Medical Device Testing

F2 Labs can assist you in determining what standards and collateral standards are required for testing and certifying your product in order to sell your medical device to global markets. With more than 20 years of experience, F2 Labs can provide you with the necessary FDA medical testing and medical device testing and certification to get your product in the hands of doctors and patients on a timely schedule.

We can provide you with the test reports that are required in order to submit your 510K to the FDA in order to obtain FDA Medical Device Approval, for inclusion in your CE Technical File for Europe, U.S. and Canadian certification mark for medical devices, and for submittal to the Brazilian Authorities, and other international submittals.

Medical Device Safety Testing

IEC 60601-1 – 3rd edition – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1 3rd edition contains a shift in thinking from the previous edition. There is more emphasis on the risk management file and process conforming to ISO 14971, as well as essential performance. We can assist you through this process.

Certain aspects of safety and performance are defined by the collateral standards (numbered 60601-1-X). The revision dates for the Collaterals and Particulars standards may not be the same as that of the General Standard.

In addition to IEC 60601-1, which is the general Safety standard for Medical Devices, we can also assist you with the part 2 product specific standards: IEC 60601-1-11 for home healthcare equipment; IEC 60601-1-6 for usability; IEC 60601-1-8 for alarms; Risk Assessment to ISO 14971; and more.

Medical Device EMC Testing

IEC 60601-1-2 – 4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

NOTICE – IEC 60601-1-2 4th EDITION HAS MANY TECHNICAL AND DOCUMENTATION CHANGES..

Below is an overview of the most significant changes. As with any other standard change, failure to complete these new requirements in a timely manner could cause costly delays in getting your device to market. With the 3rd edition of IEC 60601-1-2 still in use, it is often hard to determine which version of IEC 60601-1-2 should be used. F2 Labs can help with your FDA medical testing and medical device testing and certification. Please give us a call.

The most significant changes from IEC 60601-1-2 3rd edition to IEC 60601-1-2 4th edition are as follows:

Specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments

Specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition

Specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system

Specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition

Better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”.

This new edition also includes the following guidance in the following areas:

  • Determination of immunity test levels for special environments
  • For adjustment of immunity test levels when special considerations of mitigations or intended use are applicable
  • Risk management for basic safety and essential performance with regard to electromagnetic disturbances
  • Identification of immunity pass/fail criteria.

Click here to visit the IEC Webstore to purchase a copy.

Your medical device must comply with the 4th edition of IEC 60601-1-2 by December 31, 2018, for Europe, United States (FDA) and Canada.

However, the United States FDA prefers products to be evaluated to the 4th edition now, when submitting new applications. This is especially true for medical devices that are used in a home healthcare environment.

The FDA does not require compliance to the 4th edition for legacy devices, unless changes have been made to the product.

In the European Union (that accepts the CE Mark), medical devices must comply with the 4th edition of EN 60601-1-2. There is no allowance for legacy devices, as is allowed by the FDA.

Legacy Device Definition: A legacy device refers to a computing device or equipment that is outdated, obsolete or no longer in production. This includes all devices that are unsupported or no longer commonly used by most devices and software applications.

Definitions
  • Essential performance – performance necessary to achieve freedom from unacceptable risk.
  • Risk Management – The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.
  • Usability – ensures that interactions between the operator and the medical device will occur safely and as intended.

ISO 7176-21:2009 Wheelchairs – Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

ANSI/RESNA WC-2 2009, Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

“These standards apply to electrically powered wheelchairs and scooters with a maximum speed of not more than 15 km/h intended for indoor and/or outdoor use by people with disabilities. They are also applicable to manual wheelchairs with an add-on power kit.

They are not applicable to vehicles designed to carry more than one person. These parts also specify requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters.”

Common Collateral & Particular Standards*
  • EN 45502
    F2 Labs can perform evaluations to EN 45502, titled “Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer”

    EN 45502 Scope

    This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.

    NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.
    The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.

    This part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).

    This part of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.

    NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

    NOTE 3 In this part of EN 45502, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

  • IEC 60601-1
    F2 Labs can perform evaluations to IEC 60601-1, titled “Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance”

    IEC 60601-1 Scope

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
    MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
    ME EQUIPMENT and ME SYSTEMS.

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
    ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
    case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
    the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

    NOTE 1 See also 4.2.

    The IEC 60601 series does not apply to:
    – in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61];
    – implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or
    – medical gas pipeline systems covered by ISO 7396-1 [68].
    NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

  • IEC 60601-1-6
    F2 Labs can perform evaluations to IEC 60601-1-6 Edition 3.0 titled “Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability”

    IEC 60601-1-6 Scope

    This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

    This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

    If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).

  • IEC 60601-1-8
    F2 Labs can perform evaluations to IEC 60601-1-8 Edition 2.1 titled “Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.”

    IEC 60601-1-8 Scope

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

    This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.

    It also provides guidance for the application of ALARM SYSTEMS.

  • IEC 60601-1-9
    F2 Labs can perform evaluations to IEC 60601-1-9 1st Edition titled “General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design”

    IEC 60601-1-9 Scope
    This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.
    MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.

  • IEC 60601-1-11
    F2 Labs can perform evaluations to IEC 60601-1-11 Edition 2.0 titled “Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment”

    IEC 60601-1-11 Scope

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare
    personnel.

    The HOME HEALTHCARE ENVIRONMENT includes:
    – the dwelling place in which a PATIENT lives;
    – other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present.

    This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.

    EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment.

    NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with
    unreliable electrical sources and poor electrical grounding.

  • IEC 60601-2-3
    F2 Labs can perform evaluations to IEC 60601-2-3 Edition 3.0 titled “Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment”

    IEC 60601-2-3 Scope

    Replacement:

    This particular standard specifies the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, as defined in subclause 201.3.206.

    LOW POWER EQUIPMENT as defined in subclause 201.3.202 is exempted from certain requirements of this standard.

  • IEC 60601-2-10
    F2 Labs can perform evaluations to IEC 60601-2-10 Edition 2.0 titled “Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators”

    IEC 60601-2-10 Scope

    Replacement:

    This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine, hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS).

    NOTE: A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR.

    The following ME EQUIPMENT is excluded:
    – ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;
    – ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME EQUIPMENT);
    – ME EQUIPMENT intended for neurological research;
    – external cardiac pacemakers (see IEC 60601-2-31);
    – ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
    – ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);
    – ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).

    201.12 Accuracy of controls and instruments and protection against hazardous outputs

    Clause 12 of the general standard applies except as follows.

    201.12.1 Accuracy of controls and instruments

    Additional subclauses:

    201.12.1.101 * Output amplitude

    A means shall be provided to control the STIMULATOR output from minimum to maximum continuously, or in discrete increments of not more than 1 mA or 1 V per increment. At its minimum setting, the output shall not exceed 2 % of that available at the maximum setting of the control.

    Compliance is checked by inspection and measurement using the load impedance which is the least favourable within the load impedance range specified in the ACCOMPANYING DOCUMENTS.

    201.12.1.102 * PULSE parameters

    The values of PULSE DURATIONS, PULSE repetition frequencies and amplitudes, including any d.c. component, whether caused by an offset or by an unsymmetrical waveform, as described in the ACCOMPANYING DOCUMENTS or indicated on the ME EQUIPMENT (see 201.7.9.2), shall not deviate by more than ± 20 % when measured with a load resistance within the range specified in the ACCOMPANYING DOCUMENTS (see 201.7.9.3).

    Compliance is checked by measurement with an error not exceeding ± 10 %.

    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

    Clause17 of the general standard applies.

    202 Electromagnetic compatibility – Requirements and tests

    IEC60601-1-2:2007 applies except as follows:

    202.6.1 Emissions

    202.6.1.1.2 Tests

    a) Patient cables

    Addition:

    Connect all relevant electrodes to the contents of a 1 litre capacity phantom filled with 0,9 % saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in Figure 202.101.

