EN 60601-1 “The Third Edition” 60601-1 “The Third Edition ... for 60601-1 expected mid-2012) ... Indicator Lights Color 2nd Edition 3rd Edition Red:Published in: Obstetrics &

Christine Ruther NSAI Medical Device Seminar, Galway

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EN 60601-1 “The Third Edition”

Christine Ruther

© Copyright 2011

Family TTree:

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Transition Transition Information

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3rd Edition Transition(aka: why I should care)

Product Status

US – FDA(AAMI ES 60601-1)

Health Canada EU - MDD OthersStatus (AAMI ES 60601 1) Canada

NewDevice

mandatory (1JUL13)

mandatory (1JUN12)

mandatory (1JUN12*) ...

Existing Device

(new sale)

okay as is okay as is mandatory (1JUN12*) ...

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In the Field

(repairs)okay as is okay as is okay as is ...

* * -- see next slidesee next slide


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What’s the *

• In Europe, transition depends on particular standardsparticular standards

• Applicable particular standard?• Yes - date of transition of the

particular standard applies• 60601-2-29 radiotherapy simulators -

1NOV111NOV11• 60601-2-37 ultrasound - 1OCT10

• No - date in table applies5

Heads-Up

• All 60601 standards are being updatedAli i ith 3 d diti• Aligning with 3rd edition

• Normal technical revisions (amendment pending for 60601-1 expected mid-2012)

• Some standards are renumbered• EN ISO 80601-2-X

ll h• Still have most as EN 60601-2-X

• Standards are receiving transition dates

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Do I have to?

• Standards are voluntary but …MDD A I 2 “ l ti d t d b • MDD Annex I.2 “solutions adopted by 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”state of the art

• MDD Article 5.1 gives presumption of conformity for harmonized standards

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OverviewOverview

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Origin of Changes

• Experience with 2nd edition• Info in particular standards• County specific deviations

• US deviations strongly considered

• Other standards• EN 60950 heavily considered

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So, what’s new?

• Collaterals are included when published• Some requirements have been amended• Some requirements have been amended• New requirements have been added• Focus today, a few points regarding:

• Labeling• Risk Management• Mechanical SafetyMechanical Safety• Electrical Safety• Collaterals

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LabelingLabeling

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Marking

• On equipment:Name or trademark of MANUFACTURER• Name or trademark of MANUFACTURER

• Model or type reference• If single use, ‘do not reuse’ or symbol

• Applies to:• Equipment

Its detachable components and• Its detachable components, and• Accessories

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Indicator Lights

Color 2nd Edition 3rd Edition

Red: warning of danger and/or a need for urgent action

warning – immediate response by the operator is

required

Yellow: caution or attention required caution – prompt response by the operator is required

Green: ready for action ready for use

Oth meaning other than that of meaning other than that of Other: gred or yellow

gred, yellow or green

Symbols and Safety Signs

• New meaning for :• was “Attention: Consult accompanying • was Attention: Consult accompanying

documents“• is now “Caution”

• New “consult instructions for use” symbols:• when recommended

• when mandatory• Emergency stop symbol:

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Risk Risk Management

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Risk Management File

• “Risk” appears 666 times• Compliance to ISO 14971 is required• Specific items must be addressed to

define test or test parameters

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Examples

• Clause 11.6.3 – Spill TestWas: 200 mL tap water ≤5cm 15 sec• Was: 200 mL, tap water, ≤5cm, ~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 <10% of body on

healthy adult

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* can be 42C with justification & disclosure in IFU

Other Key Items

• Essential performance• Expected service life• Equivalent safety• Parts that contact the patient• Single fault condition• High-integrity components

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Review

• General ISO 14971 compliance• Details of RMF for 601-1 items• Expect review by

• Regulatory Authority• Notified Body• Test Lab

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Mechanical Mechanical Safety

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Pinching/Trapping

• Gaps considered NOT to present a trapping zone hazardtrapping zone hazard

• Distances for adult & child (ISO 13851-1)

a

a

a

a

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Body Head Leg Foot

a

50 max.

