Major IEC 60601-1 3rd Ed. Changes: Why 90% of Medical Products Do Not Comply
Major IEC 60601-1 3rd Ed. Changes: Why 90% of Medical Products Do Not Comply
Major IEC 60601-1 3rd Ed. Changes: Why 90% of Medical Products Do Not Comply
changes
Why 90% of Medical Products Do Not Comply
Presented By: Michael Brousseau Engineering Team Leader Medical Devices Group
Country / Agency 2005 USA (ETL mark) FDA Canada (ETL mark) Health Canada EU CB Scheme
2nd 2nd 2nd
2006
2007
2008
2009
3rd optional
2010
2011
2012
2013
2nd 2nd
3rd optional 3rd optional 3rd optional 3rd optional 3rd 3rd
3rd
2nd
3rd optional
???
FDA has announced an official date of 2010-06 when they will accept submissions to 3rd edition. The 3rd Edition will be Mandatory 2013-06-01 Health Canada has announced a mandatory date of 2012-06-01 The EU date of 2012-06-01 has been published in the Official Journal. CB Scheme mandatory use for 3rd edition varies per the policy of each member country.
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Structure of IEC 60601 General standard (Part 1 standard) IEC 60601-1 Collateral standards IEC 60601-1-XX
60601-1-2 60601-1-3 60601-1-XX
60601-2-1 60601-2-2
Amendments
CTL Decision sheets (CB Scheme)
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Collateral Standards
Obsolete standards IEC 60601-1-1 IEC 60601-1-4 IEC 60601-1-2 medical systems Software EMC risks Retained standards IEC 60601-1-2 (2007) IEC 60601-1-3 (2008) IEC 60601-1-6 (2006) IEC 60601-1-8 EMC Radiology Usability Alarms New standards IEC 60601-1-9 IEC 60601-1-10 IEC 60601-1-11
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No consistent answer but 3rd edition is now usually the better choice for new devices.
It depends on the goals & preparedness of the manufacturer, and the type of device.
Intertek issues the ETL certification mark to 3rd edition for devices where all the standards have been issued.
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Classes
Protection class I, II, (III) & internally powered
Degree of protection Type B, BF & CF Product class (MDD) I, Im, Is, IIa, IIb & III Overvoltage category I, II, III & IV Material group Pollution degree Laser class I, II, IIIa & IIIb 1, 2, 3 & 4 1, 1M, 2, 2M, 3R, 3B & 4
IP-class (solids & water) IP20 - IP68 FDA product class USA laser class I, II & III 1, 2,
(not same as MDD)
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(666 hits)
3.103 Risk analysis 3.104 Risk assessment 3.105 Risk control 3.106 Risk evaluation 3.107 Risk Management (236 hits) 3.108 Risk Management File
(109 hits)
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There are 139 terms in alphabetic order. Index on pages 749 to 777 states the pages where the term is used (even numbered pages are in French). The term LIVE deleted !
Some examples:
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3.63
Electrical equipment, provided with not more than one connection to a particular supply mains; and 2. intended to be used: a) in diagnosis, treatment, or monitoring of a PATIENT; and has an APPLIED PART or transfers energy to or from the patient or detects such energy transfer to or from the patient; or b) for compensation or allevation of a disease, injury or disability.
- (under medical supervision deleted) - Very similar to MDD Article 1
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3.76
Patient
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3.8
Applied Part
Part of the ME E that in NORMAL USE necessarily comes into physical contact with the PATIENT for the ME E or ME S to perform its function
Some parts, that are not Applied Parts, may have to be treated as Applied Parts. RMF
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Applied Part
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Applied Part
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3.27
* Essential Performance
Performance necessary to achieve freedom from unacceptable risk. EP criteria must be defined by the manufacturer.
Present versions of 2nd Edition Part 2 standards that have been recently issued have substantial performance requirements! For example, see clause 50 Accuracy of operating data & 51 Protection against hazardous output 201.12 Accuracy of controls and instruments and protection against hazardous outputs
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RISK MANAGEMENT
(subclause 4.2)
A risk management process according to ISO 14971 shall be performed. meaning Certification to IEC 60601-1 not possible without compliance with ISO 14971. IEC 60601-1 is intended to serve as a tool in the risk management process.
The manufacturer must have a policy for establishing acceptable risks and acceptance of residual risks.
RISK MANAGEMENT
(subclause 4.2)
The requirements of this standard, referring to inspection of the RMF, are considered to be satisfied if the manufacturer has:
- shown that the residual risks are acceptable (according to the policy for determining acceptable risk)
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RISK MANAGEMENT
(subclause 4.2)
- More work to be done before sending device to the test house. - Less concrete requirements in standard. - More work to be done by the test house.
- Reduces the uncertainty of the safety of the device. - Greater design flexibility. - Provides Objective Evidence when using the escape clause.
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Lack of specific means in old standard to address this meant it was usually not completely addressed.
Conversely, all fault conditions that should not be considered cannot be adequately justified without the RMF.
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Escape clause
(subclause 4.5)
Alternative means of addressing a risk is acceptable, provided that the manufacturer can justify that the Residual Risk is at least as low as if the standards requirement of addressing that particular Risk had been applied.