    202.6.2 * Immunity

    202.6.2.1.5 PATIENT-COUPLED ME EQUIPMENT and ME SYSTEMS

    Addition:

    Connect all relevant electrodes and apply them to the contents of a 1 litre capacity phantom filled with 0,9 % saline. Position the phantom within 0,4 m of the ME EQUIPMENT as shown in Figure 202.101.

  • IEC 60601-2-11
    F2 Labs can perform evaluations to IEC 60601-2-11 Edition 3.0 titled “Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment”

    IEC 60601-2-11 Scope

    Replacement:

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter referred to as ME EQUIPMENT.

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

    NOTE See also 4.2 of the general standard.

    201.4 General requirements

    Clause 4 of the general standard applies.

    9 Accuracy of controls and instruments and protection against hazardous outputs

    In addition to the requirements of 12.2 of the general standard, when performing the USABILITY ENGINEERING PROCESS, the RISKS associated with USABILITY in the HOME HEALTHCARE ENVIRONMENT for OPERATOR PROFILES including a LAY OPERATOR shall include consideration of at least:
    – changes of controls;
    – unexpected movement;
    – potential for misconnection;
    – potential for improper operation, or unsafe use;
    – potential for confusion as to current operational mode;
    – change in the transfer of energy or substance;
    – exposure to environmental conditions specified in this standard;
    – exposure to biological materials; and
    – small parts being inhaled or swallowed.

    Particular emphasis shall be placed on the limited training of a LAY OPERATOR with respect to the ability to intervene and maintain BASIC SAFETY and ESSENTIAL PERFORMANCE. The MANUFACTURER shall include the least capable intended LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION in the USABILITY ENGINEERING PROCESS. EXAMPLES LAY OPERATORS with sensory, cognitive, physical limitations or comorbidities.

    Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

    201.12 Accuracy of controls and instruments and protection against hazardous outputs

    Clause 12 of the general standard does not apply.

    NOTE This is covered by 201.10, IEC 60601-1-6 and IEC 60601-1-8.

    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

    Clause 17 of the general standard applies.

  • IEC 60601-2-18
    F2 Labs can perform evaluations to IEC 60601-2-18 Edition 3.0 titled “Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment”

    IEC 60601-2-18 Scope

    Replacement:

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS.

    201.4.3 ESSENTIAL PERFORMANCE

    Addition:

    201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements

    Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

    Table 201.101.

    Table 201.101 – List of ESSENTIAL PERFORMANCE requirements

    td>Requirement

    Subclause

    To that there is no unacceptable RISK if the view observed by the OPERATOR has an unexpected image orientation.

    Applicability and condition as defined by manufacturer

    To ensure that there is no unacceptable RISK, if there is a lack of, or significant error in, provision of a particular spectral output or frequency necessary to provide accurate diagnosis or therapy, which is not identifiable
    by a trained OPERATOR.

    201.12.1.1
    <
    To ensure that there is no unacceptable RISK that the OPERATOR is viewing the live image during an endoscopic procedure, rather than a recorded image.

    201.13.1.101

    NOTE See 201.7.9.2.2 g) for warning and safety notices related to the ESSENTIAL PERFORMANCE requirements.

  • IEC 60601-2-23
    F2 Labs can perform evaluations to IEC 60601-2-23 Edition 3.0 titled “Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment”

    IEC 60601-2-23 Scope

    Replacement:

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter referred to as ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a system.

    This standard applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in fetal monitoring during birth.

    This standard does not apply to hemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

    NOTE See also 4.2 of the General Standard.

    201.4.101 Additional ESSENTIAL PERFORMANCE requirements

    Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.

    Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
    Requirement Subclause
    Non-linearity and hysteresis 201.12.1.101.1
    Time to alarm for pO2 and pCO2 ALARM CONDITIONS 208.6.6.1.103

    201.17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT and ME SYSTEMS

    Clause 17 of the general standard applies, except as follows:

    Addition:

    Clause 202 of this particular standard applies.
    202 Electromagnetic compatibility – Requirements and tests

    IEC 60601-1-2:2007 applies, except as follows:

    202.5.2.2.2 Requirements applicable to ME EQUIPMENT and ME SYSTEMS other than those specified for use only in a shielded location

    Addition:

    ME EQUIPMENT and its ACCESSORIES shall not be considered LIFE-SUPPORTING ME EQUIPMENT.

    202.6 ELECTROMAGNETIC COMPATIBILITY

    202.6.1 EMISSIONS

    202.6.1.1.2 Tests

    a) *PATIENT cables

    Replacement:

    ME EQUIPMENT shall be tested with the TRANSDUCER with cable as specified by the MANUFACTURER with all SIP/SOP cables connected to ME EQUIPMENT (see Figure 202.101). The distances of SIP/SOP cables between the open end and floor (ground plane) shall be ≥ 40 cm.

    Figure 202.101 – Set-up for radiated and conducted EMISSIONS testing according to 202.6.1.1.2 a)

    202.6.2 * IMMUNITY

    202.6.2.1.10 Compliance criteria

    Addition:
    The ME EQUIPMENT shall not change its operating state, shall not lose or change any stored data and, for pO2 in the range 40 mmHg (5,3 kPa) to 100 mmHg (13,3 kPa) and for pCO2 in the range 30 mmHg (4,0 kPa) to 60 mmHg (8,0 kPa), the change in the accuracy (ESSENTIAL PERFORMANCE) of the partial pressure reading shall not exceed ± 6 mmHg
    (0,8 kPa).

    Compliance is checked by the following test.
    – Set up the ME EQUIPMENT and TRANSDUCER as outlined in Figure 202.101.
    – Calibrate the TRANSDUCER according to the ACCOMPANYING DOCUMENTS.
    – Expose the ME EQUIPMENT to the specified disturbances (radio frequency, transients, magnetic) at any NOMINAL sensitivity.

    202.6.2.2 ELECTROSTATIC DISCHARGE (ESD)

    202.6.2.2.1 Requirements

    Addition:

    ME EQUIPMENT may show temporary DEGRADATION during discharges. Within 60 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any OPERATOR settings or stored data, and shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE (see 202.6.2.1.10).

    202.6.2.3 Radiated RF electromagnetic fields

    202.6.2.3.1 Requirements

    Addition to item a):

    IMMUNITY TEST LEVEL of 3 V/m applies.

    202.6.2.3.2 Tests

    Addition:

    Test setup for radiated RF electromagnetic fields:

    aa) Any SIGNAL INPUT PART/SIGNAL OUTPUT PART cable and POWER SUPPLY CORD arranged generally as in Figure 202.102. Maintain distances of ≥ 40 cm between SIP/SOP and the floor (ground plane).

    Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2

    202.6.2.4 Electrical fast transients and bursts

    202.6.2.4.1 Requirements

    Addition:

    When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD, the ME EQUIPMENT shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE (see 202.6.2.1.10).

    Testing of TRANSDUCER cables and interconnecting cables specified to be more than 3 m in length may show temporary DEGRADATION during exposure of fast transients and bursts. Within 60 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any OPERATOR settings or stored data, and shall continue to perform its intended function as described in the ACCOMPANYING DOCUMENTS.

    202.6.2.4.2 Tests

    Addition:

    aa) ME EQUIPMENT shall be located 0,8 m ± 0,08 m above the reference ground plane.

    bb) The power cord provided with the ME EQUIPMENT shall be used to connect ME EQUIPMENT to the output of the EFT/B generator.

    202.6.2.6 Conducted disturbances, induced by RF fields

    202.6.2.6.1 Requirements

    Addition:

    aa) When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD, the ME EQUIPMENT shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE (see 202.6.2.1.10).

    bb) * TRANSDUCER cables are exempt from this requirement.

    202.6.2.6.2 Tests

    Addition:

    aa) Subclause 6.2.6.2, items c) and e) of IEC 60601-1-2:2007 do not apply.

