Product US – FDA Health 60601-1) 1) Status (AAMI ES 60601 Canada
EU - MDD
Others
New Device
mandatory (1JUL13)
mandatory (1JUN12)
mandatory (1JUN12*)
...
Existing Device
okay as is
okay as is
mandatory (1JUN12*)
...
In the Field
okay as is
okay as is
okay as is
...
(new sale)
(repairs) 4
* - see next slide
www.nsai.ie
2011‐12‐01
2
Christine Ruther
NSAI Medical Device Seminar, Galway
What’s the * • In Europe, transition depends on particular standards • Applicable particular standard? • Yes - date of transition of the particular standard applies • 60601-2-29 radiotherapy simulators 1NOV11 • 60601-2-37 ultrasound - 1OCT10
• No - date in table applies 5
Heads-Up • All 60601 standards are being updated • Aligning Ali i with ith 3rdd edition diti • Normal technical revisions (amendment pending for 60601-1 expected mid-2012)
• Some standards are renumbered • EN ISO 80601-2-X • Still ll h have most as EN 60601-2-X
• Standards are receiving transition dates 6
www.nsai.ie
2011‐12‐01
3
Christine Ruther
NSAI Medical Device Seminar, Galway
Do I have to? • Standards are voluntary but … • MDD A Annex II.2 2 “solutions “ l ti adopted d t d by b the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art art” • MDD Article 5.1 gives presumption of conformity for harmonized standards 7
Overview
8
www.nsai.ie
2011‐12‐01
4
Christine Ruther
NSAI Medical Device Seminar, Galway
Origin of Changes • Experience with 2nd edition • Info in particular standards • County specific deviations • US deviations strongly considered
• Other standards • EN 60950 heavily considered
9
So, what’s new? • • • •
Collaterals are included when published Some requirements have been amended New requirements have been added Focus today, a few points regarding: • • • • •
Marking • On equipment: • Name or trademark of MANUFACTURER • Model or type reference • If single use, ‘do not reuse’ or symbol
• Applies to: • Equipment • Its detachable components, components and • Accessories 12
www.nsai.ie
2011‐12‐01
6
Christine Ruther
NSAI Medical Device Seminar, Galway
Indicator Lights Color
2nd Edition
3rd Edition
warning – immediate response by the operator is required caution – prompt response Yellow: caution or attention required by the operator is required Red:
warning of danger and/or a need for urgent action
Green:
ready for action
ready for use
Oth Other:
meaning g other than that of red or yellow
meaning g other than that of red, yellow or green
Symbols and Safety Signs • New meaning for
:
• was “Attention: Attention: Consult accompanying documents“ • is now “Caution”
• New “consult instructions for use” symbols: •
when recommended
•
when mandatory
• Emergency stop symbol: 14
www.nsai.ie
2011‐12‐01
7
Christine Ruther
NSAI Medical Device Seminar, Galway
Risk Management
15
Risk Management File • “Risk” appears 666 times • Compliance to ISO 14971 is required • Specific items must be addressed to define test or test parameters
16
www.nsai.ie
2011‐12‐01
8
Christine Ruther
NSAI Medical Device Seminar, Galway
Examples • Clause 11.6.3 – Spill Test • Was: 200 mL, mL tap water, water ≤5cm ≤5cm, ~15 15 sec • Is: define fluid type, volume & duration for spill test through risk analysis
• Clause 11.1.1 – Pt. Applied Part Temp • Was: 41C • Is: 41C* if exposure
