NORMATIVE INSTRUCTION No.

9, OF DECEMBER 26th, 2013

The Collegiate Board of Directors of the Brazilian National Health Surveillance Agency
(ANVISA), in the exercise of the powers vested by Article 15, subsections III and IV, of Law
9,782, of January 26th, 1999, in view of the provisions of Article 54, paragraphs 1 and 3, of the
Internal Statute approved under the terms of Annex I of Anvisa Ordinance no. 354, of August
11th, 2006, republished on the Brazilian Official Gazette of August 21st, 2006, and its updates,
in view of the provisions of Article 2, subsection III, of Article 7, subsections III and IV, of Law
no. 9,782/1999, and the Program for Improvement of the Agency's Regulatory Process,
created by Ordinance no. 422, April 16th, 2008, in extraordinary meeting held on December
26th, 2013, hereby resolves:

Article 1. To approve the attached list of Technical Standards, the parameters of which shall be
observed for the conformity certification of the equipment subject to health surveillance
within the scope of the Brazilian Conformity Assessment System (SBAC), under the terms of
Anvisa Resolution RDC no. 27, of June 27th, 2011.

Sole Paragraph. The criteria for including Brazilian standards to the list aforementioned in the
caput shall be established at Anvisa's discretion on the grounds of the risk requirements of the
equipment subject to health surveillance.

Article 2. Should the technical standard be listed in the herein Annex, but it is not possible to
issue the certification due to the lack of testing laboratories, according to the rules of SBAC
with regard to the selection of laboratories, the Product Certification Body (OCP) shall issue a
statement certifying the impossibility of providing such certification at that moment due to the
lack of laboratories.

Article 3. Should the company requesting registro or cadastro registration be required to

include the standard to the conformity certificate issued and submitted upon registration
application but claim that the standard in question is not applicable to their equipment, a
document containing a technical justification for such non-applicability shall be submitted.

Sole Paragraph. The rationale addressed thereof shall have technical basis on the field of
application and on the requirements of the standard, the company being hereby allowed, at
their own discretion, to have such justification provided by an OCP.

Article 4. The following actions shall be taken if the herein indicated technical standards and
those referred to in the respective standards are cancelled or changed:

I - should the standard be cancelled or changed due to the publication of a more updated
version, the latter shall be adopted regardless of its international origin, whereas its national
equivalent established by the Brazilian Association of Technical Standards (ABNT) shall only be
adopted after being published and having come into force.

II - should the standard be cancelled without a direct replacement, other existing technical
standards with similar scope shall be adopted as far as possible within the scope of ABNT,
International Electrotechnical Commission (IEC), or International Organization for
Standardization (ISO).
Sole Paragraph. The replacement aforementioned in subsection II shall be duly justified,
documented, and a mutual agreement between the testing laboratory, the Product
Certification Body (PCP) and the equipment manufacturer.

Article 5. Should there not be laboratories accredited or trained (according to the

establishments of SBAC) as to the new editions of the herein technical standards of series IEC
60601, the conformity certification shall be temporarily issued according to the previous
edition of such standards for a period of 12 months, counted from the date of publication of
this Normative Instruction.

Article 6. As to the equipment being tested in laboratories until the date of publication of this
Normative Instruction, the certifications issued according to the valid versions of series IEC
60601 shall be temporarily accepted in the beginning of the certification process for a period
of 12 months, counted from the date of publication of this Normative Instruction.

Article 7. This Normative Instruction shall come into force on the date of its publication.

Article 8. Normative Instruction no. 3, of June 21st, 2011, is hereby revoked.

DIRCEU BRÁS APARECIDO BARBANO

ANNEX

List of technical standards to be adopted for the conformity certification of the equipment
subject to health surveillance within the scope of the Brazilian Conformity Assessment System
(SBAC):

1. Standard ABNT NBR IEC 60601-1:2010 Medical Electrical Equipment - Part 1: General
requirements for the basic safety and essential performance, including all their amendments,
when existing, shall be mandatory to all equipment subject to health surveillance and that is
within its field of application.