  • IEC 80601-2-24
    F2 Labs can perform evaluations to IEC 60601-2-24 Edition 2.0 titled “Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers”

    IEC 60601-2-24 Scope

    Replacement:

    This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSIONPUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT.

    This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However this standard does not specify requirements or tests for other aspects of ADMINISTRATION SETS

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

    NOTE See also 4.2 of the general standard.

    This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223.

    These particular standard does not apply to the following:
    a) devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR);
    b) devices for extracorporeal circulation of blood;
    c) implantable devices;
    d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water);
    e) ME EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography);
    f) devices covered by ISO 28620.

    201.4.3 ESSENTIAL PERFORMANCE

    Additional subclause:

    201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

    Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.

  • IEC 60601-2-36
    F2 Labs can perform evaluations to IEC 60601-2-36 First Edition titled “Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy”

    IEC 60601-2-36 Scope

    Addition:

    This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101.

    The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC standards.

    While this Particular Standard has been developed for EQUIPMENT intended for use in LITHOTRIPSY, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standard may be used as a guideline.

  • IEC 60601-2-37
    F2 Labs can perform evaluations to IEC 60601-2-37 Edition 2.0 titled “Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment”

    IEC 60601-2-37 Scope

    Addition:

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT.

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of this standard.

    NOTE See also subclause 4.2 of this standard.

    This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.

    201.4.3 ESSENTIAL PERFORMANCE

    Addition:

    201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

    Table 201.102 lists the potential sources of unacceptable risk identified to characterize the ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT and the subclauses in which the requirements are found.

    Table 201.102 – Distributed essential performance requirements

    NOTE In some circumstances the need for the repetition of an ultrasound examination should be evaluated as a
    potential hazard, for example, intra-corporeal investigation and stress testing for cardiopathic PATIENTS.

  • IEC 60601-2-39
    F2 Labs can perform evaluations to IEC 60601-2-39 Edition 2.0 titled “Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment”

    IEC 60601-2-39 Scope

    Replacement:

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

    NOTE See also 4.2 of the general standard.

    This standard can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disability.

    These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING SOLUTION CIRCUIT.

    201.4.3 ESSENTIAL PERFORMANCE

    Additional subclause:

    201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements

    Additional ESSENTIAL PERFORMANCE requirements:
    – DIALYSING SOLUTION flow to the patient;
    – DIALYSING SOLUTION flow from the patient;
    – temperature of dialysate;
    – adherence to and accuracy of the volume balancing (inflow/outflow volume).

  • IEC 60601-2-40
    F2 Labs can perform evaluations to IEC 60601-2-40 Edition 2.0 titled “Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment”

    IEC 60601-2-40 Scope

    Replacement:

    This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT. hereafter referred to as ME EQUIPMENT.

    NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of This particular standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case. the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS. as relevant.

    The following ME EQUIPMENT is excluded:

    ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.).

    201.4.3 ESSENTIAL PERFORMANCE

    Addition:

    NOTE Because of the variety of clinical applications for ELECTROMYOGRAPHS and EVOKED RESPONSE, no additional
    ESSENTIAL PERFORMANCE is specified in this particular standard. However, ESSENTIAL PERFORMANCE shall be
    determined by the manufacturer in accordance with the requirements of sub-clause 4.3 of the general standard.

    202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests

    IEC 60601-1-2:2014 applies except as follows:

    202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS

    202.8.1 General

    Addition:

    202.8.1.101 * IMMUNITY pass/fail criteria

    The IMMUNITY pass/fail criteria of the ME EQUIPMENT or ME SYSTEMS shall be one or more of the following as determined by the manufacturer.

    a) The ME EQUIPMENT or ME SYSTEMS shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during and after the IMMUNITY test. No DEGRADATION of ESSENTIAL PERFORMANCE is allowed below a level specified by the manufacturer.

    b) The ME EQUIPMENT or ME SYSTEMS shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during and after the IMMUNITY test. However, temporary loss of ESSENTIAL PERFORMANCE is allowed, provided it can be restored without manual intervention. No DEGRADATION of ESSENTIAL PERFORMANCE is allowed below a level specified by the manufacturer.

    c) The ME EQUIPMENT or ME SYSTEMS shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during and after the IMMUNITY test. However, temporary loss of ESSENTIAL PERFORMANCE is allowed, provided it can be restored with manual intervention. No DEGRADATION of ESSENTIAL PERFORMANCE is allowed below a level specified by the manufacturer.

