HCSC 2013 Q4 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
ISO/TC 106/SC 2 CIB ISO/DIS 4823 (Ed 4) Call for the member of TC 102/SG 2-Bulk
moisture determination
ISO/TC 106/SC 2 DIS ISO/DIS 6872 (Ed 4) Dentistry -- Ceramic materials
ISO/TC 106/SC 2 DIS ISO 10139-1:2005 (Ed 2, vers 2) Dentistry -- Soft lining materials for
removable dentures -- Part 1: Materials for short-term use
ISO/TC 106/SC 2 SR ISO 14233:2003 (vers 2) Dentistry -- Polymer-based die materials
ISO/TC 106/SC 2 SR ISO 14356:2003 (vers 2) Dentistry -- Duplicating material
ISO/TC 106/SC 2 SR SO/TS 14569-2:2001 (vers 2) Dental materials -- Guidance on testing
of wear -- Part 2: Wear by two- and/or three body contact
ISO/TC 106/SC 2 CD ISO/CD 15912 - Dentistry — Refractory investment and die ... Dentistry
-- Casting investments and refractory die materials
b)
SR ISO/TC 212 ISO 18153:2003 (vers 2) In vitro diagnostic medical devices -Measurement of quantities in biological samples -- Metrological traceability of values for
catalytic concentration of enzymes assigned calibrators and control materials
2014-0129
2014-0317
2014-0317
2014-0317
2014-0317
2014-0108
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Date
2014-0317
SC 3 Ophthalmics: (Following the work of CEN TC170 and ISO TC172)
Document Title and Details
ISO/TC 172/SC 7 ISO/TS 19979:2004 (vers 2) Ophthalmic optics -- Contact lenses -Hygienic management of multipatient use trial contact lenses
d)
2014-0310
SC 2 In Vitro Diagnostics: (Following the work of CEN TC 140 and ISO TC 212)
Document Title and Details
c)
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201312-16
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
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201312-16
201312-04
201312-04
201312-16
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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/DIS 1135-4 (Ed 6) Transfusion equipment for medical use -- Part 4:
Transfusion sets for single use, gravity feed (also in CEN)
ISO/TC 76 ISO/DIS 1135-5 Transfusion equipment for medical use -- Part 5: Transfusion sets
for single use with pressure infusion apparatus(also in CEN)
ISO/TC 76 ISO/DIS 3826-4 Plastics collapsible containers for human blood and blood
components -- Part 4: Aphaeresis blood bag systems with integrated features(also in CEN)
ISO/TC 76 ISO/DIS 8536-8 (Ed 2) Infusion equipment for medical use -- Part 8: Infusion
equipment for single use with pressure infusion apparatus(also in CEN)
ISO/TC 76 ISO/DIS 8536-9 (Ed 2) Infusion equipment for medical use -- Part 9: Fluid lines for
single use with pressure infusion equipment(also in CEN)
ISO/TC 76 ISO/DIS 8536-10 (Ed 2) Infusion equipment for medical use -- Part 10:
Accessories for fluid lines for single use with pressure infusion equipment(also in CEN)
ISO/TC 76 ISO/DIS 8536-11 (Ed 2) Infusion equipment for medical use -- Part 11: Infusion
filters for single use with pressure infusion equipment
SR ISO/TC 76 ISO 8871-1:2003 (vers 2) Elastomeric parts for parenterals and for devices for
pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
ISO/TC 157 ISO/FDIS 25841 (Ed 2) Female condoms -- Requirements and test methods
e)
201312-16
201403-03
201403-03
201403-10
201402-26
201402-26
201402-26
201402-26
201403-17
201311-20
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
SR ISO/TC 121/SC 6 ISO 10524-2:2005 (vers 2) Pressure regulators for use with medical
gases -- Part 2: Manifold and line pressure regulators
SR ISO/TC 121/SC 6 ISO 10524-3:2005 (vers 2) Pressure regulators for use with medical
gases -- Part 3: Pressure regulators integrated with cylinder valves
CEN TC 215 prEN ISO 5356-1 rev Anaesthetic and respiratory equipment - Conical
connectors - Part 1: Cones and sockets (ISO/DIS 5356-1:2013)
f)
12-16
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201312-17
201403-17
201403-17
201311-26
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 non-active
surgical implants -- General requirements
SR ISO/TC 150 SC 1 ISO 5832-5:2005 (Ed 3, vers 2) Implants for surgery -- Metallic materials
-- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