RMF
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Marking clearly legible at any angle of 30 maximum from 1 meter away and the least favorable light between 100 - 1500 lux with normal log MAR scale
Clearly legible after being rubbed for 15 s with water, methylated spirit and isopropyl alcohol and the cleaning agents specified by the manufacturer
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(clause 7) Continued
The risk of poor Usability shall be addressed in Risk Management Process - design, marking and instructions - arrangement of controls, signals and instruments (15.1)
RMF
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Stop (often was used for emergency stop) Emergency stop (new for 601-1, 3rd edition)
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Documentation
(subclause 7.9)
State the skills, training and knowledge required of the Operator or the Responsible Body. Be written on a level consistent with the education, training, and special needs of the person for whom the document is intended. The documentation shall written in a language understandable by the reader. The Operating manual may be provided in electronic (not internet) form and the Risk Management Process shall establish what parts that may be required also as hard copy
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Packaging
(clause 7.2)
Packaging shall be marked with the requirements for transport and storage
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Packaging
Fragile
Temperature limits
This way up
Centre of gravity
Use no forks
Do not stack
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(subclause 8.5.1)
MOP
RMF
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Insulation coordination
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But the table relies on knowing how to use strange alphanumeric codes for types of insulation.
These tables allow for a more compact and less costly design. Overall these tables are difficult for the layperson to understand unless they also have experience with IEC 60950-1 (for information technology equipment).
Continuing to use old approach of 2nd edition is generally acceptable for 3rd edition.
New approach has much more complex tables, but can allow a more compact design and at less cost in many cases.
The philosophy of two means of protection has not changed, nor have the major locations where insulation is required.
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Up to 1000 VRMS, AC & CD in this table is exactly the same as the old Table XVI of 2nd edition. However, DC working voltages to not correlate to the old table.
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This table is for the typical situation of Overvoltage Category II, as the Mains Transient Voltage for the Nominal Mains Voltage corresponds to that in Table 10. For equipment connected to an Overvoltage Category III mains, the next higher column is used. Be mindful of the Overvoltage Category as that is the real criterium one uses for which column is employed. www.intertek.com
Note that this table is not specifically for mains or secondary circuits as is the case for AC. For voltages above 1000 V, CD = AC.
Table 13 is 2 mm for 150 V > AC < 300 V for the typical Overvoltage Category II.
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Actual spacings are based on measured working voltages. MOOP parts can always be classified as MOPP, at the manufacturers choice based on the RMF. X means you can short parts after the fuse in lieu of spacings.
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(subclause 8.5.5)
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Leakage current
(subclause 8.7)
Earth Leakage Current Touch Current: Same as Enclosure Leakage Current in old edition Patient Leakage Current Total Patient Leakage Current Patient Auxiliary Current
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(subclause 8.7)
SFC 10 mA 500 A
Touch current
Irrespective of frequency no leakage current may be over 10 mA through 1 kohm Patient leakage values have not changed
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(subclause 8.10)
Secondary circuit isolated by min. 2 MOOP Max. 42.4 V peak or 60 V DC IP X1 IP X6 (15.4.7) General ICW / Op-room RMF
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(subclause 9.4)
Must not tip over at 5 degrees in Normal Condition If tipping over at 5 - 10 degrees a warning sign is required Must not tip over at 10 degrees in transport mode If >25 kg must not tip over at a static pressure of 25% of the weight but maximum 220 N
(even if labelled)
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(subclause 9.6)
Noise:
Max. 80 dBA
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Mechanical strength
(subclause 9.8)
Foot rest tested with 270 kg on 0.1 m2 Surfaces (20 x 20 cm) on which one may stand or sit are tested with 800 N
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Standards used - Non intentional X-ray limits from - Infrared and laser IEC 60950-1 (5 uSv/h at 5 cm) IEC 60825-1 (IEC 60601-2-22)
RMF
10 W/m2)
- Alfa, Beta, Gamma and Neutron - Microwave (IEC 61010-1 = 1 GHz - 100 GHz,
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RMF
At specified ambient temperature
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> 41 C = Statement in manual & Clinical effects and justification in the RMF
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Old vs. new optional fire enclosure requirements (Clause 55 vs. Sub-clause 11.3)
Part Enclosure (Transportable equipment) Enclosure (Fixed or Stationary equipment) Large panel (100 ft2 / 9.47 m2) Large panel (50 ft2 / 4.74 m2) Internal parts Connectors PC boards (& insulating material) Internal wiring N/A N/A N/A V-2 V-2
equivalent to V-1
Software
(clause 14)
Major part of the content of the old IEC 60601-1-4 for IEC 60601-1, 2nd edition constitutes clause 14. Clause 14 applies when the use of ISO 14971 is not sufficient
RMF
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Enclosure rigidity
(clause 15)
Drop test for hand-held parts from 1 m on a 50 mm hardwood surface with a density of >600 kg/m3. Three different start positions
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RMF
Mobile equipment
RMF
- Threshold obstruction (0.4 m/s against 40 mm height) - Descending step - Door obstruction
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ME System
(clause 16)
Major part of the content of the old IEC 60601-1-1 for IEC 60601-1, 2nd edition constitutes clause 16. RMF
Group of products, at least one of which is a MEE, functionally inter-connected or supplied from a Multiple Socket Outlet (MSO).
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The manufacturer shall in the RMF address the risks associated with electromagnetic
phenomena that may degrade the performance of the ME equipment and the ME equipments affect on other products.
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Most, but not all, relate to electric shock, energy, and mechanical hazards
50 % have insulation or spacing deficiencies 30 % have excessive temperatures on the patient applied parts
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Submit drafts of manuals. Submit artworks when there is uncertainty. Significant constructional & component problems caught before EMC & safety testing. Temperatures, spacings, insulation, flammability, ratings, sample requirements etc. Risk Analysis is not comprehensive.
Need help? Annex E of ISO 14971: 2007 Examples of hazards, foreseeable sequences of events and hazardous situations is a good place to start. Interteks RMF checklist.
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(4.3 of 14971) Test house input during design review? Examination of old reports for similar devices?
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A design review after the risk analysis & initial design is ideal, but often does not happen.
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The manufacturer & test lab must work together for a 3rd edition evaluation to be successful.
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