Standards Updates 2007/08
UPDATE STANDARDS SEPTEMBER 2008
BS EN PUBLICATIONS
BS EN 14931:2006
Pressure vessels for human occupancy (PVHO).
Multi-place pressure chyambers for hyperbaric
therapy. Performance, safety requirements and
testing
no current standard is superseded
ISBN 978 0 580 53337 2
CH/100/-/1
BS EN ISO 24157:2008
Ophthalmic optics and instruments. Reporting
of aberrations of the human eye
no current standard is superseded
ISBN 978 0 580 61237 4
CH/172/6
BS EN ISO 27799:2008
Health informatics. Information security
management in health using ISO/IEC 27002
no current standard is superseded
ISBN 978 0 580 56326 3
IST/35
BS EN 60601:-
Medical electrical equipment
BS EN 60601-2-37:2008
Particular requirements for the basic safety and
essential performance of ultrasonic medical
diagnostic and monitoring equipment
superseded BS EN 60601-2-37:2001 which remains
current
ISBN 978 0 580 55851 1
CH/62/2
DRAFTS FOR DEVELOPMENT
DD ISO/TS 22600:-
Health informatics. Privilege management and
access control
DD ISO/TS 22600-2:2006
Formal models
no current standard is superseded
ISBN 978 0 580 57462 7
IST/35
BRITISH STANDARDS WITHDRAWAL
BS EN 13328:-
Breathing system filters for anaesthetic and
respiratory use
BS EN 13328-2:2002
Non-filtration aspects
CH/121/5
Superseded by BS EN ISO 23328-2:2008
BS EN 50103:1996
Guidance on the application of EN 29001 and
EN 46001 and of EN 29002 and EN 46002 for the
active (including active implantable) medical
device industry
CH/210/1
This standard has been withdrawn following the
withdrawal of the European Standard
BRITISH STANDARDS UNDER REVIEW
BS 7710:-
Urine absorbing aids. Vocabulary
BS 7710-1:1993
(ISO 9949-1:1993)
Conditions of urinary incontinence
CH/173/3
BS 7710-2:1993
(ISO 9949-2:1993)
Products
CH/173/3
BS 7710-3;1993
(ISO 9949-3:1993)
Identification of product types
CH/173/3
BS EN 13610:2002
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)
CH/216
BS EN 13624:2003
Chemical disinfectants and antiseptics.
Quantitative suspension test for the evaluation
of fungicidal activity of chemical disinfectants
for instruments used in the medical areas. Test
method and requirements (phase 2, step 1)
CH/216
BS 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)
CH/216
BS EN 14204:2004
Chemical disinfectants and antiseptics.
Quantitative suspension test for the evaluation
of mycobactericidal activity of chemical
disinfectants and antiseptics used in the
veterinary field. Test method and requirements
(phase 2, step 1)
CH/216
BS ISO 8548:-
Prosthetics and orthotics. Limb deficiencies
BS ISO 8548-5:2003
Description of the clinical condition of the
person who has had an amputation
CH/168
BS ISO 8551:2003
Prosthetics and orthotics. Functional
deficiencies. Description of the person to be
treated with an orthosis, clinical objectives of
treatment, and functional requirements of the
orthosis
CH/168
NEW WORK STARTED
BS EN 1282:-
Anaesthetic and respiratory equipment.
Tracheostomy tubes
BS EN 1282-2:1997/Amendment 1
Paediatric tubes
CH/121/5
BS EN 1782:1998/Amendment 1
Tracheal tubes and connectors
CH/121/5
BS EN 1820:2005/Amendment 1
Anaesthetic reservoir bags
CH/121/5
BS EN 12342:1988/Amendment 1
Breathing tubes intended for use with
anaesthetic apparatus and ventilators
CH/121/5
BS ISO 23908:-
Sharps injury protection. Requirements and test
methods
BS ISO 23908-1
Features for protecting hypodermic needles and
introducers
CH/84
BS ISO 23908-2
Accessories for handling hypodermic needles
after use
CH/84
BS ISO 23908-3
Sharps containers
will supersede BS 7320:1990
CH/84
PD CEN/TR 15872
Health informatics. Guidance on patient
identification and cross-referencing of identities
IST/35
PD ISO/TR 25257
Health informatics. Business requirements for
an international coding system for medicinal
products
IST/35
DRAFT BRITISH STANDARDS FOR PUBLIC COMMENT – ADOPTIONS
08/30151689 DC
BS EN 60601-2-43 Medical electrical
equipment. Part 2-43. Particular requirements
for basic safety and essential performance of
X-ray equipment for interventional procedures
CH/62/2
08/30158103 DC
BS EN ISO 13666 AMD1 Ophthalmic optics.
Spectacle lenses. Vocabulary
CH/172/3
08/30168847 DC
BS EN ISO 9917-2 Dentistry. Water-based
cements. Part 2. Resin-modified cements
CH/106/1
08/30168851 DC
BS EN ISO 11609 Dentistry. Dentifrices.
