YY 1296-2016_English: PDF (YY1296-2016)
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Optics and photonics. Operation microscopes. Light hazard from operation microscopes used in ocular surgery
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YY 1296-2016
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| Standard ID | YY 1296-2016 (YY1296-2016) | | Description (Translated English) | Optics and photonics. Operation microscopes. Light hazard from operation microscopes used in ocular surgery | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 6,692 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2018-01-01 | | Quoted Standard | GB 11239.1-2005; ISO 15004-2-2007 | | Adopted Standard | ISO 10936-2-2010, MOD | | Drafting Organization | Zhejiang Medical Device Testing Institute | | Administrative Organization | National Standardization Subcommittee for Medical Optics and Instruments | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the basic requirements and test methods for optical hazards of ophthalmic surgical microscopes. |
YY 1296-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Optics and photonics - Operation microscopes -
Light hazard from operation microscopes
used in ocular surgery
(ISO 10936-2.2010, Optics and photonics - Operation microscopes - Part 2.
Light hazard from operation microscopes used in ocular surgery, MOD)
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Light radiation hazard requirements ... 5
5 Test methods ... 6
6 Additional information provided by manufacturer for group 2 instruments .. 7
7 Marks ... 7
Annex A (Informative) Examples of maximum retinal radiation guidance
information provided for operator during operation ... 8
Foreword
All technical content of this Standard is mandatory.
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
This Standard is modified on the basis of adopting ISO 10936-2.2010 Optics
and photonics - Operation microscopes - Part 2. Light hazard from operation
microscopes used in ocular surgery.
Compared with ISO 10936-2.2010, the technical differences and reasons in
this Standard are as follows.
On the normative references, this Standard has made the adjustment of
technical differences so as to meet the technical conditions of China. The
adjustment is reflected in Clause 2 "Normative references". It used GB
11239.1-2005 to replace ISO 10936-1 used as reference in ISO
10936-2.2010.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee of National
Technical Committee on Medical optics and instruments of Standardization
Administration of China (SAC/TC 103 / SC 1).
The drafting organization of this Standard. Zhejiang Medical Device Testing
Institute.
Main drafters of this Standard. Wang Jingtao, Jia Xiaohang, He Tao, Peng
Jianhua.
Optics and photonics - Operation microscopes -
Light hazard from operation microscopes
used in ocular surgery
1 Scope
This Standard specifies the basic requirements and test methods for light
hazard from operation microscopes used in ocular surgery.
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 11239.1-2005, Operation microscopes Part 1. Requirements and test
methods (ISO 10936.1.2000, MOD)
ISO 15004-2.2007, Ophthalmic instruments - Fundamental requirements
and test methods - Part 2. Light hazard protection
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 group 1 instrument
the ophthalmic instruments that have no potential light hazard and meet
requirements of 5.2 in ISO 15004-2.2007
NOTE. It is quoted from ISO 15004-2.2007.
3.2 group 2 instrument
the ophthalmic instruments that have potential light hazard and cannot meet
requirements of 5.2 in ISO 15004-2.2007.
NOTE. It is quoted from ISO 15004-2.2007.
6 Additional information provided by manufacturer
for group 2 instruments
6.1 Continuous wave light source with strong variable light intensity shall be
indicated in the instructions for use. When the instrument is set at the
maximum value and 50% of the maximum value, with or without retinal
protection device, it shall meet the time required by the maximum exposure
guidance value specified in 6.5.1 of ISO 15004-2.2007 (see Clause 7 of ISO
15004-2.2007).
During the operation, such information shall be obvious to operator (see
Clause 7 of ISO 15004-2.2007). Annex A gives the example for how to
provide such information.
6.2 If applicable, the pulsed light source with strong variable light shall be
indicated in the instructions for use. When the instrument is set at the
maximum value and 50% of the maximum value, with or without retinal
protection device, it shall meet the number of pulses required by the
maximum exposure guidance value specified in 6.5.1 of ISO 15004-2.2007.
7 Marks
The marks for operation microscopes shall be in accordance with the
provisions of GB 11239.1-2005.
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