Transcript Compliance Engineering

Compliance Engineering
Jim Dvorsky
Battelle Medical Device Solutions
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
1
Introduction to Compliance Engineering
• What is Compliance Engineering? What does it
mean to have a compliant product?
• Why is Compliance Engineering important?
• When and where does it begin? When and where
does it end?
• How is product compliance achieved?
• Who is responsible for product compliance?
• What role can I play in Compliance Engineering?
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
2
What is Compliance Engineering?
• Compliance Engineering is designing and
developing a product to meet a set of safety
standards specific to that class of products.
• A compliant product is one that has undergone an
evaluation and meets the stipulations set forth by
the market.
• The evaluation may be performed by product
manufacturer…
– CE Marking, Witnessed testing
• …Or may be performed by an independent party.
– NRTL, Certifying Body
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
3
Product Safety Requirements
• Where do product safety requirements come from?
• Who oversees the requirements and the products intended to
conform to them?
• Can anyone perform a product evaluation?
• Who or what constitutes an independent evaluator?
• Can’t a product just get a safety mark and be done with this
process?
• Is electromagnetic compatibility (EMC) different from product
safety or just a part of it?
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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Alphabet Soup
AAMI
CCC
CSA
ETL
GHTF
ITS
MDD
NRTL
TUV
ANSI
CE
EMC
EU
GS
IVD
NARTE
OSHA
UL
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BSI
CEI
EMI
FCC
IEC
JSA
NEMKO
ROHS
VDE
CB
CISPR
ESD
FDA
ISO
LVD
NOM
SEMKO
WEEE
BUSINESS SENSITIVE
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Standards Writing Organizations
AAMI
CCC
CSA
ETL
GHTF
ITS
MDD
NRTL
TUV
ANSI
CE
EMC
EU
GS
IVD
NARTE
OSHA
UL
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BSI
CEI
EMI
FCC
IEC
JSA
NEMKO
ROHS
VDE
CB
CISPR
ESD
FDA
ISO
LVD
NOM
SEMKO
WEEE
BUSINESS SENSITIVE
6
Standards Incorporating Organizations
AAMI
CCC
CSA
ETL
GHTF
ITS
MDD
NRTL
TUV
ANSI
CE
EMC
EU
GS
IVD
NARTE
OSHA
UL
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BSI
CEI
EMI
FCC
IEC
JSA
NEMKO
ROHS
VDE
CB
CISPR
ESD
FDA
ISO
LVD
NOM
SEMKO
WEEE
BUSINESS SENSITIVE
7
Standards Acceptance and Renaming
• An independent (often international) organization generates a standard
based on the consensus of the members participating on the committee
– IEC 61010-1
• Members of the European Economic Community accept the standard
– EN 61010-1
• Individual countries in EEC accept the standard, with deviations specific
to their country
–
–
–
–
BS EN 61010-1
DS EN 61010-1
TSE 61010-1
GOST-R 61010-1
• Other countries adopt standard, with deviations
– UL 61010-1
– CSA-C22.2 No. 61010-1
– JIS C 1010-1
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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Standards Testing Organizations
AAMI
CCC
CSA
ETL
GHTF
ITS
MDD
NRTL
TUV
ANSI
CE
EMC
EU
GS
IVD
NARTE
OSHA
UL
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BSI
CEI
EMI
FCC
IEC
JSA
NEMKO
ROHS
VDE
CB
CISPR
ESD
FDA
ISO
LVD
NOM
SEMKO
WEEE
BUSINESS SENSITIVE
9
Product Safety Marks
AAMI
CCC
CSA
ETL
GHTF
ITS
MDD
NRTL
TUV
ANSI
CE
EMC
EU
GS
IVD
NARTE
OSHA
UL
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BSI
CEI
EMI
FCC
IEC
JSA
NEMKO
ROHS
VDE
CB
CISPR
ESD
FDA
ISO
LVD
NOM
SEMKO
WEEE
BUSINESS SENSITIVE
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But wait, there’s more…
AAMI
CCC
CSA
ETL
GHTF
ITS
MDD
NRTL
TUV
ANSI
CE
EMC
EU
GS
IVD
NARTE
OSHA
UL
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BSI
CEI
EMI
FCC
IEC
JSA
NEMKO
ROHS
VDE
CB
CISPR
ESD
FDA
ISO
LVD
NOM
SEMKO
WEEE
BUSINESS SENSITIVE
11
Why is Compliance Engineering Important?