Requirements, Test methods and marking
CH/106/7
CEN EUROPEAN STANDARDS
EN 1041;2008
Information supplied by the manufacturer of
medical devices
CH/210/3
CENELEC PUBLICATIONS
EN 60601:-
Medical electrical equipment
EN 60601-2-31:2008
(IEC 60601-2-31:2008)
Particular requirements for basic safety and
essential performance of external cardiac
pacemakers with internal power source
CH/150/6
EN 61223:-
Evaluation and routine testing in medical
imaging departments
EN 61223-3-2:2008
(IEC 61223-3-2:2007)
Acceptance tests. Imaging performance of
mammographic X-ray equipment
CH/62/2
EN 61675:-
Radionuclide imaging devices. Characteristics
and test conditions
EN 61675-1:
(IEC 61675-1:1998/A1:2008)
Positron emission tomography
AMENDMENT 1:July 2008
to EN 61675-1:1998
CH/62/3
IEC PUBLICATIONS
IEC/TR 60977:2008
(Edition 2)
Medical electrical equipment. Medical electron
accelerators. Guidelines for functional
performance characteristics
CH/62/3
ISO PUBLICATIONS
ISO 3826:-
Plastics collapsible containers for human blood
and blood components
ISO 3826-2:2008
Graphical symbols for use on labels and
instruction leaflets
CH/212
Will be implemented as an identical British Standard
ISO 7176:-
Wheelchairs
ISO 7176-19:2008
(Edition 2)
Wheeled mobility devices for use as seats in
motor vehicles
CH/173/1
Will be implemented as an identical British Standard
ISO 11135:-
Sterilization of health care products. Ethylene
oxide
ISO 11135-2:2008
Guidance on the application of ISO 11135-1
CH/198
Will be implemented as an identical British Standard
Dentistry Base polymers
ISO 20795-1:2008
Denture base polymers
CH/106/2
Will be implemented as an identical British Standard
ISO/TS 22595:-
Dentistry Plant area equipment
ISO/TS 22595-2:2008
Compressor systems
CH/106/6
Will not be implemented as a British Standard
UPDATE STANDARDS AUGUST 2008
BS EN PUBLICATIONS
BS EN 1650:2008-
Chemical disinfectants and antiseptics.
Quantitative suspension test for the evaluation
of fungicidal or yeasticidal activity of chemical
disinfectants and antiseptics used in food,
industrial, domestic and institutional areas. Test
method and requirements 9phase 2, step 1)
supersedes BS EN 1650:1998
ISBN 978 0 580 596692 6
CH/216
BS EN 13606:-
Health informatics. Electronic health record
communication
BS EN 13606-3:2008
Reference archetypes and term lists
supersedes DD ENV 13606-3:2000
ISBN 978 0 580 57889 2
IST/35
BS EN 15546:-
Small bore connectors for liquids and gases in
healthcare applications
BS EN 15546-1:2008
General requirements
no current standard is superseded
ISBN 978 0 580 57351 4
CH/100
BS EN ISO 15883:-
Washer-disinfectors
BS EN ISO 15883-4:2008
Requirements and tests for washer-disinfectors
employing chemical disinfection for
thermolabile endoscopes
no current standard is superseded
ISBN 978 0 580 59065 8
LB1/35
BS EN 60601:-
Medical electrical equipment
BS EN 60601-1-9:2008
General requirements for basic safety and
essential performance. Collateral standard.
Requirements for environmentally conscious
design
no current standard is superseded
ISBN 978 0 580 54461 3
CH/62/1
BS IMPLEMENTATIONS
BS ISO 7176:-
Wheelchairs
BS ISO 7176-14:2008
Power and control systems for electrically
powered wheelchairs and scooters.
Requirements and test methods
supersedes BS ISO 7176-14:1997
ISBN 978 0 580 53794 3
CH/173/1
DRAFTS FOR DEVELOPMENT
DD ISO/TS 22367:2008
Medical laboratories. Reduction of error
through risk management and continual
improvement
no current standard is superseded
ISBN 978 0 580 54506 1
CH/212
AMENDMENTS TO BRITISH STANDARDS
BS EN ISO 6009:1994
Hypodermic needles for single use. Colour
coding for identification
CORRIGENDUM 1
CH/84
BS EN ISO 9999:2007
Assistive products for persons with disability.
Classification and terminology
CORRIGENDUM 1
CH/173
BS EN 60601:-
Medical electrical equipment
BS EN 60601-1-6:2007
General requirements for basic safety and
essential performance. Collateral standard.
Usability
CORRIGENDUM 1
CH/62/1
UPDATED BRITISH STANDARDS
BS EN 285:2006+A1:2008
Sterilization. Steam sterilizers. Large sterilizers
AMENDMENT 1
LB1/35
NEW WORK STARTED
BS EN 1639 (Revision)
Dentistry. Medical devices for dentistry.