SR ISO/TC 150 SC 1 ISO 5834-3:2005 (vers 2) Implants for surgery -- Ultra-high-molecularweight polyethylene -- Part 3: Accelerated ageing methods
SR ISO/TC 150 SC 1 ISO 9583:1993 (vers 4) Implants for surgery -- Non-destructive testing -Liquid penetrant inspection of metallic surgical implants
SR ISO/TC 150 SC 1 ISO 9584:1993 (vers 4) Implants for surgery -- Non-destructive testing -Radiographic examination of cast metallic surgical implants
SR ISO/TC 150 SC 1 ISO 15374:1998 (vers 3) Implants for surgery -- Requirements for
production of forgings
SR ISO/TC 150 SC 1 ISO 16428:2005 (vers 2) Implants for surgery -- Test solutions and
environmental conditions for static and dynamic corrosion tests on implantable materials and
medical devices
SR ISO/TC 150 SC 2 ISO/TS 15539:2000 (vers 2) Cardiovascular implants -- Endovascular
prostheses
SR ISO/TC 150 SC 2 ISO 25539-1:2003 (vers 2) Cardiovascular implants -- Endovascular
HCSC Q4 2013
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201401-22
201403-17
201403-17
201403-17
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devices -- Part 1: Endovascular prostheses
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 prEN ISO 16061 Instrumentation for use in association with non-active surgical
implants - General requirements (ISO/DIS 16061:2013)
g)
SC 7 Orthopaedic Implants: (Following the work of CEN TC 285 and ISO TC 168)
Document Title and Details
ISO/TC 168 ISO/DIS 16955 Prosthetics -- Quantification of physical parameters of ankle foot
devices and foot units
h)
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 102 prEN 16442 Controlled environment storage cabinet for disinfected thermolabile
endoscopes
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Date
201312-11
201312-04
201402-14
SC 9 Sterilisation and Packaging: (Following the work of CEN TC 102, 204, 195, 243 and
ISO TC 198, 209)
Document Title and Details
ISO TC 198 ISO 13408-2:2003 (vers 2) Aseptic processing of health care products -- Part 2:
Filtration
ISO TC 198 ISO 13408-6:2005 (vers 2) Aseptic processing of health care products -- Part 6:
Isolator systems
ISO TC 198 Doc. 198 N1071, NWIP, Guidance EO ster. in flexible chamber Sterilization of
health care products — Guidance on the application of ISO14937 to the sterilization of medical
devices using Ethylene Oxide in a flexible sterilization chamber
ISO TC 198 ISO/DTS 16775.3 Packaging for terminally sterilized medical devices -- Guidance
on the application of ISO 11607-1 and ISO 11607-2
CEN TC 102 prEN 16442 Controlled environment storage cabinet for disinfected thermolabile
endoscopes
CEN TC 261 prEN 16679 Packaging - Tamper verification features for medicinal product
packaging
j)
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Date
201401-31
SC 8 Sterilisers and Disinfectants: (Following the work of CEN TC 102, 204 and ISO TC
198)
Document Title and Details
i)
03-17
201401-22
201401-22
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Date
201403-17
201403-17
201401-29
201401-29
201402-14
201402-19
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 194 ISO/DTR 10993-33 - Supplement to ISO 10993-3 Biological evaluation of medical
devices -- Supplement to ISO 10993-3 -- Guidance on tests to evaluate genotoxicity -- Part 33:
ISO/TC 210 ISO/DIS 80369-20 Small-bore connectors for liquids and gases in healthcare
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2013-1216
2014-0118
2014-01-
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applications -- Part 20: Common test methods
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 IEC 62366:2007/FDAmd 1 Medical devices -- Application of usability engineering
to medical devices -- 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 Proposal to transfer IEC 62304 to IEC/SC 62A–ISO/TC 215 JWG7 Proposal to
transfer IEC 62304 to IEC/SC 62A–ISO/TC 215 JWG7
ISO/TC 210 ISO/DIS 80369-3 Small-bore connectors for liquids and gases in healthcare
applications -- Part 3: Connectors for enteral applications
k)
22
2013-1127
2013-1130
2013-1127
2014-0107
2014-0108
SC11 Ambulances: (Following the work of CEN TC 239 and ISO TC)
See SC 5 for overlap items.