2. The particular requirements of series IEC 60601 and ISO/IEC 80601 listed below, as well as
their amendments, shall be mandatory to all equipment subject to health surveillance and that
is within their respective fields of applications:

ABNT NBR IEC 60601-2-1:2011 Medical electrical equipment - Part 2-1: Particular
requirements for the basic safety and essential performance of electron accelerators in
the range of 1 MeV to 50 MeV

IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements

for the basic safety and essential performance of high frequency surgical equipment
and high frequency surgical accessories

IEC 60601-2-3:2012 Medical electrical equipment - Part 2-3: Particular requirements

for the basic safety and essential performance of short-wave therapy equipment

IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements

for the basic safety and essential performance of cardiac defibrillators
ABNT NBR IEC 60601-2-5:2012 Medical electrical equipment - Part 2-5: Particular
requirements for the basic safety and essential performance of ultrassonic
physiotherapy equipment
IEC 60601-2-6:2012 Medical electrical equipment - Part 2-6: Particular requirements
for the basic safety and essential performance of microwave therapy equipment

ABNT NBR IEC 60601-2-7:2001 Medical electrical equipment - Part 2-7: Particular
requirements for the safety of high-voltage generators of diagnostic X-ray generators

IEC 60601-2-10:2012 Medical electrical equipment - Part 2-10: Particular requirements

for the basic safety and essential performance of nerve and muscle stimulators

ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements

for basic safety and essential performance of critical care ventilators

ISO/IEC 80601-2-13:2011 Medical electrical equipment - Part 2-13: Particular

requirements for basic safety and essential performance of an anaesthetic workstation

IEC 60601-2-16:2012 Medical electrical equipment - Part 2-16: Particular requirements

for basic safety and essential performance of haemodialysis, haemodiafiltration and
haemofiltration equipment

IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements

for the basic safety and essential performance of endoscopic equipment

IEC 60601-2-19:2009 Medical electrical equipment - Part 2-19: Particular requirements

for the basic safety and essential performance of infant incubators

ABNT NBR IEC 60601-2-20:2012 Medical electrical equipment - Part 2-20: Particular
requirements for the basic safety and essential performance of infant transport
incubators

ABNT NBR IEC 60601-2-21:2013 Medical electrical equipment - Part 2-21: Particular
requirements for the basic safety and essential performance of infant radiant warmers

ABNT NBR IEC 60601-2-22:2012 Medical electrical equipment - Part 2-22: Particular
requirements for basic safety and essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment

ABNT NBR IEC 60601-2-23:2012 Medical electrical equipment - Part 2-23: Particular
requirements for the basic safety and essential performance of transcutaneous partial
pressure monitoring equipment

IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements

for the basic safety and essential performance of infusion pumps and controllers

IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements

for the basic safety and essential performance of electrocardiographs
IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Particular requirements
for the basic safety and essential performance of electroencephalographs

IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements

for the basic safety and essential performance of electrocardiographic monitoring
equipment
ABNT NBR IEC 60601-2-28:2012 Medical electrical equipment - Part 2-28: Particular
requirements for the basic safety and essential performance of X-ray tube assemblies
for medical diagnosis

IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements

for the basic safety and essential performance of automated non-invasive
sphygmomanometers

ABNT NBR IEC 60601-2-31:2013 Medical electrical equipment - Part 2-31: Particular
requirements for the basic safety and essential performance of external cardiac
pacemakers with internal power source

ABNT NBR IEC 60601-2-32:2001 Medical electrical equipment - Part 2-32: Particular
requirements for the safety of associated equipment of X-ray equipment

IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements

for the basic safety and essential performance of invasive blood pressure monitoring
equipment

ABNT NBR IEC 80601-2-35:2013 Medical electrical equipment Part 2-35: Particular
requirements for the basic safety and essential performance of heating devices using
blankets, pads and mattresses and intended for heating in medical use