    Compliance is determined as follows:

    The manufacturer shall define a method for determining whether ESSENTIAL PERFORMANCE has been maintained during and/or after IMMUNITY tests as appropriate based on the manufacturer’s RISK ASSESSMENT. Where manual intervention is required to restore ESSENTIAL PERFORMANCE, the method shall be provided in the instructions for use.

    Where automatic recovery, or manual intervention is allowed (criteria B, C) to restore ESSENTIAL PERFORMANCE, the time necessary to achieve restoration shall be justified in the RISK MANAGEMENT FILE.

    Maintenance of BASIC SAFETY shall be determined by inspection of the equipment after completion of the IMMUNITY tests and if necessary by performing the appropriate tests of the general standard.

    Automatic re-start of electrical, visual, or auditory stimulation shall not occur. See also subclauses 201.11.8 and 201.16.8 of this document.

    NOTE 1 Disturbance of the display during any test does not constitute a non-compliance with the requirements of
    this document.

    NOTE 2 Where the manufacturer has determined there is no ESSENTIAL PERFORMANCE, the ME EQUIPMENT or ME SYSTEMS can cease to function during and/or after the IMMUNITY test.

    202.8.9 IMMUNITY TEST LEVELS

    Addition:

    The pass/fail criteria of 202.8.1.101 for tests specified in Table 4 of IEC 60601-1-2:2014 are as described in Table 202.101.

    The pass/fail criteria of 202.8.1.101 for the tests specified in Table 5 of IEC 60601-1-2:2014, are as follows:
    – Pass/fail criterion A or B or C apply to the professional health care environment;
    – Pass/fail criterion A or B apply to the HOME HEALTHCARE ENVIRONMENT.
    The pass/fail criteria of 202.8.1.101 for the tests specified in Table 6 of IEC 60601-1-2:2014, are as follows:
    – Pass/fail criterion A or B or C apply to the professional health care environment;
    – Pass/fail criterion A or B apply to the HOME HEALTHCARE ENVIRONMENT.
    The pass/fail criteria of 202.8.1.101 for tests specified in Table 7 of IEC 60601-1-2:2014 are as described in Table 202.102.

    The pass/fail criteria of 202.8.1.101 for tests specified in Table 8 of IEC 60601-1-2:2014- are as described in Table 202.103.

    The pass/fail criteria of 202.8.1.101 for tests specified in Table 9 of IEC 60601-1-2:2014 are as follows:
    – Pass/fail criterion A or B or C apply to the professional health care environment;
    – Pass/fail criterion A or B apply to the HOME HEALTHCARE ENVIRONMENT.

  • IEC 60601-2-41
    F2 Labs can perform evaluations to IEC 60601-2-41 Edition 2.0 titled “Medical electrical equipment – Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis”

    IEC 60601-2-41 Scope

    Replacement:

    This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.

    This particular standard does not apply to
    – headlights;
    – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
    – luminaires used in dentistry, which are covered by ISO 9680;
    – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
    – luminaires dedicated to therapeutic purposes;
    – special purpose lights with different conditions of use such as UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
    – lights connected to surgical instruments;
    – luminaires of an emergency lighting, which are covered by IEC 60598-2-22.

    NOTE See also 4.2 of the general standard.

    201.4.3 ESSENTIAL PERFORMANCE

    Addition:

    The ESSENTIAL PERFORMANCE is the delivery of illumination and the limitation of energy to the operating field.

