 102 Systematic review of EN 868-5:2009 EN 868-5, Packaging for
terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous
materials and plastic film construction - Requirements and test methods
SR CEN TC 102 Systematic review of EN 868-6:2009 EN 868-6, Packaging for
terminally sterilized medical devices - Part 6: Paper for low temperature sterilization
processes - Requirements and test methods
SR CEN TC 102 Systematic review of EN 868-7:2009 EN 868-7, Packaging for
terminally sterilized medical devices - Part 7: Adhesive coated paper for low
temperature sterilization processes - Requirements and test methods
SR CEN TC 102 Systematic review of EN 868-8:2009 EN 868-8, Packaging for
terminally sterilized medical devices - Part 8: Re-usable sterilization containers for
steam sterilizers conforming to EN 285 - Requirements and test methods
SR CEN TC 102 Systematic review of EN 868-9:2009 EN 868-9, Packaging for
terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of
polyolefines - Requirements and test methods
CEN/TC 204 Extension of the Date of Withdrawal of EN ISO 11135: 2013 Sterilization
of health-care products - Ethylene oxide - Requirements for the development,
validation and routine control of a sterilization process for medical devices
CEN/TC 204 Adoption of ISO TS 13004 ' Sterilization of health care products Radiation - Substantiation of selected terilization doses: Method VDmaxSD' as EN
ISO TS
CEN/TC 204 Adoption of ISO 13408-7 ' Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination products' as an EN
ISO.
j)
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201310-10
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201310-03
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201310-03
SC10 Horizontal Standards: (Following the work of CEN TCs 206, 257, 258, 316,CLC TF3,
ABHS and ISO TCs 194, 210)
Document Title and Details
ISO/TC 194 SR ISO/TS 10993-20:2006 (vers 2) Biological evaluation of medical
devices -- Part 20: Principles and methods for immunotoxicology testing of medical
devices
ISO/TC 210 ISO/DIS 80369-7 Small bore connectors for liquids and gases in
healthcare applications -- Part 7: Connectors with 6% (Luer) taper for intravascular or
hypodermic applications
ISO/TC 210 ISO/DIS 80369-20 Small-bore connectors for liquids and gases in
healthcare applications -- Part 20: Common test methods
ISO/TC 210 IEC 62304:2006/CD Amd 1 Medical device software -- Software life
cycle processes -- Amendment 1
ISO/TC 210 ISO/CD 16142-1 Medical devices -- Recognized essential principles of
safety and performance of medical devices -- Part 1: General essential principles and
additional specific essential principles for all non-IVD medical devices and guidance
on the selection of standards
ISO/TC 210 ISO/CD 80369-1 Small-bore connectors for liquids and gases in
healthcare applications -- Part 1: General requirements
ISO/TC 210 Resolution 162 by correspondence: ISO 18250 series CIB concerning
splitting standard for entral connectors CIB
ISO/TC 210 ISO/DIS 80369-3 Small-bore connectors for liquids and gases in
healthcare applications -- Part 3: Connectors for enteral applications
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201312-16
201310-11
201401-22
201310-11
201311-27
201310-12
201309-26
201401-08
Chrissie Keane Note: TC 3 says new connector standards should be harmonised although 215
disagree
k)
SC11 Ambulances: (Following the work of CEN TC 239 and ISO TC)
See SC 5 for overlap items.
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Document Title and Details
l)
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201309-04
201311-27
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201310-22
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SC 12 Traditional Chinese Medicine (following the work of ISO TC 249)
Document Title and Details
m) SC 13 Cleanrooms: (Following the work of ISO TC 209)
Document Title and Details
ISO/TC 209 ISO/DIS 14644-12 Cleanrooms and associated controlled environments
-- Part 12: Classification of air cleanliness by nanoscale particle concentration
CEN/TC 195 prEN ISO 16170 In situ test methods for very high efficiency filter
systems in industrial facilities (ISO/DIS 16170:2013)
n)
SC 14 (Following the work of ISO TC 173 SC 3)
Document Title and Details
ISO/TC 173/SC 3 ISO TC 173 SC 3 NWIP N 449 Urine absorbing aids - Test method
for the determination of the absorption before leakage using an adult mannequin
Check Hollister
o)
SC 15 Aesthetic Surgery Services (Following the work of CEN TC 403)
Document Title and Details
Margaret O’Donnell Note:
p)
SC 16 Osteopathic Services (Following the work of CEN TC 414)
Document Title and Details
Document will be going out for enquiry and we need to highlight dates..
q)
New Areas of Interest
Document Title and Details
CEN/TC 140 Decision 10/2013 - NWIP CEN/TS frozen tissue Proteins Molecular invitro diagnostic examinations - Specifications for pre-examination processes for snap
frozen tissue - Proteins
CEN/TC 140 Decision 11/2013 - NWIP CEN/TS frozen tissue RNA Molecular in-vitro
diagnostic examinations - Specifications for preexamination
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processes for snap frozen tissue - RNA
CEN/TC 140 Decision 12/2013 - NWIP CEN/TS Metabolomics Molecular in-vitro
diagnostic examinations - Specifications for pre-examination
processes for metabolomics in urine, serum and plasma
CEN/TC 140 Decision 4/2013 - NWIP CEN/TS Blood ccfDNA Molecular in-vitro
diagnostic examinations - Specifications for pre-examination processes for blood Circulating cell free DNA
CEN/TC 140 Decision 5/2013 - NWIP CEN/TS Blood Genomic DNA Molecular invitro diagnostic examinations - Specifications for pre-examination processes for blood
- Genomic DNA
CEN/TC 140 Decision 6/2013 - NWIP CEN/TS Blood Cellular RNA Molecular in-vitro
diagnostic examinations - Specifications for pre-examination processes for blood Cellular RNA
CEN/TC 140 Decision 7/2013 - NWIP CEN/TS FFPE tissue DNA Molecular in-vitro
diagnostic examinations - Specifications for pre-examination processes for FFPE
tissue - DNA
CEN/TC 140 Decision 8/2013 - NWIP CEN/TS FFPE tissue Proteins Molecular invitro diagnostic examinations - Specifications for pre-examination processes for FFPE
tissue - Proteins
CEN/TC 140 Decision 9/2013 - NWIP CEN/TS FFPE tissue RNA Molecular in-vitro
diagnostic examinations - Specifications for pre-examination processes for FFPE
tissue - RNA
CEN/TC 140 Systematic Review of EN 13612:2002 Performance evaluation of in
vitro diagnostic medical devices
CEN/TC 140
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