YY/T 0932-2014 English PDF (YY/T0932-2014)

YY/T 0932-2014: Medical luminaries. Medical head-mounted luminaires
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YY/T 0932-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 40
Medical luminaires - Medical head-mounted luminaires
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 01, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marking ... 8
Medical luminaries - Medical head-mounted luminaries
1 Scope
This Standard specifies the requirements and test methods of head-mounted luminaries.
Medical head-mounted luminaries are clinically worn on the doctor's head for
diagnostic examination and illumination of patients.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 5702-2003, Methods of measuring the color of light sources
GB/T 7922-2008, Method of measuring the color of light sources
GB 9706.1, Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
GB/T 14710-2009, Environmental requirement and test methods for medical
electrical equipment
GB/T 16886.1-2011, Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process
GB/T 16886.5-2003, Biological evaluation of medical devices - Part 5: Test for in
vitro cytotoxicity
GB/T 16886.10-2005, Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity
GB/T 20145-2006, Photobiological safety of lamps and lamp systems
JB/T 7403-1994, Illuminance meter
ISO 15004-2: 2007, Ophthalmic instruments -Fundamental requirements and test
methods - Part 2: Light hazard protection
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
medical head-mounted luminaries
Lighting device worn on a doctor's head for diagnostic examination of patients.
4 Requirements
4.1 Optical requirements
4.1.1 Illuminance
The manufacturer shall specify the illumination at the specified distance from the light
outlet, with a tolerance of ±20%.
4.1.2 Spot diameter
The manufacturer shall specify the spot diameter at the specified distance from the light
outlet, with a tolerance of ±10%.
4.1.3 Color rendering index
The color rendering index of emitted light shall be ≥ 85.
4.1.4 Color temperature
The color temperature of emitted light shall be between 3 000 K ~ 6 700 K.
4.2 Headband adjustment range (if applicable)
The adjustment range of headband shall be no less than 520 mm ~ 640 mm.
4.3 Brightness adjustment function
The light output shall be adjustable from at least 10% of the maximum value to the
maximum value, and an indication of the relative light intensity ratio or intensity change
direction corresponding to the maximum light intensity shall be given.
4.4 Material biocompatibility
Application site materials in direct contact with the operator’s skin, such as headbands,
shall be proven to be biocompatible in one of the following ways:
a) According to the biological evaluation principles of GB/T 16886.1-2011, the
following requirements shall be met:
-- No cytotoxicity;
-- No delayed-type hypersensitivity.
Emphasize the light of the light source to the maximum position; respectively measure
the spot diameter in horizontal direction and vertical direction at the distance specified
by the manufacturer, and calculate the average value.
5.1.4 Color rendering index
5.1.4.1 Equipment
For the spectral radiation measurement system, the spectral measurement range is not
less than 380 nm ~ 780 nm, the wavelength resolution is not more than 2 nm, and the
relative spectral radiance difference is not more than 1%.
5.1.4.2 Steps
The wavelength step of the spectral radiation system is selected at 5 nm.
Measure the relative spectral power distribution S(λ) of the light source when the light
intensity setting of the light source is adjusted to the maximum value.
5.1.4.3 Calculation
It shall be carried out according to the provisions of GB/T 5702-2003 and GB/T 7922-
2008.
5.1.5 Correlated color temperature
According to the relative spectral power distribution S (λ) of the light source measured
in 5.1.3.2, calculate the color coordinates u and v according to GB/T 5702-2003, and
then find the corresponding correlated color temperature according to the blackbody
radiation trajectory in the uv chromaticity coordinate diagram.
5.2 Headband adjustment range
Check with a general measuring tool.
5.3 Brightness adjustment function
Proceed according to the method of 5.1.2.
5.4 Biocompatibility of materials
5.4.1 General
The following materials can be finished parts or test pieces processed by the same
method. The shape and size of test materials shall be prepared and treated according to
the test requirements.
5.4.2 Cytotoxicity test
YY/T 0932-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 40
Medical luminaires - Medical head-mounted luminaires
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 01, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marking ... 8
Medical luminaries - Medical head-mounted luminaries
1 Scope
This Standard specifies the requirements and test methods of head-mounted luminaries.
Medical head-mounted luminaries are clinically worn on the doctor's head for
diagnostic examination and illumination of patients.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 5702-2003, Methods of measuring the color of light sources
GB/T 7922-2008, Method of measuring the color of light sources
GB 9706.1, Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
GB/T 14710-2009, Environmental requirement and test methods for medical
electrical equipment
GB/T 16886.1-2011, Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process
GB/T 16886.5-2003, Biological evaluation of medical devices - Part 5: Test for in
vitro cytotoxicity
GB/T 16886.10-2005, Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity
GB/T 20145-2006, Photobiological safety of lamps and lamp systems
JB/T 7403-1994, Illuminance meter
ISO 15004-2: 2007, Ophthalmic instruments -Fundamental requirements and test
methods - Part 2: Light hazard protection
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
medical head-mounted luminaries
Lighting device worn on a doctor's head for diagnostic examination of patients.
4 Requirements
4.1 Optical requirements
4.1.1 Illuminance
The manufacturer shall specify the illumination at the specified distance from the light
outlet, with a tolerance of ±20%.
4.1.2 Spot diameter
The manufacturer shall specify the spot diameter at the specified distance from the light
outlet, with a tolerance of ±10%.
4.1.3 Color rendering index
The color rendering index of emitted light shall be ≥ 85.
4.1.4 Color temperature
The color temperature of emitted light shall be between 3 000 K ~ 6 700 K.
4.2 Headband adjustment range (if applicable)
The adjustment range of headband shall be no less than 520 mm ~ 640 mm.
4.3 Brightness adjustment function
The light output shall be adjustable from at least 10% of the maximum value to the
maximum value, and an indication of the relative light intensity ratio or intensity change
direction corresponding to the maximum light intensity shall be given.
4.4 Material biocompatibility
Application site materials in direct contact with the operator’s skin, such as headbands,
shall be proven to be biocompatible in one of the following ways:
a) According to the biological evaluation principles of GB/T 16886.1-2011, the
following requirements shall be met:
-- No cytotoxicity;
-- No delayed-type hypersensitivity.
Emphasize the light of the light source to the maximum position; respectively measure
the spot diameter in horizontal direction and vertical direction at the distance specified
by the manufacturer, and calculate the average value.
5.1.4 Color rendering index
5.1.4.1 Equipment
For the spectral radiation measurement system, the spectral measurement range is not
less than 380 nm ~ 780 nm, the wavelength resolution is not more than 2 nm, and the
relative spectral radiance difference is not more than 1%.
5.1.4.2 Steps
The wavelength step of the spectral radiation system is selected at 5 nm.
Measure the relative spectral power distribution S(λ) of the light source when the light
intensity setting of the light source is adjusted to the maximum value.
5.1.4.3 Calculation
It shall be carried out according to the provisions of GB/T 5702-2003 and GB/T 7922-
2008.
5.1.5 Correlated color temperature
According to the relative spectral power distribution S (λ) of the light source measured
in 5.1.3.2, calculate the color coordinates u and v according to GB/T 5702-2003, and
then find the corresponding correlated color temperature according to the blackbody
radiation trajectory in the uv chromaticity coordinate diagram.
5.2 Headband adjustment range
Check with a general measuring tool.
5.3 Brightness adjustment function
Proceed according to the method of 5.1.2.
5.4 Biocompatibility of materials
5.4.1 General
The following materials can be finished parts or test pieces processed by the same
method. The shape and size of test materials shall be prepared and treated according to
the test requirements.
5.4.2 Cytotoxicity test