•
This question requires a two-part answer:
1. Product safety compliance, which may or may not
include electromagnetic compatibility, is
necessary for acceptance of the product into
specific markets.
2. Designing the product with compliance in mind
throughout the development process is a proven
method of obtaining the desired outcome with
maximum efficiency.
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
12
When and Where does the Product
Compliance Process Begin (and End)?
• It begins with the targeted end user
– Determine where you plan to sell your product: specific countries or
regions
– Determine if you would like a product safety mark on the product and
which one(s)
– Decisions are Market-driven
• Compliance engineering takes place throughout product
development
• Compliance process continues through manufacturing and
product placement
– On-site inspections
– Customer feedback
• It ends at the end of life for product (device retirement)
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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Facets of Product Compliance
• Protection of Operator
– Electrical shock (hazardous voltages, currents)
– Mechanical hazards (moving parts, pinch, impact)
– Thermal hazards (hot surfaces, fire)
– Radiation (ionizing, optical, acoustic, EM)
• Protection of Patient
– Similar to protection of operator, but more stringent
• Protection of Environment
– Electromagnetic interference (EMI)
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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Facets of Product Compliance
(con’t)
• Product Installation
– Facility requirements
– Instructions
• Operation of Product
– User interface (ease of use, interpretation of displays, effectiveness of
interface)
– Alarm features (intensity, frequency content)
– Instruction manual
• Product Maintenance
– Operator-performed
– Maintenance personnel
– Training requirements
• Special precautions and circumstances
– Unique to product
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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Hierarchy of Product Standards
• General Safety Standard
– Suited to family of products having similar operating environments or uses
– Standard number has no dash number or “-1”
• Collateral Standard
– Focuses on safety subject that is common to the family, but deserves more
detailed attention
– Standard number ends in -1-X, where X is specific to the subject
• Particular Standard
– Focuses on a particular type of product within the family because special or
unique attention is required
– Standard number ends in -2-Y, where Y is specific to the sub-classification of
products
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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How is Product Compliance Achieved?
• Product Design
– Always the primary approach to safety
– Prescriptive requirements specified in the standards
– Use of listed products within the scope of their intended use
– Design must always be mindful of maintaining safety under normal (NC) and
single-fault conditions (SFC)
• Product Labeling
– Markings on product itself
– Instructions on accompanying documents
• Risk assessment of product
– Documentation supporting risk assessment and decision process
• Following guidelines provided by regulatory body
– FDA
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
17
Who is Responsible for Product Compliance?
• Short answer: everyone associated with the product!
• Long answer
– Manufacturer is responsible for designing a compliant product
– Independent evaluator stands behind the quality of the evaluation and
results
– Manufacturer maintains consistency in manufacturing
– Owner of product safety mark stands behind the quality of the
evaluation and results AND performs regular inspections
– User (ultimate customer) operates device as intended and follows
instructions
– Manufacturer responds to feedback to modify product or remove it
from the market
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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What role can I play in Compliance
Engineering?
• Know and utilize your Compliance Engineering
experts
• Be product safety conscious
• Realize that Compliance Engineering is part of the
product development process
• Know what you talking about; get educated
• Educate others
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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“A man’s got to know his limitations.”
Harry Callahan
“Magnum Force” (1973)
Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions
BUSINESS SENSITIVE
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