ABNT NBR IEC 60601-2-36:2006 Medical electrical equipment - Part 2-36: Particular
requirements for the basic safety and essential performance of extracorporeally
induced lithotripsy

IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements

for the basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment

ABNT NBR IEC 60601-2-38:1998 Medical electrical equipment - Part 2-38: Particular
requirements for the safety of electrically operated hospital beds

ABNT NBR IEC 60601-2-39:2010 Medical Electrical Equipment - Part 2-39: Particular
requirements for basic safety and essential performance of peritoneal dialysis
equipment

ABNT NBR IEC 60601-2-40:1998 Medical electrical equipment Part 2-40: Particular
requirements for the safety of eletromyographs and evoked response equipment

ABNT NBR IEC 60601-2-41:2012 Medical electrical equipment Part 2-41: Particular
requirements for basic safety and essential performance of surgical luminaires and
luminaires for diagnosis
ABNT NBR IEC 60601-2-43:2012 Medical electrical equipment - Part 2-43: Particular
requirements for the basic safety and essential performance of X-ray equipment for
interventional procedures

IEC 60601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements

for the basic safety and essential performance of X-ray equipment for computed
tomography

ABNT NBR IEC 60601-2-45:2013 Medical electrical equipment - Part 2-45: Particular
requirements for basic safety and essential performance of mammographic X-ray
equipment and mammomagraphic stereotactic devices

ABNT NBR IEC 60601-2-46:2012 Medical electrical equipment - Part 2-46: Particular
requirements for basic safety and essential performance of operating tables

IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements

for the basic safety and essential performance of ambulatory electrocardiographic
systems

IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements

for the basic safety and essential performance of multifunction patient monitoring
equipment

ABNT NBR IEC 60601-2-50:2010 Medical Electrical Equipment - Part 2-50: Particular
requirements for the basic safety and essential performance of infant phototherapy
equipment

ABNT NBR IEC 60601-2-51:2005 Medical electrical equipment - Part 2-51: Particular
requirements for safety, including essential performance, of recording and analyzing
single channel and multichannel electrocradiographs

ABNT NBR IEC 60601-2-52:2013 Medical electrical equipment - Part 2-52: Particular
requirements for basic safety and essential performance of medical beds

ABNT NBR IEC 60601-2-54:2011 Medical electrical equipment - Part 2-54: Particular
requirements for the basic safety and essential performance of X-ray equipment for
radiography and radioscopy

ABNT NBR ISO/IEC 80601-2-56:2013 Medical electrical equipment Part 2-56: Particular
requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement

ABNT NBR ISO/IEC 80601-2-58:2013 Medical electrical equipment Part 2-58: Particular
requirements for the basic safety and essential performance of lens removal devices
and vitrectomy devices for ophthalmic surgery

ISO 80601-2-61:2011 Medical electrical equipment-- Part 2-61: Particular requirements

for basic safety and essential performance of pulse oximeter equipment

IEC 60601-2-63:2012 Medical electrical equipment - Part 2-63: Particular requirements

for the basic safety and essential performance of dental extra-oral X-ray equipment
 IEC 60601-2-65:2012 Medical electrical equipment - Part 2-65: Particular requirements
for the basic safety and essential performance of dental intra-oral X-ray equipment

3. The particular requirements of series ABNT NBR IEC 60601 listed below, as well as their
amendments, shall be mandatory to all equipment subject to health surveillance and that is
within their respective fields of applications:

ABNT NBR IEC 60601-1-1:2004 Medical Electrical Equipment - Part 1-1: General
requirements for safety - Collateral standard: Safety requirements for medical
electrical systems

ABNT NBR IEC 60601-1-2:2010 Medical Electrical Equipment - Part 1-2: General
requirement for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and test

ABNT NBR IEC 60601-1-3:2011 Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance - Collateral standard:
Radiation protection in diagnostic x-ray equipment

ABNT NBR IEC 60601-1-4:2004 Medical Electrical Equipment - Part 1-4: General
requirements for safety - Collateral standard: Programmable electrical medical
systems