Instruments
will supersede BS EN 1639:2004
CH/106
BS EN 1640 (Revision)
Dentistry. Medical devices for dentistry.
Equipment
will supersede BS EN 1640:2004
CH/106
BS EN 1641 (Revision)
Dentistry. Medical devices for dentistry.
Materials
will supersede BS EN 1641:2004
CH/106
BS EN 1642 (Revision)
Dentistry. Medical devices for dentistry. Dental
implants
will supersede BS EN 1642:2004
CH/106
BS EN 1828 (Revision)
Health informatics. Categorical structure for
classifications and coding systems of surgical
procedures
will supersede BS EN 1828:2002
IST/35
BS EN 80601:-
Medical electrical equipment
BS EN 80601-2-60
Particular requirements for basic safety and
essential performance of dental equipment
CH/62/1
DD ISO/TS 21547:-
Health informatics. Security requirements for
archiving of electronic health records
DD ISO/TS 21547-1
Principles and requirements
IST/35
PD ISO/TR 21547:-
Health informatics. Security requirements for
archiving of electronic health records
PD ISO/TR 21547-2
Guidelines
IST/35
PD ISO/TR 28380:-
Health informatics. IHE Global Standards
Adoption
PD ISO/TR 28380-2
Integration and content profiles
IST/35
BS ISO/IEC 80600
Medical electrical equipment. Deployment,
implementation and operational guidelines for
identifying febrile humans using a screening
thermograph
CH/121/5
DRAFT BRITISH STANDARDS FOR PUBLIC COMMENT –
ADOPTIONS
08/30170500 DC
BS EN 60601-2-33 Medical electrical
equipment. Part 2-33. Particular requirements
for basic safety and essential performance of
magnetic resonance equipment for medical
diagnosis
CH/62/2
08/30173423 DC
BS EN 60601-2-5 Medical electrical equipment
Part 2-5. Particular requirements for basic safety
and essential performance of ultrasonic
physiotherapy equipment
CH/62/4
Comments for the above document are required by
31 October 2008
08/30174059 DC
BS ISO 81060-2 Non-invasive
sphygmomanometers. Part 2. Clinical validation
of automated measurement type
CH/121/5
08/30184486 DC
BS EN ISO 1135-4 Transfusion equipment for
medical use. Part 4. Transfusion sets for single
use
CH/212
IEC PUBLICATIONS
IEC 60601:-
Medical electrical equipment
IEC 60601-2-29:2008
(Edition 3)
Particular requirements for basic safety and
essential performance of radiotherapy
simulators
CH/62/3
IEC 62220:-
Medical electrical equipment. Characteristics of
digital X-ray imaging devices
IEC 62220-1-3:2008
Determination of the detective quantum
efficiency. Detectors used in Dynamic Imaging
CH/62/2
ISO PUBLICATIONS
ISO 3823:-
Dentistry. Rotary bur instruments
ISO 3823-2:-
Finishing burs
AMENDMENT 1:June 2008
to ISO 3823-2:2003
CH/106/4
Will be implemented as an identical British Standard
ISO 5364:2008
(Edition 4)
Anaesthetic and respiratory equipment.
Oropharyngeal airways
CH/121/5
Will be implemented as an identical British Standard
ISO 9170:-
Terminal units for medical gas pipeline systems
ISO 9170-1:2008
(Edition 2)
Terminal units for use with compressed medical
gases and vacuum
CH/121/6
Will be implemented as an identical British Standard
ISO 9170-2:2008
(Edition 2)
Terminal units for anaesthetic gas scavenging
systems
CH/121/6
Will be implemented as an identical British Standard
ISO 11143:2008
(Edition 2)
Dentistry. Amalgam separators
CH/106/4
Will be implemented as an identical British Standard
ISO 12189:2008
Implants for surgery. Mechanical testing of
implantable spinal devices. Fatigue test method
for spinal implant assemblies using an anterior
support
CH/150/5
Will not be implemented as a British Standard
ISO 13408:-
Aseptic processing of health care products
ISO 13408-1:2008
(Edition 2)
General requirements
CH/198
Will not be implemented as a British Standard
ISO 15002:2008
(Edition 2)
Flow-metering devices for connection to
terminal units of medical gas pipeline systems
CH/121/6
Will be implemented as an identical British Standard
ISO 15223:-
Medical devices. Symbols to be used with
medical device labels, labelling and information
to be supplied
ISO 15223-1:-
General requirements
AMENDMENT 1:June 2008
to ISO 15223-1:2007
CH/210/3
Will not be implemented as a British Standard
ISO 24157:2008
Ophthalmic optics and instruments. Reporting
aberrations of the human eye
CH/172/6
Will be implemented as an identical British Standard
ISO 27799:2008
Health informatics. Information security
management in health using ISO/IEC 27002
IST/35
Will be implemented as an identical British Standard