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YY 1296-2016

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YY 1296-2016 英文版 320 购买 现货,9秒内自动发货PDF,有增值税发票。 光学和光子学手术显微镜眼科用手术显微镜的光危害 有效

   
标准编号: YY 1296-2016 (YY1296-2016)
中文名称: 光学和光子学手术显微镜眼科用手术显微镜的光危害
英文名称: Optics and photonics. Operation microscopes. Light hazard from operation microscopes used in ocular surgery
行业: 医药行业标准
中标分类: C40
国际标准分类: 11.040.70
字数估计: 6,611
发布日期: 2016-03-23
实施日期: 2018-01-01
引用标准: GB 11239.1-2005; ISO 15004-2-2007
采用标准: ISO 10936-2-2010, MOD
起草单位: 浙江省医疗器械检验院
归口单位: 全国医用光学和仪器标准化分技术委员会
标准依据: 食品药品监督管理总局公告(2016年第74号)
提出机构: 国家食品药品监督管理总局
发布机构: 国家食品药品监督管理总局
范围: 本标准规定了眼科用手术显微镜光危害的基本要求和试验方法。

YY 1296-2016
Optics and photonics.Operation microscopes.Light hazard from operation microscopes used in ocular surgery
ICS 11.040.70
C40
中华人民共和国医药行业标准
光学和光子学 手术显微镜
眼科用手术显微镜的光危害
(ISO 10936-2:2010,Opticsandphotonics-Operationmicroscopes-
2016-03-23发布
2018-01-01实施
国家食品药品监督管理总局 发 布
前言
本标准的全部技术内容为强制性。
本标准按照GB/T 1.1-2009给出的规则起草。
本标准使用重新起草法修改采用ISO 10936-2:2010《光学和光子学 手术显微镜 第2部分:眼科
用手术显微镜的光危害》。
本标准与ISO 10936-2:2010相比存在技术差异及其原因如下:
关于规范性引用文件,本标准做了具有技术差异的调整,以适应我国的技术条件,调整的情况集中
反映在第2章“规范性引用文件”中,具体调整为用修改采用国际标准的 GB 11239.1-2005代替
ISO 10936-2:2010引用的ISO 10936-1。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由国家食品药品监督管理总局提出。
本标准由全国医用光学和仪器标准化分技术委员会(SAC/TC103/SC1)归口。
本标准起草单位:浙江省医疗器械检验院。
本标准主要起草人:王敬涛、贾晓航、何涛、彭建华。
光学和光子学 手术显微镜
眼科用手术显微镜的光危害
1 范围
本标准规定了眼科用手术显微镜光危害的基本要求和试验方法。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB 11239.1-2005 手术显微镜 第1部分:基本要求和试验方法(ISO 10936.1:2000,MOD)
ISO 15004-2:2007 眼科仪器 基本要求和试验方法 第2部分:光危害防护(Ophthalmicinstru-
ments-Fundamentalrequirementsandtestmethods-Part2:Lighthazardprotection)
3 术语和定义
下列术语和定义适用于本文件。
3.1
1类仪器 group1instrument
不存在潜在的光危害并且能满足ISO 15004-2:2007中5.2要求的眼科仪器。
注:引用自ISO 15004-2:2007。
3.2
2类仪器 group2instrument
存在潜在的光危害并且不能满足ISO 15004-2:2007中5.2要求的眼科仪器。
注:引用自ISO 15004-2:2007。
4 光辐射危害的要求
4.1 概述
手术显微镜应符合ISO 15004-2:2007中光辐射危害防护的要求。
4.2 分类的确定
手术显微镜应按照ISO 15004-2:2007中第4章的定义分为1类仪器或2类仪器。第5章中的试
验方法用于确定该分类。
4.3 1类仪器的要求
4.3.1 概述
手术显微镜应符合ISO 15004-2:2007中5.2的要求。

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)
光学和光子学 手术显微镜 眼科用手术显微镜的光危害
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
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.
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
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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