ABNT NBR IEC 60601-1-6:2011 Medical electrical equipment - Part 1-6: General
requirement for basic safety and essential performance - Collateral standard: Usability

ABNT NBR IEC 60601-1-8:2010 Medical Electrical Equipment - Part 1-8: General
requirement for basic safety and essential performance - Collateral standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment
and medical eletrical systems

ABNT NBR IEC 60601-1-9:2010 Medical Electrical Equipment - Part 1-9: General
requirements for basic safety and essential performance - Collateral
Standard: Requirements for environmentally conscious design

ABNT NBR IEC 60601-1-10:2010 Medical electrical equipment - Part 1-10: General
requirement for basic safety and essential performance - Collateral standard:
Requirements for the development of physiologic closed-loop controllers

ABNT NBR IEC 60601-1-11:2012 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

4. The technical standards listed below, as well as their amendments, shall be mandatory to all
equipment subject to health surveillance and that is within their respective fields of
applications:

ISO 14457:2012 Dentistry Handpieces and motors

ISO 6875:2011 Dentistry Patient chair

ISO 9680:2007 Dentistry Operating lights

ABNT NBR ISO 11195: 2000 Gas mixers for medical use - Stand-alone gas mixers

ABNT NBR ISO 10651-4:2011 Lung ventilators Part 4: Particular requirements for
operator-powered resuscitators

ABNT NBR ISO 7176-1:2009 Wheelchairs Part 1: Determination of static stability

ISO 7176-2:2001 Wheelchairs Part 2: Determination of dynamic stability of electric

wheelchairs

ABNT NBR ISO 7176-3:2009 Wheelchairs Part 3: Determination of breaks efficiency

ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and

scooters for determination of theoretical distance range

ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and

manoeuvring space

ISO 7176-6:2001 Wheelchairs Part 6: Determination of maximum speed, acceleration

and deceleration of electric wheelchairs

ABNT NBR ISO 7176-7:2009 Wheelchairs Part 7: Measurement of seating and wheel
dimensions

ABNT NBR ISO 7176-8:2009 Wheelchairs Part 8: Requirements and test methods for
static, impact and fatigue strenghts

ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs

ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of

electrically powered wheelchairs

ABNT NBR ISO 7176-13:2009 Wheelchairs Part 13: Determination of coefficiente of

friction of test surfaces

ISO 7176-14:2008 Wheelchairs Part 14: Power and control systems for electrically
powered wheelchairs and scooters – Requirements and test methods

ISO 7176-16:2012 Wheelchairs Part 16: Resistance to ignition of postural support

devices

ISO 7176-19:2008 Wheelchairs Part 19: Wheeled mobility devices for use as seats in
motor vehicles

ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for
electromagnetic compatibility of electrically powered wheelchairs and scooters, and
battery chargers
ABNT NBR ISO 7176-22:2009 Wheelchairs Part 22: Set-up procedures

ISO 7176-25:2013 - Wheelchairs Part 25: Batteries and chargers for powered
wheelchairs

IEC 60118-0:1983 Hearing aids. Part 0: Measurement of electroacoustical

characteristics

IEC 60118-7:2005 Electroacoustics - Hearing aids - Part 7: Measurement of the

performance characteristics of hearing aids for production, supply and delivery quality
assurance purposes

IEC 60118-13:2011 Electroacoustics - Hearing aids - Part 13: Electromagnetic

compatibility (EMC)

ABNT NBR ISO 15883-2:2013 Washer-disinfectors Part 2: Requirements and tests for
washer-disinfectors employing thermal disinfection for surgical instruments,
anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-

disinfectors employing chemical disinfection for thermolabile endoscopes

ISO 15883-6:2011 Washer-disinfectors Part 6: Requirements and tests for washer-

disinfectors employing thermal disinfection for non-invasive, non-critical medical
devices and healthcare equipment

ISO 15197:2013 In vitro diagnostic test systems – Requirements for blood-glucose

monitoring systems for self-testing in managing diabetes mellitus

IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement,

control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic
(IVD) medical equipment