OElekta
MANUFACTURER'S DECLARATION OF CONFORMITY
AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULA TIONS 2002
FULL QUALITY ASSURANCE PROCEDURES
This is a declaration of conformity made under clause 1.B of Schedule 3 to the Therapeutic Goods (Medical Devices)
Regulations 2002.
Manufacturer's name: Elekta Ltd.
Business address: 2050 Bleury, SUite 200
Montreal, Quebec H3A 2J5
Canada
Medical device(s): Clarity" System 310COO
Including:
- Clarity" Software 4.1 / 4.2 REF 9310-0001B / -00042
- Clarity" Acquisition Station (310COO) REF 9100-00060
- Clarity" Curved Probe (C5-2/60) REF 9100-00037
- Clarity" Linear Probe (L14-5W/60) REF 9100-0003!l
- Clarity" TPUS Autoscan Probe Kit (m4DC7-3/40) REF B010-00059-6
Classification: Class lib
GMDN code and term: 4 5446 - Patient positioning sys tem, ultrasound
Scope of application: 3D ultrasound system for use in image guided radiation therapy
Each kind of medical device to which the system has been a pplied complies with the applicable provisions of the
essential principles, the classification rules, and the full quality assurance procedures, at each stage, from the design
of the device until its final inspection before being supplied.
Full quality assurance (E 611575
procedures certificate: European conformity assessme nt certificate under Annex II. excluding Section 4,
of Council Directive 93/42/EEC on Medical Devices.
BSI (Notified Body No,: 00!l6)
Kitemark Court, Davy Avenue
Knowhill, Milton Keynes MKS BPP
United Kingdom
Standards applied: See Page 2
Place, Date of Issue: Montreal,28-Jun-2018
Authorised signatory:
Alex Carrillo, Director of Quality Assurance, Am ericas
Management Representative
Page 1 of2 SM IC[.A-AU DoC-OS
C2 and Pl - Restricted Information and Basic Personal Data
MANUFACTURER’S DECLARATION OF CONFORMITY
AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002
FULL QUALITY ASSURANCE PROCEDURES
Elekta Ltd.
Clarity® System 310C00
Class IIb
Standards applied:
EN ISO 13485:2012 Medical devices ‐ Quality management systems ‐ Requirements for
(ISO 13485:2003) regulatory purposes
EN ISO 14971:2012 Medical devices ‐ Application of risk management to medical devices
(ISO 14971:2007)
EN 62304:2006/AC:2008 Medical device software ‐ Software life cycle process
(IEC 62304:2006)
NEMA DICOM:2018a The Digital Imaging and Communications in Medicine (DICOM) Standard
EN ISO 15223‐1:2012 Symbols for use in the labelling of medical devices
EN 1041:2008/A1:2013 Information supplied by the manufacturer of medical devices
EN ISO 10993‐1:2009/AC:2010 Biological evaluation of medical devices ‐ Part 1: Evaluation and testing
(ISO 10993‐1:2009) within a risk management process
EN 60601‐1:2006/A1:2013 Medical electrical equipment ‐ Part 1: General requirements
(IEC 60601‐1:2005/A1:2012) for basic safety and essential performance
EN 60601‐2‐37:2008 Medical electrical equipment ‐ Part 2‐37: Particular requirements
(IEC 60601‐2‐37:2007) for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment
EN 60601-2-37:2008 Medical electrical equipment ‐ Part 1‐2: General requirements
/A1:2015/A11:2011 for basic safety and essential performance ‐ Collateral standard:
(IEC 60601-2-37:2007/A1:2015) Electromagnetic compatibility ‐ Requirements and tests
EN 60601‐1‐2:2015 Medical electrical equipment ‐ Part 1‐2: General requirements
(IEC 60601‐1‐2:2014) for basic safety and essential performance ‐ Collateral standard:
Electromagnetic compatibility ‐ Requirements and tests
EN 60601‐1‐6:2010 Medical electrical equipment ‐ Part 1‐6: General requirements
(IEC 60601‐1‐6:2010) for basic safety and essential performance ‐ Collateral standard: Usability
EN 62366:2008 Medical devices ‐ Application of usability engineering to medical devices
(IEC 62366:2007)
Page 2 of 2 SMICLA‐AUDoC‐05
C2 and P1 - Restricted Information and Basic Personal Data