    Requirement Subclause
    DELIVERY OF A MINIMUM AND ADEQUATE ILLUMINATION ON THE OPERATING FIELD 201.12.1.102.1.1 a)
    and 201.12.1.102.4
    LIMITATION OF ENERGY IN THE OPERATING FIELD 201.12.1.102.1.1 a) 201.10.7 and
    201.12.1.102.3

    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

    Clause 17 of the general standard applies.

  • IEC 60601-2-46
    F2 Labs can perform evaluations to IEC 60601-2-46 Edition 2.0 titled “Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables”

    IEC 60601-2-46 Scope

    Replacement:

    This particular standard specifies safety requirements for OPERATING TABLES, whether or not having electrical parts, including TRANSPORTERS, used for the transportation of the table top to or from the base or pedestal of an OPERATING TABLE with detachable table top.

    NOTE See also 4.2 of the General Standard.

    This particular standard does not apply to:
    – dental patient chairs;
    – examination chairs and couches;
    – patient-supporting systems of diagnostic and therapeutic devices;
    – OPERATING TABLE heating blankets;
    – patient transfer equipment;
    – delivery tables and beds;
    – medical beds;
    – field tables.

    NOTE If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the relevant requirements of each particular standard have to be considered.

    201.4.3 Essential performance

    Addition:

    Besides the definition of the MANUFACTURER, the following ESSENTIAL PERFORMANCE is required from OPERATING TABLES:
    – no unwanted movement in any SINGLE FAULT CONDITION and any combined fault conditions
    as derived from RISK MANAGEMENT specified by the MANUFACTURER.

    201.12 Accuracy of controls and instruments and protection against hazardous outputs

    Clause 12 of the general standard applies.

    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

    Clause 17 of the general standard applies.

    202 Electromagnetic compatibility – Requirements and tests

    IEC 60601-1-2:2007 applies, except as follows:

    202.6.2.2.1 Requirements

    Replacement:

    ME EQUIPMENT shall comply with the requirements of 6.2.1.10 [of IEC 60601-1-2:2007] as modified below. For this requirement, the following conditions associated with BASIC SAFETY and ESSENTIAL PERFORMANCE shall apply:

    No permanent DEGRADATION or loss of function or OPERATOR settings which are not recoverable shall be observed at any immunity test level.

    No inappropriate movement shall occur at all immunity test levels.

    At all immunity test levels the ME EQUIPMENT shall maintain ESSENTIAL PERFORMANCE within the specification limits.

    At all immunity test levels the temporary DEGRADATION or loss of function or performance is acceptable.

    Within 10 s or after OPERATOR intervention without requiring the use of a tool, the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss ofany OPERATOR settings or stored data, and shall continue to perform its intended function as described in the ACCOMPANYING DOCUMENTS.

    Check compliance by application of the tests in 6.2.2.2. Evaluate the response of the ME EQUIPMENT or ME SYSTEM during and after these tests in accordance with 6.2.1.10 [of IEC 60601-1-2:2007] as modified in above, considering each discharge individually.

    Additional subclause:

    202.6.2.2.1.101 Interference with high-frequency surgical equipment

    OPERATING TABLES and remote control devices for OPERATING TABLES shall not present a HAZARDOUS SITUATION when used together with high-frequency surgical equipment.

    Compliance is checked by the following tests:

    NOTE 1 To accommodate the huge variety of high-frequency surgical equipment, two different test-scenarios have been created.
    a) The high-frequency surgical equipment which is used for this test shall comply with IEC 60601-2-2, shall have a rated output power of 300 W at least for an impedance between 200 Ohms and 500 Ohms, a quasi-square wave output frequency characteristic and shall operate in the frequency range of 400 kHz to 1 MHz.

    b) The high frequency surgical equipment which is used for this test shall comply with IEC 60601-2-2, shall have an argon plasma coagulation mode with a peak voltage of 4 000 Vp (open circuit voltage) and 120 W power capability

    NOTE 2 For details, see Annex A.