Toe

a

Arm

a

Hand

a

Finger

Safe Distances

• Sufficient distance between people and trapping zone hazard

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Mechanical Tests

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Mechanical Tests

• Push: 250 N force over 30 mm dia. area for 5 seconds

• Impact: UL “ball impact test”

• Drop: 1 m (hand-held) / 2, 3, 5 cm dependent on mass

• Rough Handling: ascending (hit & stop), descending step (40 mm) and threshold descending step (40 mm) and threshold -“up & over” barrier

• Mould Stress: “bake” plastic enclosure24


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Continuous Activation

• Control system with momentary t t it hcontact switch

• Operator reaction and part momentum such that operator can release switch before injury

• Control must be single fault tolerant to stop motion (e.g. emergency stop stop motion (e.g. emergency stop switch), and prevent unwanted movement (e.g. enable switch).

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Use of Emergency Stops

• Must:• Consider proximity & response capability of Consider proximity & response capability of

operator.• Be accessible• Can not be part of normal use• Can not introduce added hazards• Must completely open related electrical circuit• Require a single action• Be red & marked with E-Stop Symbol

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Mechanical Safety Factors

TENSILE SAFETY FACTOR

A B

Not impaired by wear Ductile 2.5 4

Not impaired by wear Brittle 4 6

I i d b D til 5 8Impaired by wear Ductile 5 8

Impaired by wear Brittle 8 12

A – Quantifiable load and material properties with high confidence

B – Other than A

TENSILE SAFETY FACTOR

A B

Impaired by wear w/MECHANICAL SAFETY

DEVICEDuctile 2.5 4

Impaired by wear w/MECHANICAL SAFETY

DEVICEBrittle 4 6

MECHANICAL SAFETYMECHANICAL SAFETY DEVICE 2.5 4

A – Quantifiable load and material properties with high confidence

B – Other than A


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Patient/Operator Support Systems

Surfaces that can be used as foot rests• A mass equivalent to twice the intended

person load is be applied to a 0.1 m2 area

Areas a PATIENT or OPERATOR can sit• A mass equivalent to the SAFE WORKING LOAD

representing the PATIENT or OPERATOR is representing the PATIENT or OPERATOR is dropped onto seating surfaces from 150mm

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Oxygen Enriched Atmospheres

• A source of ignition exists if:The temperature exceeds the ignition point of the p g pmaterial (in oxygen).Temperatures could affect the solder such that loosening could occur.Components that could cause sparks (in failure) would crack or change their outer shape resulting in temperatures exceeding 300º C.Temperatures exceed 300º C in NC.Sparks can be generated in NC or SFC.

• If exists, then mitigate by containing or preventing fire

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Other Items to Consider

• Vibration (8 hour limit of 2.5m/s2)• Noise (continuous or impulse)• Thermal (time and material type)• Component heating (within rating)• Exposure to cold (include in RMF)

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Electrical SafetyElectrical Safety

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MUST Specify• Classification – shock protection

I – relies on protective earth

II – no reliance on protective earth, double insulated

• Applied Part Type – shock & leakage current

B – basic, may be ground referenced (limited use)

BF – basic floating, higher protection than B

CF – cardiac floating, acceptable for direct cardiac contact

• Defibrillation Proof Rating (yes or no)

• Method of Sterilization33

MUST Specify (con’t)

• Ingress Protection (EN 60529) – IPXYX – protection from particles (uncommon to use)Y – protection from fluids (common but not req’d)Examples:IPX0 (normal),IPX1 (drip-proof),IPX7 (watertight)

NOTE: Adequate X rating may allow smaller spacings!

• Use in an oxygen rich environment(concentrations over 25 % at one atmosphere or partial pressures up to 27.5 kPa for higher atmospheric pressures)

• Anesthetic Use (generally no, if yes then Annex G) AP – flammable anesthetic mixture with airAPG – flammable anesthetic mixture with oxygen or nitrous oxide

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MUST Specify (new)

• High Altitude Use (yes or no)

• Over 2,000 m

• See requirements in clause 8.9.1.5

• Pollution degree (clause 8.9.1.8)

• Overvoltage category (clause g g y (8.9.1.11)

(mains transient peak voltages)35

Pollution Environments

(also all apply to micro-environments)

• Degree 1: sealed to exclude dust and moisture

• Degree 2: generally only non-conductive pollution

Degree 3: d ti ll ti• Degree 3: some conductive pollution

• Degree 4: continuously conductive pollution

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Overvoltage Category

(refers to max. mains voltage transient equipment is design to withstand)q p g )

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Sample Product• Device defined as