Document Title and Details
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Date
No ballots
l)
SC 12 Traditional Chinese Medicine (following the work of ISO TC 249)
Document Title and Details
ISO/TC 249 ISO/FDIS 17218 Sterile acupuncture needles for single use
ISO/TC 249 N129 Traditional Chinese Medicine —Categories of TCM Clinical Terminological
System
ISO/TC 249 N130 Coding system of Chinese medicines -- Part 2: Codes of decoction pieces
ISO/TC 249 N131 Coding System of Chinese Medicines — Part 3: Coding Rules for Chinese
Medicines in Supply Chain Management
ISO/TC 249 N132 Coding System of Chinese Medicines — Part 4: Coding Rules for Formulas
and Their Codes
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2013-1224
2013-1213
2013-1213
2013-1213
2013-1213
m) SC 13 Cleanrooms: (Following the work of ISO TC 209)
Document Title and Details
CEN/TC 195 prEN ISO 16170 In situ test methods for very high efficiency filter systems in
industrial facilities (ISO/DIS 16170:2013)
n)
Close
Date
2013-1127
SC 14 (Following the work of ISO TC 173 SC 3)
Document Title and Details
SR ISO/TC 173/SC 3 ISO 9949-1:1993 (vers 4) Urine absorbing aids -- Vocabulary -- Part 1:
Conditions of urinary incontinence
SR ISO/TC 173/SC 3 ISO 9949-2:1993 (vers 4) Urine absorbing aids -- Vocabulary -- Part 2:
Products
SR ISO/TC 173/SC 3 ISO 9949-3:1993 (vers 4) Urine absorbing aids -- Vocabulary -- Part 3:
Identification of product types
ISO/TC 173/SC 3 ISO/FDIS 12505-1 Skin barrier for ostomy aids -- Test methods -- Part 1:
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Date
2014-0317
2014-0317
2014-0317
2013-12-
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Size, surface pH and water-absorbency
ISO/TC 173/SC 1 ISO/DTR 16840-9 - N690_TechReport— Wheelchair seating -- Part 9:
Clinical interface pressure mapping guidelines for seating
o)
04
2014-0125
SC 15 Aesthetic Surgery Services (Following the work of CEN TC 403)
Document Title and Details
CEN TC 403 N171 Public consultation on the preliminary opinion on the safety of the poly
implant prostheses (PIP) silicone breast implants: EU Commission site
p)
SC 16 Osteopathic Services (Following the work of CEN TC 414)
Document Title and Details
CEN TC 414 prEN 16686 Osteopathic healthcare provision
q)
Close
Date
2014-0103
Close Date
2014-04-07
New Areas of Interest
Document Title and Details
Close
Date
ISO/TC 247 N 105 ISO/IEC 17021-7 -- Conformity assessment for bodies providing audit and
certification of management systems -- Part 7: Competence requirements for auditing and
certification of security management system standards.
201402-06
ISO/TC 247 N 107 Product Fraud Countermeasures and Control - General Principles
201402-06
For further information on any of the above items,
currently out for ballot and comment, please contact
Chrissie Keane: chrissie.keane@nsai.ie
HCSC Q4 2013
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