AIRCRAFT MEDICAL
Medtronic External Temporary Pacemakers
ARTG Certificate Temporary Pacemaker Sept 2013
ARTG Certificate
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CONFIDENTIAL DOCUMENT/RECORD
Header
This document/record is electronically controlled, printed copies are considered uncontrolled.
Identifier MDT2069592-Australian Declaration of Conformity - Temporary Pacemaker, Models 5348, 5388
Title:
Version
3.0
Author
Paul O'Byrne
Australian Declaration of Conformity - Temporary Pacemaker, Models 5348, 5388, 5392
Approvals Signed By
Meaning of Signature
Date/Time (GMT)
Paul O'Byrne
Approver
09/12/2013 11:08:48 PM
Jose Ventura
Approver
09/17/2013 09:53:07 PM
MDT2069592, 3.0
Page Page 1 of 2
AUSTRALIAN DECLARATION OF CONFORMITY
Temporary Pacemaker, models 5348, 5388, 5392
Product Name/Product Model
Revision History
Version 2.0
Implementation Date 16-May-2013
Update to EC Full Quality Cert number and addition of model 5392 to DoC
3.0
Upon Approval
Initial Release
This document is electronically controlled. Printed copies are considered uncontrolled. MDT2069592, 3.0
Medtronic Confidential
CSS-2102-0118-0005 Rev 1A
Page 1 of 2
MANUFACTURER’S DECLARATION OF CONFORMITY AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002
FULL QUALITY ASSURANCE PROCEDURES This is a declaration of conformity made under clause 1.8 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002. Manufacturer Name:
Medtronic Inc.
Business Address:
710 Medtronic Parkway Minneapolis MN 55432 USA
Medical Device(s)
Temporary Pacemaker, models 5348, 5388, 5392
Classification:
IIb
GMDNS Code:
35224, Pacemaker, cardiac, external, invasive
Scope of Application:
All
Each kind of medical device to which the Full Quality Assurance Procedures have been applied complies with the applicable provisions of the essential principles, the classification rules, at each stage, from the design of the device until its final inspection before being supplied. Full Quality Assurance procedures Certificate:
EC Certificate G1 13 02 39709 857 issued by TUV (designated number 0123) in accordance with Directive 93/42/EEC on Medical Devices Annex 2.3
Standards Applied:
Refer to Essential Requirements Matrices (ER Matrix) MDT1923407 (model 5348), MDT1923403 (model 5388) & MDT2101990 (model 5392)
Authorized Signatory: Validity DoC from date: Refer to Cover page
Place: Medtronic Inc. Minneapolis, MN
Name: Jose Ventura Title: Reliability Engineering Manager
Date: Refer to cover page
Signature: Refer to cover page for electronic signature Available upon request: Non-electronic Date and Signature
This document is electronically controlled. Printed copies are considered uncontrolled. MDT2069592, 3.0
Medtronic Confidential
CSS-2102-0118-0005 Rev 1A
Page 2 of 2
File Code: MDT2101990
Rev. 6.0
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Essential Requirements Matrix for Models 5392 & 53922
CONFIDENTIAL
MMD CONFORMITY ASSESSMENT REFERENCED STANDARDS REFRENCED STANDARDS
TITLE
EN 60601-1: 2006 / AC 2010 EN 60601-1-2: 2007 / AC:2010 EN 60601-1-6: 2010 EN 60601-2-31: 2008 EN ISO 10993-1: 2009 / AC: 2010
Medical Electrical Equipment, General Requirements for Safety Medical Electrical Equipment - Part 1: General Requirements for Safety - Section 2: Collateral Standard: Electromagnetic Compatibility Requirements and Tests Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.31: Specification for External Cardiac Pacemakers with Internal Power Source Biological Evaluation of Medical Devices
COMPLIANCE
Full Compliance
Full Compliance
Full Compliance
Full Compliance Partial Compliance for EN ISO 10993-1:2009/AC:2010. Compliance only to EN ISO 10993-1:2009/AC: 2010 postproduction monitoring. Evaluation testing that was performed per ISO 10993-1:2009.
EN ISO 14971: 2012
Medical Device Risk Analysis
EN 1041: 2008
Information Supplied by the Manufacturer with Medical Devices (Labeling)
Full Compliance
EN 980: 2008
Graphical Symbols for Use in the Labeling of Medical Devices
Full Compliance
EN 62304: 2006 / AC: 2008
Medical device software. Software life-cycle processes
EN 62366: 2008
Medical devices – Application of usability engineering to medical devices
Full Compliance
Full Compliance Full Compliance
Table 3. MDD Conformity Assessment References Standards for the 53922 MMD CONFORMITY ASSESSMENT REFERENCED STANDARDS REFRENCED STANDARDS
EN 60601-1: 2006 / AC 2010 EN 60601-1-6: 2010
Medtronic Confidential
TITLE
Medical Electrical Equipment, General Requirements for Safety Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
COMPLIANCE
Full Compliance Full Compliance
This document is electronically controlled. Printed copies are considered uncontrolled. FRM001115 Rev 5.0
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