• Class I (relies on protective earth)• Type BF (applied part)• Type BF (applied part)• Not defib proof• Not AP nor APG• IPX0• Non-sterile• High altitude (8,000 ft = 2.44 km)• Pollution degree 2Pollution degree 2• Overvoltage category II

• Example would be a stimulator suitable for use in aircraft

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Block Diagram

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Patient Applied Parts

40Parts Need to Treat asPatient Applied Parts


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Dielectric Withstand = Means of Protection• Rather than A-a1 …, B-a …

• MOOP (means of operator protection)• MOPP (means of patient protection)

• 2 MOOP/MOPP = double (or reinforced) insulation

• 1 MOOP/MOPP = basic insulation1 MOOP/MOPP basic insulation• Supplementary insulation in 2nd ed. still

in 3rd ed. (but meaning is simpler)41

Creepage / Clearance

(same meaning but new values)

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ComparisonID description

Vtest cr (mm) cl (mm)

2nd Ed. 3rd Ed. 2nd Ed. 3rd Ed. 2nd Ed. 3rd Ed.

A Line to neutral 1,500 1,500 3 3 1.6 1.9

B Mains to accessible parts that are 4 000 3 000 8 4 8 5 4 6B pnot protectively earthed 4,000 3,000 8 4.8 5 4.6

C Mains to accessible parts that are protectively earthed 1,500 1,500 4 2.4 2.5 2.3

D Mains input to low voltage 4,000 4,000 8 7.9 5 5

E Low voltage to accessible parts that are not protectively earthed 500 n/a 4 2.4 2 2.3

F Low voltage to accessible parts that are protectively earthed 500 n/a 2 1.2 1 1.2that are protectively earthed

G Low voltage to treatment voltage 3,000 2,000 4.6 5 2.4 3.2

HTreatment voltage to all accessible parts (whether or not protectively earthed)

1,500 1,500 4 4 2.5 2.5

500 1,000 4.6 4.4 2.4 2.4

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CollateralsCollaterals

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Incorporated

• EN 60601-1-1• Medical electrical systems• Now clause 16

• EN 60601-1-4• Programmable medical electrical systems• Now clause 14• Now clause 14

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Still Standing Alone

• EN 60601-1-2* EMCd• EN 60601-1-3 Radiation Protection

• EN 60601-1-6 Usability• EN 60601-1-8* Alarms• EN 60601-1-9 Env Conscious Design

EN 60601 1 10 Phys Closed Loop• EN 60601-1-10 Phys Closed Loop• EN 60601-1-11 Home Use

46* revisions pending


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Coming Soon

• EN 60601-1-12 Emergency Medical Environment

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BonusBonus

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RoHS – MDD & IVDD

• 2011/65/EU –– Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive

• Transition:• MDD Devices: 22 July 2014• IVDD Devices: 22 July 2016• IVDD Devices: 22 July 2016• Parts for repair may continue past this date

• AIMDD devices remain exempt49

RoHS

• Concerns are for:• Lead

M• Mercury• Cadmium• Hexavalent chromium• Polybrominated biphenyls (PBB)• Polybrominated diphenyl ethers (PBDE)

Exemptions

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• Exemptions• 32 current exemptions• Reviewed every 5 years


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Significant Points

• Requires CE marking (and declaration)

b l• Labeling (mostly covered by MDD)

• Record retention = 10 years• Technical documentation, register of non-

conforming product and product recalls• List of any economic operator who has supplied

you with electrical or electronic equipment andyou with electrical or electronic equipment, and• List of any economic operator to whom you have

supplied any electrical or electronic equipment.

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Showing Showing Compliance to the 3rd Edition

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Basic Options

• Complete re-evaluation• New test report• Ensures complete coverage

• Gap analysis• Addendum to existing report• Must be careful to:• Must be careful to:

• Catch everything• Address changes

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Guidance

• NB-MED guidance is pending• Draft guidance includes:

• Presumption of conformity needs to be reconsideration when standard changes

• Yes, re-testing (re-evaluation) is required• Power supply must have 3rd edition eval. Power supply must have 3 edition eval.

(re-testing or gap analysis + testing)

• Standard was published in 2006 …

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Documents

EN 60601-1 “The Third Edition” 60601-1 “The Third Edition ... for 60601-1 expected mid-2012) ... Indicator Lights Color 2nd Edition 3rd Edition Red:Published in: Obstetrics &