14. Writing Instrument Standards
• ISO 11540:1993 - Caps for writing and marking instruments
H intended for use by children up to 14 years of age -- Safety
i requirements
g • Specifies safety requirements for cap size, ventilated caps
(vent area, air flow) and marking. Annex A describes the
h test for air flow. Caps which do not comply should have
l the instrument or its packaging labelled with a warning as
to the dangers of asphyxiation from pen caps.
i
• ASTM D4236 - 94(2005) Standard Practice for Labeling Art
g Materials for Chronic Health Hazards
h • Scope 1, 1.1... chronic health hazards known to be
t associated with a product or product component(s), when
the component(s) is present in a physical form, volume, or
e concentration that in the opinion of a toxicologist (see
r 2.1.11) has the potential to produce a chronic adverse
health effect(s).
13
15. Importance of Risk Management
• Prepare and respond to your Customers!
• Business strategy
• Business security
• Provide a Competitive advantage
• Communicate information
• Good news
• Bad news
• Not counting everything else
– Regulatory requirement
14
17. New requirements
• Medical Device Directive 93/42/EEC (M5)
• Add’s Usability - See Annex I, 1st paragraph
• Subset of Risk Management
• EC 62366 - Medical devices -- Application
of usability engineering to medical devices
16
18. Structure
Design (ISO Usability (EC Process (ISO
14971) 62366) 14971)
New Risks?
Risk Analysis
process
Mitigation & Control
17
19. This presentation was originally
conducted by Pete Davis of
Neomend at the MD&M West
Conference, Feb 11 2013.
VISIT HERE for the full presentation.