    In all cases shall leads of the active and neutral electrodes be draped along the side rails and/or the exposed metal parts of the OPERATING TABLE top. The high frequency surgical equipment shall then be operated in a mode which generates
    an output power of 300 W (“conventional”) or 4 000 Vp/120 W (argon plasma coagulation).
    c) Compliance
    1) Operating the high frequency surgical equipment at open circuit shall cause no movement of the OPERATING TABLE.
    2) Operating the high-frequency surgical equipment while short-circuiting the active and neutral electrodes and sparking with the active electrodes at the side rails and/or the exposed metal parts of the OPERATING TABLE top, shall cause no movement of the OPERATING TABLE.

    NOTE 3 If operating tables will be used in combination with diagnostic X-ray equipment, the relevant
    requirements of the collateral standard have to be considered.

  • IEC 60601-2-52
    F2 Labs can perform evaluations to IEC 60601-2-52 Edition 1.0 titled “Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds”

    IEC 60601-2-52 Scope

    Replacement:

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in 201.3.212.

    If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.

    HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

    NOTE See also 4.2 of the General Standard.

    201.12 Accuracy of controls and instruments and protection against hazardous outputs

    Clause 12 of the general standard applies, except as follows:

    201.12.2 USABILITY

    Addition:

    USABILITY analysis shall take into account MEDICAL BED design aspects such as the MATTRESS SUPPORT PLATFORM height, with regard to both OPERATOR and PATIENT, as relevant to the APPLICATION ENVIRONMENT.

    NOTE Access to PATIENT for the purposes of medical treatment should not be delayed significantly by the SIDE RAILS and their respective control systems.

    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

    Clause 17 of the general standard applies.

  • IEC 60601-2-57
    F2 Labs can perform evaluations to IEC 60601-2-57 Edition 1.0 titled “Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use”

    IEC 60601-2-57 Scope

    Replacement:

    This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring,
    cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).

    This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.

    NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope.

    LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without power supply, or may be incorporated into a complex system that includes optical, electrical or mechanical systems or sources of other radiation.

    NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitive or exhaustive.

    201.4 General requirements

    Clause 4 of the general standard applies.

  • IEC 62366
    F2 Labs can perform evaluations to IEC 62366 Edition 1.1 titled “Medical devices – Application of usability engineering to medical devices”

    IEC 62366 Scope

    This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

    NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE.

    If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2).

    This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

  • IEC 80601-2-35
    F2 Labs can perform evaluations to IEC 80601-2-35 Edition 2.0 titled “Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use”

    IEC 80601-2-35 Scope

    Replacement:

    This Inter-national Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this International Standard.

    If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

    If a clause or subclause is specifically intended to apply to a specifically defined type of MEEQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled.

    HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7 .2.13 and 8.4.1 of the general standard.

    NOTE See also 4.2 of the general standard.

    This particular standard does not apply to:
    – HEATING DEVICES intended for physiotherapy; radiant warmers; for information, see IEC 60601 -2-21 (12]2; incubators; for information, see I EC 60601-2-19 (1 OJ;
    – transport incubators, for information, see I EC 60601-2-20 (11 ];
    – cooling devices.

    201.4.3 ESSENTIAL PERFORMANCE

    Addition:

    201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE

    Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.

    Requirement Subclause
    Essential Performance requirement 1 201 .12.4.104 or generation of a TECHNICAL
    ALARM CONDITION in compliance with
    201 .12.3.103

  • ISO 14708-1
    F2 labs can perform evaluations to ISO 14708-1 titled “Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer”

    ISO 14708-1 Scope

    This part of ISO 14708 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.

    NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular parts of ISO 14708.
    The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.

    This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure 01′ by springs).

    This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.

    NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single device, a combination of de vices, 01′ a combination of a device or devices and one or mare accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

    NOTE 3 In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

    NOTE 4 The terminology used in this part of ISO 14708 is intended to be consistent with the terminology of ISO/TR 14283:2004.

* Please note: This is a partial list of particular and collateral standards.

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